GORE-TEX VASCULAR GRAFT; GORE-TEX STRETCH VASCULAR GRAFT

K013250 · W. L. Gore & Associates, Inc. · DSY · Oct 26, 2001 · Cardiovascular

Device Facts

• Record ID: K013250
• Device Name: GORE-TEX VASCULAR GRAFT; GORE-TEX STRETCH VASCULAR GRAFT
• Applicant: W. L. Gore & Associates, Inc.
• Product Code: DSY · Cardiovascular
• Decision Date: Oct 26, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3450
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

GORE TEX Vascular Grafts and GORE-TEX Stretch Vascular Grafts are intended for use for replacement or bypass of diseased vessels in patients suffering occlusive or aneurysmal diseases, in trauma patients requireing vascular replacement, or for other vascular procedures.

Device Story

GORE-TEX Vascular Graft and GORE-TEX Stretch Vascular Graft are ePTFE-based vascular prostheses. Device consists of ePTFE basetube radially reinforced with thin ePTFE film wrap. Modification involves alternative thin ePTFE film wrap specifically for pediatric shunt configurations. Used by surgeons for vessel replacement or bypass in occlusive/aneurysmal disease or trauma. Implanted surgically to restore blood flow; provides structural conduit for vascular repair.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material similarity to predicate devices.

Technological Characteristics

Materials: expanded polytetrafluoroethylene (ePTFE). Construction: ePTFE basetube with radially reinforced ePTFE film wrap. Modification: alternative thin ePTFE film wrap for pediatric shunt configurations.

Indications for Use

Indicated for patients suffering from occlusive or aneurysmal vascular diseases, trauma patients requiring vascular replacement, or patients requiring other vascular procedures.

Regulatory Classification

Identification

A vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. It is commonly constructed of materials such as polyethylene terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or collagen, or a synthetic coating, such as silicone. The graft structure itself is not made of materials of animal origin, including human umbilical cords.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular Prostheses 510(k) Submissions.”

Predicate Devices

• GORE-TEX® Vascular Grafts and GORE-TEX® Stretch Vascular Grafts (K013250)

Submission Summary (Full Text)

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KU 13250

OCT 2 6 2001

## Attachment IV

Page 1 of 2

# Special Premarket Notification Summary of Safety and Effectiveness

### Applicant:

W.L. Gore & Associates, Inc. 3450 West. Kiltie Lane P.O. Box 500 Flagstaff, AZ 86002-0500

## Contact

Timothy J. Rynn

#### Date Prepared

24 October 2001

#### Trade or Proprietary Name

GORE-TEX® Vascular Graft; GORE-TEX® Stretch Vascular Graft

#### Common or Usual Name

Vascular Graft Prosthesis

#### Classification Name

Vascular Graft Prosthesis

#### Device Predicates

GORE-TEX® Vascular Grafts and GORE-TEX® Stretch Vascular Grafts

## Device Description

GORE-TEX® Vascular Grafts and GORE-TEX® Stretch Vascular Grafts are composed of expanded polytetrafluoroethylene (ePTFE), and utilize an ePTFE basetube radially reinforced with a thin layer of ePTFE film wrapped around the basetube circumference. The device modification that is the subject of this Special 510(k) involves an alternative thin ePTFE film wrapped around the basetube circumference for use on vascular grafts configured for pediatric shunt.

## Statement of Intended Use

GORE TEX Vascular Grafts and GORE-TEX Stretch Vascular Grafts are intended for use for replacement or bypass of diseased vessels in patients suffering occlusive or aneurysmal diseases, in trauma patients requireing vascular replacement, or for other vascular procedures.

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## Summary of Safety and Effectiveness

Page 2 of 2

## Substantial Equivalence

The applicant device is substantially equivalent in design, materials, and intended use to currently marketed ePTFE vascular grafts prostheses. No new types of safety and effectiveness issues are raised by the proposed modification.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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OCT 2 6 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Tomothy J. Rynn Regulatory Affairs W.L. Gore & Associates, Inc. 3450 West Kiltie Lane P.O. Box 500 Flagstaff, AZ 86002-500

Re: K013250

Trade Name: Gore-Tex® Vascular Graft; Gore-Tex® Stretch Vascular Graft Regulation Number: 21 CFR 870.3460 Regulation Name: Vascular Graft Prosthesis Regulatory Class: Class II (two) Product Code: DSY Dated: September 27, 2001 Received: September 28, 2001

Dear Mr. Rynn:

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 - Mr. Tomothy J. Rynn

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 and additionally 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

James E. Dillard III
Director

Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Attachment II

## Indications For Use Statement

Page **_ of _**

510(k) Number (if known) k013250

Device Name: GORE-TEX® Vascular Graft; GORE-TEX® Stretch Vascular Graft

# INDICATIONS FOR USE:

GORE TEX Vascular Grafts and GORE-TEX Stretch Vascular Grafts are intended for use for GORE TEX Vascular Grans and CONE TEX Suffering occlusive or aneurysmal diseases, in teplacement or bypaos of alsociation replacement, or for other vascular procedures.

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|----------|
| Division of Cardiovascular & Respiratory Devices | |
| 510(k) Number | KO 13250 |

| Prescription Use (per 21 CFR 801.109) | X | OR | Over-The-Counter Use ____ |
|---------------------------------------|---|----|---------------------------|
|---------------------------------------|---|----|---------------------------|

(Optional Format 1-2-96)