PTA BALLOON CATHETER

K032931 · Cook, Inc. · DQY · Oct 22, 2003 · Cardiovascular

Device Facts

• Record ID: K032931
• Device Name: PTA BALLOON CATHETER
• Applicant: Cook, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Oct 22, 2003
• Decision: SESE
• Submission Type: Special
• 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 are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Device Story

Over-the-wire balloon catheter; used for percutaneous transluminal angioplasty (PTA) of peripheral artery lesions and arteriovenous dialysis fistulae. Device utilizes 5.0 French nylon tubing; compatible with 0.035-inch guidewire. Operated by physicians in clinical settings. Inflation of balloon dilates narrowed or obstructed vessels; restores blood flow. Supplied sterile for single-use.

Clinical Evidence

Bench testing only. Tests included tensile strength, balloon deflation, balloon burst, balloon compliance, balloon fatigue, and balloon profile. No clinical data provided.

Technological Characteristics

Over-the-wire balloon catheter; 5.0 French nylon tubing; 0.035-inch guidewire compatibility. Sterile, single-use. Mechanical dilation principle.

Indications for Use

Indicated for patients requiring percutaneous transluminal angioplasty of peripheral artery lesions (iliac, renal, popliteal, infrapopliteal, femoral, iliofemoral) or 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.

Submission Summary (Full Text)

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OCT 2 2 2003

K032931

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

## 510(k) Summary

#### Submitted Bv:

Karen Bradburn, RAC Regulatory Affairs Coordinator Cook Incorporated 750 Daniels Wav, PO Box 489 Bloomington, IN 47402 812-339-2235 September 19, 2003

## Device:

| Trade Name: |
|--------------------------|
| Proposed Classification: |

ATB™ All-Terrain Balloon™ PTA Dilatation Catheter Catheter, Angioplasty, Peripheral, Transluminal (74 DQY)

## Predicate Devices:

The ATB™ All-Terrain Balloon™ PTA Dilatation Catheter is similar in terms of intended use, materials of constructions and technological characteristics to predicate devices reviewed as devices for transluminal percutaneous angioplasty of vessel lumens which are narrowed or obstructed.

#### Device Description:

The ATB™ All-Terrain Balloon™ PTA Dilatation Catheter is an over-the wire balloon catheter indicated for percutaneous transluminal angioplasty of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and illo femoral and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device will be made with 5.0 French nylon tubing compatible with an 0.035-inch guidewire. It will be supplied sterile, intended for one-time use.

# Substantial Equivalence:

This device will be manufactured according to specified process controls and a Quality Assurance Program. This device will undergo packaging similar to the devices currently marketed and distributed by Cook Incorporated. This device will undergo sterilization similar to the devices currently marketed and distributed. Being similar with respect to indications for use, materials and physical construction to predicate devices, this device meets the requirements for section 510(k) substantial equivalence.

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

## Test Data:

The ATB™ All-Terrain Balloon™ PTA Dilatation Catheter was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of:

- 1 -Tensile tests
- 2. Balloon deflation tests
- 3. Balloon burst tests
- 4. Balloon compliance
- 5. Balloon fatigue tests
- 6. Balloon profile

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 PTA dilatation balloon catheter.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

OCT 2 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cook, Incorporated c/o Ms. Karen Bradburn, RAC Regulatory Affairs Coordinator 750 Daniels Way P.O. Box 489 Bloomington, Indiana 47402

Re: K032931

Trade Name: ATB™ All-Terrain Balloon™ PTA Dilatation Catheter Regulation Number: 21 CFR §870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: September 19, 2003 Received: September 22, 2003

Dear Ms. Bradburn:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Ms. Karen Bradburn, RAC

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): 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. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Ashley B. Bairn

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

4032331 510(k) Number (if known):

Device Name: PTA Balloon Catheter

Indications for Use:

For percutaneous transluminal angioplasty of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and ilio femoral and are 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)

OR

Prescription Use (Per 21 CFR 801.109)

**Prescription Use**
(Per 21 CFR 801.109)

Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________

Elias Mallis

on Sigif-Only Devices

KO32931 510(k) Number_

1