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510(k) Data Aggregation

    K Number
    K042672
    Device Name
    14F DUAL FLOATING DIALYSIS CATHETER/TRAY
    Manufacturer
    CARDIOMED SUPPLIES, INC.
    Date Cleared
    2005-03-23

    (175 days)

    Product Code
    MSD
    Regulation Number
    876.5540
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    CMS Dual Floating Dialysis Catheters are indicated for use in attaining vascular access sites for Hemodialysis and Apheresis treatments. The device is attended to be inserted into the internal jugular vein of an adult patient. Catheter greater than 40cm are intended for femoral vein insertion

    Alternate insertion site is the subclavian vein as required. This catheter is indicated for duration not to exceed 12 months

    Device Description

    CardioMed-CMS 14F Dual Floating Dialysis Catheters

    AI/ML Overview

    I am sorry, but the provided text from the FDA document (K042672) describes a traditional medical device submission for a "CardioMed-CMS 14F Dual Floating Dialysis Catheters," not an AI/ML-driven device. As such, it does not contain information related to acceptance criteria, device performance metrics (like sensitivity, specificity, or AUC), sample sizes for test/training sets, ground truth establishment, expert qualifications, or MRMC studies that would be relevant for an AI/ML device.

    The document is a 510(k) clearance letter confirming that the device is substantially equivalent to a legally marketed predicate device. It focuses on regulatory aspects such as the device's classification, regulation number, product code, and general controls provisions of the Act, along with its indications for use.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and study proving device meets criteria for an AI/ML device based on this input.

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