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510(k) Data Aggregation

    K Number
    K142614
    Device Name
    AngioDynamics VenaCure EVLT Tre’ Sheath and VenaCure EVLT NeverTouch Procedure Kits
    Manufacturer
    AngioDynamics, Inc.
    Date Cleared
    2014-10-10

    (24 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    AngioDynamics VenaCure EVLT Tre’ Sheath and VenaCure EVLT NeverTouch Procedure Kits

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

    The VenaCure EVLT Tre' Sheath and VenaCure EVLT NeverTouch Procedure Kits are indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity.

    Device Description

    The VenaCure EVLT Tre' Sheath is a 4F sheath used during endovascular venous laser treatment procedures. The sheath is used as a conduit for placing a laser fiber. The product will be offered in 25, 45, 65 and 90cm lengths. The VenaCure EVLT Tre' Sheath will be provided both as a standalone product and also packaged with a variety of procedural accessories.

    AI/ML Overview

    The provided document is a 510(k) summary for a medical device (VenaCure EVLT Tre' Sheath and VenaCure EVLT NeverTouch Procedure Kit). It details the device's intended use and claims substantial equivalence to a predicate device.

    Crucially, this document describes a traditional medical device, not an AI/ML-based device. Therefore, the concepts of "acceptance criteria for an AI algorithm," "sample size for a test set," "ground truth establishment," "MRMC studies," "standalone performance," or "training sets" as they relate to AI/ML are not applicable here.

    The "performance data" mentioned in the document refers to non-clinical performance and material testing for the physical device, such as tensile strength, torque, and biocompatibility, as per regulatory requirements for medical devices.

    If this were an AI/ML device, the detailed information about studies and acceptance criteria would be essential. However, for a physical medical device submission, the focus is on demonstrating safety and effectiveness through different types of testing and comparison to legally marketed predicate devices.

    Therefore, I cannot extract the requested information as it pertains to AI/ML device validation from this document.

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