DIASTAT VASCULAR ACCESS GRAFT

K955533 · W. L. Gore & Associates, Inc. · DYF · May 15, 1996 · Cardiovascular

Device Facts

• Record ID: K955533
• Device Name: DIASTAT VASCULAR ACCESS GRAFT
• Applicant: W. L. Gore & Associates, Inc.
• Product Code: DYF · Cardiovascular
• Decision Date: May 15, 1996
• Decision: ST
• Submission Type: Traditional
• Regulation: 21 CFR 870.3450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DIASTAT Vascular Access Graft, intended for use as a vascular prosthesis in patients requiring vascular access, and which may be cannulated within one week of implantation

Device Story

Expanded PTFE vascular graft; features externally applied cannulation segments of expanded PTFE fibers and covering; optional external FEP rings (fixed/removable, extensible/non-stretch). Used as vascular access prosthesis; allows early cannulation (within one week). Mechanical low-bleed feature reduces blood loss and hematoma incidence post-cannulation. Physician-implanted in clinical setting. Output is physical graft structure; clinical benefit is reduced time to hemostasis and earlier access for dialysis/treatment. Labeling emphasizes strict aseptic technique to mitigate infection risks associated with early cannulation.

Clinical Evidence

No prospective randomized clinical study performed. Evidence consists of bench testing (fluid leakage using water) and in vivo animal testing (hemostasis time, blood loss, hematoma incidence). Clinical observations confirm mechanical low-bleed performance consistent with predicate Plasma TFE graft.

Technological Characteristics

Expanded PTFE (ePTFE) vascular graft; externally applied cannulation segments (ePTFE fibers/covering); optional FEP reinforcement rings. Mechanical design provides low-bleed characteristics. Biocompatibility consistent with existing ePTFE grafts.

Indications for Use

Indicated for patients requiring vascular access who need a vascular prosthesis capable of being cannulated within one week of implantation.

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

• DIASTAT Vascular Access Grafts (various configurations)
• GORE-TEX Vascular Grafts (various configurations)
• Atrium Plasma TFE Vascular Graft

Submission Summary (Full Text)

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MAR 24 95 09:29PM W.L. GORE TEX ASG P.5/6
K955533
TAB E
MAY 15 1995

SUMMARY OF SAFETY AND EFFECTIVENESS
UPON WHICH SUBSTANTIAL EQUIVALENCE IS BASED

510(k) SUBMITTER:

NAME: W.L. Gore & Associates Inc.
ADDRESS: 1505 N. Fourth Street
P.O. Box 2200
Flagstaff, AZ 86003-2200

CONTACT PERSON:
Timothy J. Rynn
W.L. Gore & Associates, Inc.
1505 N. Fourth Street
P.O. Box 2200
Flagstaff, AZ 86003-2200
[phone]
FAX [phone]

Date Summary Prepared: November 13, 1995

DEVICE NAME:

CLASSIFICATION NAME: Vascular Graft Prosthesis less than 6 mm diameter
COMMON/USUAL NAME: Vascular Graft
TRADE/PROPRIETARY NAME: DIASTAT® VASCULAR ACCESS GRAFT

The DIASTAT Vascular Access Graft, intended for use as a vascular prosthesis in patients requiring vascular access, and which may be cannulated within one week of implantation, is substantially equivalent to various configurations of legally marketed predicate DIASTAT Vascular Access Grafts, various configurations of GORE-TEX® Vascular Grafts and the Atrium Plasma TFE™ Vascular Graft. DIASTAT Vascular Access Grafts are subject to the same general Quality Assurance systems and controls as GORE-TEX Vascular Grafts.

Substantially equivalent performance is demonstrated by a variety of mechanical and non-clinical in vivo tests. Reduced fluid leakage was demonstrated in bench testing using water, a liquid more likely to leak than heparinized blood. Animal testing confirmed this performance characteristic, with reduced times to hemostasis and reduced blood loss in vivo, and also demonstrated reduced incidence of hematoma.

Early cannulation techniques, including poor aseptic practice, and cannulation into swollen tissue, may tend to increase the risk of infection and thereby affect graft patency. These risks are addressed in the proposed labeling changes emphasizing strict aseptic technique for early cannulations.

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MAR 24 2016 03:00 PM

P.6/6

# TAB E SUMMARY OF SAFETY AND EFFECTIVENESS UPON WHICH SUBSTANTIAL EQUIVALENCE IS BASED

A prospective randomized clinical study of early cannulation of the DIASTAT Vascular Access Graft was not performed. The DIASTAT Vascular Access Graft possesses a specific mechanical low bleed feature which has been characterized in bench testing, tested in vivo, and observed in the clinical setting. These characterizations, tests, and observations confirm that the DIASTAT Vascular Access Graft is substantially equivalent to the Plasma TFE Vascular Graft for cannulation within one week of implantation, and that the DIASTAT Vascular Access Graft does not raise any new issues of safety and effectiveness.

The DIASTAT Vascular Access Graft is essentially an expanded PTFE vascular graft with the addition of one or more externally applied cannulation segments comprised of expanded PTFE fibers and an expanded PTFE covering. The graft is provided with or without external reinforcement in the form of FEP rings which may be fixed or removable, and in either extensible or non-stretch configurations. A comparison of the technological characteristics of the DIASTAT Vascular Access Graft and predicate devices reveals that no new types of safety and effectiveness questions are raised. No new biocompatibility or blood-contact issues are presented by the DIASTAT Vascular Access Graft.

The claims, labeling, and intended use of the DIASTAT Vascular Access Graft are substantially equivalent to those for the predicate DIASTAT Vascular Access Graft, all other GORE-TEX Vascular Grafts, and the Plasma TFE Vascular Graft. They have been modified only as necessary to accurately describe the product and to ensure that adequate and proper instructions for use as a vascular access prosthesis are provided.

© GORE-TEX and DIASTAT are registered trademarks of W.L. Gore & Associates, Inc.

*Plasma TFE is a trademark of Atrium Medical Corporation