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510(k) Data Aggregation

    K Number
    K200540
    Device Name
    BRAINSTREAM Disposable Deep Cup EEG Electrodes
    Manufacturer
    CONMED Corporation
    Date Cleared
    2020-06-01

    (90 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K032278
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The single patient EEG Cup Electrode is intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals, for example: Electroencephalograph (EEG) and Nerve potentials signals. The electrodes are for single patient use only.

    Device Description

    A cutaneous electrode is an electrode that is applied directly to a patient's skin to record physiological (biopotential) signals. Cutaneous electrodes are used in the acquisition of signals for the purpose of monitoring and recording electroencephalograph (EEG), electromyograph (EMG), and evoked potentials (EP).

    The CONMED BRAINSTREAM™ Disposable Deep Cup EEG Electrodes are disposable electrodes for single patient use. The electrodes are provided non-sterile. The device consists of 10 electrode assemblies, each consisting of the following: passive Ag/AgCl plated ABS disc permanently adhered to a lead wire, with the leadwire terminated in a touch proof connector (DIN 42 802) for electrical safety.

    AI/ML Overview

    This document describes the CONMED BRAINSTREAM™ Disposable Deep Cup EEG Electrodes. The information provided is for regulatory clearance based on substantial equivalence to a predicate device, not an AI/ML device, therefore, many requested criteria are not applicable.

    Here's the breakdown of the information that can be extracted:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (from predicate device standards)Reported Device Performance (BRAINSTREAM™)
    Compliance with ANSI AAMI EC 12 (Electrode performance)Demonstrated compliance with design specifications and applicable sections of ANSI AAMI EC 12.
    Compliance with ANSI AAMI ES60601-1 (General requirements for basic safety and essential performance)Demonstrated compliance with design specifications and applicable sections of ANSI AAMI ES60601-1.
    Compliance with ANSI AAMI IEC 60601-1-2 (Electromagnetic compatibility)Demonstrated compliance with design specifications and applicable sections of ANSI AAMI IEC 60601-1-2.
    Biocompatibility (Irritation, Sensitization, Cytotoxicity)Verified with Irritation, Sensitization, and Cytotoxicity testing per ISO 10993-5:2009 and ISO 10993-10:2010.
    Performance equivalent to predicate devicePerformance testing demonstrates substantial equivalence to the predicate device.

    2. Sample size used for the test set and the data provenance

    Not applicable. This is a medical device clearance based on engineering and biocompatibility testing against standards and comparison to a predicate device, not an AI/ML study with a test set of data.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

    Not applicable. Ground truth as typically understood for AI/ML models (e.g., expert consensus on medical images) is not relevant for this device clearance. The "truth" is established through adherence to recognized international standards and engineering performance metrics.

    4. Adjudication method for the test set

    Not applicable.

    5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

    Not applicable. This is not an AI/ML device.

    6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

    Not applicable. This is not an AI/ML device.

    7. The type of ground truth used

    The "ground truth" for this device clearance is established by:

    • Adherence to recognized international standards for medical devices, specifically:
      • ANSI AAMI EC 12 (for electrode performance)
      • ANSI AAMI ES60601-1 (for basic safety and essential performance)
      • ANSI AAMI IEC 60601-1-2 (for electromagnetic compatibility)
      • ISO 10993-1, ISO 10993-5:2009, and ISO 10993-10:2010 (for biocompatibility)
    • Substantial equivalence to a legally marketed predicate device (AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE).

    8. The sample size for the training set

    Not applicable. This is not an AI/ML device that requires a training set.

    9. How the ground truth for the training set was established

    Not applicable.

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