Navient Image Guide Navigation System (955-NC-NC), Cranial

Navient is a computerized surgical navigation system designed to assist surgeons in precisely locating anatomical structures during open or percutaneous neurosurgical procedures. It uses infrared optical tracking technology to guide surgical instruments relative to preoperative CT or MR images, supporting procedures such as tumor resections, cranial biopsies, craniotomies, and catheter shunt placements.

Navient employs stereoscopic optical (infrared) tracking without electromagnetic (EM) capability, supporting only CT and MR imaging inputs (whereas the predicate supports X-ray, MR, and nuclear medicine). It requires one cart housing the optical tracking system; the predicate requires two carts (one main, one camera). Both use landmark-based registration followed by surface matching for patient-to-image alignment, with identical performance accuracy specifications of ≤2.0 mm positional error and ≤2.0° angular error.

AAMI TIR 30:2011(R)2016 for reprocessing validation; ANSI/AAMI/ISO 17665-1:2006/(R)2013 for steam sterilization to SAL ≤10⁻⁶; IEC 60601-1 and IEC 60601-1-2 for electrical safety and electromagnetic compatibility; IEC 62366-1:2015+AMD1:2020 for human factors and usability evaluation.

Navient and StealthStation S8 share identical intended use (image-guided neurosurgical navigation), identical regulatory classification (Class II stereotaxic instrument), and identical performance accuracy (≤2.0 mm, ≤2°). Although Navient supports fewer imaging modalities (CT/MR only) and lacks EM tracking capability, these are reductions in scope, not functional innovations that raise new safety or effectiveness questions. The core navigation principle—optical tracking with landmark-based registration and surface matching—is identical. Testing in accordance with appropriate non-clinical methodologies demonstrates performance equivalence, establishing substantial equivalence despite these narrower capabilities.