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510(k) Data Aggregation

    K Number
    K961288
    Device Name
    BODYTRODE
    Manufacturer
    MARQUETTE ELECTRONICS, INC.
    Date Cleared
    1996-08-08

    (126 days)

    Product Code
    DRX
    Regulation Number
    870.2360
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The BodyTrode is a short term, single use (disposable), adult and pediatric ECG electrode which is applied to the intact skin surface to acquire electrocardiographic activity of the heart which can be displayed and analyzed when used in combination with leadwires, cables, and a monitor. They are intended to be used in both hospital and prehospital settings under the direction of a licensed health care practitioner.

    Device Description

    The Marquette BodyTrode ECG Electrodes are adhesive hydrogelled, single use ECG electrodes intended for use with adult and pediatric patients. The product is a polymer electrode comprised of three elements: a top polymer, a conductive adhesive hydrogel, and a radiotranslucent stud. The BodyTrode electrodes are applied to the patient's skin surface to acquire electrocardiographic activity of the heart. They are used in combination with patient leadwires, cables, and a monitor to display and/or analyze a patient's ECG.

    AI/ML Overview

    This document describes the testing and acceptance criteria for the "BodyTrode" Electrocardiograph (ECG) Electrode.

    1. Acceptance Criteria and Device Performance

    Acceptance CriteriaDevice Performance (Reported)
    Adherence to ANSI/AAMI EC12-1991 standard"Testing done on the proposed BodyTrode and the predicate Marquette ECG electrode (PN 9408-401) indicates that the proposed provides an equivalent when compared to the ANSI/AAMI standard of EC12-1991"
    Biocompatibility (ISO 10993-1:1992 and FDA Matrix)"Bio-compatibility tests were conducted for the patient contact materials (the hydrogel). The tests were selected in accordance to ISO 10993-1:1992 and the FDA Matrix."
    Equivalence to Predicate Device"Marquette Electronics, Inc. concludes that the proposed BodyTrode is as safe and effective and performs substantially equivalent to the predicate Marquette ECG Electrode."

    2. Sample Size and Data Provenance

    The document does not explicitly state the sample size used for the tests. It mentions "package aging using both real time and the Von't Hoff rule" for the ANSI/AAMI standard tests, and "biocompatibility tests... for the patient contact materials (the hydrogel)." The data provenance is not specified regarding country of origin or whether it was retrospective or prospective, though the nature of the tests suggests prospective lab-based testing.

    3. Number of Experts and Qualifications for Ground Truth

    This type of device (ECG electrode) does not typically involve interpretation by human experts to establish ground truth in the way AI/ML algorithms might. The "ground truth" for these tests are objective technical and biological standards. Therefore, information on the number and qualifications of experts for establishing ground truth is not applicable and not provided.

    4. Adjudication Method

    Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving human interpretation or subjective assessments. For the objective technical and biocompatibility testing of an ECG electrode against established standards, such adjudication methods are not applicable and not mentioned.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study type is relevant for evaluating the impact of AI algorithms on human reader performance, which is not applicable to the evaluation of an ECG electrode.

    6. Standalone (Algorithm Only) Performance Study

    A standalone performance study was not done in the context of an AI algorithm. This device is a physical electrode, and its performance is assessed through its ability to meet established technical and biological standards, not through an algorithm's output.

    7. Type of Ground Truth Used

    The ground truth used was based on objective technical standards (ANSI/AAMI EC12-1991 for ECG electrode performance) and biocompatibility standards/guidelines (ISO 10993-1:1992 and the FDA Matrix).

    8. Sample Size for the Training Set

    This question is not applicable to the evaluation of a physical medical device like an ECG electrode. There is no AI/ML algorithm involved, and therefore, no "training set."

    9. How Ground Truth for the Training Set was Established

    This question is not applicable, as there is no training set for an AI/ML algorithm in the context of this device.

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