Clinical Evaluation Report for Compressor Nebulizers

VEGA-Clinical Evaluation Report
Clinical Evaluation Report
Product Name: Compressor Nebulizers
Models:
CN-01M, CN-01W, CN-02M, CN-02W, CN-01MX, CN-01WX, CN-02MX,

CN-02WX, CN-11WX, CN-11MX, CN-12WX, CN-12MX, NA100, Nebufirst,
Nebujunior penguin, Nebujunior bear，
1093235,1093237,1093268,1119462,1136955,1093270,1082456,1082731, 1114373,
1112278, 1112279,1110066,1110064,1110057,1110058,1131761,1110062, 1110060,
1110063,1110059, 1110061, 1130531,1130530, 1130529, 1136915, 1133818, 1133796
(“X” stands for any English/digital character, means different appearance)
Version: 6.5
File No.:VEGA-CER-001
presented by
VEGA Technologies Inc.
Yang Wu District, Da Lang Town, Dong Guan City

Guang Dong Prov., CHINA
VEGA TECHNOLOGIES INC. 2019-05-06 1

Revision History
N Revision Versi Appro
Revision Description Drafter
O. Date on ver
Donnie
1 2011/04/20 Originated 1.0 Sean Yu
Lee
Donnie
2 2012/05/05 Re-evaluate clinical data 1.1 Sean Yu
Lee
2013//01/1 Donnie
3 Re-evaluate clinical data 1.2 Sean Yu
3 Lee
Donnie
4 2014/10/31 Add new literature search results 2.0 Sean Yu
Lee
Update the members of the Risk Management
Team & Clinical Evaluation Team, add new Donnie
5 2016/01/08 3.0 Sean Yu
production and post-production information Lee
assessment of 2014
Add new production and post-production Donnie
6 2016/03/08 4.0 Sean Yu
information assessment of 2015 Lee
Add CN-02MU as the Model and add the detailed Donnie
7 2016/06/24 5.0 Sean Yu
model list of CN series Lee
Update the information of the member of the
Christin Donnie
8 2016/11/15 clinical evaluation team, the analysis of the 5.1
e Yuan Lee
literature and the signature.
Update the information of the Particle Size of Christin Donnie
9 2016/11/22 5.2
CN-02MU e Yuan Lee
Update the report according to the MEDDEV 2.7.1 Donnie Donnie
10 2017/4/24 6.0
rev.4 Lee Lee
Donnie Donnie
11 2017/6/12 Update the section 5 Risk management 6.1
Lee Lee
Donnie Donnie
12 2017/8/23 Update the version of Risk management 6.2
Lee Lee
Deleted models of CN-03 series and added model Sunky Donnie
13 2017/11/20 6.3
Nebufirst, Nebujunior penguin, Nebujunior bear Deng Lee
Added models
1093235,1093237,1093268,1119462,1136955,1093
270,1082456,1082731, 1114373, 1112278,
Sunky Donnie
14 2018/03/26 1112279,1110066,1110064,1110057,1110058,1131 6.4
Deng Lee
761,1110062, 1110060, 1110063,1110059,
1110061, 1130531,1130530, 1130529, 1136915,
1133818, 1133796
Updated the literature search and the Production Jacy Donnie
15 2019/05/06 6.5
and Post-production Information. Jiang Lee

The detailed model list of CN series:
CN-01M, CN-01W, CN-02M, CN-02W, NA100
CN-01MA, CN-02MB, CN-01MC, CN-02MD, CN-01MI
CN-01WA, CN-01WB, CN-01WC, CN-01WD, CN-01WE, CN-01WF, CN-01WG,

CN-01WH, CN-01WI, CN-01WJ, CN-01WK, CN-01WM, CN-01WN
CN-02MA, CN-02MB, CN-02MC, CN-02MD, CN-02ME, CN-02MF, CN-02MG,

CN-02MH, CN-02MI, CN-02MK, CN-02MN, CN-02MO, CN-02MP, CN-02MQ,
CN-02MR, CN-02MT, CN-02MV, CN-02MX, CN-02MY, CN-02MJ, CN-02ML,
CN-02MS, CN-02MM, CN-12MC
CN-02WA, CN-02WB, CN-02WC, CN-02WD, CN-02WE, CN-02WF, CN-02WG,

CN-02WH, CN-02WI, CN-02WJ, CN-02WK, CN-02WL, CN-02WM, CN-02WN,
CN-02WO, CN-02WP, CN-02WQ, CN-02WS, CN-02WT, CN-02WU, CN-02WV,
CN-02WW, CN-02WY, CN-02WZ, CN-12WA, CN-12WB, CN-12WC
Nebufirst, Nebujunior penguin, Nebujunior bear
CN-02WR,1093235,1093237,1093268,1119462,1136955,1093270,1082456,
1082731,1114373,
CN-01WL,1112278,1112279,1110066,1110064,1110057,1110058,1131761,
1110062,1110060, 1110063,1110059, 1110061,
CN-02MU, 1130531,1130530, 1130529, 1136915
CN-02WX, 1133818, 1133796

Table of Content
1. General details…………………………………………………………………… 5
2. Description of the device…………………………………………………………5
3. Intended application of the device…………………………………………………6
4. Biocompatibility……………………………………………………………………6
5. Risk management…………………………………………………… ……………..7
6. Clinical evaluation on the base of a literature search…………………………….17
7. QUERY AND EVALUATION OF ADVERSE EVENT………………………..28
8 POST-MARKET SURVEILLANCE………………...…………………………….30
9. Risk – benefit evaluation………………………………………………………….39
10. Conclusions and Signatures…………………………………………………….39
Reference…………………………………………………………………………….40
Attachment 1…………………………………………………………………………41

1. General details
Product name: Compressor Nebulizer

Model: CN-02WQ & CN-02MU
Manufacturer: Vega Technologies Inc.
VEGA compressor nebulizers all have the same or similar characteristics in technical principle,
manufacture, material and technical specifications. We have chosen CN-02WQ & CN-02MU as
our representative model in this clinical evaluation report.
This clinical evaluation report is prepared according to MEDDEV.2.7.1-Evaluation of clinical data:
a guide for manufactures and notified bodies. The evaluation of clinical data is the process by
which clinical data from literature is assessed, analyzed and deemed appropriate and adequate to
establish conformity of the device with the pertinent essential requirements of the Directive as
they relate to safety and performance, and to demonstrate that the device performance as intended
by the manufacturer. The outcome of this process is a report which includes a conclusion on the
acceptability of risks and side effects when weighed against the intended benefits of the device.
This clinical evaluation report is written by Donnie Lee.
2，Description of the device
A compressor nebulizer system converts liquid medication into a mist so it can be easily and more
effectively inhaled through a mask or mouthpiece, just by breathing naturally. The system is based
on the compressor (drived by an AC or DC motor) which provides specific air pressure(s) and
flow(s) into the nebulizer bottle. This process forces the liquid to "break up" into a particulate
form. The effectiveness of this is measured in "microns” -----lot of technical jargon for particle
size
The compressor nebulizer system is often used to treat respiratory ailments, such as asthma,
COPD, chronic laryngitis, laryngitis, URI, tonsillitis, and so on. Different medicines should be
used for different symptoms, which should be consulted with a licensed doctor or physician.

3. Intended application of the device

3.1 Intended use
VEGA Compressor Nebulizer (Model CN-02WQ & CN-02MU) is intended to be used with a
compatible pneumatic nebulizer to convert certain inhalable drugs into an aerosol form for
inhalation by a patient for the treatment of asthma, COPD, and other respiratory ailments. The
device is intended for both home care use and hospital use. The nebulizer accessories are to be
provided for use with a single adult, pediatric, or infant patient.
3.2 Contraindication
Small children should be using a compressor nebulizer with the supervision of an adult.
3.3 Warnings／precautions
Please refer to the part " IMPORTANT SAFEGUARDS" of instruction manual.
4. Biocompatibility
The material-body contact of the compressor nebulizer in use is considered as direct (cuff); it is a
surface-contacting device with a limited short exposure time. Based on ISO 10993-1, ISO 10993-5
and IOS 10993-10, the following tests are needed to be performed:
- Cytotoxicity test
- Sensitization test
- Skin irritation test
Please refer to the Biocompatibility test report about the details.

