Stereotaxic Guiding Surgical Devices, NaoTrac S

The NaoTrac S is a robotized stereotaxic guidance platform for neurosurgery that positions and orients instrument holders to guide standard surgical instruments (biopsy needles, electrodes) to anatomical targets. It comprises a 6-axis robotic arm mounted on a wheeled trolley with integrated computer and display screen, intended for any stereotactic neurosurgical procedure where precise instrument navigation is appropriate.

NaoTrac S uses a 6-axis robotic arm with absolute encoders, blue LED light (465nm) for optical registration instead of the predicate's Class 2 laser, and a Moving Detector system (Tag S/Tag Support Arm with IR module) for detecting patient movement without fixed securing. It omits endoscope guidance, multimodality image fusion, and fiducial marker registration that the predicate offers, but retains surface matching registration, image-guided surgery, real-time instrument tracking, and factory calibration.

IEC 60601-1 and ANSI AAMI ES 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 62304 (software lifecycle), ISO 17665-1, ISO 17664, ISO 11737-1, ISO 11737-2, AAMI TIR12 (sterilization/reprocessing validation), ISO 11137-1 (single-use sterilization), ASTM F1980, ISO 11607-1 (shelf-life and packaging).

Both devices are computer-controlled electromechanical robotic arms providing identical indications for spatial positioning and orientation of surgical instruments in neurosurgical operating rooms. The NaoTrac S achieves the same key performance specifications (< 2mm positional error, < 2 degrees angular error) and uses the same fundamental workflow (preoperative imaging, surgical planning, patient registration via optical surface matching, and robotic guidance). Differences in optical source (LED vs. laser), patient movement detection method, and omission of endoscope capability do not affect safety or effectiveness because the core surgical guidance function and accuracy requirements are functionally equivalent to the predicate ROSA ONE Brain.