You are on page 1of 6

A PTCA catheter is a device that operates on the principle of hydraulic pressurization

applied through an inflatable balloon attached to the distal end. A PTCA balloon catheter
has a single or double lumen shaft. The catheter features a balloon of appropriate
compliance for the clinical application, constructed from a polymer. The balloon is designed
to uniformly expand to a specified diameter and length at a specific pressure as labeled,
with well characterized rates of inflation and deflation and a defined burst pressure. The
device generally features a type of radiographic marker to facilitate fluoroscopic
visualization of the balloon during use. A PTCA catheter is intended for balloon dilatation of
a hemodynamically significant coronary artery or bypass graft stenosis in patients
evidencing coronary ischemia for the purpose of improving myocardial perfusion. A PTCA
catheter may also be intended for the treatment of acute myocardial infarction; treatment of
in-stent restenosis (ISR) and/or post-deployment stent expansion.

Table 1: Risk / Mitigation Recommendations for PTCA Devices

Identified Risk Recommended Mitigation Measures

Adverse Tissue Reaction Section VI. Biocompatibility Testing
Device Failure Section VIII. Performance Testing

Section XI. Sterilization and Shelf Life

Adverse Interaction with Other Devices Section VIII. Performance Testing

Section IX. Animal Testing

User Error Section IX. Animal Testing

Section X. Clinical Information

Section XII. Labeling

Vessel Damage Section IX. Animal Testing

Section X. Clinical Information

Infection Section XI. Sterilization and Shelf Life


Use of International Standard ISO-10993, Biological Evaluation of Medical Devices

Part-1: Evaluation and Testing, for external devices in contact with the circulating blood
for a limited duration (i.e., less than 24 hours)

Standards Development Organization

CEN European Committee for Standardization
ISO 10555-5 Second edition 2013-06-15
Intravascular catheters -- Sterile and single-use catheters -- Part 5: Over-needle peripheral catheters

ISO 23908 First edition 2011-06-11

Sharps injury protection - Requirements and test methods - Sharps protection features for single-use
hypodermic needles, introducers for catheters and needles used for blood sampling

ISO 10555-1 Second edition 2013-06-15

Intravascular catheters -- Sterile and single-use intravascular catheters -- Part 1: General requirements

ASTM F623 -99 (Reapproved 2013)

Standard Performance Specification for Foley Catheter

This performance specification establishes performance requirements for the short-term utilization of a single-use,
balloon-retention catheter, French s 12 through 26 inclusive, used by the medical professions for providing a
means of bladder drainage by means of the urethra. The product is manufactured in various s and materials such as
latex, silicone, rubber, and various polymers (as well as combinations of these) and is provided nonsterile for
sterilization and sterile for single use only. Catheters whose surface has been chemically treated to effect
biocompatibility or microbial properties may be tested to this specification.

Tipos cateteres

Percutaneous, implanted, long-term intravascular catheter.

(a) Identification. A percutaneous, implanted, long-term intravascular

catheter is a device that consists of a slender tube and any necessary
connecting fittings, such as luer hubs, and accessories that facilitate
the placement of the device. The device allows for repeated access to
the vascular system for long-term use of 30 days or more, and it is
intended for administration of fluids, medications, and nutrients; the
sampling of blood; and monitoring blood pressure and temperature. The
device may be constructed of metal, rubber, plastic, composite
materials, or any combination of these materials and may be of single
or multiple lumen design.
(b) Classification. Class II (special controls) Guidance Document:
"Guidance on Premarket Notification [510(k)] Submission for Short-Term
and Long-Term Intravascular Catheters."
[65 FR 37043, June 13, 2000]


Subpart B--Cardiovascular Diagnostic Devices
Sec. 870.1250 Percutaneous catheter.

(a) Identification. A percutaneous catheter is a device that is

introduced into a vein or artery through the skin using a dilator and
a sheath (introducer) or guide wire.
(b) Classification. Class II (performance standards).

FDA Specialty Task Group (STG)

General Plastic Surgery/General Hospital

Sec. 876.5130 Urological catheter and accessories.

(a) Identification. A urological catheter and accessories is a

flexible tubular device that is inserted through the urethra and used
to pass fluids to or from the urinary tract. This generic type of
device includes radiopaque urological catheters, ureteral catheters,
urethral catheters, coude catheters, balloon retention type catheters,
straight catheters, upper urinary tract catheters, double lumen female
urethrographic catheters, disposable ureteral catheters, male
urethrographic catheters, and urological catheter accessories
including ureteral catheter stylets, ureteral catheter adapters,
ureteral catheter holders, ureteral catheter stylets, ureteral
catheterization trays, and the gastro-urological irrigation tray (for
urological use).
(b) Classification. (1) Class II (performance standards).
(2) Class I for the ureteral stylet (guidewire), stylet for
gastrourological catheter, ureteral catheter adapter, ureteral
catheter connector, and ureteral catheter holder. The devices subject
to this paragraph (b)(2) are exempt from the premarket notification
procedures in subpart E of part 807 of this chapter subject to the
limitations in 876.9.
[48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996;
66 FR 38801, July 25, 2001]


Subpart F--Therapeutic Devices

Sec. 876.5010 Biliary catheter and accessories.

