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510(k) Data Aggregation

    K Number
    K082404
    Device Name
    NAVIGATION PROBES
    Manufacturer
    WE SENSE LTD
    Date Cleared
    2009-02-25

    (188 days)

    Product Code
    GZL
    Regulation Number
    882.1330
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K033173
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    We Sense Navigation Probes electrodes are intended to be used in operation room during neurosurgery for temporary (less than two hours) recording and stimulation of defined small area in the brain, and for recording electrical signals from target brain cells. These electrodes can be used only by professional staff and not sell over the counter

    Device Description

    NavigationProbes are equipped with a Micro tip and a Macro tip. The micro tip is used to for recording cell potentials of single cells or of cell clusters and for MicroStimulation. The Macro tip is used for stimulation and recording of local field potentials.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies conducted on the "Navigation Probes" device. The document is a 510(k) summary for the device, focusing on its substantial equivalence to a predicate device rather than presenting performance study results.

    Therefore, I cannot provide the requested information.

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