SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS

K013022 · Sulzer Carbomedics, Inc. · DSY · Jun 13, 2002 · Cardiovascular

Device Facts

• Record ID: K013022
• Device Name: SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS
• Applicant: Sulzer Carbomedics, Inc.
• Product Code: DSY · Cardiovascular
• Decision Date: Jun 13, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sulzer Vascutek® Gelweave Valsalva™ Vascular Prosthesis is indicated for the repair or replacement of damaged and diseased thoracic aorta in cases of aneurysm, dissection or coarctation.

Device Story

Gelatin-sealed, woven polyester vascular graft; designed for repair or replacement of thoracic aorta. Gelatin sealant eliminates need for preclotting procedures; sealant safety established via PMA #P890045. Implanted by surgeons during vascular procedures to treat aneurysm, dissection, or coarctation. Provides structural replacement for diseased aortic tissue.

Clinical Evidence

Bench testing only. Evaluated base graft water porosity, blood porosity, burst strength, tensile strength, suture retention, and hydrodynamic performance. Biocompatibility and animal testing data were referenced.

Technological Characteristics

Woven polyester graft impregnated with absorbable mammalian gelatin sealant. Designed for thoracic aorta repair. Biocompatible materials.

Indications for Use

Indicated for repair or replacement of damaged and diseased thoracic aorta in patients with aneurysm, dissection, or coarctation.

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

• Sulzer Vascutek Gelweave™ Vascular Prosthesis (K952293)

Submission Summary (Full Text)

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KOI3022

Image /page/0/Picture/2 description: The image shows the logo for Sulzer Medica. The text "SULZER" is in bold, block letters, followed by "MEDICA" in a slightly smaller font. The logo appears to be for a medical company, given the name Medica.

### Sulzer Carbomedics Inc.

1300 East Anderson Lane Austin, Texas 78752-1793

Phone [phone] FAX [phone] WATS [phone] (US and Canada) www.sulzercarbomedics.com

## 510(k) SUMMARY

per 21 CFR §807.92

| Submitter | Contact |
|--------------------------|-----------------------------------|
| Sulzer Carbomedics Inc. | Lisa Peterson |
| 1300 East Anderson Lane | Regulatory Affairs Associate |
| Austin, Texas 78752-1793 | Telephone: [phone] |
| | Facsimile: [phone] |
| | E-mail: [e-mail] |

Date of Summary: Common Name: Proprietary Name:

September 5, 2001 Vascular Graft Sulzer Vascutek Gelweave Valsalva™ Vascular Prosthesis

Description of Device: The Sulzer Vascutek Gelweave Valsalva™ Vascular Graft is a gelatin-sealed, woven polyester graft. The woven polyester material has been impregnated with an absorbable mammalian gelatin which seals the prosthesis in the same manner as the fibrin deposited in traditional preclotting procedures. The gelatin sealant obviates the need for preclotting prior to implantation. This gelatin has been shown to be safe and effective through PMA #P890045 on January 11, 1993.

Statement of Intended Use: The Sulzer Vascutek Gelweave Valsalva™ Vascular Graft is indicated for the repair or replacement of damaged and diseased thoracic aorta in cases of aneurysm, dissection or coarctation.

Technological Comparison: For purposes of this submission, the Sulzer Vascutek Gelweave Valsalva™ Vascular Prosthesis was compared to the following predicate devices:

- � Sulzer Vascutek Gelweave™ Vascular Prosthesis: K952293 (Straight)
Testing: In vitro testing which evaluated Base Graft Water Porosity, Blood Porosity, Burst Strength, Tensile Strength, Suture Retention, and Hydrodynamic testing was performed on the Sulzer Vascutek Gelweave Valsalva™. In addition, flow visualization, biocompatibility and animal testing are referenced. The testing demonstrated that the Gelweave Valsalva™ is substantially equivalent to the Gelweave™ graft predicate device.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract human profiles facing to the right, with flowing lines suggesting movement or progress. The overall design is simple and conveys a sense of health, well-being, and service.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 3 2002

Sulzer Carbomedics, Inc. c/o Ms. Lisa Peterson Regulatory Affairs Associate 1300 East Anderson Lane Austin, TX 78752-1793

Re: K013022

Trade Name: Sulzer Vascutek® Gelweave Valsalva™ Vascular Prosthesis Regulation Number: 21 CFR 870.3460 Regulation Name: Vascular Graft Prosthesis Regulatory Class: Class II (two) Product Code: DSY Dated: March 13, 2002 Received: March 15, 2002

Dear Ms. Peterson:

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 - Ms. Lisa Peterson

. 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 [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 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

N. O'Dell

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications For Use

.

.

| 510(K) Number: | Unknown |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Sulzer Vascutek® Gelweave Valsalva™ Vascular Prosthesis |
| Indications for Use: | The Sulzer Vascutek® Gelweave Valsalva™ Vascular Prosthesis is indicated for the repair or replacement of damaged and diseased thoracic aorta in cases of aneurysm, dissection or coarctation. |

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div style="text-align:center;">X</div> |
|----------------------|-----------------------------------------|
| (Per 21 CFR 801.109) | |

OR

| Over-The-Counter Use | _________________ |
|----------------------|-------------------|
|----------------------|-------------------|

(Optional Format 1-2-96)


| Division of Cardiovascular & Respiratory Devices | |
|--------------------------------------------------|---------|
| 510(k) Number | K013022 |