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510(k) Data Aggregation

    K Number
    K162459
    Device Name
    AccuPoint Electrode
    Date Cleared
    2017-06-15

    (286 days)

    Product Code
    Regulation Number
    882.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICROPROBES FOR LIFE SCIENCE, INC. DBA NEURON

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Neuron AccuPoint™ Electrodes are intended for use in intraoperative recording of single unit neuronal activity or intraoperative stimulation of neural elements in the brain.
    Device Description
    The AccuPoint™ Electrode is used for monitoring, recording, or microstimulation during intraoperative procedures to map the electrical activity of single unit neurons at subsurface levels of the brain. Intraoperative microelectrode recording (MER) and microstimulation equipment is utilized with depth electrodes during stereotactic surgery to assist in localization for further applications such as permanent implant placement. The MER or microstimulation equipment which connects to the AccuPoint Electrode are supplied by other manufacturers and is not sold by MicroProbes for Life Science, Inc. The AccuPoint Electrode is produced with standard connectors to connect with other manufacturers' cables that then connect to MER and microstimulation equipment. The AccuPoint Electrode is a long, extremely thin metal needle insulated with a Parylene C coating. This needle will be composed of either tungsten or a platinum-iridium alloy, depending on the preference of the clinician. The tip of this needle is exposed using either an electric arc or laser process, to create an electrode. The tip exposure length can be carefully controlled to imbue the electrode with a particular impedance. This core needle electrode is situated within a stainless steel and polyimide cannula, with the electrode and cannula being employed together as an integrated unit. The electrode will be capable of sliding within the cannula. allowing the clinician to extend the tip during use, or retract the tip back within the cannula during handling and storage. The rear portion of the cannula will be equipped with a "stop collar", or a thick stainless steel ring which assures proper placement of the electrode within the surgical frame. A laver of stainless steel within the cannula will serve as a second electrode or "reference contact". The electrode may or may not be equipped with an outer stainless steel shield. The electrode will be equipped with two gold pin connectors on the back end, which allow the electrode to be connected to the cable leading to the MER or microstimulation equipment possessed by the surqeon. The model number of each electrode configuration was chosen to be analogous to the comparable predicate electrode model from one of two other manufacturers (FHC and Alpha Omega), allowing clinicians to easily adopt the AccuPoint Electrode with minimal confusion. Only a length within 5 cm of the AccuPoint Electrode comes into direct contact with patient tissue. Accessories include stainless steel spacer and insertion tubes and stylets which are used during stereotaxic functional neurosurgical procedures to accurately guide a microelectrode or instrument into the brain. The insertion tubes with the stylet inserted are initially placed through the stereotaxic frame access locations for determining the estimated depth of the target location to then insert the depth electrode (AccuPoint Electrode). The AccuPoint Electrodes and Accessories will be sold sterile, for single patient use, and will be disposable.
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