5. Risk management
5.1 Risk management plan -Risk assessment Methodology & Acceptance Criteria.
The risk assessment is based on the method recommended in EN ISO 14971:2012 Annex D.
According to the methodology specified in Annex D, the risk level could be defined by the
following two factors:
● The Qualitative severity levels: As table D.3
Table D.3 — Example of five qualitative severity levels
Common terms Possible description Level
ID
Catastrophic Results in patient death 5
Critical Results in permanent impairment or 4
life-threatening injury
Serious Results in injury or impairment requiring 3
professional medical intervention
Minor Results in temporary injury or impairment not 2
requiring professional medical intervention
Negligible Inconvenience or temporary discomfort 1
Note: In case the risk item is not relevant for the device, the severity level is “0” .
● The quantitative probability levels: As table D.4

Table D.4 — Example of semi-qualitative probability levels
Common terms Examples of probability range Level ID
Frequent Occurring often or repeatedly 5
Probable Reasonably likely to occur 4
Occasional Irregular occurrence infrequent 3
Remote Nor likely to occur 2
Improbable Unlikely to ever occur 1
Note: In case the risk item is not relevant for the device, the probability level is “0” .
The risk of probability is based on the product put into clinical use, according to the
product and post-product information, product clinical tracking information statistics
and evaluation to determine.
Acceptance Criteria : The acceptance criteria is determined according to Annex D.3.4.2 as

listed hereafter.

To identify the Acceptance Situation, We abbreviate the Acceptance condition of “insignificant

risk” as “I” ; “investigate further risk reduction” as “R”, and “unacceptable risk” as “U”.
Improvement Requirement :
Based upon the definition of acceptance identification as above mentioned, the improvement
requirement could be determined according to the following table.
Rank Acceptance Situation Assessment result(S*P) Improvement

ID requirement
No need for any further
I Insignificant risk 0*0, 1*1, 1*2, and 2*1
improvement
Provide reasonable
Investigate further risk 1*3, 2*2, 2*3, 3*1,
R improvement as far as
reduction 3*2, 4*1, and 5*1
possible
the actual and practical
U Unacceptable risk others
improvement is necessary
Risk Management Team

When a new project design is approved, a risk management team is established together with
the new product design team. This risk management team will carry out the risk management
activities though out the whole product life cycle.
The team should include the following personnel as team members:

Employee(s) from R&D department，
Employee(s) from marketing department，
Employee(s) from production/engineering department，
Employee(s) from quality control department，
Employee(s) from material department
The Management Representative
At least one licensed doctor or nurse

This staff composition of the risk management team would ensure the risk management
activities play a part in every stage of the product life cycle.
As to this product, the members of the risk management team are listed below:
Donnie Lee, The Management Representative, leader of risk management team
John Liao, R&D Director
Sunky Deng, R&D Safety Engineer
Baoxing Zhang， R&D Engineer
Sunny Xie， Director of Sales Department
Yuanguo Feng， Supervisor of Engineering Department
Jinming Yang， Supervisor of QC Department
Huarong Hou， Director of Material Department
Baigao Hong, A licensed physician at JiSheng clinic，Dalang Town, Dongguan City, China

5.2 Risk evaluation results and measures to eliminate or reduce the risk & its
improvement.
Through the risk assessment, the following items are found relevant. The results of
the evaluation are described as the table on the next page.
According to the Acceptance Criteria, all risks which are with the rank of “R” and
“U” are re-evaluated after improvement. Finally, all the risk ranks are reduced to “I”.
For the details of the risk management, please refer to:

Risk Management Report
File No. VEGA-RMF-001
File Version: 9.0

Table 3-1 Risk evaluation results
Before Improvement Improvement After Improvement

No Potential Risk Rank Rank
Severity Probability Result Needed? Severity Probability Result
(S) (P) (S*P) (Y or N) (S) (P) (S*P)
1 Essential performance degrade 2 2 2*2 I Y 2 1 2*1 I
2 Expected service life is not clear to the user 1 1 1*1 I N
3 Biocompatibility risk 2 2 2*2 R Y 2 1 2*1 I
4 Electromagnetic hazard, mechanical hazard and biological hazard 3 2 3*2 R Y 3 1 3*1 I
in SINGLE FAULT CONDITION
5 Device working at high temperature and voltage 2 2 2*2 R Y 2 1 2*1 I

6 Misuse 2 2 2*2 R Y 2 1 2*1 I
7 Misidentification of the device 2 2 2*2 R Y 2 1 2*1 I
Premature unpacking and the permissible transportation 2 2 2*2 R Y 2 1 2*1 I
8 environmental conditions
9 Power supply terminals are interchanged 3 2 3*2 R Y 3 1 3*1 I
10 The degrade of the protection against electric shock 2 2 2*2 R Y 2 1 2*1 I
11 Electric shock by accessible parts including applied parts 1 1 1*1 I N
12 Electric shock due to material degeneration caused by heat 2 2 2*2 R Y 2 1 2*1 I
13 Hazard caused by movement of components 2 2 2*2 R Y 2 1 2*1 I
14 Hazard caused by movement of wiring 2 2 2*2 R Y 2 1 2*1 I
15 Hazard caused by damage of wiring 2 2 2*2 R Y 2 1 2*1 I
16 User hurt by sharp corners and edges 1 1 1*1 I N
17 Over heating 2 2 2*2 R Y 2 1 2*1 I
18 Over heating 2 2 2*2 R Y 2 1 2*1 I
19 Ingress of water or particulate matter 2 2 2*2 R Y 2 1 2*1 I
20 Hazard caused by cleaning and disinfection 2 2 2*2 R Y 2 1 2*1 I

21 Device damage caused by accidentally dropping 2 2 2*2 R Y 2 1 2*1 I
22 Hazards caused by over current or over heating 2 2 2*2 R Y 2 1 2*1 I
23 Electromagnetic compatibility hazard 2 2 2*2 R Y 2 1 2*1 I
24 Potential risks to children 3 2 3*2 R Y 3 1 3*1 I

