EPTFE RINGED GORE-TEX VASCULAR GRAFT

K991602 · W. L. Gore & Associates, Inc. · DSY · Jul 9, 1999 · Cardiovascular

Device Facts

• Record ID: K991602
• Device Name: EPTFE RINGED GORE-TEX VASCULAR GRAFT
• Applicant: W. L. Gore & Associates, Inc.
• Product Code: DSY · Cardiovascular
• Decision Date: Jul 9, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ePTFE Ringed GORE-TEX Vascular Graft is intended for use as a vascular prosthesis for replacement or bypass of diseased vessels in the patients suffering occlusive or aneursymal diseases, in trauma patients requiring vascular replacement, for dialysis access, or for other vascular procedures.

Device Story

ePTFE Ringed GORE-TEX Vascular Graft is a vascular prosthesis; used for replacement or bypass of diseased vessels. Device consists of expanded polytetrafluoroethylene (ePTFE) base tube with integrated ePTFE reinforcing rings within graft wall; replaces previous FEP external rings. Optional gold dots added for identification. Used by surgeons in clinical settings for vascular procedures. Mechanical and in vivo testing confirms performance equivalent to predicate grafts.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by mechanical testing and in vivo testing demonstrating performance equivalent to predicate devices.

Technological Characteristics

Expanded polytetrafluoroethylene (ePTFE) vascular graft. Features internal ePTFE reinforcing rings integrated into the graft wall. Optional gold markers for orientation. Non-software, mechanical implant.

Indications for Use

Indicated for patients with occlusive or aneurysmal vascular disease, trauma patients requiring vascular replacement, or patients requiring dialysis access or 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
• IMPRA Flex PTFE Vascular Graft
• Atrium Hybrid Vascular Graft

Submission Summary (Full Text)

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#### Tab 6

#### Summary of Safety and Effectiveness Page 1 of 2

#### Applicant:

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

#### Contact

Timothy J. Rynn

### Date Prepared

May 7, 1999

## Trade or Proprietary Name

ePTFE Ringed GORE-TEX® Vascular Graft

### Common or Usual Name

Vascular Graft Prosthesis

#### Classification Name

Vascular Graft Prosthesis 6 mm and greater diameter

#### Device Predicates

GORE-TEX Vascular Grafts; IMPRA Flex PTFE Vascular Graft; Atrium Hybrid Vascular Graft.

## Device Description

The ePTFE Ringed GORE-TEX Vascular Graft is an expanded polytetrafluoroethylene (ePTFE) vascular graft base tube with ePTFE reinforcing film and optional manufacturing modifications. The proposed modifications consist of replacing external, semi-rigid reinforcing rings of fluorinated ethylene propylene (FEP) with rings created within the graft wall of the ePTFE. These ring structures alternate with a typical graft structure the entire length of the graft. Additionally, small gold dots may be placed at intervals anywhere along the graft, in conjunction with, or as an alternative to the blue orientation markers. The proposed modifications do not present new issues of safety and effectiveness compared to predicate vascular grafts.

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Summary of Safety and Effectiveness

#### Statement of Intended Use

The ePTFE Ringed GORE-TEX Vascular Graft is intended for use as a vascular prosthesis for replacement or bypass of diseased vessels in the patients suffering occlusive or aneursymal diseases, in trauma patients requiring vascular replacement, for dialysis access, or for other vascular procedures.

#### Substantial Equivalence

The applicant device is substantially equivalent in materials to currently marketed ePTFE vascular grafts. Mechanical testing data demonstrate the applicant device has mechanical characteristics substantially equivalent to the predicate devices. In vivo testing demonstrates that applicant device performance is substantially equivalent to the predicate devices.

The applicant device is composed of the same ePTFE biomaterial as other GORE-TEX® Vascular Grafts

No new types of safety and effectiveness issues are raised by the proposed modifications.

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Public Health Service

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JUL - 9 1999

Mr. Timothy J. Rynn Regulatory Associate W.L. Gore & Associates, Inc. 3450 West Kiltie Lane P.O. Box 500 Flagstaff, AZ 86002-0500

Re: K991602 ePTFE Ringed GORE-TEX® Vascular Graft Requlatory Class: II (Two) Product Code: DSY Dated: May 7, 1999 Received: May 10, 1999

Dear Mr. Rynn:

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 Regulations, 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 Please note: this response to your premarket Federal Register. 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.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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Page 2 - Mr. Timothy J. Rynn

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. Callahon

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

Enclosure

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#### Tab 7

#### Indications For Use

Page ***_ of _***

911,82 510(k) Number (if known) Device Name: ePTFE Ringed GORE-TEX Vascular Graft

## INDICATIONS FOR USE:

The ePTFE Ringed GORE-TEX Vascular Graft is intended for use as a vascular prosthesis for r ho of 11 = 1 ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . diseases, in trauma patients requiring vascular replacement, for dialysis access, or for other vascular procedures.

(R) GORE-TEX is a registered trademark of W.L. GORE & Associates, Inc.

# (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 _

(Optional Format 1-2-96)

Bete L. Campuele
(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number

25