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 Description

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the DIASTAT® VASCULAR ACCESS GRAFT:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the acceptance criteria are implicitly linked to the concept of "substantial equivalence" to predicate devices. The performance metrics reported focus on aspects where the DIASTAT graft demonstrates specific advantages or similar performance to these predicates.

Acceptance Criteria (Implicit)	Reported Device Performance
Substantial equivalence in performance to predicate devices (e.g., Plasma TFE Vascular Graft, GORE-TEX Vascular Grafts)	Confirmed through characterizations, tests, and observations that the DIASTAT Vascular Access Graft is substantially equivalent to the Plasma TFE Vascular Graft for cannulation within one week of implantation.
Does not raise new issues of safety and effectiveness compared to predicate devices.	"DIASTAT Vascular Access Graft does not raise any new issues of safety and effectiveness." No new biocompatibility or blood-contact issues.
Reduced fluid leakage (compared to predicates or general expectations for vascular grafts).	Demonstrated in bench testing (using water, a liquid more likely to leak than heparinized blood).
Reduced times to hemostasis (compared to predicates or general expectations for vascular grafts).	Demonstrated in animal testing.
Reduced blood loss in vivo (compared to predicates or general expectations for vascular grafts).	Demonstrated in animal testing.
Reduced incidence of hematoma (compared to predicates or general expectations for vascular grafts).	Demonstrated in animal testing.
Mechanical low bleed feature.	Possesses a "specific mechanical low bleed feature which has been characterized in bench tested in vivo and observed in the clinical setting."
Appropriately addresses potential risks of early cannulation (e.g., infection, patency).	Risks addressed in proposed labeling changes emphasizing strict aseptic technique for early cannulations.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not explicitly stated. The text mentions "bench testing," "animal testing," and being "observed in the clinical setting," but no specific sample sizes for these tests are provided.
Data Provenance:
- Bench Testing: In-house (W.L. Gore & Associates Inc. laboratories).
- Animal Testing: In-house (W.L. Gore & Associates Inc. laboratories).
- Clinical Setting: Observations in a "clinical setting" are mentioned, but it's not described as a formal clinical trial with a defined population. It is stated that a "prospective randomized clinical study of early cannulation of the DIASTAT Vascular Access Graft was not performed." This suggests the clinical observations were likely retrospective or informal case observations rather than a structured prospective study.
- Country of Origin: Implied to be the USA, given the headquarters of W.L. Gore & Associates Inc.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided. The document describes mechanical tests and animal studies, not human expert evaluations for establishing ground truth in the traditional sense of diagnostic accuracy studies.

4. Adjudication Method for the Test Set

Not applicable/Not provided. The studies described are primarily performance and safety characteristic evaluations, not a diagnostic test being adjudicated by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done. The document explicitly states: "A prospective randomized clinical study of early cannulation of the DIASTAT Vascular Access Graft was not performed." The comparison is based on substantial equivalence to predicate devices through mechanical and animal testing, and observations, rather than a clinical trial directly comparing human readers with and without AI assistance (which is what MRMC studies often evaluate when AI is involved).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the device is a physical vascular graft, not an algorithm or AI system for diagnostic interpretation. The performance discussed is inherent to the physical device.

7. The Type of Ground Truth Used

Bench Testing: Physical measurements and observations of fluid leakage using water.
Animal Testing: Direct observation and measurement of physiological parameters (hemostasis time, blood loss, hematoma incidence) in animal models.
Clinical Setting: "Observations" indicate real-world outcomes, likely without a formally established "ground truth" as would be defined in a clinical trial. The "ground truth" here is implied to be the direct observed in vivo performance and absence of unexpected adverse events.

8. The Sample Size for the Training Set

Not applicable as this is a physical medical device, not a machine learning model requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

{0}------------------------------------------------

P.57
K955533

TAB E

MAY 1 5 1996

SUMMARY OF SAFETY AND EFFECTIVENESS UPON WHICH SUBSTANTIAL EQUIVALENCE IS BASED

510(k) SUBMITTER:

NAME:	W.L. Gore & Associates Inc.
ADDRESS:	1505 N. Fourth StreetP.O. Box 2200Flagstaff, 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 (520)526-3030 FAX (520) 526-3815

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 nonclinical 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.

{1}------------------------------------------------

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 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

Regulation Number and Section

§ 870.3450 Vascular graft prosthesis.

(a)
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.(b)
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.”