(97 days)
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
The DIASTAT Vascular Access Graft is essentially an expanded PTFE vascular graft with the addition of one or more externally applied cannulation seqments 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.
The provided text does not contain information about acceptance criteria and a study proving a device meets those criteria in the context of AI/ML or diagnostic performance. Instead, it describes a traditional medical device (vascular graft) and aims to establish substantial equivalence to predicate devices, focusing on mechanical and in vivo performance rather than diagnostic accuracy.
Therefore, I cannot populate the requested table and answer the specific questions about acceptance criteria, device performance, ground truth, expert involvement, or AI study details because this information is not present in the provided submission.
Here's a breakdown of why the specific questions cannot be answered based on the provided text:
- Acceptance Criteria and Reported Device Performance (Table): The text mentions "reduced fluid leakage," "reduced times to hemostasis," "reduced blood loss in vivo," and "reduced incidence of hematoma" as performance characteristics. However, it does not provide specific quantitative acceptance criteria (e.g., "fluid leakage less than X mL/min") or quantitative reported device performance values against which such criteria would be measured. It only states that these characteristics were demonstrated or observed.
- Sample size for the test set and data provenance: No information on a "test set" in the context of diagnostic or AI performance. The studies mentioned are bench, animal, and "clinical setting observation." No sample sizes for these are given, nor is country of origin.
- Number of experts and qualifications: No experts are mentioned in the context of establishing ground truth for a test set.
- Adjudication method: Not applicable as there is no mention of a diagnostic test set requiring adjudication.
- MRMC comparative effectiveness study: No mention of human readers, AI assistance, or an MRMC study.
- Standalone study: No mention of an "algorithm only" performance study.
- Type of ground truth used: For the vascular graft, "ground truth" would relate to physiological outcomes (e.g., actual patency rates, infection rates) or observed mechanical performance. The text mentions "bench testing," "animal testing," and "clinical setting observation."
- Sample size for the training set: Not applicable as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
The document focuses on establishing substantial equivalence for a physical medical device (vascular graft) through comparisons of technological characteristics, bench testing, and animal studies, not AI/ML performance.
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TAB E K955532
SUMMARY OF SAFETY AND EFFECTIVENESS UPON WHICH SUBSTANTIAL EQUIVALENCE IS BASED
1
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 (520)526-3030 FAX (520) 526-3815
Date Summary Prepared: November 13, 1995
DEVICE NAME:
CLASSIFICATION NAME: Vascular Graft Prosthesis 6 mm and greater 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.
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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 seqments 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 prober 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
§ 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.”