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510(k) Data Aggregation

    K Number
    K040979
    Device Name
    ELEKTA MICRODRIVE, MODEL 916716
    Manufacturer
    ELEKTA INSTRUMENT AB
    Date Cleared
    2004-07-23

    (99 days)

    Product Code
    HAW
    Regulation Number
    882.4560
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K011775
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ELEKTA Microdrive is intended to be used for accurate positioning of electrodes or other devices during stereotactic neurosurgery.

    Device Description

    The ELEKTA Microdrive consists of a drive which is connected to the instrument holder of the stereotactic system, the MicroGun that holds the guide tubes and the Electrode holder where the electrodes are fixed. The guide tubes are inserted into the MicroGun and fixed with the lower end of the guidetubes 11 or 21 mm (two different lengths of guide tubes exist) in front of the target point. By moving a sledge with a fine-pitch screw the electrodes are advanced through the guide tubes into the brain. It is possible to position up to five electrodes simultaneously.

    AI/ML Overview

    I'm sorry, but this document does not contain the information requested. The document is a 510(k) summary for the ELEKTA Microdrive, which is a stereotaxic instrument. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not include any information about acceptance criteria, study data, sample sizes, expert involvement, or ground truth establishment. It is a regulatory filing, not a scientific study report.

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