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510(k) Data Aggregation

    K Number
    K250893
    Date Cleared
    2025-09-04

    (163 days)

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

    The Ball Joint Guide Array (BJGA) is intended to assist with stereotactic guidance, placement, and fixation for the operation of surgical instruments or devices during the planning and operation of neurological procedures performed in conjunction with preoperative and perioperative MR imaging. These procedures include laser coagulation, biopsies, catheter placement, and electrode placement procedures.

    Device Description

    The Ball Joint Guide Array (BJGA) is a skull-mounted, single use stereotactic neurosurgical guidance device. It is manually operated and facilitates trajectory planning and guides instruments or devices to a specific location within the brain. The ball joint system can be used to support a wide range of surgical trajectories into the brain. An image-guided neuronavigational system is used to register cranial landmarks and utilize presurgical neuroimaging data to align the BJGA with an optimal skull entry point to achieve the planned trajectory. Once aligned, the BJGA assembly is securely attached to the skull and locked in position to provide a stable instrument/device guide. Intraoperative magnetic resonance imaging (MRI) is then used to confirm intraoperative trajectory alignment with the planned trajectory and make additional trajectory adjustments, as needed, prior to insertion of the neurosurgical instrument, guided via the BJGA, into the brain.

    AI/ML Overview

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