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510(k) Data Aggregation

    K Number
    K030723
    Device Name
    IVS INTRODUCER SET, MODEL 1003
    Manufacturer
    INTEGRATED VASCULAR SYSTEMS, INC.
    Date Cleared
    2003-04-03

    (27 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K020789,K021004,K964814
    Predicate For
    K031583,K060902
    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 6 French Introducer Sheath, a Dilator and a 0.38" (0.97mm) 'J' tip Guidewire

    AI/ML Overview

    The provided text is a 510(k) summary for the IVS Introducer Set, Model 1003. It primarily focuses on demonstrating substantial equivalence to predicate devices and does not describe a study with specific acceptance criteria and performance metrics for a novel medical device like AI algorithms.

    Therefore, I cannot provide the requested information about acceptance criteria and study results because the submitted document does not contain this type of data. The 510(k) summary is for a device seeking clearance based on substantial equivalence, not a new device requiring performance studies against defined acceptance criteria in the manner an AI device would.

    Here's a breakdown of why this information isn't present in the provided text:

    • Type of Device: The IVS Introducer Set is a physical medical device (catheter introducer, dilator, guidewire), not an AI/software device.
    • Regulatory Pathway: The 510(k) pathway for this device relies on demonstrating "substantial equivalence" to a legally marketed predicate device, meaning it has the same intended use, technological characteristics, and raises no new questions of safety or effectiveness. This is different from the rigorous performance studies often required for novel AI devices.
    • Testing Information: The document states, "The IVS Introducer Set has been tested in vitro and in clinical model systems. Test results show that the modifications to the device do not affect the safety or effectiveness of the device for the intended use." This is a very high-level statement and does not provide specific acceptance criteria, performance metrics, sample sizes, or details about ground truth and experts as would be expected for an AI device study.

    If you can provide a document describing a performance study for an AI device, I would be happy to complete the requested table and information.

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