Table 3-2 Risk evaluation results related to the Warning, Cautions of the IFU

No Potential Risk Rank Rank
Severity Probability Result Needed? Severity Probability Result
(S) (P) (S*P) (Y or N) (S) (P) (S*P)
25 The device is used on unconscious persons 2 1 2*1 I N
26 The device is used for the purpose does not described in the 2 1 2*1 I N
IFU
27 Handel the device or power cord with the wet hands. 1 1 1*1 I N
28 Immerse the AC adapter or unit in liquid. 1 1 1*1 I N
29 Use the device while bathing. 1 1 1*1 I N
30 Reaching for the device that has fallen into water. 2 1 2*1 I N
31 Still use the device when its power cord or plug damaged or 2 1 2*1 I N
it has been submersed in water or dropped.
The device has been used where flammable gas, oxygen or aerosol 1 1 1*1 I N
32 spray products are being used.
33 Operate the device when the medication cup is empty. 1 1 1*1 I N
34 Use the device when any abnormality occurs. 1 1 1*1 I N
35 Left after opening the device. 1 1 1*1 I N
36 Using expect water solution in the tank. 1 1 1*1 I N
37 Tilt or shake the device when in operation. 1 1 1*1 I N
38 Opening the clear cover during operation. 1 1 1*1 I N
39 Still connect the device with electrical outlet while cleaning, 2 1 2*1 I N
filling and after used.
40 Use attachments which is not provided by the manufacturer. 1 1 1*1 I N
41 Use the device uninterruptedly. 1 1 1*1 I N
42 Children or invalids use this device by themselves. 1 1 1*1 I N
43 The eyes staring the output of medication mist. 1 1 1*1 I N
44 Have not changed the water after each use. 1 1 1*1 I N
45 Overfilled the medication cup. 1 1 1*1 I N
46 Using this device while operating a vehicle. 1 1 1*1 I N
47 Still use the device while feeling uncomfortable 2 1 2*1 I N
48 Store the device in direct sunlight, high temperature or 1 1 1*1 I N
humidity.
49 The children can reach the device easily. 1 1 1*1 I N
50 Keep the device plugged while not in use. 1 1 1*1 I N
51 The medication cup mouth nozzle and air filter are dirty and still 1 1 1*1 I N
be used.
52 Immerse the device in water. 1 1 1*1 I N
53 Put all necessary parts aside after each use without cleaning. 1 1 1*1 I N
54 Clean the necessary and the main device with unsuitable liquid and 1 1 1*1 I N
cloth.
55 Use the unsuitable battery with the device. 1 1 1*1 I N
56 Store the battery in direct sunlight, high temperature or humidity. 1 1 1*1 I N
57 Placing the battery on metal or wet surface or inside a metal box. 1 1 1*1 I N
58 The children use the animal model of nebulizers as a toy. 1 1 1*1 I N
Table 3-3 Risk evaluation results related to the filter

No Potential Risk Effect of Potential Risk
Needed?
Severity Probability Result Rank Severity Probability Result Rank
(Y or N)
(S) (P) (S*P) (S) (P) (S*P)
59 Filter breaking after a period of The fragments of the filter may 2 4 2*4 U Y 2 1 2*1 I
use, especially when the user be sucked into the pump, which
attempts to replace the old filter will cause low pressure and flow
with a new one. of the machine.
60 Filter breaking after a period of The fragments of the filter may 2 2 2*2 R Y 2 1 2*1 I
use, especially when the user be sucked into the pump and
attempts to replace the old filter then may be inhaled by the
with a new one. patient.
Table 3-4 Risk evaluation results related to the lubricant in the cylinder block of the motor
Needed?
(Y or N)
(S) (P) (S*P) (S) (P) (S*P)
61 Using the lubricant in the In the process of atomization, 2 2 2*2 R Y 2 1 2*1 I
cylinder block of the motor. the lubricant may emit harmful
substances, causing discomfort
or injury to the user
Table 3-5 Risk evaluation results of supplementary requirements

Needed?
(Y or N)
(S) (P) (S*P) (S) (P) (S*P)
62 7.9.3.2 It may cause electric 2 2 2*2 R Y 2 1 2*1 I
shock to the user or the
Fuses and power supply appliance will work
cords are replaced by a abnormally
not qualified persons or
used wrong rating of the
components.

Needed?
(Y or N)
(S) (P) (S*P) (S) (P) (S*P)
63 11.1.2.2 APPLIED PART The surface temperature 2 2 2*2 R Y 2 1 2*1 I
may be affected by of an APPLIED PART may
operation of the ME exceeds 41 C and it
EQUIPMENT including in may cause overheated
SINGLE FAULT danger to the user
CONDITIONS

Needed?
(Y or N)
(S) (P) (S*P) (S) (P) (S*P)
64 11.1.3 For ME EQUIPMENT The surface temperature 2 2 2*2 R Y 2 1 2*1 I
parts that are likely to be of an APPLIED PART and
touched and for APPLIED ME EQUIPMENT
PARTS , the duration of
enclosure parts may
contact is too long.
exceed and it may
cause overheated
danger to the user.

Needed?
(Y or N)
(S) (P) (S*P) (S) (P) (S*P)

65 12.4.4 The air tube which The appliance will be with 2 2 2*2 R Y 2 1 2*1 I
connected the motor may be incorrect output and which
fold when installation. will cause low pressure and flow
of the machine.

Needed?
(Y or N)
(S) (P) (S*P) (S) (P) (S*P)
66 15.4.1 The output of gas The appliance will be with 2 2 2*2 R Y 2 1 2*1 I
connection may be block incorrect output.

Needed?
(Y or N)
(S) (P) (S*P) (S) (P) (S*P)
67 9.7.2 Failure of pressure It may emit harmful 2 2 2*2 R Y 2 1 2*1 I
components pump substances or cause
dangerous moving parts
which causing injury to the
user
Table 3-6 Risk evaluation results of supplementary requirements

Needed?
(Y or N)
(S) (P) (S*P) (S) (P) (S*P)
68 The problem of mains The appliance won’t 2 1 2*1 I N
plug fracture operate.

Needed?
(Y or N)
(S) (P) (S*P) (S) (P) (S*P)

69 The problem of misuse The appliance won’t 2 1 2*1 I N
the rated voltage to a operate normally or
inappropriate power motor may break and it
supply may cause overheated
danger to the user.

6．Clinical evaluation on the base of a literature search
The member of the clinical evaluation team
Donnie Lee: The Management Representative, leader of clinical evaluation team, controls all
products develop and production, college degree and more than 35 years working
experience.
John Liao: R&D Director, college degree
Christine Yuan: R&D Assistang, college degree, has 3 years experience in risk analysis.
Sunky Deng: R&D Safety Engineer
Baoxing Zhang : R&D Engineer, college degree ,has 8 years experience in products development, risk analysis and
clinical evaluation.
Sunny Xie : Director of Sales Department, college degree, has 9 years experience in products marketing, product
information searching and clinical evaluation.
Yuanguo Feng: Supervisor of Engineering Department, college degree, has 15 years experience in engineering,
manufacturing and clinical evaluation.
Jinming Yang: Supervisor of QC Department, college degree, has 8 years experience in quality controlling and clinical
evaluation.
Huarong Hou: Director of Material Department, college degree, has 8 years experience in material controlling and
clinical evaluation.
Baigao Hong: A licensed physician at JiSheng clinic，Dalang Town, Dongguan City, China, college degree, has more
than 10 years experience in the field of respiration.
Literature retrieval by Donnie Lee, Paul Zhang, Christine Yuan, Jacy Jiang, Sunny Xie and Jinming Yang.
Literature evaluation by Donnie Lee, Paul Zhang, Baoxing Zhang, Xianglai Zheng and Huarong Hou.
6.1 Scope
The clinical evaluation of compressor nebulizer was carried out using the literature route. Compressor nebulizer is based
on medical aerosol generation. This approach is being considered as appropriate, since the product is considered to be
essentially similar to products which are used in the field with regard to clinical, technical, and biological aspects as
mentioned in the MEDDEV 2.7.1 guideline. These products were applied in clinical practice for several years with a
sufficiently available published data. Therefore, it is acceptable to evaluate the clinical use of compressor nebulizer by
the literature route.
This clinical evaluation is based on a comprehensive analysis of available pre- and post market
clinical data relevant to the intended use of the device in question, with special regard to clinical
performance data and safety data. This includes data specific to the device in question as well as
any data relating to devices claimed as equivalent by the manufacturer.
As described in the above product description, the medical device considered in this clinical
evaluation is designed as a method of medical aerosol generation by a motor powered compressor. Thus, the literature
search is focused on nebulizers with this technology.
6.2 Scientific background on compressor nebulizers
Inhaled therapy - Inhaled therapies have been used since ancient times and may have had their origins with the smoking
of datura preparations in India 4,000 years ago. In the late 18th and in the 19th century, earthenware inhalers were
popular for the inhalation of air drawn through infusions of plants and other ingredients. Atomizers and nebulizers were
developed in the mid-1800s in France and were thought to be an outgrowth of the perfume industry as well as a response
to the fashion of inhaling thermal waters at spas. Around the turn of the 20th century, combustible powders and
cigarettes containing stramonium were popular for asthma and other lung complaints. Following the discovery of the
utility of epinephrine for treating asthma, hand-bulb nebulizers were developed, as well as early compressor nebulizers.
The marketing of the first pressurized metered-dose inhaler for epinephrine and isoproterenol, by Riker Laboratories in
1956, was a milestone in the development of inhaled drugs. There have been remarkable advances in the technology of
devices and formulations for inhaled drugs in the past 50 years. These have been influenced greatly by scientific
developments in several areas: theoretical modeling and indirect measures of lung deposition, particle sizing techniques
and in vitro deposition studies, scintigraphic deposition studies, pharmacokinetics and pharmacodynamics, and the 1987
Montreal Protocol, which banned chlorofluorocarbon propellants. We are now in an era of rapid technologic progress in
inhaled drug delivery and applications of aerosol science, with the use of the aerosolized route for drugs for systemic
therapy and for gene replacement therapy, use of aerosolized antimicrobials and immunosuppressants, and interest in
specific targeting of inhaled drugs.
There are two main kinds of nebulizers used in inhaled therapy:

