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 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.

AI/ML Overview

The provided text describes a Special Premarket Notification (510(k)) for a medical device: GORE-TEX® Vascular Graft; GORE-TEX® Stretch Vascular Graft. This type of submission is used to demonstrate that a device is "substantially equivalent" to a legally marketed predicate device.

Key takeaway for your request: A 510(k) submission, especially one for a modification to an existing device, typically does not include detailed clinical studies with acceptance criteria, test sets, or ground truth establishment in the way you might expect for a novel or high-risk device requiring a PMA (Premarket Approval).

Instead, the documentation focuses on demonstrating that the modified device is equivalent to the predicate device in terms of design, materials, and intended use, and that the modification does not raise new safety and effectiveness issues.

Given this context, I will address your points based on the information typically available in a 510(k) summary and what can be inferred from the provided text.

Here's an analysis of the provided text with respect to your questions:

A table of acceptance criteria and the reported device performance
- No explicit acceptance criteria or performance table is provided in this 510(k) summary. For a 510(k) of this nature (a modification to an existing, well-established device), the "acceptance criterion" is primarily substantial equivalence to the predicate device. This is demonstrated by showing that the design change (alternative thin ePTFE film for pediatric shunts) does not alter the fundamental safety or effectiveness and that the materials and intended use remain largely the same.
- The "reported device performance" is essentially that the modified device performs comparably to the predicate GORE-TEX® Vascular Grafts and GORE-TEX® Stretch Vascular Grafts. The text states: "No new types of safety and effectiveness issues are raised by the proposed modification." This is the core "performance" statement for a 510(k) of this kind.
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 provided. The text does not mention a "test set" in the context of clinical data for performance evaluation in the way one would for a diagnostic or AI device. This 510(k) is for a physical implantable device (vascular graft). The "test set" would likely refer to engineering and biocompatibility testing, not human-in-the-loop clinical performance testing.
- For such a device, bench testing (e.g., burst strength, suture retention, porosity) and biocompatibility testing would be performed to ensure the modified device meets established standards for vascular grafts, and that the material change does not adversely affect these properties. These tests are typically conducted in a lab environment.
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 / Not provided. The concept of "ground truth" established by experts is not relevant in the context of this 510(k) for a vascular graft. Ground truth is typically used in the evaluation of diagnostic devices or AI systems where expert interpretation is compared against the device's output.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. Adjudication methods are used to resolve discrepancies in expert opinions when establishing ground truth, which isn't part of this 510(k) submission described.
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 physical vascular graft, not an AI software or a diagnostic imaging system that would be evaluated with MRMC studies or AI assistance for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical vascular graft, not an algorithm or AI system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. As established, "ground truth" in this context is not relevant. The safety and effectiveness are established through material characterization, mechanical testing, biocompatibility testing, and comparison to the well-established predicate device. For vascular grafts, long-term clinical performance is typically tracked through post-market surveillance or larger clinical trials for novel designs, but not usually provided as "ground truth" for a premarket notification of a modification.
The sample size for the training set
- Not applicable. This is not an AI device, so there is no "training set."
How the ground truth for the training set was established
- Not applicable. As above, no training set or ground truth in this context.

In summary, the provided 510(k) documentation is for a modification to a physical medical implant (vascular graft), not a diagnostic or AI-driven device. Therefore, the detailed performance criteria, test sets, expert ground truth, and AI-specific study methodologies requested are not presented because they are not typically part of a 510(k) submission for this type of device.

The "study that proves the device meets the acceptance criteria" in this context refers to the demonstration of substantial equivalence through:

Comparison of materials and manufacturing processes to the predicate device.
Likely extensive bench testing and biocompatibility testing to ensure the modification (alternative ePTFE film) does not negatively impact the graft's mechanical properties or biological compatibility.
Confirmation that the intended use remains the same or within the scope of the predicate device.

The FDA's letter explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This statement confirms that the device met the acceptance criteria for a 510(k) submission, which is substantial equivalence.

Summary

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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

Statement of Intended Use

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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

Image /page/2/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle, with its wings spread and its head turned to the left.

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 (301) 594-4646. 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 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 (800) 638-2041 or (301) 443-6597 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 ____
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(Optional Format 1-2-96)

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.”