The GORE HYBRID Vascular Graft is indicated 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 HYBRID Vascular Graft is an ePTFE vascular prosthesis that has a section reinforced with nitinol The nitinol reinforced section (NRS) is partially constrained to allow for easy insertion and deployment into a vessel to form an end-to-end anastomosis. The constraint is made up of an ePTFE fiber which is knitted into a tubular shape. The GORE HYBRID Vascular Graft with a continuous lumen and has immobilized heparin bonded to the luminal surface.

AI/ML Overview

The provide document is a 510(k) premarket notification for the GORE HYBRID Vascular Graft, which is a medical device. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device rather than establishing new acceptance criteria or conducting studies that prove the device meets acceptance criteria against novel performance standards.

Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria tables, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or detailed ground truth establishment for a diagnostic device.

The document outlines in vitro and in vivo testing performed to demonstrate that the new device is comparable to existing predicate devices. This testing is for design verification and validation to show substantial equivalence, not to establish or meet independent acceptance criteria in the way a diagnostic AI/ML device would.

Here's what the document does provide in relation to the prompt's themes, and why it doesn't directly answer them:

A table of acceptance criteria and the reported device performance:
- No such table is provided. The document lists various in vitro tests (e.g., Wall thickness, Suture Retention, Burst Testing, Corrosion Testing) and states that "The results from these tests demonstrate that the technological characteristics and performance criteria of the GORE HYBRID Vascular Graft are comparable to the predicate devices." It does not provide specific numerical acceptance criteria or the reported performance values for each test.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable in the context of this device. The "test set" concept with data provenance is relevant for diagnostic algorithms. For this physical medical device, verification and validation testing was done. The in vivo study was conducted in a "canine model," which implies animal testing, not human data. The sample size for this canine study is not specified.
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 concept of "ground truth" established by experts is for diagnostic devices where human interpretation is the gold standard. For this vascular graft, performance was assessed via physical measurements (in vitro) and direct observation/palpation by the surgeon (in vivo). The "surgeon" is an expert, but not in the context of establishing diagnostic ground truth on a test set.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This relates to diagnostic interpretation consensus and is not relevant for the physical performance testing of a vascular graft.
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:
- No MRMC study was done. This type of study is specifically for evaluating the effectiveness of AI-assisted diagnostic tools and is not relevant for this physical implantable device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical implant and does not have an "algorithm only" or "human-in-the-loop" component in the diagnostic sense.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the in vitro tests, the "ground truth" would be the engineering specifications and established test methods (e.g., ISO standards), with the device passing or failing based on meeting those specifications.
- For the in vivo canine study, the "ground truth" was visual assessment and palpation by the surgeon ("The implanted device remains patent and in position throughout the in-life period in the canine model. This was assessed visually and via palpation by the surgeon.") as well as observation of biocompatibility and lack of deleterious tissue response. This is essentially direct observation and clinical assessment by a qualified professional.
The sample size for the training set:
- Not applicable. The concept of a "training set" is for machine learning models. This device is a manufactured physical product, not an AI/ML algorithm.
How the ground truth for the training set was established:
- Not applicable. (See point 8).

In summary, the provided document describes a traditional medical device (vascular graft), and the regulatory submission (510(k)) focuses on demonstrating substantial equivalence through a battery of in vitro physical property tests and a limited in vivo animal study. The framework of acceptance criteria, sample sizes, expert adjudication, and ground truth establishment, as typically applied to diagnostic AI/ML devices, simply does not fit this type of product or its regulatory pathway.

Summary

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L093934

MAR 1 7 2010

510(k) SUMMARY OF SUBSTANTIAL EQUIVALENCE

Proprietary Name:

Common Name:

REPUBLIC

HYBRID Vascular Graft

GORE HYBRID Vascular Graft

Classification Name:

Vascular Graft Prosthesis (per 21 CFR 870.3450)

Device Classification:

Class II

Product Classification and Code: DSY

Classification Panel:

Cardiovascular Devices

Establishment Registration Number: 2017233

Contact Person:

Michael Ivey Regulatory Affairs Medical Products Division W. L. Gore & Associates, Inc. 3250 West Kiltie Lane Flagstaff, AZ 86001-0500

Telephone: (928) 864-3790 Facsimile: (928) 779-4219 E-mail: mivey@wlgore.com

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510(k) Premarket Notification GORE HYBRID Vascular Graft 510(k) Summary of Substantial Equivalence

Performance Standards

Performance standards do not currently exist for these devices. None are established under Section 514.