Compressor and ultrasonic nebulizers - One of the most common questions that is asked is what is the exact difference
between a compressor nebulizer and a ultrasonic nebulizer. Well the difference between these two devices actually lies in
their technological make-up and the way that they actually help to deliver the medication. To get a better understanding
of the difference we have to start with just a brief background as to what these devices are. The product is used
specifically for the purpose of transforming special respiratory medication into vapor form whereby it can be breathed in
through the lungs. The main benefit of taking it via vapor form is because it will begin to work far more quickly than if it
were taken in another other form. There also have been studies done that actually show that breathing it in actually
reduces side effects.
The compressor nebulizer works by shooting compressed air at the medicine whereby it is then transformed into a mist
form which can be inhaled. This is quite dependable and effective and is considered the standard in the industry. The
other method is the ultrasonic nebulizer whereby high frequency vibrations are sent through the prescription thus
transforming it into a fine mist. By using this method ensures that the medicine can be delivered far more quickly and
thus begin to work and reduce the symptoms faster as well. There does exist a price difference but it really depends on
how fast you would want the whole process to take effect. Both models however offer great portability which is the
ultimate benefit of using these products. The ability to take it from one place to another and still have access to take your
prescription is very important when you live with a respiratory condition and require the constant need to control your
symptoms.
Particle size - Critical issue is related to the particle size generated (aerosol characteristics). It is important to underline
that, among nebulizers, poor performing nebulizers may not be able to generate a sufficient amount of aerosolized
particles able to reach the lower airways. Required size for aerosolized particles to have a therapeutic significance is less
than 5 µm. The size is inversely related to the flow rate of compressed gas trough the device. High pressure supply and
consequently low nebulization time are recommended to increase patient compliance.
6.3 Literature search report
6.3.1 Device name/model

Compressor Nebulizer/ CN-02WQ & CN-02MU
6.3.2 Scope of the literature search

According to MEDDEV 2.7.1 all selected literature was evaluated in order to determine its suitability to address
questions about the device, and its contribution to demonstrating the safety and performance of the device.
6.3.3 Methods
i) Date of search
2019/05/06
ii) Name of person(s) undertaking the literature search
Donnie Lee
iii) Period covered by search
Publication Date from 1990/01/01 to 2019/05/06
iv) Literature sources used to identify data:
MEDLINE is the National Library of Medicine's premier bibliographic database covering the fields of medicine,
nursing, dentistry, veterinary medicine, the health care system, and the preclinical sciences.
The database contains more than 18 million records from approximately 5,000 selected publications covering
biomedicine and health from 1950 to the present. Originally the database covered articles starting from 1965, but
this has been enhanced and records as far back as 1950/51 are now available within the main index. The database is
freely accessible on the Internet via the PubMed interface and new citations are added Tuesday through Saturday.
For citations added during 1995-2003: about 48% are for cited articles published in the U.S., about 88% are
published in English, and about 76% have English abstracts written by authors of the articles.
v) Database search details:
Limits Activated: Humans, Publication Date from 1990/01/01 to 2019/05/06
Key word: compressor nebulizer, aerosol therapy
vi) Selection criteria used to choose articles the assessment was based upon the following criteria (if traceable or
evident from the available public sources):
- the author's background and expertise in relation to the particular device and/or medical procedure
- the reputation of the textbook, journal, or the medium in which the data are published, e.g. peer-reviewed articles
only, etc.
- the scientific appropriateness of data, current medical practice, and “state of the Art”
- in the case of genuine clinical studies: the quality of the study, the study design, inclusion and exclusion criteria,
the compliance with legal and normative requirements. Number of patients, the selection of primary and secondary
study variables clinical outcome (efficacy) and adverse events (safety)

6.3.4 Outputs
36 results were obtained. All identified literature references were evaluated regarding their relevance for this clinical
evaluation. All selected information sources which were primarily used for the clinical evaluation are referenced in
Chapter 6.4.2 and 6.4.3 of this report.
6.4 Clinical data referring to safety and performance

6.4.1 Scope
Inhaled therapy is commonly used in the management of patients with asthma, chronic obstructive pulmonary disease
(COPD) and other respiratory ailments. Compressor nebulizer systems are widely used all over the world for inhaled
therapy. The safety and efficiency of compressor nebulizer systems was established by many clinical practices and
published articles.
6.4.2 Literature introduction
(l) Literature 1: S.P. Newman*, G.R. Pitcairn*, G. Hooper*, M. Knoch** - Efficient drug delivery to the lungs
from a continuously operated open-vent nebulizer and low pressure compressor system.
Principles and techniques of compressor nebulizers
Compressor nebulizers are widely used for the inhalation of drug solutions in a variety of respiratory diseases. The
efficacy of nebulizer therapy is influenced by a great number of factors, including the design of the device and the
characteristics of the drug solution. Incorrect cleaning, maintenance and disinfection procedures may change the
nebulizer performance in time, whereas patient factors can influence the lung deposition of the generated aerosol. Two
main parameters are generally used to evaluate the performance of nebulizers: the droplet size distribution of the aerosol
and the drug output rate. The droplet size distribution and the drug output rate are basically determined by the design and
user conditions of the nebulizer. A higher gas flow of the compressor in a compressor nebulizer decreases the droplet
size. The major part of the mass or volume distribution should preferably correspond with aerodynamic particle
diameters in the range of 1 to 5 micrometer. The intended drug output must be realized within a reasonable nebulization
time (less than 30 min). From the drug output only a minor fraction will be deposited in the lung. The relation between in
vitro and in vivo deposition is only partly understood and to date it has not been possible to predict drug delivery only
from in vitro studies on nebulizers. Therefore, studies in patients should be performed before a drug solution for
nebulization can be recommended for clinical practice.
(2) Literature 2: Jillian B. Phillips - Importance of Particle Size For Nebulized Medication
Importance of Particle Size For Nebulized Medication
The physics of inhaled pharmaceutical aerosols (IPAs) is complex and involves aerosol mechanics, multiphase fluid
mechanics, transport phenomena, and interfacial science, (in addition to pharmaceutics, chemistry, physiology, and
medicine). Present understanding and prediction of the behaviour of IPAs remains relatively undeveloped.
Many researches are aimed at exploring and controlling the physics of inhaled pharmaceutical aerosols. Such aerosols
are used in the therapeutic nebulized medication treatment of lung and respiratory diseases such as asthma, cystic fibrosis
and even sinusitis, but are also being developed for the treatment of many other diseases where traditional delivery
methods suffer drawbacks. Examples of the latter include pain management, as well as vaccinations using inhaled
aerosols.
It is important to develop and improve the understanding and prediction of IPAs for the treatment of nose, sinus or lung
disease using a mix of experimental, theoretical and numerical methods. One major factor to consider in areosolized
treatments is the the importance of particle size of nebulized medication.
When the sinus or lung is the target for the aerosol, the inhaled aerosol must consist of particles in a certain size range.
This is because particles larger than a certain size tend to simply land in the mouth and throat and mostly do not make it
into the target destination. Particles somewhat smaller than a certain size tend to get inhaled and then exhaled right back
out, while very small particles usually can't be made in high enough numbers to give high enough dosages.
The importance of particle size for nebulized medication is seen in the ff:
• Inhaled pharmaceutical aerosols (IPAs) are usually designed to produce drug particles each having the incredibly small
mass of between approximately 1 trillionth and 100 trillionths of a gram.
• For particles with densities near that of water, this corresponds to particle diameters of a few millionths of a meter (i.e.
a few micrometers). The probability that inhaled droplets of different diameters will deposit in the mouth-throat and
tracheobronchial and alveolar regions of the lung for a particular aerosol, will be different for a another aerosol and
cannot be used to evaluate other aerosols.
• Although specific size ranges are often quoted as being ideal for IPAs (e.g. 1-5 micrometers in diameter), significant
amounts of particles outside this size range can still deposit in the lung, so that these size ranges should not be viewed as
strict criteria. This is partly because the speed of the inhaled air plays a significant role in determining what size of
particles will deposit where in the respiratory tract. For instance, someone breathing very slowly may cause larger
particles to make it deeper in the sinus or lung than someone inhaling very rapidly.

