The Navient Image Guide Navigation System is a computerized surgical navigation system designed to assist surgeons in precisely locating anatomical structures during neurosurgical procedures. It helps surgeons plan and navigate in real time using CT or MR images, improving accuracy and safety in cranial operations such as tumor resection and biopsies.
Intended Use
Navient is a computerized surgical navigation system intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical procedures. The system is indicated for medical conditions where stereotactic surgery may be appropriate using CT or MR based models of anatomy. Example procedures include tumor resections, cranial biopsies, craniotomies, and catheter shunt placements.
Technology
Navient functions via infrared optical tracking technology combined with preoperative CT or MR images. It includes a main computer unit, IR camera, navigation software, and surgical instruments. The system spatially registers patient images with anatomy by landmark matching and surface tracing. It allows real-time positioning of surgical tools during procedures using image-guided navigation.
Performance
The Navient system achieved a mean positional error of 1.36 mm and a mean angular error of 1.01 degrees, meeting accuracy requirements of ≤ 2.0 mm and ≤ 2.0 degrees. Validation was done on representative phantoms. Software and human factors/usability tests, biocompatibility, cleaning validation, and electrical safety/EMC testing were also performed according to relevant standards.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/10/2024
9 months - 2
FDA Approval
2/5/2025
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