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510(k) Data Aggregation

    K Number
    K970305
    Device Name
    PRINTER INTERFACE
    Manufacturer
    MICROMEDICAL, INC.
    Date Cleared
    1997-08-15

    (200 days)

    Product Code
    DXH
    Regulation Number
    870.2920
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Micromedical Printer Interface is used to download ECG data from a Micromedical ECG monitor and print ECG recordings on standard letter-sized paper by using one of a number of standard commercially available Canon or Hewlett Packard ink jet printers.

    Device Description

    The Micromedical Printer Interface receives data from a Micromedical ECG monitor and transmits it through a parallel cable to one of a number of commonly available Canon or H-P bubble jet printers to print the ECG tracing on standard-sized paper.

    AI/ML Overview

    This 510(k) pertains to a hardware device (Printer Interface) rather than an AI/ML powered software device. Therefore, the requested information regarding acceptance criteria, study details, and ground truth establishment, which are typical for AI/ML device evaluations, are not applicable here.

    The provided document describes the Micromedical Printer Interface as a device that receives data from a Micromedical ECG monitor and transmits it to a standard ink jet printer to print ECG tracings. The basis for clearance is substantial equivalence to an existing predicate device, the Ralin CorFax.

    Here's why the AI/ML-specific questions are not applicable:

    • Device Type: This is a hardware interface for printing, not an algorithm or software that processes or interprets medical data.
    • Substantial Equivalence: The clearance is based on comparing the new device to a legally marketed predicate device, demonstrating that it's as safe and effective. This typically involves performance bench testing, electrical safety, EMC testing, and ensuring the output is clinically equivalent to the predicate, rather than clinical studies with human readers or specific statistical performance metrics against a ground truth as would be done for an AI/ML algorithm.
    • Lack of AI/ML Component: The submission explicitly mentions "proprietary algorithms to receive the data from ECG monitors and transmit it to a printing device," but this refers to the internal software/firmware necessary for device function (e.g., data formatting, communication protocols), not AI/ML algorithms for medical diagnosis or interpretation.

    Therefore, the requested table and detailed study information for AI/ML devices cannot be extracted from this 510(k) submission.

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