VASCUTEK TWILLWEAVE VASCULAR GRAFT

K964959 · Vascutek, Ltd. · DSY · Mar 10, 1997 · Cardiovascular

Device Facts

• Record ID: K964959
• Device Name: VASCUTEK TWILLWEAVE VASCULAR GRAFT
• Applicant: Vascutek, Ltd.
• Product Code: DSY · Cardiovascular
• Decision Date: Mar 10, 1997
• Decision: ST
• Submission Type: Traditional
• Regulation: 21 CFR 870.3450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Twillweave™ Vascular Graft is indicated for repair or replacement of damaged and diseased vessels of the arterial system in cases of aneurysmal or occlusive disease.

Device Story

Woven polyester vascular graft; straight tube or bifurcated configurations. Used for arterial repair/replacement in aneurysmal or occlusive disease. Supplied sterile; requires preclotting by clinician prior to implantation. Device functions as mechanical conduit for blood flow. Evaluated via in-vitro performance testing and animal studies to confirm safety and efficacy.

Clinical Evidence

No clinical data. Evidence based on in-vitro bench testing (burst strength, suture retention, tensile strength, water porosity) and animal testing demonstrating acceptable in-vivo performance.

Technological Characteristics

Woven polyester material; 350 ml/min/cm² porosity. Straight and bifurcated configurations. Sterilized via Ethylene Oxide. 5-year shelf life.

Indications for Use

Indicated for patients requiring repair or replacement of damaged or diseased arterial 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 (K952293)

Submission Summary (Full Text)

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CarboMedics
A company of SULZERmedica
1300 East Anderson Lane, Austin, Texas 78752-1793 ▼ 512 435 3200 ▼ 512 435 3350 FAX
K964959

# 510(k) SUMMARY
## VASCUTEK TWILLWEAVE™ VASCULAR GRAFT

MAR 10 1997

The Twillweave™ vascular graft is a woven polyester graft, with a porosity of 350 ml/min/cm² which is available in a straight tube and bifurcated configurations. The Twillweave™ Vascular Graft is indicated for repair or replacement of damaged and diseased vessels of the arterial system in cases of aneurysmal or occlusive disease.

The Twillweave™ vascular graft is manufactured from materials that have an extensive history of use in cardiovascular and other medical applications. This polyester material has been thoroughly tested and characterized with regard to biocompatibility and suitability for its intended use. The Twillweave™ vascular graft is supplied sterile and must be preclotted prior to use. The method of sterilization used is Ethylene Oxide. A shelf-life of 5 years has been established for the Vascutek Twillweave™ vascular graft.

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

CarboMedics considers the Vascutek Twillweave™ vascular graft safe, effective, and substantially equivalent in intended use, base material (polyester), and function to the Vascutek Gelweave™ vascular graft 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 Twillweave™ vascular graft

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: December 10, 1996.

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