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510(k) Data Aggregation

    K Number
    K183649
    Device Name
    Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable
    Manufacturer
    Baylis Medical Company Inc.
    Date Cleared
    2019-06-07

    (163 days)

    Product Code
    DRF
    Regulation Number
    870.1220
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K970853
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Diagnostic Fixed Electrophysiology Catheter and Diagnostic Electrophysiology Cable are intended for electrogram recording and pacing during diagnostic electrophysiology studies.

    Device Description

    The Diagnostic Fixed Electrophysiology Catheter is a sterile, single-use 2F diagnostic catheter with multiple electrodes and a fixed distal curve. The catheter is intended to be placed in the heart percutaneously for the purpose of temporary cardiac pacing and electrophysiology studies of the heart, such as the coronary sinus and atrioventricular annulus. The catheter is connected to separately cleared diagnostic electrophysiology equipment via an accessory, the Diagnostic Electrophysiology Cable. The cable is supplied sterile and is reusable.

    AI/ML Overview

    The provided document is a 510(k) summary for a medical device (Diagnostic Fixed Electrophysiology Catheter and Diagnostic Electrophysiology Cable) and primarily focuses on proving substantial equivalence to a predicate device. It does not contain the kind of detailed information about acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, or adjudication methods that would be relevant for an AI-powered diagnostic device's performance study.

    The performance testing section (page 5) lists various non-clinical verifications and validations (Biocompatibility, Mechanical, Electrical, Bench, Cleaning/Re-Sterilization, Reuse, Animal Studies, Packaging). These are standard tests for the safety and functionality of an electrophysiology catheter and cable, not for evaluating the diagnostic accuracy of an AI algorithm.

    Therefore, I cannot extract the requested information regarding acceptance criteria and performance study details for an AI device from this document. The document confirms that "The Diagnostic Fixed Electrophysiology Catheter and accessory cable met all requirements as specified by the test protocols," but these protocols are about device safety and fundamental physical/electrical performance, not diagnostic accuracy of an AI.

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