(a) Identification. A biliary catheter and accessories is a tubular

flexible device used for temporary or prolonged drainage of the
biliary tract, for splinting of the bile duct during healing, or for
preventing stricture of the bile duct. This generic type of device may
include a bile collecting bag that is attached to the biliary catheter
by a connector and fastened to the patient with a strap.
(b) Classification. Class II (performance standards).

Trade/Device Name: Argyle™ Peritoneal Dialysis Catheter and Kits; Argyle™ Presternal
Peritoneal Dialysis Catheter and Kits; Argyle™ Peritoneal Dialysis Accessory Two Part Titanium
Luer Adapter; Argyle™ Adult Peritoneal Dialysis Accessory Titanium Catheter Extender

Biocompatibility: The biocompatibility evaluation was conducted for an externally

communicating, tissue/bone/dentin, and permanent duration (>30 days) device. The series of
testing was conducted utilizing the PD Catheter and using Good Laboratory Practice (GLP). The
testing procedures are based on the requirements of ISO 10993-1 and the following series of
testing was conducted utilizing the Argyle Peritoneal Dialysis Catheter: • Cytotoxicity •
Sensitization • Irritation • Acute Systemic Toxicity • Subchronic Toxicity • Genotoxicity o AMES
o Mouse Lymphoma o Mouse Micronucleaus • Implantation • Chronic Toxicity The results of
the biocompatibility tests conducted on the PD catheter meet the ISO 10993 requirements and
have been deemed acceptable.

Biocompatibility Testing
FDA recommends that you conduct biocompatibility testing as described in the FDA
guidance, Use of International Standard ISO-10993, Biological Evaluation of Medical
Devices Part-1: Evaluation and Testing, for external devices in contact with the
circulating blood for a limited duration (i.e., less than 24 hours).[3] We recommend that you
select biocompatibility tests appropriate for the duration and level of contact with your
device. If identical materials and identical material processing are used in a predicate
device with the same type and duration of patient contact, you may identify the predicate
device in lieu of providing biocompatibility testing.

Sample Preparation

It is important to understand how the test samples compare to the final sterilized
product. For biocompatibility testing conducted using extraction samples, we recommend
that you:

 determine the appropriate amount of test material as outlined in ISO 10993-12 or an

equivalent method, using surface area to extractant volume ratios (mass to extractant
volume ratios should only be used if surface area cannot be calculated)
 use both polar and nonpolar extractants
 describe the condition of the extraction vehicle (e.g., color, presence of any particles)
 explain any changes in the post-extraction vehicle (compared to pre-extraction)
 describe the details of storage conditions, if applicable.

If extraction samples are not used immediately, we recommend that you follow the storage
conditions described in ISO 10993-12 or an equivalent method. We also recommend that
you explain how storage does not affect your test results.
You should also consider the following additional recommendations when conducting your
biocompatibility assessment:


We recommend that extractions be conducted at 37°C for 24 hours using a vehicle with
both mammalian cell culture media (MEM) and 5% serum, as these materials will allow for
extraction of both polar and nonpolar constituents from the test sample.

Sensitization (Guinea Pig Maximization Method)

We recommend that test reports confirm that all female animals used in the testing are not
pregnant, as pregnancy can reduce the ability of a female animal to detect a sensitization

We recommend either that you run concurrent controls, or that the test laboratory run
controls within 3 months of the test samples. We also recommend you provide protocols
and results from positive control testing to confirm that you used the same methods for both
the positive control testing and the test samples.


For blood-contacting devices (regardless of contact duration), we recommend that you

consider hemolysis, immunology (complement activation), and in vivo thromboresistance.

Immunology testing should appropriately address the various complement activation

pathways. We recommend that you assess in vitro C3a and SC5b-9 fragment activation
using standard testing methods, such as those outlined in ASTM F2065-
00e1[4] and ASTM F1984-99 (2003)[5], or an equivalent method. Alternatively, you may
provide a rationale for omitting this testing, if all the materials used in the formulation and
processing of the device have a history of previous use in blood-contacting devices with
similar contact duration.

In addition, you may assess in vivo thrombogenicity during preclinical animal testing in lieu
of a separate canine in vivo thrombogenicity test. If a 4 hour canine in vivo thrombogenicity
study is needed (e.g., due to the use of novel materials never before used in a medical
devices or questionable findings from the vascular animal studies), we recommend the
study be conducted in a venous, unheparinized model.


Genotoxicity testing should be performed if new materials are included that have never
been used in blood-contacting devices or implants in order to evaluate the genotoxic
response to any particulates and leachables which still may be present after the catheter is
removed from the body.[6]

Material-mediated Pyrogenicity

We recommend that you assess pyrogenic responses to chemical leachants over the
duration of device contact with the patient. We recommend that you assess material-
mediated pyrogenicity using traditional biocompatibility extraction methods, such as those
outlined in the USP 28 <151> Rabbit Pyrogen Test (e.g., 50°C for 72 hours; 70°C for 24
hours; or 120°C for 2 hours) or an equivalent method. You should consider that
temperatures above 37°C may result in toxicities not representative of the final product.