MEADOX EXXCEL EPTFE VASCULAR GRAFT

K962433 · Meadox Medicals, Div. Boston Scientific Corp. · DSY · Mar 17, 1997 · Cardiovascular

Device Facts

• Record ID: K962433
• Device Name: MEADOX EXXCEL EPTFE VASCULAR GRAFT
• Applicant: Meadox Medicals, Div. Boston Scientific Corp.
• Product Code: DSY · Cardiovascular
• Decision Date: Mar 17, 1997
• Decision: ST
• Submission Type: Traditional
• Regulation: 21 CFR 870.3450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MEADOX® EXXCEL™ 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. Externerally Supported Grafts are used where kinking and compression resistance are desired.

Device Story

Expanded polytetrafluoroethylene (ePTFE) vascular graft; core tube structure; externally supported versions include continuous PTFE spiral support coil. Used for peripheral artery repair/replacement and vascular access. Implanted by surgeons. Device provides conduit for blood flow; externally supported versions resist kinking/compression. Benefits include restoration of arterial patency and reliable vascular access.

Clinical Evidence

Bench testing only. No clinical data presented. Performance evaluated via AAMI standard testing including internodal distance, water entry pressure, radial/longitudinal tensile strength, burst strength, suture retention, kink diameter, crush resistance, and burst after repeated puncture.

Technological Characteristics

Material: Expanded polytetrafluoroethylene (ePTFE). Construction: Extruded, heated, stretched, and wound tube; optional PTFE spiral support coil. Mechanical properties verified per AAMI standards (e.g., 8.2.1.3, 8.3.1, 8.3.3.3, 8.9). Biocompatibility per ISO 10993. Sterilization: Single-cycle steam.

Indications for Use

Indicated for patients requiring peripheral artery repair/replacement or vascular access. Mid-Flex grafts for vascular access; Stepped grafts for vascular access with reduced steal syndrome risk; Externally Supported grafts 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

• IMPRA® Vascular Graft (Preamendment)
• IMPRA® Vascular Graft (K791810)
• EXXCEL™ ePTFE Graft (6 - 10mm) (K955460)
• EXXCEL™ ePTFE Graft (3 - 5mm) (K960766)

Submission Summary (Full Text)

{0}

PREMARKET NOTIFICATION
Meadox
MEADOX® EXXCEL™ Unwrapped ePTFE Vascular Graft
Friday, June 21, 1996
MAR 17 1997
K962433

# SUMMARY OF SAFETY & EFFECTIVENESS

## GENERAL INFO:
Sponsor - Meadox Medicals, Inc.
Contact Person - Susan Eichler-Huston
Submission Date - June 21, 1996

## DEVICE INFO:
Generic Name - Expanded PTFE Vascular Graft
Trade Name - MEADOX® EXXCEL™ ePTFE Vascular Graft
Classification Name - Vascular Graft Prosthesis (less than 6 mm)
Vascular Graft Prosthesis (6 mm and greater)

## PREDICATE DEVICES:

| K Number | Proprietary Name | Company |
| --- | --- | --- |
| Preamendment | IMPRA® Vascular Graft | IMPRA, Inc. |
| K791810 | IMPRA® Vascular Graft | IMPRA, Inc. |
| K955460 | EXXCEL™ ePTFE Graft (6 - 10mm) | Meadox Medicals, Inc. |
| K960766 | EXXCEL™ ePTFE Graft (3 - 5mm) | Meadox Medicals, Inc. |

## DEVICE DESCRIPTION:
The unwrapped version of the MEADOX® EXXCEL™ ePTFE Vascular Graft is comprised of an expanded polytetrafluoroethylene (ePTFE) core tube. Externally supported grafts have a continuous PTFE spiral support coil wound around a portion of the graft.

## BIOCOMPATIBILITY:
Biocompatibility testing on MEADOX® EXXCEL™ ePTFE Vascular Grafts was performed on single-cycle steam sterilized grafts in accordance with the ISO-10993¹ standard for biological evaluation of medical devices. Carcinogenicity testing was not performed on MEADOX® EXXCEL™ ePTFE Vascular Grafts due to the established nontoxic properties of the graft materials. Prior biocompatibility testing was performed indicates that MEADOX® EXXCEL™ ePTFE Vascular Grafts are safe for their intended use.

| Summary of Biocompatibility Testing | | | |
| --- | --- | --- | --- |
| Test Description | ISO 10993 | MEADOX® EXXCEL™ | Pass or Fail |
| Cytotoxicity | ☑ | ☑ | pass |
| Sensitization | ☑ | ☑ | pass |
| Irritation or Intracutaneous reactivity | ☑ | ☑ | pass |
| Systemic Toxicity (acute) | ☑ | ☑ | pass |
| Sub-chronic toxicity (sub-acute) | ☑ | ☑ | pass |
| Genotoxicity / Mutagenicity | ☑ | ☑ | pass |
| Implantation | ☑ | ☑ | pass |
| Hemocompatibility (Hemolysis) | ☑ | ☑ | pass |
| Chronic Toxicity | ☑ | ☑ | pass |
| Carcinogenicity | ☑ | N/A | N/A |

* IMPRA is a registered trademark of IMPRA, Inc.
* MEADOX is a registered trademark of MEADOX MEDICALS, INC. a Division of the Boston Scientific Corporation
™ EXXCEL is a trademark of MEADOX MEDICALS, INC. a Division of the Boston Scientific Corporation

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{1}

PREMARKET NOTIFICATION
Meadox®
MEADOX® EXXCEL™ Unwrapped ePTFE Vascular Graft
Friday, June 21, 1996

## INDICATIONS:

The MEADOX® EXXCEL™ 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. Externerally Supported Grafts are used where kinking and compression resistance are desired.

## DESIGN MATERIALS:

Design materials of the MEADOX® EXXCEL™ ePTFE Vascular Grafts are substantially equivalent to the predicate devices identified above.

## MANUFACTURING:

The MEADOX® EXXCEL™ ePTFE Vascular Graft is produced by heating, stretching and winding an extruded polytetrafluoroethylene tube.

## SPECIFICATIONS:

Performance specifications of the MEADOX® EXXCEL™ ePTFE Vascular Grafts are substantially equivalent to the range of performance specifications found in the previously identified predicate devices. The following tests were performed to evaluate equivalence to predicate devices:

| Test Description | AAMI Standard (reference) | Equivalence pass/fail |
| --- | --- | --- |
| Internodal Distance | ✔ (8.2.1.3) | pass |
| Water Entry Pressure | ✔ (8.2.4) | pass |
| Radial Tensile Strength | ✔ (8.3.1) | pass |
| Longitudinal Tensile Strength | ✔ (8.3.2) | pass |
| Burst Strength | ✔ (8.3.3.3) | pass |
| Suture Retention Strength (longitudinal) | ✔ (8.8.4.1) | pass |
| Suture Retention Strength (oblique) | ✔ (8.8.4.2) | pass |
| Suture Hole Elongation | N/A | pass |
| Kink Diameter | ✔ (8.9) | pass |
| Crush Resistance | N/A | pass |
| Burst After Repeated Puncture (12 months) | ✔ (8.3.4) | pass |
| Burst After Repeated Puncture (18 months) | ✔ (8.3.4) | pass |
| Relaxed Internal Diameter | ✔ (8.5) | pass |
| Usable Length | ✔ (8.4) | pass |
| Nominal Wall Thickness | ✔ (8.7) | pass |

## CONCLUSION:

The MEADOX® EXXCEL™ ePTFE Vascular Graft has a level of safety and effectiveness comparable to currently marketed ePTFE Vascular Grafts.

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