Device Description

Indications for Use

Substantially Equivalent Devices

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

· GORE PROPATEN® Vascular Graft (K062161) Cleared November 9, 2006
· GORE VIABAHN® Endoprosthesis (K013648) Cleared January 8, 2002
· ATRIUM Graduated Wall Flixene Graft (K071923) Cleared August 14, 2007
· ATRIUM Advanta T-Graft (K051332) Cleared September 29, 2005

Brief Comparison Summary

To demonstrate substantial equivalence of the applicant GORE HYBRID Vascular Graft to the predicate devices, the technological characteristics and performance criterion were evaluated using in vitro and in vivo testing performed in accordance with ISO 7198:1998 "Cardiovascular Implants - Tubular Vascular Prostheses" and ISO 25539-1: 2003 "Cardiovascular Implants - Endovascular Devices" as outlined below:

In Vitro Testing

Using FDA guidance documents on non-clinical testing of medical devices the following in vitro tests were performed:

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510(k) Premarket Notification GORE HYBRID Vascular Graft 510(k) Summary of Substantial Equivalence

Wall thickness .
� Internal and External Diameter
Suture Retention . (transverse and longitudinal)
. Kink Radius (Pressurized and Non-Pressurized)
Repeated Punctured Burst .
Burst Testing ●
Water Entry Pressure (WEP) .
Tensile Strength
Constrained Profile .
Deployment Accuracy ●
Deployment Force .
Deployment Reliability
. Pre and Post Deployment Dimensional Testing
Nitinol Reinforced Section . (NRS) Flexibility
. Radial Compression Resistance
Integral Water Permeability .
Fibril Length .
Pressurized Internal Diameter .
Tensile Strength .
Corrosion Testing .
Simulated Device Use .

The results from these tests demonstrate that the technological characteristics and performance criteria of the GORE HYBRID Vascular Graft are comparable to the predicate devices and that it can perform in a manner equivalent to devices currently on the market for the same intended use.

In Vivo Testing

To assess the performance of the GORE HYBRID Vascular Graft, as well as evaluate the biocompatibility of the graft in a vascular application, an in vivo study was conducted in a canine model to evaluate 3 device attributes:

Device Deployment: the device can be accurately and easily deployed at the . desired location by the surgeon.
Device Sealing: the device achieves hemostasis successfully post deployment . and allows for closure of the incision site by the surgeon.
Device Patency: The implanted device remains patient and in position . throughout the in-life period in the canine model. This was assessed visually and via palpation by the surgeon.

The results of this study show that the GORE HYBRID Vascular Graft can be successfully delivered, deployed, remain patent, and maintain position at the intended target location. The device is well tolerated with no deleterious tissue response observed within a normal arteriovenous canine test system.

Conclusion (Statement of Equivalence)

W.L. Gore & Associates Inc. believes that the data and information presented in this application, including in vitro testing, in vivo animal data, and numerous device similarities support a determination of substantial equivalence, and therefore market clearance of the GORE HYBRID Vascular Graft through this 510(k) Premarket Notification

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized image of an eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

W.L. Gore & Associates, Inc. c/o Mr. Michael Ivey Regulatory Affairs Medical Products Division 3250 Kiltie Lane P. O. Box 2400 Flagstaff, AZ 86001

MAR 1 7 2010

Re: K093934

GORE HYBRID Vascular Graft Regulation Number: 21 CFR 870.3450 Regulation Name: Vascular Graft Prosthesis Regulatory Class: Class II Product Code: DSY Dated: December 18, 2009 Received: December 22, 2009

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 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 Ivev

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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

era R. Vidmer

Image /page/4/Picture/7 description: The image shows a black and white drawing of a stylized letter 'f'. The letter is drawn in a cursive style, with a loop at the top and a curved line extending downwards. The lines are thick and bold, giving the letter a strong presence. The background is plain white, which makes the letter stand out.

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 HYBRID Vascular Graft Indication For Use

INDICATION FOR USE

510(k) Number (if known):	TBDK093934
Device Name:	GORE HYBRID Vascular Graft
Intended Use / Indication For Use:	The GORE HYBRID Vascular Graft is indicated 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.

(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)

Over-The-Counter Use

(Optional Format 1-2-96)

sunn R.V.V.V

(Division Sign-Off) (Division Sign-Om)
Division of Cardiovascular Devices

510(k) Number Kory 3 7 3 4

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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.”