Geniant Cranial (Navigated Neurosurgical Positioning Robot)

Geniant Cranial is a navigated neurosurgical positioning robot that aids neurosurgeons in locating anatomical structures and positioning surgical instruments during stereotactic neurosurgery. It uses preoperative CT or MR images, displays them in multiple viewing planes, allows surgeons to plan surgical routes before operation, and provides real-time tracking of surgical tools during the procedure to guide the surgeon along the planned trajectory.

The subject device includes a console with optical sensor, a robotic arm with patient positioning module, planning software (KGuide V3.0), optical markers, head frame, and probes. It uses an infrared camera and robot arm relative encoders for localization, supports DICOM image import/export, and achieves 3D positional accuracy with mean error ≤1.5 mm and trajectory angle accuracy ≤2.0 degrees. The predicate devices use different planning software, localization methods, and some support network connectivity rather than only removable media.

IEC 60601-1:2020 and IEC 60601-1-2:2020 for electrical safety and EMC; ISO 10993 series for biocompatibility; IEC 62304 for software life cycle; ISO 9283:1998 for robot performance criteria; ASTM F2554-18 for positional accuracy measurement; ISO 17665-1 for sterilization validation; IEC 62366-1:2020 for usability engineering; and multiple FDA guidance documents on cybersecurity, software, and human factors.

Geniant Cranial has identical indications for use and anatomical site (neurosurgical procedures requiring stereotactic navigation of the head) as the predicate devices, uses the same fundamental principles of preoperative planning, patient registration, and real-time instrument tracking, and demonstrates equivalent or superior performance through rigorous accuracy testing under worst-case clinical conditions. Technological differences in software, localization methods, and system architecture do not raise new safety or effectiveness questions because the device meets the same applicable safety standards and achieves performance specifications that are comparable to or better than the predicates.