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510(k) Data Aggregation

    K Number
    K991602
    Device Name
    EPTFE RINGED GORE-TEX VASCULAR GRAFT
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Date Cleared
    1999-07-09

    (60 days)

    Product Code
    DSY
    Regulation Number
    870.3450
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ePTFE Ringed GORE-TEX Vascular Graft is intended for use as a vascular prosthesis for replacement or bypass of diseased vessels in the patients suffering occlusive or aneursymal diseases, in trauma patients requiring vascular replacement, for dialysis access, or for other vascular procedures.

    Device Description

    The ePTFE Ringed GORE-TEX Vascular Graft is an expanded polytetrafluoroethylene (ePTFE) vascular graft base tube with ePTFE reinforcing film and optional manufacturing modifications. The proposed modifications consist of replacing external, semi-rigid reinforcing rings of fluorinated ethylene propylene (FEP) with rings created within the graft wall of the ePTFE. These ring structures alternate with a typical graft structure the entire length of the graft. Additionally, small gold dots may be placed at intervals anywhere along the graft, in conjunction with, or as an alternative to the blue orientation markers. The proposed modifications do not present new issues of safety and effectiveness compared to predicate vascular grafts.

    AI/ML Overview

    The provided document describes a medical device, the ePTFE Ringed GORE-TEX® Vascular Graft, and its clearance through the FDA's 510(k) process, which demonstrates substantial equivalence to predicate devices. This type of submission does not typically involve the detailed clinical studies with acceptance criteria, ground truth establishment, or human-AI performance comparisons that one would find for novel devices or software.

    Therefore, many of the requested categories are not applicable to this document as it pertains to a traditional medical device demonstrating substantial equivalence based on material and mechanical properties, and in vivo performance compared to existing predicate devices, rather than a device with performance metrics based on, for example, image analysis or diagnostic accuracy.

    Here's a breakdown of the requested information based on the provided text:

    1. A table of acceptance criteria and the reported device performance

    Acceptance CriteriaReported Device Performance
    Material Equivalence: Composed of similar biomaterials to predicate devices.The applicant device is composed of the same ePTFE biomaterial as other GORE-TEX® Vascular Grafts. (Implied accepted, as it was cleared)
    Mechanical Testing Data: Mechanical characteristics substantially equivalent to predicate devices.Mechanical testing data demonstrate the applicant device has mechanical characteristics substantially equivalent to the predicate devices. (Implied accepted, as it was cleared)
    In vivo Testing: Performance substantially equivalent to predicate devices.In vivo testing demonstrates that applicant device performance is substantially equivalent to the predicate devices. (Implied accepted, as it was cleared)
    Safety and Effectiveness: No new issues raised by modifications.The proposed modifications do not present new issues of safety and effectiveness compared to predicate vascular grafts. No new types of safety and effectiveness issues are raised by the proposed modifications. (Implied accepted, as it was cleared)

    2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

    • Not applicable / Not explicitly stated. The document refers to "mechanical testing data" and "in vivo testing" but does not provide specific sample sizes or details on the test sets, data provenance, or study design (e.g., retrospective vs. prospective). This type of information is typically provided in detailed study reports, which are not part of this summary document.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

    • Not applicable. The "ground truth" for this device's performance is established through material characterization, mechanical property testing, and animal (in vivo) studies, rather than expert consensus on diagnostic interpretations. The document does not mention human experts establishing ground truth in this context.

    4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

    • Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for expert review of images or clinical cases to establish a definitive diagnosis or outcome. This is not relevant for the type of testing described (material, mechanical, in vivo performance).

    5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

    • Not applicable. This device is a vascular graft, not an AI-powered diagnostic tool. Therefore, MRMC studies and the concept of human readers improving with AI assistance are irrelevant to this submission.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

    • Not applicable. This device is a physical medical implant, not an algorithm, so standalone performance is not a relevant concept in this context.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

    • The ground truth for demonstrating substantial equivalence for this device would be based on:
      • Material specifications and established standards: For ePTFE biomaterial properties.
      • Mechanical engineering principles and test standards: For burst strength, suture retention, fatigue resistance, and other mechanical characteristics.
      • Histopathological analysis and physiological responses: From in vivo animal studies to assess biocompatibility, host tissue integration, and patency, as compared to predicate devices.
      • Clinical outcomes from predicate devices: The safety and effectiveness of the predicate GORE-TEX Vascular Grafts are already established.

    8. The sample size for the training set

    • Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."

    9. How the ground truth for the training set was established

    • Not applicable. As there is no training set, this question is irrelevant.
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