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510(k) Data Aggregation

    K Number
    K113584
    Device Name
    PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER
    Manufacturer
    ST. JUDE MEDICAL
    Date Cleared
    2012-03-02

    (88 days)

    Product Code
    DXO,DQX,DRG
    Regulation Number
    870.2870
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K080813
    Why did this record match?
    Device Name :

    PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    PressureWire® is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a vessel. The signal output of the sensor is used for calculation and presentation of any physiological parameters, functions or indices based on temperature or pressure, e.g. Fractional Flow Reserve (FFR).

    Pressure Wire® is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the heart and in the coronary and peripheral blood vessels.

    Device Description

    The Subject Device, PressureWire is a 0.014'' guidewire with a pressure and temperature sensor integrated into the tip to enable measurements of physiological parameters.

    The PressureWire is available in 2 configurations:

    • . Wired version using a cable (PressureWire Certus) to connect with the diagnostic computer
    • . Wireless version (PressureWire Aeris).

    Both PressureWire connection configurations connect to a diagnostic computer or a catheter laboratory hemodynamic recording system and are available in two lengths, 183 cm or 300 cm.

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to compose the type of response you are looking for. The document is a 510(k) summary for a medical device (PressureWire), outlining its description, intended use, indications for use, and a statement of substantial equivalence to a predicate device. It also includes the FDA's clearance letter.

    However, the summary does not provide details regarding:

    1. Acceptance criteria and reported device performance in a table.
    2. Sample size, data provenance, number of experts, qualifications of experts, or adjudication methods for any test set.
    3. Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or an effect size for human readers with and without AI assistance. The device described is a physical guidewire with a pressure/temperature sensor, not an AI-assisted diagnostic tool.
    4. Whether a standalone (algorithm only) performance study was done. Again, this is not an AI algorithm.
    5. The type of ground truth used.
    6. Sample size for the training set or how ground truth for the training set was established.

    The document focuses on demonstrating substantial equivalence to a predicate device based on functional, safety, and biocompatibility testing, rather than presenting a detailed clinical study with performance metrics against pre-defined acceptance criteria for an AI or diagnostic algorithm. The "Summary of performance testing" section broadly states that "The successful completion of verification activities demonstrates that the PressureWire meets the required product specifications," but it doesn't quantify those specifications or the results in a detailed manner.

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