• In addition, the filtering for particle deposition are slowly varying functions of particle size, and do not give ideal
"bandpass" filtering of particle size.
• Finally, droplet evaporation or condensation can be different for different aerosols and result in different deposition
patterns with different aerosols.
(3) Literature 3: Dean Hess, Daniel Fisher, Purris Williams, Sharon Pooler, and Robert M. Kacmarek -
Medication Nebulizer Performance Effects Of Diluent Volume, Nebulizer Flow, and Nebulizer Brand
Medication nebulizers are commonly used to delivery aerosolized medications to patients with respiratory disease. We
evaluated output and respirable aerosol available to the patient (inhaled mass) for 17 medication nebulizers using a
spontaneous breathing lung model.
Three nebulizer fill volumes (3, 4, and 5 mL containing 2.5 mg of albuterol) and 3 oxygen flows (6, 8, and 10 L/min)
were evaluated using the 17 nebulizers. A cotton plug at the nebulizer mouthpiece was used to trap aerosol during
simulated spontaneous breathing. Following each trial, the amount of albuterol remaining in the nebulizer and the
amount deposited in the cotton plug were determined spectrophotometrically. Aerosol particle size was determined using
an 11-stage cascade impactor.
Increasing fill volume decreased the amount of albuterol trapped in the dead volume (p<0.001) and increased the amount
delivered to the patient (p<0.001). Increasing flow increased the mass output of particles in the respirable range of 1 to 5
µm (p=0.004), but the respirable mass delivered to the patient was affected to a greater extent by nebulizer brand
(p<0.001) than flow. Although 2.5 mg of albuterol was placed into the nebulizers, less than 0.5 mg in the respirable range
of 1 to 5 µm was delivered to the mouthpiece.
The performance of medication nebulizers is affected by fill volume, flow, and nebulizer brand. When they are used for
research applications, the nebulizer characteristics must be evaluated and reported for the conditions used in the
investigation.
(4) Literature 4: Melani AS - Effects on aerosol performance of mixing of either budesonide or beclomethasone
dipropionate with albuterol and ipratropium bromide.
Mixing of nebulized drugs is common in real life, but its consequences on aerosol output and granulometry are poorly
known.
In an in vitro study I evaluated the effects on aerosol output, drug output, and aerosol particle size characteristics of
mixing either beclomethasone dipropionate or budesonide with albuterol and ipratropium bromide. I tested the
SideStream and VentStream-Pro nebulizers, run with the AirClinic compressor. Using the same fill volume in all
experiments, I nebulized and evaluated each studied drug alone, and 2 drug mixtures: beclomethasone plus albuterol plus
ipratropium; and budesonide plus albuterol plus ipratropium. I measured aerosol output via gravimetrics. I measured
drug delivery by collecting the aerosolon a filter in the inspiratory limb, and the residual solution in the reservoir and the
circuit after nebulization, and assayed those liquids with chromatography. I measured particle size distribution via
cascade impaction.
Mixing tended to reduce drug output and to increase mass median aerodynamic diameter with the SideStream, but not
always with the VentStream-Pro. However, the drug output always remained satisfactory and the mass median
aerodynamic diameters were within the respirable range. When nebulized alone, the respirable mass of bronchodilators
ranged from 18% to 40% of the nominal dose; when mixed, it ranged from 13% to 37%. When nebulized alone, the
respirable mass of corticosteroids ranged from 10% to 24% of the nominal dose; when mixed, it ranged from 10% to
17%.
Both the SideStream and VentStream-Pro have good aerosol performance in nebulizing budesonide or beclomethasone
dipropionate alone, and when mixed with albuterol and ipratropium bromide.
(5) Literature 5: Reisner C1, Katial RK, Bartelson BB, Buchmeir A, Rosenwasser LJ, Nelson HS.-
Characterization of aerosol output from various nebulizer/compressor combinations.
OBJECTIVES: Different commercially available nebulizers and compressors are available. However, the optimal
combination for drug delivery is unknown.
METHODS: Flow rates of five different compressors (n = 3/compressor) tested alone and in combination with five
different commercial nebulizers (n = 9 of each brand of nebulizer) were evaluated. Thereafter, the performances of
the different nebulizers were evaluated using 2.5 mg albuterol solution (0.5 mL) added to 2.5 mL saline at flow rates
of 2, 3, 4, and 5 L/minute using a laser particle analyzer. Volume median diameter and percentage of particles in the
respirable range (1-5 microm) were calculated from this data. Time for nebulization (in seconds) and residual
volume (in milliliters) were also recorded.

RESULTS: The mean flow rates for the compressors evaluated without a nebulizer attached ranged from 6.6
L/minute (LifeCare Freedom-neb; LifeCare International, Lafayette, CO) to 12.2 L/minute (DeVilbiss Pulmo-Aide;
DeVilbiss Health Care, Somerset, PA). Flow rates for the nebulizer/compressor combinations ranged from 2.08
L/minute (Pari LC Jet Proneb; Pari Respiratory Equipment, Richmond, VA) to 5.42 L/minute (Puritan Bennett
Raindrop; Puritan Bennett, Lenexa, KS/Omron Compare; Omron, Health Care,Vernon Hills, IL). Using the repeated
measure ANOVA model, the interaction between flow rate and device was significant (P < 0.001) for both
percentage of particles in the respirable range and log volume median diameter. It was observed that the
percentage of particles in the respirable range for the Pari LC Jet did not increase across flow rates in contrast to
the other 4 nebulizers. All comparisons to the Pari LC Jet at 2 L/minute were significant.
CONCLUSIONS: Marked variability exists in the flow rates among different commercially available compressors
used for home nebulization of inhaled pulmonary medications. Different nebulizer/compressor combinations have
markedly different performance characteristics which could result in different efficacy and safety profiles of the
medications being administered via these devices. We recommend that this type of information be used as a
starting point for selecting different nebulizer/compressor combinations. Further clinical evaluation is warranted.
6.4.3 Literature review result
Literature 1: This literature shows there are two main parameters which are generally used to evaluate the performance
of nebulizers: the droplet size distribution of the aerosol and the drug output rate.
Literature 2: This literature underlines the importance of particle size for nebulized medication. It points out that the
common accepted ideal size range for IPAs is 1-5 micrometers in diameter but significant amounts of particles outside
this size range can still deposit in the lung, so that this size range should not be viewed as strict criteria.
Literature 3: This literature indicates that the performance of a nebulizer system is affected by many factors in which
the characteristics of the nebulizer bottle plays a great part.
Literature 4: This literature shows that both the SideStream and VentStream-Pro have good aerosol performance in
nebulizing budesonide or beclomethasone dipropionate alone and when mixed with albuterol and ipratropium bromide.
In fact, SideStream is one of the standard accessories of VEAG’s compressor nebulizers.
Literature 5: This literature indicates that different nebulizer/compressor combinations have markedly different
performance characteristics which could result in different efficacy and safety profiles of the medications being
administered. VEGA compressor nebulizers have the similar performance principle with Omron Compressor, so we
believe that VEGA compressor nebulizers have the equivalent performance to Omron Compressor. Please see the
comparison table below.

