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510(k) Data Aggregation

    K Number
    K955460
    Device Name
    MEADOX MEDICALS, INC., EXPANDED & EXTERNALLY SUPPORTED EXPANDED PTFE VASCULAR GRAFT
    Manufacturer
    MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
    Date Cleared
    1996-05-30

    (183 days)

    Product Code
    DSY
    Regulation Number
    870.3450
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    K962433
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MEADOX® 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. Externally Supported Grafts are used where kinking and compression resistance are desired.

    Device Description

    The ePTFESSENDOS, Vascular Graft is comprised of an expanded polytetrafluoroethylene (ePTFE) core tube reinforced by a multi-filament PTFE yarn helically wound around the exterior of the tube. Externally supported grafts have a continuous PTFE spiral support coil wound around a portion of the graft.

    AI/ML Overview

    The provided text describes a medical device, the Meadox Medicals, Inc., Expanded Reinforced PTFE Vascular Graft, and its characteristics, rather than an AI/ML powered device. Therefore, the requested information regarding acceptance criteria and a study proving an AI/ML device meets them (including details like sample size for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) is not applicable to this document.

    The document focuses on:

    • Device Description: Material composition (ePTFE core with PTFE yarn reinforcement, optional external support coil).
    • Biocompatibility Testing: Demonstrates the device passed various tests (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Sub-chronic Toxicity, Genotoxicity/Mutagenicity, Implantation, Hemocompatibility, Chronic Toxicity) in accordance with ISO-10993 standards.
    • Predicate Devices: Lists similar commercially available devices to establish substantial equivalence.
    • Performance Specifications: States that the device's performance specifications (e.g., Internodal Distance, Water Entry Pressure, Tensile Strengths, Burst Strength, Suture Retention, Kink Diameter, Crush Resistance) are "Equivalent to marketed products" (predicate devices).

    Therefore, I cannot extract the requested information as it pertains to AI/ML device evaluation, which is not described in this document.

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