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510(k) Data Aggregation

    K Number
    K981737
    Device Name
    K-DEFIB/PACE ADULT ELECTRODE MODEL NUMBER KDP-60
    Manufacturer
    KATECHO, INC.
    Date Cleared
    1998-12-09

    (205 days)

    Product Code
    MKJ,MLN
    Regulation Number
    870.5310
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    K-DEFIB/PACE ADULT ELECTRODE MODEL NUMBER KDP-60

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

    The Katecho "K-Defib/Pace Adult Electrode it is indicated for use in external Pacing. Defibrillation and Monitoring applications as a non-sterile, disposable device, for single patient use, only. The KDP-60 K-Defib/Pace Adult Electode provides the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patients skin. The electrode is intended for use on adult patients.

    When a patient requires defibrillation or external pacing these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 Joulc maximum).

    This device has been tested to the ANSI/AAMI DIF39-1993 standard for use with equipment by the following manufacturers; Laerdal, Heartstream, Marquette, Physio Control, Survivalink, First Medic, and Hewlett-Packard.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for the "K-Defib/Pace Adult Electrode." It does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device. Instead, it describes clearance based on substantial equivalence to predicate devices and adherence to a specific standard.

    Therefore, I cannot provide the requested information. The document does not describe:

    1. A table of acceptance criteria and reported device performance.
    2. Sample size used for a test set, data provenance, or number of experts.
    3. Adjudication method.
    4. MRMC comparative effectiveness study.
    5. Standalone algorithm performance.
    6. Type of ground truth used.
    7. Sample size for a training set.
    8. How ground truth for a training set was established.

    The document indicates that the device has been tested to the ANSI/AAMI DF39-1993 standard for use with equipment by specific manufacturers. This suggests compliance with an existing industry standard, rather than a novel study to establish performance against new acceptance criteria.

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