MEADOX MEDICALS, INC., EXPANDED & EXTERNALLY SUPPORTED EXPANDED PTFE VASCULAR GRAFT

K955460 · Meadox Medicals, Div. Boston Scientific Corp. · DSY · May 30, 1996 · Cardiovascular

Device Facts

• Record ID: K955460
• Device Name: MEADOX MEDICALS, INC., EXPANDED & EXTERNALLY SUPPORTED EXPANDED PTFE VASCULAR GRAFT
• Applicant: Meadox Medicals, Div. Boston Scientific Corp.
• Product Code: DSY · Cardiovascular
• Decision Date: May 30, 1996
• Decision: ST
• Submission Type: Traditional
• Regulation: 21 CFR 870.3450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MEADOX® ePTFE 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 PTFE vascular graft; core tube reinforced by helically wound multi-filament PTFE yarn; externally supported versions include continuous PTFE spiral coil. Used by surgeons for peripheral artery repair/replacement and vascular access. Provides structural conduit for blood flow; external support prevents kinking/compression. Biocompatible material; steam sterilized. Clinical benefit: restoration of arterial patency or reliable vascular access.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO-10993, including cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, implantation, and hemocompatibility. All tests passed. Performance specifications (tensile, burst, suture retention, crush resistance) verified as equivalent to predicate devices.

Technological Characteristics

Expanded polytetrafluoroethylene (ePTFE) core tube; multi-filament PTFE yarn reinforcement; optional PTFE spiral support coil. Manufacturing: heating, stretching, and winding extruded PTFE. Sterilization: single-cycle steam. Mechanical properties equivalent to predicate ePTFE grafts.

Indications for Use

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

• 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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K955460

# SUMMARY OF SAFETY & EFFECTIVENESS

**GENERAL INFO:** Sponsor - Meadow Medicals, Inc
Contact Person - Stephen B Anderson
Submission Date - November 22, 1995
**MAY 30 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 (6 mm and greater)

**PREDICATE DEVICES:**

| K Number | Proprietary Name | Company |
| --- | --- | --- |
| 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.

Cytotoxicity - Passed
Sensitization - Passed
Irritation or
Intracutaneous Reactivity - Passed
Systemic Toxicity (acute) - Passed
Sub-chronic Toxicity (sub-acute) - Passed
Genotoxicity/Mutagenicity - Passed
Implantation - Passed
Hemocompatibility (hemolysis) - Passed
Chronic Toxicity - Passed

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# SUMMARY OF SAFETY & EFFECTIVENESS

## INDICATIONS:

The MEADOX® ePTFE 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.

| Internodal Distance - | Equivalent to marketed products |
| --- | --- |
| Water Entry Pressure - | Equivalent to marketed products |
| Radial Tensile Strength - | Equivalent to marketed products |
| Longitudinal Tensile Strength - | Equivalent to marketed products |
| Burst Strength - | Equivalent to marketed products |
| Suture Retention Strength (Longitudinal) - | Equivalent to marketed products |
| Suture Retention Strength (Oblique) - | Equivalent to marketed products |
| Suture Hole Elongation - | Equivalent to marketed products |
| Kink Diameter - | Equivalent to marketed products |
| Crush Resistance - | Equivalent to marketed products |
| Burst After Repeated Puncture (12 months) - | Equivalent to marketed products |
| Burst After Repeated Puncture (18 months) - | Equivalent to marketed products |
| Relaxed Internal Diameter - | Equivalent to marketed products |
| Usable Length - | Equivalent to marketed products |
| Nominal Wall Thickness - | Equivalent to marketed products |

## CONCLUSION:

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