HEMASHIELD VANTAGE (VASCULAR GRAFT

K961847 · Meadox Medicals, Div. Boston Scientific Corp. · DSY · Jan 22, 1997 · Cardiovascular

Device Facts

• Record ID: K961847
• Device Name: HEMASHIELD VANTAGE (VASCULAR GRAFT
• Applicant: Meadox Medicals, Div. Boston Scientific Corp.
• Product Code: DSY · Cardiovascular
• Decision Date: Jan 22, 1997
• Decision: ST
• Submission Type: Traditional
• Regulation: 21 CFR 870.3450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For use in systemic vascular reconstructions, e.g., replacement in the case of aneurysmal or occlusive disease, in the peripheral region.

Device Story

HEMASHIELD VANTAGE Vascular Graft; woven polyester textile graft impregnated with bovine collagen. Device features smooth inner surface and veloured outer surface. Used by surgeons for peripheral vascular replacement in cases of aneurysmal or occlusive disease. Functions as prosthetic conduit to replace or bypass diseased vessels. Benefits patient by restoring blood flow in peripheral vasculature.

Clinical Evidence

Bench testing only. Evaluated burst strength, tensile strength, suture pull-out, wall thickness, needle penetration, crush resistance, flexural rigidity, water permeability, collagen bonding strength, shrinkage temperature, glycerol/collagen content, and hydrolytic stability. All results equivalent to predicate devices.

Technological Characteristics

Woven polyester textile graft; bovine collagen impregnated. Features smooth inner surface and veloured outer surface. Biocompatibility testing performed per ISO 9000 standards.

Indications for Use

Indicated for patients requiring systemic vascular reconstruction due to aneurysmal or occlusive disease in the peripheral region.

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

• HEMASHIELD MICROVEL Double Velour Knitted Vascular Grafts (K954848)
• HEMASHIELD Woven Double Velour Vascular Grafts (K954848)

Submission Summary (Full Text)

{0}

JAN 22 1997
CONFIDENTIAL
K961847

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

Owner: Meadox Medicals, Inc.
112 Bauer Drive
Oakland, NJ 07436
[phone]
Fax# [phone]

Contact Person: Carolyn Tauber
Senior Regulatory Affairs Specialist

Submission Date: May 9, 1996

Device Name: HEMASHIELD VANTAGE™ Vascular Grafts

Predicate Devices: HEMASHIELD® CARDIOVASCULAR GRAFTS:
HEMASHIELD® MICROVEL® Double Velour Knitted Vascular Grafts
HEMASHIELD® Woven Double Velour Vascular Grafts
[510(k) #K954848, determined substantially equivalent Feb. 1, 1996)

Description of Device: The HEMASHIELD VANTAGE™ Vascular Graft is a woven polyester graft, impregnated with bovine collagen.

Intended Uses: For use in systemic vascular reconstructions, e.g., replacement in the case of aneurysmal or occlusive disease, in the peripheral region. The indications are substantially equivalent to the predicate devices, except for the specification of the region of application (peripheral region) of the devices.

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CONFIDENTIAL

## Substantial Equivalence:

The HEMASHIELD VANTAGE™ Vascular Graft is substantially equivalent in design, components, materials, intended use and labeling to the currently marketed predicate devices. The modifications in this device compared to the predicate devices are:

- It combines a smooth inner surface and veloured outer surface in the same graft; predicate Meadox grafts have the same inner and outer surface: both surfaces are either smooth or velour.

- Like its predicate devices, it is intended for use in vascular replacement in the case of aneurysmal or occlusive disease; with the exception that this device is intended for application in the peripheral region.

- The labeling is distinct from that for the predicate devices to reflect the above described modifications in this device compared to the predicate devices.

Testing has been performed which demonstrates that in spite of these modifications in the proposed device, the proposed devices are substantially equivalent in safety and performance to the currently marketed predicate devices.

## Product Testing:

The following testing has been conducted on HEMASHIELD VANTAGE™ Vascular Grafts to demonstrate the equivalency in safety and efficacy of these devices to their currently marketed predicate devices.

- Burst Strength - equivalent to marketed product
- Tensile Strength - equivalent to marketed product
- Suture Pull Out - equivalent to marketed product
- Wall Thickness - equivalent to marketed product
- Needle Penetration - equivalent to marketed product
- Crush Resistance - equivalent to marketed product
- Flexural Rigidity - equivalent to marketed product
- Integral Water Permeability - equivalent to marketed product
- Integral Water Permeability under load - equivalent to marketed product
- Strength of Collagen Bonding - equivalent to marketed product
- Shrinkage Temperature - equivalent to marketed product
- Glycerol Content - equivalent to marketed product
- Collagen Content - equivalent to marketed product
- Hydrolytic Stability Testing - equivalent to marketed product

RG1059

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CONFIDENTIAL

## Biocompatibility Testing:

Testing performed in accordance with ISO 9000 Standards indicates that the HEMASHIELD VANTAGE™ Vascular Grafts fabricated from polyester textile materials and with the same collagen composition and method of manufacture as its predicate devices are safe for their intended use and substantially equivalent in biocompatibility to the currently marketed predicate devices.

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