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510(k) Data Aggregation

    K Number
    K031583
    Device Name
    MODIFICATION TO IVS INTRODUCER SET, MODEL 1003
    Manufacturer
    INTEGRATED VASCULAR SYSTEMS, INC.
    Date Cleared
    2003-06-16

    (26 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K030723
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The IVS Introducer Set is indicated for use in procedures requiring percutaneous introduction of intravascular devices.

    Device Description

    The IVS Introducer Set consists of a 7 French Introducer Sheath and a Dilator with or without a 0.38" (0.97mm) 'J' tip Guidewire.

    AI/ML Overview

    This submission does not contain information about acceptance criteria or a study that proves the device meets acceptance criteria. The document is a 510(k) summary for the IVS Introducer Set, Model 1003-7, indicating its substantial equivalence to a predicate device (Model 1003-6).

    The relevant sections state:

    • "Testing: The IVS Introducer Set is tested in vitro and in clinical model systems. The modifications to the device do not affect the safety or effectiveness of the device for the intended use."

    This statement confirms that some testing was performed, but it lacks specific details about:

    • What acceptance criteria were used.
    • The results of the tests.
    • The methodology of the "clinical model systems."
    • Any statistical analysis or sample sizes.
    • An AI/Software component that would involve ground truth, expert review, or training/test sets.
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