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510(k) Data Aggregation

    K Number
    K043091
    Device Name
    NAVIGUS NEXDRIVE, MODEL MI-3000
    Manufacturer
    IMAGE-GUIDED NEUROLOGICS, INC.
    Date Cleared
    2005-02-07

    (90 days)

    Product Code
    HAW
    Regulation Number
    882.4560
    Type
    Traditional
    Panel
    Neurology (NE)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    NAVIGUS NEXDRIVE, MODEL MI-3000

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

    The NeXdrive Disposable Micro-drive for use the with FHC microTargeting® Drive System Display and Power Assist Accessories is intended to be used in conjunction with the Navigus™ family of Trajectory Guides for the precise positioning of microelectrodes, stimulating electrodes, implantable electrodes, or other instruments in the brain or nervous system.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) clearance letter for the "NeXdrive Disposable Microdrive" and primarily addresses its substantial equivalence to a predicate device and its indications for use.

    The letter does not include:

    • A table of acceptance criteria and reported device performance.
    • Details about a study (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance).
    • Information about training sets.

    Therefore, I cannot fulfill your request for this specific information from the provided text.

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