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510(k) Data Aggregation

    K Number
    K082890
    Device Name
    VNUS CLOSUREFAST INTRAVASCULAR CATHETER, MODELS CF7-7-60-2, CF7-7-100-2
    Manufacturer
    VNUS MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    2008-10-15

    (15 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VNUS CLOSUREFAST INTRAVASCULAR CATHETER, MODELS CF7-7-60-2, CF7-7-100-2

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

    The ClosureFAST™ Catheter is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text from the FDA letter about the "ClosureFAST™ Intravascular Catheter" (K082890) does not contain the specific details required to answer your request regarding acceptance criteria and a study proving device performance.

    The document is a 510(k) clearance letter, which primarily states that the device has been found substantially equivalent to a predicate device and can be marketed. It lists the device name, regulation number, product code, and indications for use. However, it does not include information about:

    • Acceptance criteria or reported device performance metrics.
    • Details of any specific study (sample size, data provenance, ground truth, expert qualifications, adjudication methods).
    • Whether a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study was done.
    • Training set details for any AI/algorithm (which isn't applicable here as this is a catheter, not an AI device).

    Therefore, I cannot generate the requested table and study details based on the provided text.

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