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 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.

AI/ML Overview

The provided document is a 510(k) summary for the GORE PROPATEN Vascular Graft, not a study report. It states that the device has been tested to meet applicable sections of AAMI/ANSI/ISO 7198:1998/2001(R) 2004, which is a performance standard for cardiovascular implants, specifically vascular prostheses. However, the document does not contain the acceptance criteria or reported device performance in a table format, nor does it describe a specific study proving the device meets those criteria.

Therefore, I cannot extract the information required for your request. The document focuses on demonstrating substantial equivalence to predicate devices based on material composition and intended use, rather than detailing a specific performance study with acceptance criteria and results.

To directly answer your numbered points based on the absence of this information in the provided text:

A table of acceptance criteria and the reported device performance: Not provided in the document. The document states only that "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." The specific criteria and results are not detailed.
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not provided in the document.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document does not describe a study involving expert-established ground truth.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This document does not describe a study involving adjudication.
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 is a medical device (vascular graft), not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided in the document. The document refers to meeting a performance standard but does not detail how compliance was verified beyond general "testing or rationale."
The sample size for the training set: Not applicable. This is a physical medical device, not a machine learning algorithm requiring a training set.
How the ground truth for the training set was established: Not applicable.

Summary

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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 IveyRegulatory AffairsMedical Products DivisionW. L. Gore & Associates, Inc.3450 West Kiltie LaneFlagstaff, AZ 86002-0500
	Telephone: (928) 864-3790Facsimile: (928) 779-3480E-mail: mivey@wlgore.com

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

Indications for Use

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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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 / IndicationFor 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)

	Dmnar. Vohner
(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.

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.”