GORE HYBRID VASCULAR GRAFT

K093934 · W.L. Gore & Associates · DSY · Mar 17, 2010 · Cardiovascular

Device Facts

• Record ID: K093934
• Device Name: GORE HYBRID VASCULAR GRAFT
• Applicant: W.L. Gore & Associates
• Product Code: DSY · Cardiovascular
• Decision Date: Mar 17, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3450
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

The GORE HYBRID Vascular Graft is an ePTFE vascular prosthesis featuring a nitinol-reinforced section (NRS) to facilitate insertion and deployment. The NRS is partially constrained by a knitted ePTFE fiber tube. The graft includes a continuous lumen with immobilized heparin bonded to the luminal surface. It is intended for use by surgeons in clinical settings for vascular replacement or bypass. The device is delivered to the target vessel site, where the surgeon deploys it to form an end-to-end anastomosis. The nitinol reinforcement provides structural support and flexibility during placement. The heparin coating is designed to improve hemocompatibility. The device aids in restoring blood flow in patients with occlusive or aneurysmal disease or trauma, and provides a conduit for dialysis access.

Clinical Evidence

No human clinical data provided. Evidence consists of bench testing and an in vivo canine study. Bench testing evaluated mechanical properties including wall thickness, suture retention, kink radius, burst pressure, and deployment reliability. The canine study (n=not specified) assessed device deployment, sealing (hemostasis), and patency. Results confirmed successful delivery, deployment, and maintenance of position/patency with no deleterious tissue response.

Technological Characteristics

ePTFE vascular prosthesis with nitinol-reinforced section (NRS). NRS constrained by knitted ePTFE fiber. Luminal surface features immobilized heparin bonding. Dimensions include variable internal/external diameters. Testing performed per ISO 7198:1998 and ISO 25539-1:2003. Non-active, mechanical device.

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 PROPATEN® Vascular Graft (K062161)
• GORE VIABAHN® Endoprosthesis (K013648)
• ATRIUM Graduated Wall Flixene Graft (K071923)
• ATRIUM Advanta T-Graft (K051332)

Submission Summary (Full Text)

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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: [phone] Facsimile: [phone] E-mail: [e-mail]

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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

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.

#### Indications 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.

## 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 [phone] or [phone] 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): | TBD<br>K093934 |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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)

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

X

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

Image /page/5/Picture/11 description: The image contains the Gore logo on the left side. The logo consists of the word "GORE" in bold letters with a stylized arrow pointing to the right. Below the logo, there is some smaller text that is difficult to read. To the right of the logo, the word "Confidential" is written in a simple, sans-serif font. The text is horizontally aligned.