Contrast VEGA CN-02MU with OMRON Compressor Nebulizer NE-C09

Characteristic VEGA CN-02MU OMRON Compressor Comment
Nebulizer (NE-C09)
Type of compressor Compressor Compressor Same
Clinical Home use and hospital use Home use Similar
Environment
Intended Use It is intended to be used with a It is intended to spray liquids Similar
compatible pneumatic in aerosol form into gases
nebulizer to convert certain that are delivered directly to
inhalable drugs into an aerosol the patient for breathing.
form for inhalation by a
patient for the treatment of
asthma, COPD, and other
respiratory ailments.
Patients treated Respiratory tract Respiratory tract Same
areas
Applicable People Adult, Pediatric, infant Adult, Pediatric Similar
Power 120V AC, 60Hz or 230V AC, 115V AC, 60Hz Similar
50Hz
Medicine Capacity 8 ml 10 ml Similar
Particle Size 0.5 to 5 microns 0.5 to 5 microns Similar
Sound Level ≤60 dBA 50 dBA Similar
Average 0.15 ml/minute (2.5% NaF) 0.2 ml/minute Similar
Nebulization Rate
Operating Pressure 8 to 13.05 psi 9 to 10 psi Similar
Range
Liter Flow Range 5 to 8 lpm 5 to 6 lpm Similar
Operating 5℃ to 40℃ 10℃ to 40℃ Similar
Temperature Range
Operating Humidity 10% to 95% RH 10% to 90% RH Similar
Range
Storage -25℃ to 70℃ -25℃ to 70℃ Same
Temperature and 10% to 95% FH 10% to 95% FH
Humidity
Dimensions 6.7” x 9.3” x 3.8” 6.5” x 10” x 4” Similar
Weight 2.6 lbs 5.5 lbs Similar
Standard Compressor Nebulizer, Air Compressor Nebulizer, Air Similar
Accessories Tube, Mouthpiece, Air Filters, Tubing, Mouthpiece, Extra
Instruction manual Filters(5), Instruction manual
Optional Child Mask, Adult Mask, Adult Mask, Pediatric Mask Similar
Accessories Carrying Bag
Contact with the Hands & Face Hands & Face Similar
body parts
Materials Nebulizer case made by ABS, Nebulizer case made by ABS, Similar
Mask made by PVC, Air Tube Mask made by Silicone and
made by PVC, Air filter made Air Tubing also made by
by Polyurethane Silicone

Photo Similar
CE Certificate CE 0197 CE 0197 Same

6.4.4 Literature suitability evaluation

Table 1: Literature suitability evaluation
Suitability Description Literature 1 Literature 2 Literature 3 Literature 4 Literature 5
Criteria
Appropriate Was the data D2 D2 D2 D2 D2
generated from the
device device in question?
Appropriate Was the device used A1 A1 A1 A1 A1
for the same
device intended use?
application
Appropriate Was the data P1 P1 P1 P1 P1
Generated
patient from a patient group
group that is representative
of the intended
treatment population
and clinical
condition?
Acceptable Do the reports or R2 R2 R1 R1 R1
collations of data
report/data contain sufficient
collation information to be
able to undertake a
rational and
objective
assessment?
Note:
D1-Actual device A1-Same use P1-Applicable R1-High quality
D2-Equivalent device A2-Minor deviation P2-Limited R2-Minor deficiencies
D3-Other device A3-Major deviation P3-Different population R3-Insufficient information

6.5 Particle size distribution test
Particle size distribution is one of the key parameters that severely affect the efficiency of a compressor nebulizer system.
Based on the previous literature research the common accepted ideal size range for IPAs is 1-5 micrometers in diameter, which
should not be viewed as strict criteria.
VEGA Compressor nebulizers with standard nebulizer bottle have been tested for the particle size distribution, and the
test results show what the system gives quite efficient distribution.
Please refer to particle size distribution test report for details. (Attachment 1)

6.6 Clinical evaluation data

6.6.1 General description
We have conducted a clinical evaluation to validate the clinical efficiency and safety of our product. The clinical
evaluation was performed at a legal clinic (Ji Sheng Clinic, Dalang Town, Dongguan City, China) by a licensed
physician. During the evaluation, the product was used to treat asthma, COPD, Chronic laryngitis, laryngitis, URI,
tonsillitis and other respiratory ailments.
6.6.2 Evaluation protocol

VEGA provide one compressor nebulizer (CN-02WQ which is same or similar characteristics with CN-02MU in the
technical principle, manufacture, material and technical specifications) system to Ji Sheng Clinic, Dalang Town,
Dongguan City, China. 20 subjects should be chosen covering the age from 5 ~ 52, both male and female. The output air
pressure, prescribed medicine and the treatment time/frequency are decided by the physician.
As to the evaluation results, we have set three columns which refer to three aspects of the treatment for the physician and
the patients to fill out:
Adverse Reaction - Filled out by the physician, which indicates whether or not the treatment has caused any adverse
reaction.
Doctor Evaluation - Filled out by the physician, which shows the clinical efficiency of the product.
User Score – Filled out by the patients, which tells us how the patients feel about the treatment.
6.6.3 Summarized results

The results of this clinical evaluation are summarized as the following with respect to the three columns.
6.6.3.1 Adverse Reaction

19 out of 20 subjects (95%) showed no adverse reaction after the treatment.
One subject (5%) showed slight dizziness and retching after the treatment.
6.6.3.2 Doctor Evaluation

For the doctor evaluation, please see the table below for details.
Table 1: Doctor Evaluation
Results Total Number %
Cured 2 10
Condition has been
11 55
remarkably improved
Improvement has
6 30
shown
No effect 1 5
Total 20 100
6.6.3.3 User Score

For the user score, please see the table below for details.
Table 2: User Score

Score Total Number %
100(Excellent) 0 0
90 3 15
80 8 40
70 3 15
60 5 25
Under 60(Not good) 1 5
Total 20 100
6.6.4 Results Analysis

Table 3: Data contribution evaluation
Data Description Grading
contributionC
riteria
Data source Was the design of the study T1
type appropriate?
Outcome Do the outcome measures reported O1
measures reflect the intended performance of the

device?
Follow up Is the duration of the follow up long F1
enough to assess whether duration of
treatment effects and identify the
complications?
Statistical Has a statistical analysis of the data S1
significance been provided and is it appropriate?
Clinical Was the magnitude of the treatment C1

significance effect observed clinical significant?
Note:
T1-Yes O1-Yes F1-Yes S1-Yes C1-Yes
T2-No O2-No F2-No S2-No C2-No
Based on the results presented in 6.6.2.1, no severe side effect has occurred during the evaluation. 95% of the subjects
showed no adverse reaction after the treatment; only one (5%) subject felt slight dizziness and retching (could be caused
by the drug) after the treatment.
From 6.6.2.2, we can see that the treatments have shown effect on 19 out of 20 (95%) subjects, 2 cured, 11 condition has
been remarkably improved, 6 improvement has shown. Only one (5%) subject’s condition has not been effected by the
treatment.
Finally, as we can see in 6.6.2.3, only one (5%) subject has graded the treatment under 60(Not good). 19(95%) subjects
have graded the treatment above 60.
Based on the results analysis in 6.6.3, we are confident to say our product has great clinical
efficiency and is quite safe for inhaled therapy. Further more, VEGA compressor
nebulizers are tested and found comply with the requirement of EN60601-1-11:2015,
so they are suitable for both hospital and home use.

