MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT

K960766 · Meadox Medicals, Div. Boston Scientific Corp. · DYF · Mar 19, 1997 · Cardiovascular

Device Facts

• Record ID: K960766
• Device Name: MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT
• Applicant: Meadox Medicals, Div. Boston Scientific Corp.
• Product Code: DYF · Cardiovascular
• Decision Date: Mar 19, 1997
• Decision: ST
• Submission Type: Traditional
• Regulation: 21 CFR 870.3450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ePTFE_MEADOX Vascular Grafts are designed to repair or replace peripheral arteries and to provide vascular access. Mid-Flex grafts are specifically indicated for vascular access, as are Stepped grafts which are designed to reduce the risk of steal syndrome. Externally Supported Grafts are used where kinking and compression resistance are desired.

Device Story

Expanded polytetrafluoroethylene (ePTFE) vascular graft; core tube reinforced with helically wound multi-filament PTFE yarn; externally supported versions include continuous PTFE spiral coil. Used by vascular surgeons for peripheral artery bypass or vascular access. Device provides structural conduit for blood flow; prevents kinking/compression in supported models. Benefits include arterial repair and reliable vascular access. Manufactured via heating, stretching, and winding extruded PTFE tubes.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO-10993 standards. Carcinogenicity testing not performed due to established nontoxic properties of PTFE materials.

Technological Characteristics

Materials: ePTFE core tube, multi-filament PTFE yarn reinforcement, PTFE spiral support coil. Manufacturing: Extrusion, heating, stretching, winding. Sterilization: Single-cycle steam. Biocompatibility: ISO-10993 compliant.

Indications for Use

Indicated for patients requiring peripheral artery repair/replacement or vascular access. Mid-Flex and Stepped grafts indicated for vascular access (Stepped specifically for steal syndrome risk reduction). Externally supported grafts indicated for applications requiring kinking/compression resistance.

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

• GORE-TEX® Vascular Graft (Preamendment)
• IMPRA® Vascular Graft (Preamendment)
• IMPRA® Vascular Graft (K791810)
• GORE-TEX® FEP Ringed Vascular Graft (K811510)
• Bard® PTFE Vascular Prosthesis (K821716)
• GORE-TEX® Vascular Graft (K830806)
• GORE-TEX® Stretch Vascular Graft (K842144)
• GORE-TEX® Removable FEP Ring Graft (K880167)
• Baxter Reinforced Expanded PTFE Graft (K933590)

Submission Summary (Full Text)

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PREMARKET NOTIFICATION
Meadow Medicals, Inc.
ePTFE Vascular Grafts 3 - 5mm
Friday, February 23, 1996
MAR 19 1997
K960766

# SUMMARY OF SAFETY & EFFECTIVENESS

## GENERAL INFO:
Sponsor - Meadow Medicals, Inc.
Contact Person - Stephen B Anderson
Submission Date - February 23, 1996

## DEVICE INFO:
Generic Name - Expanded Reinforced PTFE Vascular Graft
Trade Name - Meadow Medicals, Inc., Expanded PTFE Vascular Graft
Meadox Medicals, Inc., Expanded PTFE Vascular Graft w/External Support
Classification Name - Vascular Graft Prosthesis (less than 6 mm)

## PREDICATE DEVICES:

| K-Number | Proprietary Name | Company |
| --- | --- | --- |
| Preamendment | GORE-TEX® Vascular Graft | W.L. Gore & Associates |
| Preamendment | IMPRA® Vascular Graft | IMPRA, Inc. |
| K79 1810 | IMPRA® Vascular Graft | IMPRA, Inc. |
| K81 1510 | GORE-TEX® FEP Ringed Vascular Graft | W.L. Gore & Associates |
| K82 1716 | Bard® PTFE Vascular Prosthesis | C.R. Bard, Incorporated |
| K83 0806 | GORE-TEX® Vascular Graft | W.L. Gore & Associates |
| K84 2144 | GORE-TEX® Stretch Vascular Graft | W.L. Gore & Associates |
| K88 0167 | GORE-TEX® Removable FEP Ring Graft | W.L. Gore & Associates |
| K93 3590 | Baxter Reinforced Expanded PTFE Graft | Baxter Healthcare, Corp. |

## DEVICE DESCRIPTION:
The ePTFE$_{MEADOX}$ Vascular Graft is comprised of an expanded polytetrafluoroethylene (ePTFE) core tube reinforced by a multi-filament PTFE yarn helically wound around the exterior of the tube. Externally supported grafts have a continuous PTFE spiral support coil wound around a portion of the graft.

## BIOCOMPATIBILITY:
Biocompatibility testing on the ePTFE$_{MEADOX}$ Vascular Graft was performed on single-cycle steam sterilized grafts in accordance with the ISO-10993 standard for biological evaluation of medical devices. Carcinogenicity testing was not performed on ePTFE$_{MEADOX}$ grafts due to the established nontoxic properties of the graft materials. These tests indicate that the ePTFE$_{MEADOX}$ Vascular Graft is safe for its intended use.

## INDICATIONS:
The ePTFE$_{MEADOX}$ Vascular Grafts are designed to repair or replace peripheral arteries and to provide vascular access. Mid-Flex grafts are specifically indicated for vascular access, as are Stepped grafts which are designed to reduce the risk of steal syndrome. Externally Supported Grafts are used where kinking and compression resistance are desired.

## DESIGN MATERIALS:
Design materials of the ePTFE$_{MEADOX}$ Vascular Graft are substantially equivalent to the predicate devices identified above.

## MANUFACTURING:
The ePTFE$_{MEADOX}$ Vascular Graft is produced by heating, stretching and winding an extruded polytetrafluoroethylene tube.

## SPECIFICATIONS:
Performance specifications of the ePTFE$_{MEADOX}$ Vascular Graft are substantially equivalent to the range of performance specifications found in the previously identified predicate devices.

## CONCLUSION:
The Meadow Medicals, Inc., Vascular Graft has a level of safety and effectiveness comparable to currently marketed ePTFE Vascular Grafts.

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