PTA BALLOON CATHETER

K980390 · Cook, Inc. · LIT · Aug 20, 1998 · Cardiovascular

Device Facts

• Record ID: K980390
• Device Name: PTA BALLOON CATHETER
• Applicant: Cook, Inc.
• Product Code: LIT · Cardiovascular
• Decision Date: Aug 20, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For percutaneous transluminal angioplasty of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and ilio femoral and is also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Device Story

PTA Balloon Catheter is a double-lumen catheter with a distal balloon; used for percutaneous transluminal angioplasty (PTA) to dilate peripheral artery lesions and arteriovenous dialysis fistulae. Operated by physicians in clinical settings. Device features high-density polyethylene minimally compliant balloon; compatible with 0.014-inch wire guides. Two radiopaque marker bands facilitate fluoroscopic visualization during placement and inflation. Balloon expands to specific diameter (2.5mm–4.0mm) and length (1.5cm–4.5cm) at labeled pressures. Physician uses fluoroscopy to guide catheter to lesion site; inflates balloon to dilate obstruction. Procedure restores vessel patency, improving blood flow and potentially alleviating symptoms of stenosis or fistula obstruction.

Clinical Evidence

Bench testing only. Testing included balloon minimum burst strength, distensibility, inflation/deflation, fatigue, bond strength, diameter/profile, and biocompatibility. No clinical data provided.

Technological Characteristics

Double-lumen catheter; high-density polyethylene balloon; 135cm length; 2.5mm-4.0mm diameters; 1.5cm-4.5cm lengths; 0.014-inch wire guide compatibility; two radiopaque marker bands for fluoroscopic visualization. Mechanical device; no software or energy source.

Indications for Use

Indicated for patients requiring percutaneous transluminal angioplasty for lesions in peripheral arteries (iliac, renal, popliteal, infrapopliteal, femoral, iliofemoral) and treatment of obstructive lesions in native or synthetic arteriovenous dialysis fistulae.

Regulatory Classification

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.

Reference Devices

• Medi-Tech Corporation balloon catheters
• United States Catheter and Instrument of C.R. Bard balloon catheters

Submission Summary (Full Text)

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# AUG 20 1998

510(k) Premarket Notification PTA Balloon Catheter COOK INCORPORATED

## Safety and Effectiveness Information

April Lavender, RAC Submitted By: Vice President, Regulatory Affairs COOK INCORPORATED 925 South Curry Pike P.O. Box 489 Bloomington, In 47402 [phone] January 30, 1998

Device: Trade Name: Proposed Classification Name: None Catheter, Cardiovascular Balloon Type (79GBR)

## Predicate Devices:

The PTA balloon catheter is similar in terms of intended use, materials of construction, and technological characteristics to predicate devices reviewed as devices for dilation of lesions in peripheral arteries (iliac, renal popliteal, infra popliteal, femoral and ilio femoral).

## Device Description

The PTA Balloon Catheter is a double lumen catheter with a balloon near the distal tip. The catheter features a minimally compliant balloon constructed from high density polyethylene material. The balloon is designed to expand to a specified diameter and length at a specific pressure as labeled. The balloon catheter is provided in an overall length of 135cm. The catheter will be made in four balloon diameters of 2.5mm, 3.0mm, 3.5mm and 4.0mm. Balloon lengths will be 1.5cm, 2.0cm, 3.0cm and 4.5cm. The catheter is compatible with 0.014-inch standard PTA wire guides. Two radiopaque marker bands located at the proximal and distal ends of the balloon segment facilitate fluoroscopic visualization of the balloon during use.

## Substantial Equivalence

The PTA Balloon Catheter is similar to many devices already in commercial distribution for percutaneous transluminal angioplasty (PTA). The similar indications for use and technological characteristics of the PTA Balloon Catheter as compared to the predicate devices supports a

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## 510(k) Premarket Notification PTA Balloon Catheter COOK INCORPORATED

determination of substantial equivalency. Other companies with similar balloon catheters for PTA are Medi-Tech Corporation of Watertown, Massachusetts, United States Catheter and Instrument of C.R. Bard, as well as COOK INCORPORATED.

# Test Data

The balloon catheter was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of:

- Balloon Minimum Burst Strength Test જુન
- જુન Balloon Distensibility Test
- જુન Balloon Inflation/Deflation Test
- な Balloon Fatigue Test
- ન્દ્ર Bond Strength Test
- 中 Diameter and Profile Test
- નું Biocompatibility Test

The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a vascular PTA balloon.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 20 1998

Ms. April Lavender, RAC Vice President, Regulatory Affairs COOK Inc. 925 South Curry Pike P.O. Box 489 Bloomington, IN 47402

K980390 Re : PTA Balloon Catheter Trade Name: Regulatory Class: II Product Code: LIT Dated: May 21, 1998 Received: May 22, 1998

Dear Ms. Lavender:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. . In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this

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Paqe 2 - Ms. April Lavender

response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respirator and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### 510(k) Premarket Notification PTA Balloon Catheter COOK INCORPORATED

K980390 510(k) Number (if known):

:

PTA Balloon Catheter Device Name:

Indications for Use:

For percutaneous transluminal angioplasty of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and ilio femoral and is also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-the-Counter Use

. Rughi

(Division Sign-Off) Division of Cardiovascular. Respiratory, and Neurological Devices

510(k) Number_