Stereotaxic Guiding Surgical Devices, NaoTrac S
Brain Navi Biotechnology Co., Ltd.The Stereotaxic Guiding Surgical Device, NaoTrac S, is a robotic system designed to assist neurosurgeons in accurately positioning and guiding surgical instruments during stereotactic neurosurgical procedures. By using preoperative MRI or CT images for planning and intraoperative guidance, it helps surgeons precisely target brain regions for biopsies, electrode placement, or other interventions, improving surgical accuracy and patient safety.
Intended Use
Stereotaxic Guiding Surgical Devices, NaoTrac S is intended for the spatial positioning and orientation of instrument holder or instrument tool to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode). The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be appropriate.
Technology
NaoTrac S is a robotized platform composed of a compact 6-axis robotic arm and display screen mounted on a wheeled trolley. It guides neurosurgical instruments by integrating patient preoperative 3D MRI/CT images for surgical planning, performing patient registration via optical tracking and surface matching, and providing real-time image-guided instrument positioning with automatic robotized adjustments.
Performance
Performance testing included accuracy validation showing positional error of 1.13 mm and angular error of 0.64 degrees, electrical safety and electromagnetic compatibility testing per IEC and ANSI standards, and software verification per FDA guidance and IEC 62304. Clinical data were not required; validation was based on bench and software testing. The device demonstrated substantial equivalence to the predicate.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/29/2024
8 months - 2
FDA Approval
5/23/2025
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