Professional Documents
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Jolife AB
℅ John Smith
Partner
Hogan Lovells US LLP
555 Thirteenth Street NW
Washington, District of Columbia 20004
Re: K173553
Trade/Device Name: LUCAS 3 Version 3.1 Chest Compression System
Regulation Number: 21 CFR 870.5200
Regulation Name: External cardiac compressor
Regulatory Class: Class II
Product Code: DRM
Dated: December 11, 2017
Received: December 11, 2017
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced
above and have determined the device is substantially equivalent (for the indications for use stated in the
enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the
enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance
with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a
premarket approval application (PMA). You may, therefore, market the device, subject to the general
controls provisions of the Act. The general controls provisions of the Act include requirements for annual
registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding
and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties.
We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be
subject to additional controls. Existing major regulations affecting your device can be found in the Code of
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements
concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA
has made a determination that your device complies with other requirements of the Act or any Federal
statutes and regulations administered by other Federal agencies. You must comply with all the Act's
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good
manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR
1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part
803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's
Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including
information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn
(http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and
Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website
(http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone
(1-800-638-2041 or 301-796-7100).
Sincerely,
Nicole G. Ibrahim -S
Enclosure
DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120
Food and Drug Administration Expiration Date: January 31, 2017
Indications for Use See PRA Statement on last page
LUCAS Chest Compression System is to be used for performing external cardiac compressions on adult
Patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and
loss of consciousness.
LUCAS must only be used in cases where chest compressions are likely to help the patient.
The LUCAS device is intended for use as an adjunct to manual CPR when effective manual CPR is not
possible (e.g., during patient transport or extended CPR when fatigue may prohibit the delivery of effective/
consistent compressions to the victim, or when insufficient EMS personnel are available to provide effective
CPR).
FORM FDA 3881 (8/14) Page 1 of 1 FDA PSC Publishing Services (301) 443-6740 EF
510(k) SUMMARY
Jolife’s LUCAS 3 CHEST COMPRESSION SYSTEM version 3.1
Submitter
Malin Melander
Jolife AB
Scheelevagen 17
Ideon Science Park
SE-223 70 Lund
Sweden
Purpose of 510(k)
The purpose of this 510(k) is to modify the LUCAS 3 Chest Compression System by introducing the
option to change device factory default settings according to local protocols such as compression rate and
depth, number of ventilation alerts, audible alert signal on/off, compression to ventilation ratio, ventilation
pause duration, and automatic adjustment of the Pressure Pad. The device can also be configured to alter
between compression rates by pushing the ACTIVE (continuous or 30:2) key during ongoing
compressions.
Performance Data
Device Set up is controlled by software. The LUCAS 3 version 3.1 software is a modification of the
software for the predicate device LUCAS 3 (K161768). The LUCAS 3 software has been developed based
on the methods of IEC 62304: 2006 + A1:2015, the FDA Guidance for the Content of Premarket
Submissions for Software Contained in Medical Device, Guidance for Industry - Cybersecurity for
Networked Medical Devices Containing Off-the-Shelf (OTS) Software and Guidance for Off-the-Shelf
Software use in Medical Devices. In addition the FDA guidance documents addressing Content of
Premarket Submissions for Management of Cybersecurity in Medical Devices and Post market
Management of Cybersecurity in Medical Devices have been used during the software development
process.
Verification and validation testing have been performed for LUCAS 3 version 3.1 with approved result.
Nonclinical performance testing under simulated physiological conditions has been performed
demonstrating the reliability of delivering specific compression depth and rate over the intended duration
of use. Additional verification and validation activities are recorded in system and, where appropriate, unit
test reports.
In all instances, the LUCAS 3 version 3.1 functioned as intended and results observed were as expected.