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510(k) Data Aggregation

    K Number
    K181803
    Device Name
    Medax Biopsy Systems III
    Manufacturer
    Medax Srl Unipersonale
    Date Cleared
    2018-10-18

    (105 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    K192099,K192101,K210946
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    MEDEASY, UNIVERSAL DUO, VELOX, VELOX 2, UNIVERSAL PLUS, UNIVERSAL, LUX, LUX 2, FACILE, CAESAR biopsy needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue masses. It is not intended for use in bone biopsy
    NEO OXUS, HEMAX biopsy needle must be used for bone marrow aspiration and the posterior iliac crest biopsy
    PERFECTUS, HANDLEX biopsy needle must be used for bone marrow aspiration from sternum or litac crest
    HEPAX biopsy needle is intended for use in obtaining histological biopsies of soft tissues. It is not intended for use in bone biopsy.
    FNA (Chiba(Quincke/Turner/Westcott/Fransen) biopsy needles is intended for use in obtaining biopsies from soft tissues such as thyroid, liver, breast, spleen, abdomen, pancreas, lungs, lymph nodes and various soft tissue masses. It is not intended for use in bone biopsy.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text from the FDA 510(k) clearance letter for the Medax Biopsy Systems III does not contain any information about acceptance criteria or a study proving the device meets those criteria, specifically concerning AI/algorithm performance.

    The document is a standard 510(k) clearance letter, which focuses on:

    • Substantial equivalence to legally marketed predicate devices.
    • Regulatory classifications and general controls.
    • Indications for Use of the biopsy needles (e.g., for soft tissues, bone marrow aspiration).

    Therefore, I cannot extract the information requested for point 1 through 9. The text simply confirms the clearance of medical biopsy devices and their intended uses, not a study involving AI or algorithm performance metrics.

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