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510(k) Data Aggregation

    K Number
    K093184
    Device Name
    ENVOY GUIDING CATHETERS
    Manufacturer
    Codman & Shurtleff, Inc.
    Date Cleared
    2009-11-06

    (28 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K693184
    Predicate For
    K102418,K132542,K140080,K140307
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ENVOY® Guiding Catheter is intended for use un the peripheral, coronary, and neurovasculature for the intravascular introduction of interventional/diagnostic devices.

    Device Description

    The ENVOY Guiding Catheter is intended for use in the peripheral, coronary, and neurovasculature for the intravascular introduction of interventional/diagnostic devices.

    AI/ML Overview

    Due to the nature of the provided text, which is an FDA 510(k) summary and clearance letter for a medical device (ENVOY® Guiding Catheter), it does not contain the kind of information typically found in a study describing acceptance criteria for an AI/device performance.

    This document is a regulatory submission for a physical medical device, not a software or AI-driven diagnostic tool. Therefore, it does not involve:

    • Algorithm performance metrics (like sensitivity, specificity, AUC)
    • Sample sizes for test or training sets for AI models
    • Expert consensus for ground truth on images (as there are no images being analyzed by AI)
    • MRMC studies to compare human reader performance with and without AI assistance
    • Standalone algorithm performance studies

    The 510(k) summary focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific quantitative acceptance criteria for an AI output.

    Therefore, I cannot provide a table of acceptance criteria and reported device performance or other details related to AI study design based on the provided text.

    The document primarily states:

    • Intended Use: The ENVOY guiding catheter is intended for use in the peripheral, coronary, and neurovasculature for the intravascular introduction of interventional/diagnostic devices.
    • Substantial Equivalence: The device is substantially equivalent to the previously cleared ENVOY Guiding Catheter (from Cordis Endovascular Systems, Inc.).
    • Biocompatibility: All materials are biocompatible.

    These points are the core "acceptance criteria" and "performance" relevant to this type of regulatory submission for a physical catheter. They don't lend themselves to the AI-specific questions requested.

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