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510(k) Data Aggregation

    K Number
    K011775
    Device Name
    MICRO TARGETING DRIVE SYSTEM
    Manufacturer
    FHC, INC.
    Date Cleared
    2001-08-30

    (84 days)

    Product Code
    HAW
    Regulation Number
    882.4560
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K003776,K992721,K991077
    Why did this record match?
    Device Name :

    MICRO TARGETING DRIVE SYSTEM

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

    The FHC microTargeting® Drive System is intended to be used with commercially available stereotactic systems for neurosurgical procedures which require the accurate positioning of microelectrodes, stimulating electrodes, DBS™ electrodes or other instruments in the brain or nervous system.

    Device Description

    The microTargeting® Drive System with maTrix drive mount permits the accurate positioning of microelectrodes, stimulating electrodes, DBS electrodes, lesion positioning on thereficeroded, climataling aerous in the brain and nervous system and is adaptable to all major stereotactic systems.

    microTargeting™ Drive System Components

    • microTargeting™ drive
    • maTrix™ drive mount and lower guide
    • maTrix™ guide bushings
    • DBS™ holder with DBS/lesion stop
    • verification probe
    • sterilization case
    • cleaning brushes
    • hex wrench

    microTargeting™ Drive System Accessories

    • Radionics adaptor
    • Leksell adaptor
    • BrainLab adaptor
    • Leibinger RM adaptor
    • Leibinger ZD adaptor
    • Leibinger Ost-Reg™ (STarFix™) adaptor
    • NeuroMate™ adaptor
    • single electrode insertion tube set
    • array electrode insertion tube set
    • lesion insertion tube kit and depth stops
    • custom microelectrode depth stops
    AI/ML Overview

    I am sorry, but the provided text does not contain the information needed to answer the question about acceptance criteria and study details for the microTargeting® Drive System. The document is primarily a 510(k) summary for regulatory clearance, focusing on general device information, legal marketing, description, intended use, and substantial equivalence to predicate devices. It does not include specific performance data, study designs, or acceptance criteria.

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