SULZER VASCUTEK GELSOFT VASCULAR PROSTHESIS

K990503 · Sulzermedica · DSY · Dec 9, 1999 · Cardiovascular

Device Facts

• Record ID: K990503
• Device Name: SULZER VASCUTEK GELSOFT VASCULAR PROSTHESIS
• Applicant: Sulzermedica
• Product Code: DSY · Cardiovascular
• Decision Date: Dec 9, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Sulzer Vascutek Gelsoft™ Vascular Prosthesis is indicated for abdominal and peripheral vascular repair, i.e. replacement or bypass in aneurysmal and occlusive disease of arteries.

Device Story

The Sulzer Vascutek Gelsoft™ Vascular Prosthesis is a woven polyester graft impregnated with absorbable bovine-derived USP gelatin. The gelatin sealant eliminates the need for preclotting prior to implantation, even in anticoagulated patients. The device is intended for surgical replacement or bypass of diseased arteries in the abdomen and periphery. It is implanted by a surgeon during vascular repair procedures. The graft provides a structural conduit for blood flow, mimicking the function of natural fibrin deposition. The device is supplied sterile via ethylene oxide and has a 5-year shelf life.

Clinical Evidence

A prospective randomized clinical trial compared graft patency between the Gelsoft™ graft and the Impra ePTFE graft for femoropopliteal bypass. Investigators concluded there was no difference in graft patency between the two devices.

Technological Characteristics

Woven polyester graft; impregnated with absorbable bovine-derived USP gelatin sealant; base graft porosity 2118 ml/cm²/min; sterilization via ethylene oxide; 5-year shelf life.

Indications for Use

Indicated for patients requiring abdominal or peripheral vascular repair, specifically replacement or bypass for aneurysmal or occlusive arterial disease. Contraindicated for coronary vascular repair and blood access fistula (e.g., hemodialysis).

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

• Meadox Hemashield Vantage Graft
• Meadox Hemashield Microvel Double Velour Knitted Graft
• Impra ePTFE Graft

Submission Summary (Full Text)

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DEC - 9 1999

# SULZER MEDICA

K990503

#### Sulzer Carbomedics Inc.

1300 East Anderson Lane Austin, Texas 78752-1793

Phone [phone] FAX [phone] WATS [phone] (US and Canada)

### 510(k) SUMMARY SULZER VASCUTEK GELSOFT™ VASCULAR PROSTHESIS

The Sulzer Vascutek Gelsoft™ Vascular Prosthesis is a gelatin-sealed, woven polyester graft with a base graft porosity of 2118 ml/cm³/min. The knitted polyester material has been impregnated with an absorbable mammalian gelatin that seals the prosthesis in the same manner as the fibrin deposited in traditional procedures. The gelatin sealant obviates the need for preclotting prior to implantation. The gelatin is of USP standard and is derived from bovine bone sourced exclusively in the United States. The result is a vascular prosthesis that does not require preclotting even when patients have been anticoagulated or when bleeding is a prime concern. The gelatin has been shown to be safe and effective through the approval of PMA P890045 for the Sulzer Vascutek Gelseal™ Vascular Prosthesis on January 11, 1993 and PMA P890045/SI for the Sulzer Vascutek Gelsoft™ Vascular Prosthesis on July 5, 1995.

Sulzer Vascutek Gelsoft™ Vascular Prosthesis is indicated for abdominal and peripheral vascular repair, i.e. replacement or bypass in aneurysmal and occlusive disease of arteries. Coronary vascular repair and blood access fistula (e.g. hemodialysis) are contraindicated with this device.

The Sulzer Vascutek Gelsoft™ Vascular Prosthesis is manufactured from materials that have an extensive history of use in cardiovascular and other medical applications. The polyester material and gelatin sealant have been thoroughly tested and characterized with regard to biocompaibility for their intended use. The Sulzer Vascutek Gelsoft™ Vascular Prosthesis is supplied sterilization used is Ethylene Oxide. A shelf-life of 5 years has been established.

Side-by-side in vitro testing which evaluated burst strength, suture retention, tensile strength, and nominal wall thickness was performed using the Sulzer Vascutek Gelsoft™ graft and predicate devices that include the Meadox Hemashield Vantage Graft, Meadox Hemashield Microvel Double Velour Knitted Graft, and Impra ePTFE Graft, This testing demonstrated the acceptable structural and performance characteristics of the Gelsoft™ graft for peripheral vascular repair.

A prospective randomized clinical trial was performed to compare graft patency between the Gelsoft™ and Impra ePTFE grafts for femoropopliteal bypass. The investigators concluded that there was no difference in graft patency between the two grafts.

Sulzer Carbomedics considers the Sulzer Vascutek Gelsoft™ Vascular Prosthesis to be substantially equivalent to the currently marketed predicate devices for peripheral vascular repair.

| Common name of the Device: | Vascular Graft |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade name of Proprietary Name: | Sulzer Vascutek Gelsoft™ Vascular Prosthesis |
| Submitter and Contact Person: | Edward E. Newton<br>Sr. Regulatory Affairs Specialist<br>1300 E. Anderson Lane, Austin, TX 78752<br>Phone: [phone]<br>Fax: [phone] |
| Submission Submitted on: | February 16, 1999 |

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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 9 1999

Mr. Edward E. Newton Regulatory Affairs Manager Sulzer Carbomedics Inc. 1300 East Anderson Lane Austin, Texas 78752

K990503 /S2 Re: Sulzer Vasutek Gelsoft Vascular Prosthesis Regulatory Class: II Product Code: DSY Dated: November 4, 1999 Received: November 5, 1999

Dear Mr. Newton:

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 leqally 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 reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with 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 Federal Reqister. Please note: this response to your premarket 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.

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## Page 2 - Mr. Edward E. Newton

This letter will allow you to begin marketing your device as rnio recei will as a more to 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Celia M. Witten, Ph.D., M Acting Director Division of Cardiovascular Respiratory and Neuroloqical Devices Office of Device Evaluation Center for Device and Radiological Health

Enclosure

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# INDICATIONS FOR USE STATEMENT

| 510(K) Number (if known): | Unknown |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Sulzer Vascutek Gelsoft™ Vascular Prosthesis |
| Indications for Use: | Sulzer Vascutek Gelsoft™ Vascular Prosthesis is indicated<br>for abdominal and peripheral vascular repair, i.e.<br>replacement or bypass in aneurysmal and occlusive<br>disease of arteries. |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

lege Kemper a

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K990563

Prescription Use

OR

Over-the-Counter Use

(Optional Format 1-2-96)