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510(k) Data Aggregation

    K Number
    K040666
    Device Name
    STEP-TIP CHRONIC HEMODIALYSIS CATHETER
    Manufacturer
    ARROW INTERNATIONAL, INC.
    Date Cleared
    2004-05-14

    (60 days)

    Product Code
    MSD
    Regulation Number
    876.5540
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K040078
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Arrow® Step-Tip Catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. It is inserted percutaneously in internal jugular or subclavian vein. It is intended to be used only in adult patients.

    Device Description

    The Step-Tip Catheter consists of a double lumen catheter with a detached connector assembly. This allows the arterial port at the catheter tip to be precisely positioned within the right atrium and the venous port to be positioned within the superior vena cava. After the catheter has been positioned, the proximal end of the catheter is tunneled retrograde to the exit site. The connector assembly is then fastened to the proximal end of the catheter using a compression sleeve and compression cap.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for the "Step-Tip chronic hemodialysis catheter." This document is a regulatory submission demonstrating substantial equivalence to a legally marketed predicate device, rather than a clinical study reporting performance against specific acceptance criteria in the way an AI/ML medical device submission would.

    Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set information) are not applicable to this type of regulatory submission for a traditional medical device like a catheter. The device's performance is established through bench testing and a comparison to a predicate device, not through an AI algorithm's diagnostic accuracy.

    Here's a breakdown of the available information:

    Acceptance Criteria and Device Performance (as inferred from the 510(k) Summary)

    Acceptance Criteria (Implied)Reported Device Performance
    Substantial equivalence to the predicate device (Arrow Cannon Catheter™ II Plus) in terms of safety and effectiveness."The results of the laboratory and in-vivo tests demonstrate that the device is as safe and effective as the legally marketed predicate devices."
    Functional performance characteristics (e.g., adequate flow rate)."Tests were performed to demonstrate substantial equivalence in the following areas: - Flow rate tests"
    Biocompatibility and safety (e.g., minimal red blood cell damage)."Tests were performed to demonstrate substantial equivalence in the following areas: - Hemolysis tests"
    Efficiency of dialysis (e.g., minimizing recirculation of blood)."Tests were performed to demonstrate substantial equivalence in the following areas: - Recirculation tests"
    Identical technological characteristics to the predicate device."The proposed device has the same technological characteristics as the predicate device."

    Detailed Study Information

    1. Sample size used for the test set and the data provenance: Not applicable. Performance was demonstrated through laboratory and in-vivo tests, not a clinical "test set" in the context of an AI/ML algorithm. The document doesn't specify the sample sizes for these tests or their provenance.
    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not an AI/ML device, so there's no diagnostic "ground truth" to be established by experts for a test set.
    3. Adjudication method for the test set: Not applicable.
    4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a physical medical device (catheter), not an AI algorithm.
    5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
    6. The type of ground truth used: Not applicable in the context of diagnostic accuracy. For a physical device, "ground truth" would relate to engineering specifications, validated test methods (e.g., hemolysis standards, flow rate measurements), and comparison to the predicate device's established performance.
    7. The sample size for the training set: Not applicable. This device does not involve a "training set" as it's not an AI/ML algorithm.
    8. How the ground truth for the training set was established: Not applicable.
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