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    K Number
    K091594
    Device Name
    HEART-EXERCISE
    Manufacturer
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES GMBH
    Date Cleared
    2009-07-29

    (57 days)

    Product Code
    MHX,DOK
    Regulation Number
    870.1025
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K031561
    Why did this record match?
    Device Name :

    HEART-EXERCISE

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

    The HEART-Exercise is to be used in a hospital, doctor's office, or clinical environment by competent healthcare professionals for assessing exercise test results.

    The results of HEART-Exercise are intended to be used by qualified personnel in evaluating the patient in conjunction with the patient's clinical history, symptoms, other diagnostic tests, as well as the professional's clinical judgment.

    HEART-Exercise provides measurements, prognostic scores, and interpretive statements of the exercise test for which the physician renders his/her own opinion. HEART-Exercise does not offer a diagnostic opinion to the user.

    The Exercise Test Interpretation (XTI) is restricted to adults (age ≥ 18 years). The measurements apply to adults and children able to accomplish an exercise test.

    Device Description

    HEART-Exercise is an algorithm library for exercise testing systems. It is able to process up to 15 lead ECGs with a high noise and artifact level and provides real-time and retrospective computerized analysis of stress test ECGs for evaluation by the user.

    AI/ML Overview

    The provided documentation does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in terms of performance metrics.

    Instead, the document states:

    • "The subject of this premarket submission, HEART-Exercise, did not require clinical studies to support substantial equivalence."
    • "GE Healthcare considers the HEART-Exercise algorithm library to be as safe, as effective, and performance is substantially equivalent to the predicate device."

    This indicates that the submission relies on demonstrating substantial equivalence to a predicate device (CardioSoft/CASE Cardiac Testing System, K031561) rather than presenting a de novo study with specific performance acceptance criteria for the HEART-Exercise device itself.

    Therefore, the requested details regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance studies are not available in the provided text. The document focuses on regulatory compliance and the scientific technology similarity to the predicate device.

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