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510(k) Data Aggregation

    K Number
    K982333
    Device Name
    MODIFICATION TO ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET AND TRAY
    Manufacturer
    COOK, INC.
    Date Cleared
    1999-02-12

    (225 days)

    Product Code
    MSD
    Regulation Number
    876.5540
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K923468,K871749
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Uldall Double Lumen Hemodialysis Catheter is designed for short or long-term hemodialysis access in the presence of renal failure. Percutaneously placed double lumen catheter is intended for blood infusion and withdrawal. This device and components of the tray are supplied sterile and intended for single-use only.

    Device Description

    The Uldall Double Lumen Hemodialysis catheter is a silicone double lumen catheter to be used for blood withdrawal and infusion. The silicone material will be the same the material used for the commercially available Uldall Double Lumen Hemodialysis Catheter. The double lumen construction will allow for blood withdrawal through the distal port and blood infusion through the proximal port. The ports will be separated by cutting away 1 cm of the thin walled lumen. The catheter will have standard Luer lock fittings on the proximal end. Lumen volume information will be printed on the extension tubes of the manifold assembly. Tubing clamps will be placed on the extension tubes. A synthetic fiber cuff will be affixed to the catheter to allow for device fixation.

    AI/ML Overview

    The provided text describes the Uldall Double Lumen Hemodialysis Catheter and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device.

    The document is a 510(k) submission for a medical device (a hemodialysis catheter), not an AI/ML device. Therefore, the requested information about AI model performance, test sets, ground truth, experts, MRMC studies, or training sets is not applicable and not present in the provided text.

    The "Test Data" section only lists the types of physical tests performed on the catheter to assure reliable design and performance, which are:

    • Pull Testing - Cuff Adhesion to Catheter Shaft
    • Pull Testing - Fitting/Extension Tube Junction
    • Pull Testing - Tunneler
    • Lumen Volume

    It states that "The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a hemodialysis catheter." However, specific numerical acceptance criteria or the detailed results of these tests are not provided in the document.

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