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510(k) Data Aggregation

    K Number
    K231392
    Device Name
    NaviNetics Reusable Stereotactic System (NN1000)
    Manufacturer
    Date Cleared
    2023-07-14

    (63 days)

    Product Code
    Regulation Number
    882.4560
    Why did this record match?
    Applicant Name (Manufacturer) :

    NaviNetics Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Intended Purpose of the NaviNetics D1 Stereotactic System is target localization and fixation of the patient head in a coordinate system in order to perform stereotactic neurosurgical procedures, for example; deep brain stimulation, lesioning, biopsies, targeted injections, aspirations and minimal invasive tumor treatments.
    Device Description
    The NaviNetics Reusable Stereotactic System is a device used for minimally invasive neurosurgical procedures. During image acquisition and treatment, the system's Skull Anchor Key ("Key") achieves reduced weight and patient invasiveness versus common stereotactic head frames that travel extensively around the patient's head and are restrictive to the airway access when positioned. The system consists of a Key that is affixed to the patient's skull with three titanium stand-off pins and four bone anchor screws. The Key serves as the common attachment platform for the Stereotactic Positioner and MRI and CT localizers. The system is based on established stereotactic center-of-arc principles with compatible instruments. These instruments rely on the active working length of 150 mm (arc radius) with stops and guide holders to ensure proper trajectory angle to the brain target. The two degrees of freedom of the arc-quadrant, the Arc and Collar angles, can be manipulated allowing the target from a multitude of directions. Linear adjustments can move the ar-quadrant, medial/ateral (Y), and superior/inferior (Z) to bring the focus to the surgical target. The output of surgical planning software provides the target coordinates (X, Y, Z) and the surgical trajectory (CT, AT) which dictate the settings of the stereotactic device.
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