VASCUTEK VASCUSOFT PLUS VASCULAR GRAFT

K960706 · Carbomedics, Inc. · DSY · Apr 25, 1996 · Cardiovascular

Device Facts

• Record ID: K960706
• Device Name: VASCUTEK VASCUSOFT PLUS VASCULAR GRAFT
• Applicant: Carbomedics, Inc.
• Product Code: DSY · Cardiovascular
• Decision Date: Apr 25, 1996
• Decision: SESP
• Submission Type: Traditional
• Regulation: 21 CFR 870.3450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vascusoft™ Plus Vascular Graft is indicated for systemic 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.

Device Story

Warp-knitted polyester vascular prosthesis; straight tube or bifurcated configurations. Used for systemic arterial replacement or bypass. Requires preclotting by clinician prior to implantation. Supplied sterile via ethylene oxide. Provides structural conduit for blood flow in aneurysmal or occlusive disease. Benefits patient by restoring arterial patency.

Clinical Evidence

Bench testing (in-vitro) included burst strength, suture retention, tensile strength, and water permeability. Animal testing performed to demonstrate acceptable in-vivo performance.

Technological Characteristics

Warp-knitted polyester material; porosity 2591 ml/min/cm²; straight or bifurcated form factor; ethylene oxide sterilization; 5-year shelf life.

Indications for Use

Indicated for systemic vascular repair, including replacement or bypass in aneurysmal and 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

• Vascutek Vascusoft™ Vascular Graft (K830016/F, K910866)

Submission Summary (Full Text)

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CarboMedics®
A company of SULZERmedica
1300 EAST ANDERSON LANE, AUSTIN, TEXAS 78752-1793
K960706
APR 25 1996

# 510(k) SUMMARY
## VASCUTEK VASCUSOFT™ PLUS VASCULAR GRAFT

The Vascusoft™ Plus Vascular Graft is a warp knitted polyester prosthesis with a porosity of 2591 ml/min/cm² which is available in a straight tube and bifurcated configurations. The Vascusoft™ Plus Vascular Graft is indicated for systemic 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 Vascusoft™ Plus vascular graft is manufactured from material that has 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 Vascusoft™ Plus 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 Vascusoft™ Plus vascular graft.

Comprehensive performance testing has been performed on the Vascutek Vascusoft™ Plus Vascular Graft, which includes in-vitro and animal evaluations. In-vitro performance testing performed on both the Vascusoft™ Plus and the Vascusoft™ vascular graft, which includes burst strength, suture retention, tensile strength and water permeability provides evidence that the Vascusoft™ "Plus" vascular graft is substantially equivalent to the Vascusoft™ vascular graft and has shown enhanced resistance to dilatation in in-vitro studies. Animal testing has demonstrated acceptable in-vivo performance for the Vascusoft™ Plus graft’s intended purpose.

CarboMedics considers the Vascutek Vascusoft™ Plus Vascular Graft safe, effective and substantially equivalent in intended use, material (polyester), and function to the Vascutek Vascusoft™ Vascular Graft, which received 510(k) marketing clearance under K830016/F, later reassigned 510(k) number K910866 on April 1, 1991.

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