7. QUERY AND EVALUATION OF ADVERSE EVENT

7.1 Device name
Compressor nebulizers
7.2 Methods
i) Date of query
05-06-2019
ii) Name of person(s) undertaking the literature search
Donnie Lee
iii) Period covered by query
Date from 2003/01/01 to 2019/05/06
iv) Data sources:
The FDA MAUDE database
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM
v) Key word: injury, malfunction, death, Manufacturer, Brand name, etc.
7.3 Outputs
See the table below.
Search criteria Hits

Manufacturer: Omron 1
Event type: Injury
Manufacturer: Omron 0
Event type: Death
Brand name: Pary 0
Event type: malfunction
Manufacturer: K-Jump Health Co., Ltd. 0
Event type: injury
Manufacturer: Respironics 1
Event type: malfunction
Manufacturer: Mabis Healthcare, Inc. 0
510K Number: Injury
Manufacturer：Dongguan Aidisy Machinery & 0
Electronic E
Event type: Injury
------

7.4 Query results evaluation

Two hits was found during the query, they are evaluated below.
Hit 1:
Model Number NE-C21 BATTERY PACK
Event Type Injury
Event Description
Patient purchased device from omron and it did not work. Patient called manufacturer, and 2 battery packs were
shipped to him, but battery would not charge. Patient ended up in the hospital, because of this portable nebulizer's issues.
Fda needs to put some kind of safety regulations on medical devices. Manufacturers sell defective equipment to patients.
Evaluation:
From this event, the device was defective when it was purchased by the patient. But the reason why the patient was
injured by the device was not clear.
Hit 2:
Model Number RDD491
Device Problem Failure to deliver
Event Date 10/14/2014
Event Type Injury
Manufacturer Narrative
According to info received from the pt, she indicates that she has used the same nebulizer since 2011 and is currently is
hosp with pneumonia. She allegedly sates that it is as a result of not being able to use her nebulizer. Device is not life
sustaining/supporting. The pt has been contacted on three separate occasions for the return of the device with no
response; therefore, we are unable to confirm if the device malfunctioned or not. Complaint cannot be verified. The mfr
believes it will be unable to gather additional info. The mfr is submitting a final report at this time. If pertinent info
becomes available to the mfr at a later date, an addendum to this final report will be filed.
Event Description
The mfr received info that allegedly a pt received no treatment from her micro elite device. Pt was allegedly admitted
into hosp as she had contracted pneumonia. (b)(4).
Evaluation:
From the description of the event, FDA was not able to get response from the patient to define is the device
malfunctioned or not. A final conclusion will be available after the submitting of the final report by the manufacturer.
7.5 Adverse event to used in the home healthcare environment
From the query result above, we can see that no obvious adverse events about used in the home healthcare environment
has been found. And our product, compressor nebulizer, has passed the Standard IEC 60601-1-11, the report number is
160805013GZU-006, please refer to the Test Report for detail. So we can make a conclusion that our product,
compressor nebulizer, is suit to be used in the home healthcare environment.

8. POST-MARKET SURVEILLANCE
This kind of the product belongs to mature medical equipment, the product of medium and long-term safety and
effectiveness is known. So do not need to perform PMCF, only need to perform the PMS.
For every new product, 3 pilot-run must be done to ensure that the finished products conform to defined user needs and
intended uses.
To ensure the production will not raise any new risks about the product, the standard operating procedure (SOP) must
be approved by the risk management team as well as the standard inspection procedure (SIP).
As for the post-production stage, the marketing department collects all the customer complaints， and we deal with the
complaints according to our Customer Complaints Management Procedure(Q216). Besides this, an annually
Customer Satisfaction Inspection is done to find any unsatisfactory feedback about our products from the customers.
During these processes, the risk management team monitors any new raised risks and evaluates if improvement should
be carried out so the new risks will be eliminated or reduced to an acceptable level.
An annually Production and Post-production Information Assessment is carried out by the risk management team to
evaluate the new risks raised in Production and Post-production stage during the products’ life cycle. For the
details of the Production and Post-production Information Assessment， please refer to the next several pages.

Production and Post-production Information Assessment

Date：2011-01-13
Assessment team：

CF.Zou, R&D Director
Sean Yu, R&D Electronic Supervisor
Mark Wang, R&D Engineer
Cindy Wang, Director of Sales Department
Xinglai Zheng, Supervisor of Engineering Department
Heping Yu, Supervisor of QC Department
Huarong Hou, Director of Material Department
Products：Compressor Nebulizers
year 2010 Items Description Investigation Measures

(analysis) Results
Design changes Several design changes No new risk raised Not needed
Quality problems in manufacturing Not happened No new risk raised Not needed
Quality problems in purchasing Not happened No new risk raised Not needed
Returns (customer Several customer No new risk raised Not needed
complaints)research complaints, no returns.
Recall Not happened No new risk raised Not needed
Advisory notice Not happened No new risk raised Not needed
Incidents Not happened No new risk raised Not needed
FDA quality system inspection Not happened No new risk raised Not needed
ISO13485（Notified Body）inspection No significant violation No new risk raised Not needed
found
Changes of rules and standards No obvious effect to No new risk raised Not needed
VEGA’s products
Performance of similar device No recalls and advisory No new risk raised Not needed
notice detected
Review of literature No change of principle No new risk raised Not needed
Conclusion:
No new risks are raised in Production and Post-production stage during year 2010. No further risk management
measures needed.


Date：2012-02-05
Assessment team：

Eric Yan, Director of Sales Department
Jingming Yang, Supervisor of QC Department

(analysis) Results
FDA quality system inspection No significant violation No new risk raised Not needed
found
found
VEGA’s products
notice detected
Conclusion:
measures needed.


Date：2013-01-11
Assessment team：

Sunny Xie, Director of Sales Department

(analysis) Results
FDA quality system inspection Not happened No new risk raised Not needed
found
VEGA’s products
notice detected
Conclusion:
measures needed.


Date：2014-03-20
Assessment team：


(analysis) Results
found
found
VEGA’s products
notice detected
Conclusion:
measures needed.


Date：2015-03-20
Assessment team：


(analysis) Results
found
found
VEGA’s products
notice detected
Conclusion:
No new risks are raised in Production and Post-production stage during year 2014 No further risk management
measures needed.


Date：2016-03-08
Assessment team：


(analysis) Results
found
found
VEGA’s products
notice detected
Conclusion:
No new risks are raised in Production and Post-production stage during year 2015 No further risk management
measures needed.


Date：2017-01-20
Assessment team：
Paul Zhang, Director of R&D Department
Baoxing Zhang, R&D Engineer
year Items Description Investigation Measures
2016 (analysis) Results
Returns (customer complaints) Several customer The production line 1. Add inspection SOP in
research complaints, no returns. didn’t count the subassembly processes after
One of the customers replaced filters before filter placement.
complained no packing and this 2. Add trays to place filter
replaced filters (5pcs in probably caused (100pcs per tray) instead of
a PE bag) in several replaced filters bulk packing at production
boxes. missing. line.
3. Add components balance
check per shift (2 hours) via
a new form. PQC should
verify both balance data and
physical operation
accordingly.
found
ISO13485（Notified Body） No significant violation No new risk raised Not needed
inspection found
VEGA’s products
notice detected
Conclusion:
As for the missing replaced filter issue, it could be controlled by modify SOP to improve production
process.
measures needed


Date：2018-03-26
Assessment team：
John Liao, Director of R&D Department
Yuanguo Feng, Supervisor of Engineering Department
Returns (customer complaints) Several customer No new risk raised Not needed
research complaints, no returns.
found
ISO13485 （ Notified Body ） No significant violation No new risk raised Not needed
inspection found
VEGA’s products
notice detected
Conclusion:
process.
measures needed.


