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 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.

AI/ML Overview

The provided document describes a medical device, the ePTFE Ringed GORE-TEX® Vascular Graft, and its clearance through the FDA's 510(k) process, which demonstrates substantial equivalence to predicate devices. This type of submission does not typically involve the detailed clinical studies with acceptance criteria, ground truth establishment, or human-AI performance comparisons that one would find for novel devices or software.

Therefore, many of the requested categories are not applicable to this document as it pertains to a traditional medical device demonstrating substantial equivalence based on material and mechanical properties, and in vivo performance compared to existing predicate devices, rather than a device with performance metrics based on, for example, image analysis or diagnostic accuracy.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Material Equivalence: Composed of similar biomaterials to predicate devices.	The applicant device is composed of the same ePTFE biomaterial as other GORE-TEX® Vascular Grafts. (Implied accepted, as it was cleared)
Mechanical Testing Data: Mechanical characteristics substantially equivalent to predicate devices.	Mechanical testing data demonstrate the applicant device has mechanical characteristics substantially equivalent to the predicate devices. (Implied accepted, as it was cleared)
In vivo Testing: Performance substantially equivalent to predicate devices.	In vivo testing demonstrates that applicant device performance is substantially equivalent to the predicate devices. (Implied accepted, as it was cleared)
Safety and Effectiveness: No new issues raised by modifications.	The proposed modifications do not present new issues of safety and effectiveness compared to predicate vascular grafts. No new types of safety and effectiveness issues are raised by the proposed modifications. (Implied accepted, as it was cleared)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable / Not explicitly stated. The document refers to "mechanical testing data" and "in vivo testing" but does not provide specific sample sizes or details on the test sets, data provenance, or study design (e.g., retrospective vs. prospective). This type of information is typically provided in detailed study reports, which are not part of this summary document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The "ground truth" for this device's performance is established through material characterization, mechanical property testing, and animal (in vivo) studies, rather than expert consensus on diagnostic interpretations. The document does not mention human experts establishing ground truth in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for expert review of images or clinical cases to establish a definitive diagnosis or outcome. This is not relevant for the type of testing described (material, mechanical, in vivo performance).

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a vascular graft, not an AI-powered diagnostic tool. Therefore, MRMC studies and the concept of human readers improving with AI assistance are irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical implant, not an algorithm, so standalone performance is not a relevant concept in this context.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for demonstrating substantial equivalence for this device would be based on:
- Material specifications and established standards: For ePTFE biomaterial properties.
- Mechanical engineering principles and test standards: For burst strength, suture retention, fatigue resistance, and other mechanical characteristics.
- Histopathological analysis and physiological responses: From in vivo animal studies to assess biocompatibility, host tissue integration, and patency, as compared to predicate devices.
- Clinical outcomes from predicate devices: The safety and effectiveness of the predicate GORE-TEX Vascular Grafts are already established.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."

9. How the ground truth for the training set was established

Not applicable. As there is no training set, this question is irrelevant.

Summary

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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

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Summary of Safety and Effectiveness

Statement of Intended Use

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

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.

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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

Regulation Number and Section

§ 870.3450 Vascular graft prosthesis.

(a)
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.(b)
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.”