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510(k) Data Aggregation

    K Number
    K180957
    Device Name
    exGraft, exGraft Carbon ePTFE Vascular Grafts
    Manufacturer
    PECA Labs
    Date Cleared
    2018-08-21

    (131 days)

    Product Code
    DSY
    Regulation Number
    870.3450
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K004011,K954582
    Why did this record match?
    Device Name :

    exGraft, exGraft Carbon ePTFE Vascular Grafts

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The exGraft and exGraft Carbon ePTFE Vascular Grafts are indicated for use as vascular prostheses.

    The exGraft and exGraft Carbon ePTFE Vascular Grafts are intended for use as subcutaneous arteriovenous conduits for blood access, bypass, or reconstruction of peripheral arterial blood vessels.

    Device Description

    The exGraft and exGraft Carbon ePTFE Vascular Grafts are single use sterile vascular grafts constructed of expanded polytetrafluoroethylene (ePTFE) with a radiopaque ink applied to the outer surface. The exGraft Carbon ePTFE vascular grafts also contain a carbon coating impregnated into the inner surface of the graft wall.

    AI/ML Overview

    The provided text describes the 510(k) summary for the exGraft and exGraft Carbon ePTFE Vascular Grafts. While it details the device and its comparison to predicate devices, it does not contain information about a study involving AI or human readers for diagnostic purposes.

    The performance data section outlines:

    • Biocompatibility Evaluation: Conducted according to ISO 10993-1, including tests for cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogen testing, implantation, and hemocompatibility. It also mentions chemical characterization and toxicological risk assessment for subacute/subchronic systemic toxicity, chronic systemic toxicity, genotoxicity, and carcinogenicity.
    • Bench Testing: Included probe burst strength, suture retention strength, longitudinal tensile strength, circumferential tensile strength, water entry pressure, microscopic porosity, strength after repeated puncture, kink radius, ink thickness, accelerated ink wear, and MRI safety evaluation.

    Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details because this information is not present in the provided document.

    The document describes the physical and chemical testing of a vascular graft device, not the performance of a diagnostic AI system.

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