Date：2019-05-06
Assessment team：
Emily Hsueh, Director of R&D Department
Yuanguo Feng, Supervisor of Engineering Department
Returns (customer complaints) Several customer No new risk raised Not needed
research complaints, no returns.
found
ISO13485 （ Notified Body ） No significant violation No new risk raised Not needed
inspection found
VEGA’s products
notice detected
Conclusion:
process.
measures needed.

9. Risk – benefit evaluation
Compressor nebulizer systems have been proved very effective at delivering medication to the
lungs in as little time as possible by many researches and clinical practices. Nebulization has
become a common method for generating medical aerosol during the past few decades and it has
been largely used by adults and children all over the world, particularly for asthma and COPD. In
fact children and older patients may have difficulty with conventional inhalation devices and
therefore they may benefit from the easy-to-use delivery mechanism of the nebulizer. So the
benefit is quite obvious.
On the other hand, with the ISO 13485 quality system, Good Manufacturing Practice, risk
management, the thorough pre-market testing/validation and post market vigilance system, we are
confident in controlling the risk caused by our compressor nebulizer products to a minimum level.
10. Conclusions and Signatures
Considering the evaluated scientific data, clinical evaluation data, post-market surveillance results
and technical results for VEGA CN-02WQ compressor nebulizer, the product can be expected to
give proper treatments for respiratory ailments for both Home Care use and Hospital use. And the
risk caused by the device is well controlled by technical design/manufacturing and accompany
documents. .
As to the other VEGA compressor nebulizer models, such as the CN-02MU, which have been in
the market for many years or new model, because they all have the same or similar characteristics
in technical principle, manufacture, material and technical specifications to CN-02WQ and the
main difference between them is appearance/shape, it is reasonable to say they are also with good
clinical efficiency and safety and quite capable to give proper treatments for respiratory ailments.
Report prepared by Clinical supervisor

Signature: Signature:
VEGA Technologies Inc. Date: May 06, 2019

Date: May 06, 2019 Qualification:
Qualification: A licensed physician at
The Management Representative Leader of JiSheng clinic，Dalang Town, Dongguan City,
Risk Management Team China

Reference
1. MEDDEV.2.7.1-EvaILiation of clinical data: a guide for manufactures and notified bodies

2016
2. P.P.H. Le Brun, A.H. de Boer, H.W. Frijlink and H.G.M. Heijerman - A review of the technical
aspects of drug nebulization
3. C. TERZANO, A. PETROIANNI, D. PAROLA, A. RICCI - Compressor/nebulizers differences
in the nebulization of corticosteroids. The CODE study (Corticosteroids and Devices Efficiency)
4. S.P. Newman*, G.R. Pitcairn*, G. Hooper*, M. Knoch** - Efficient drug delivery to the lungs
from a continuously operated open-vent nebulizer and low pressure compressor system.
5. E.C. Smith, J. Denyer, A.H. Kendrick. - Comparison of twenty three nebulizer/compressor
combinations for domiciliary use.
6. Samuel O. Akapo, June Gupta, Eloisa Martinez and Mark Roach Dey LP, Napa, CA, USA -
In vitro deposition properties of nebulized formoterol fumarate: effect of nebulization time,
airflow, volume of fill and nebulizer type
7. Jillian B. Phillips - Importance of Particle Size For Nebulized Medication
8. Dean Hess, Daniel Fisher, Purris Williams, Sharon Pooler, and Robert M. Kacmarek -
Medication Nebulizer Performance Effects Of Diluent Volume, Nebulizer Flow, and Nebulizer
Brand
9. Melani AS - Effects on aerosol performance of mixing of either budesonide or beclomethasone
dipropionate with albuterol and ipratropium bromide.
10. Reisner C1, Katial RK, Bartelson BB, Buchmeir A, Rosenwasser LJ, Nelson HS.-
Characterization of aerosol output from various nebulizer/compressor combinations.

Attachment 1
The particle size distribution test report.


Clinical Evaluation Report for Compressor Nebulizers

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VEGA-Clinical Evaluation Report

Clinical Evaluation Report

Product Name: Compressor Nebulizers

CN-01M, CN-01W, CN-02M, CN-02W, CN-01MX, CN-01WX, CN-02MX,

VEGA Technologies Inc.

Yang Wu District, Da Lang Town, Dong Guan City

VEGA TECHNOLOGIES INC. 2019-05-06 1

VEGA TECHNOLOGIES INC. 2019-05-06 2

The detailed model list of CN series:

CN-01M, CN-01W, CN-02M, CN-02W, NA100

CN-01MA, CN-02MB, CN-01MC, CN-02MD, CN-01MI

CN-01WA, CN-01WB, CN-01WC, CN-01WD, CN-01WE, CN-01WF, CN-01WG,

CN-02MA, CN-02MB, CN-02MC, CN-02MD, CN-02ME, CN-02MF, CN-02MG,

CN-02WA, CN-02WB, CN-02WC, CN-02WD, CN-02WE, CN-02WF, CN-02WG,

Nebufirst, Nebujunior penguin, Nebujunior bear

VEGA TECHNOLOGIES INC. 2019-05-06 3

2. Description of the device…………………………………………………………5

3. Intended application of the device…………………………………………………6

5. Risk management…………………………………………………… ……………..7

6. Clinical evaluation on the base of a literature search…………………………….17

7. QUERY AND EVALUATION OF ADVERSE EVENT………………………..28

9. Risk – benefit evaluation………………………………………………………….39

10. Conclusions and Signatures…………………………………………………….39

VEGA TECHNOLOGIES INC. 2019-05-06 4

Product name: Compressor Nebulizer

This clinical evaluation report is written by Donnie Lee.

2，Description of the device

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3. Intended application of the device

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● The quantitative probability levels: As table D.4

Acceptance Criteria : The acceptance criteria is determined according to Annex D.3.4.2 as

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To identify the Acceptance Situation, We abbreviate the Acceptance condition of “insignificant

Rank Acceptance Situation Assessment result(S*P) Improvement

Risk Management Team

The team should include the following personnel as team members:

VEGA TECHNOLOGIES INC. 2019-05-06 8

VEGA TECHNOLOGIES INC. 2019-05-06 9

For the details of the risk management, please refer to:

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Before Improvement Improvement After Improvement

5 Device working at high temperature and voltage 2 2 2*2 R Y 2 1 2*1 I

20 Hazard caused by cleaning and disinfection 2 2 2*2 R Y 2 1 2*1 I

VEGA TECHNOLOGIES INC. 2019-05-06 11

Before Improvement Improvement After Improvement

Table 3-3 Risk evaluation results related to the filter

Before Improvement Improvement After Improvement

Table 3-5 Risk evaluation results of supplementary requirements

Before Improvement Improvement After Improvement

Before Improvement Improvement After Improvement

Before Improvement Improvement After Improvement

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Before Improvement Improvement After Improvement

Before Improvement Improvement After Improvement

Table 3-6 Risk evaluation results of supplementary requirements

Before Improvement Improvement After Improvement

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6．Clinical evaluation on the base of a literature search

The member of the clinical evaluation team

6.2 Scientific background on compressor nebulizers

5 Device working at high temperature and voltage 2 2 22 R Y 2 1 21 I

20 Hazard caused by cleaning and disinfection 2 2 22 R Y 2 1 21 I