VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION)

K964665 · Carbomedics, Inc. · DSY · Feb 19, 1997 · Cardiovascular

Device Facts

• Record ID: K964665
• Device Name: VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION)
• Applicant: Carbomedics, Inc.
• Product Code: DSY · Cardiovascular
• Decision Date: Feb 19, 1997
• Decision: ST
• Submission Type: Traditional
• Regulation: 21 CFR 870.3450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Gelweave™ vascular graft (bifurcated configuration) is indicated for repair or replacement of damaged and diseased vessels of the abdomen in cases of aneurysmal or occlusive disease.

Device Story

Gelatin-sealed, woven polyester vascular graft; bifurcated configuration. Gelatin sealant (bovine bone-derived, USP standard) eliminates need for preclotting; mimics fibrin deposition. Implanted by surgeons in clinical settings for abdominal vessel repair/replacement. Device provides structural replacement for damaged/diseased vessels; gelatin sealant improves handling and reduces intraoperative bleeding risk in anticoagulated patients.

Clinical Evidence

Bench testing (burst strength, suture retention, tensile strength, water porosity) and animal testing performed. No human clinical trial data provided.

Technological Characteristics

Woven polyester graft; gelatin-sealed (bovine bone-derived, USP standard). Base graft porosity 350 ml/min/cm². Supplied sterile via Ethylene Oxide. 4-year shelf life.

Indications for Use

Indicated for patients requiring repair or replacement of damaged/diseased abdominal vessels due to aneurysmal or occlusive disease.

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

• Vascutek Gelweave™ vascular graft (straight configuration) (K952293)

Reference Devices

• PMA# P890045

Submission Summary (Full Text)

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CarboMedics
A company of BULZBUMmedica
1300 EAST ANDERSON LANE, AUSTIN, TEXAS 78752-1793
K964665
FEB 9 1997

# 510(k) SUMMARY
## VASCUTEK GELWEAVE™ VASCULAR GRAFT (BIFURCATED CONFIGURATION)

The Gelweave™ vascular graft (bifurcated configuration) is a gelatin-sealed, woven polyester graft, with a base graft porosity of 350 ml/min/cm². 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. The gelatin is of United States Pharmacopeia (USP) standard and is derived from bovine bone. The result is a vascular prosthesis that does not require preclotting even when patients have been anticoagulated or when bleeding is a prime concern. This gelatin has been shown to be safe and effective through the approval of PMA# P890045 on January 11, 1993.

The Gelweave™ vascular graft (bifurcated configuration) is indicated for repair or replacement of damaged and diseased vessels of the abdomen in cases of aneurysmal or occlusive disease.

The Gelweave™ vascular graft (bifurcated configuration) is manufactured from materials that have an extensive history of use in cardiovascular and other medical applications. This polyester material and gelatin sealant have been thoroughly tested and characterized with regard to biocompatibility and suitability for their intended use. The Gelweave™ vascular graft is supplied sterile. The method of sterilization used is Ethylene Oxide. A shelf-life of 4 years has been established for the Vascutek Gelweave™ vascular graft.

CarboMedics considers the Vascutek Gelweave™ vascular graft (bifurcated configuration) to be substantially equivalent to the Vascutek Gelweave™ vascular graft (straight configuration) in intended use, composition, and function. Side-by-side in-vitro performance testing has been performed on the Vascutek Gelweave™ straight and bifurcated vascular grafts. In-vitro performance testing performed on the Gelweave™ including burst strength, suture retention, tensile strength and base graft (water) porosity provides evidence that the Gelweave™ vascular graft (bifurcated configuration) is substantially equivalent to the straight configuration. Animal testing has demonstrated acceptable in-vivo performance for the Gelweave™ graft’s intended purpose.

CarboMedics considers the Vascutek Gelweave™ vascular graft (bifurcated configuration) safe, effective, and substantially equivalent in intended use, composition, and function to the straight configuration which received marketing clearance on December 19, 1995 510(k) via K952293.

Common name of the device: Prosthesis, Vascular Graft

Trade or Proprietary name: Vascutek Gelweave™ vascular graft (bifurcated configuration)

Submitter and Contact name: Teena M. Augostino, Manager, Regulatory Affairs
1300 E. Anderson Lane, Austin, TX 78752
Phone: [phone] Fax: [phone]

Submission Prepared/Submitted on: November 20, 1996

PH: [phone]
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