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510(k) Data Aggregation

    K Number
    K991522
    Device Name
    MICROTARGETING ELECTRODE
    Manufacturer
    FHC, INC.
    Date Cleared
    2000-08-04

    (459 days)

    Product Code
    GZL
    Regulation Number
    882.1330
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K991522,K991077,K981015,K961858
    Why did this record match?
    Device Name :

    MICROTARGETING ELECTRODE

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

    The microTargeting™ Electrodes are intended for use in intra-operative recording of single unit neuronal activity in the brain.

    Device Description

    The microTargeting™ Electrodes (K991522) are for intra-operative single-unit recording during functional neurosurgery.
    microTargeting™ Electrodes Components

    • Electrodes
    • Protective Tube (Shielded) .
      microTargeting™ Electrodes Accessories
    • . Sterilizable Case (E5-75)
    AI/ML Overview

    This document is a 510(k) premarket notification for the FHC, Inc. microTargeting™ Electrodes, dated August 4, 2000. It seeks to establish substantial equivalence to legally marketed predicate devices, not primarily to demonstrate performance against acceptance criteria through a study.

    Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving device performance against those criteria. The document is a regulatory submission for premarket clearance and focuses on establishing substantial equivalence based on technological characteristics and intended use, rather than presenting a performance study with specific acceptance criteria.

    The sections for acceptance criteria, study details, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth, and training set information are not applicable to this type of document.

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