GORE PROPATEN VASCULAR GRAFT

K062161 · W. L. Gore & Associates, Inc. · DSY · Nov 9, 2006 · Cardiovascular

Device Facts

• Record ID: K062161
• Device Name: GORE PROPATEN VASCULAR GRAFT
• Applicant: W. L. Gore & Associates, Inc.
• Product Code: DSY · Cardiovascular
• Decision Date: Nov 9, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

GORE PROPATEN VASCULAR GRAFT is intended for use as a vascular prosthesis for replacement or bypass of diseased vessels in patients suffering occlusive or aneurysmal diseases, in trauma patients requiring vascular replacement, for dialysis access, or for other vascular procedures.

Device Story

GORE PROPATEN Vascular Graft is a biocompatible vascular prosthesis; constructed from expanded polytetrafluoroethylene (ePTFE) with covalently bound, luminal, bioactive heparin using Carmeda Bioactive Surface (CBAS) technology. Device serves as a conduit for replacement or bypass of diseased vessels; used in surgical settings by vascular surgeons. Heparinization aims to improve patency by reducing thrombogenicity. Device is implanted during vascular procedures; provides structural support for blood flow in occlusive/aneurysmal disease or dialysis access.

Clinical Evidence

Bench testing only. Device met all applicable sections of AAMI/ANSI/ISO 7198:1998/2001(R) 2004 for vascular prostheses.

Technological Characteristics

Expanded polytetrafluoroethylene (ePTFE) graft material; luminal surface modified with covalently bound bioactive heparin (Carmeda Bioactive Surface/CBAS technology). Complies with AAMI/ANSI/ISO 7198:1998/2001(R) 2004 standards.

Indications for Use

Indicated for patients requiring vascular replacement or bypass due to occlusive or aneurysmal disease, trauma, or for dialysis access.

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 Graft (K830806)
• GORE-TEX® Stretch Vascular Graft (K903931)
• FEP Ringed GORE-TEX® Stretch Vascular Graft with Removable Rings (K933943)

Submission Summary (Full Text)

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## 510(k) SUMMARY OF SUBSTANTIAL EQUIVALENCE

NOV - 9 2006

| Proprietary Name: | GORE PROPATEN Vascular Graft |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Vascular Graft |
| Classification Name: | Prosthesis, Vascular Graft of 6 mm and greater diameter (per 21 CFR 870.3460) |
| Device Classification: | Class II |
| Product Classification and Code: | DSY |
| Classification Panel: | Cardiovascular Devices |
| Establishment Registration Number: | 2017233 |
| Contact Person: | Michael Ivey<br>Regulatory Affairs<br>Medical Products Division<br>W. L. Gore & Associates, Inc.<br>3450 West Kiltie Lane<br>Flagstaff, AZ 86002-0500 |
| | Telephone: [phone]<br>Facsimile: [phone]<br>E-mail: [e-mail] |

#### Performance Standards

The GORE PROPATEN VASCULAR GRAFT has been tested, or rationale has been provided, to meet all applicable sections of Cardiovascular Implants-Vascular Prostheses AAMI / ANSI / ISO 7198:1998/2001(R) 2004.

Image /page/0/Picture/7 description: The image contains the Gore logo on the left side and the word "Confidential" on the right side. The Gore logo consists of the word "GORE" in bold letters with a stylized arrow above it. Below the logo, there is some smaller text that is difficult to read. The word "Confidential" is written in a simple, sans-serif font.

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#### Device Description

The GORE PROPATEN Vascular Graft is constructed from the same materials used in the predicate devices: the GORE-TEX Vascular Graft, the GORE-TEX Stretch Vascular Graft, and the FEP Ringed GORE-TEX Stretch Vascular Graft with Removable Rings, which have a successful history of clinical use and were cleared for use in the United States through the Premarket notifications K830806, K903931 and K933943.

The GORE PROPATEN Vascular Graft is a biocompatible device comprised of expanded polytetrafluoroethylene (ePTFE) with covalently bound, luminal, bioactive heparin. The heparin used in creating this device has been derivatized by a proprietary process established by Carmeda AB, Stockholm, Sweden. The heparinization process is based upon the Carmeda Bioactive Surface (CBASTM) technology. Heparin activity is retained in a binding process that does not interfere with the heparin active site.

#### Indications for Use

GORE PROPATEN VASCULAR GRAFT is intended for use as a vascular prosthesis for replacement or bypass of diseased vessels in patients suffering occlusive or aneurysmal diseases, in trauma patients requiring vascular replacement, for dialysis access, or for other vascular procedures.

## Substantially Equivalent Devices

W.L. Gore and Associates cites the following devices as substantially equivalent predicate devices listed below:

- GORE-TEX® Vascular Graft (K830806) .
- GORE-TEX® Stretch Vascular Graft (K903931) .
- FEP Ringed GORE-TEX® Stretch Vascular Graft with Removable . Rings (K933943)

## Conclusion (Statement of Equivalence)

The data and information presented show numerous similarities between the predicate devices and the applicant device, which support a determination of substantial equivalence, and therefore market clearance, of the GORE PROPATEN Vascular Graft through this 510(k) Premarket Notification.

Image /page/1/Picture/14 description: The image contains the Gore logo on the left side and the word "Confidential" on the right side. The Gore logo consists of the word "GORE" in bold letters with a right-pointing arrow above it, and the words "Creative Technologies Worldwide" in smaller letters below it. The word "Confidential" is written in a simple, sans-serif font.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 9 2006

W. L. Gore & Associates, Inc. c/o Mr. Michael Ivey Regulatory Affairs 3450 West Kiltie Lane P.O. Box 2400 Flagstaff, AZ 86003-2400

Re: K062161

GORE PROPATEN™ Vascular Graft Regulation Number: 21 CFR 870.3450 Regulation Name: Vascular Graft Prosthesis Regulatory Class: Class II (Two) Product Code: DSY Dated: October 5, 2006 Received: October 6, 2006

Dear Mr. Ivey:

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. Michael Ivey

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/industry/support/index.html.

Sincerely yours,

R. Vahner

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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510(k) Premarket Notification GORE PROPATEN VASCULAR GRAFT Indication For Use

# INDICATION FOR USE

| 510(k) Number (if known): | TBD |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | GORE PROPATEN VASCULAR GRAFT |
| Intended Use / Indication<br>For Use: | GORE PROPATEN VASCULAR GRAFT is intended for use as a vascular prosthesis for replacement or bypass of diseased vessels in patients suffering occlusive or aneurysmal diseases, in trauma patients requiring vascular replacement, for dialysis access, or for other vascular procedures. |

Over-The-Counter Use Prescription Use 区 AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <div style="text-align:center">Dmnar. Vohner</div> |
|--------------------------------------------------------|----------------------------------------------------|
| (Division Sign-Off) Division of Cardiovascular Devices | |
| 510(k) Number | K062161 |

Image /page/4/Picture/6 description: The image contains the word "Confidential" in a simple, sans-serif font. The word is presented in a straightforward manner, suggesting a document or information that is intended to be kept private or restricted. The text is left-aligned and appears to be the primary, if not only, element in the image. The overall impression is one of discretion and the need for careful handling of the associated content.