Navient Image Guided Navigation System (ENT) (955-NC-NC)

The Navient Image Guided Navigation System (ENT) is a computerized surgical navigation system that assists surgeons in precisely locating anatomical structures during stereotactic ENT procedures. It uses optical tracking technology to register patient CT or MR images to the patient's anatomy in real-time, enabling precise instrument positioning during transsphenoidal, sinus, and other skull base procedures.

The subject device uses an All-in-One PC (AIO) with touch screen monitor instead of the predicate's MacBook laptop, and mounts the camera at the top of the cart rather than mid-section. The optical tracking technology, software workflow, instrumentation, registration methodology (landmark-based followed by surface matching), and accuracy specification (≤2.0mm error) remain identical to the predicate device.

IEC 60601-1 and IEC 60601-1-2 (electrical safety and EMC); AAMI TIR 30:2011(R) 2016 (cleaning validation); ANSI/AAMI/ISO 17665-1:2006/(R)2013 (steam sterilization); IEC 62366-1:2015+AMD1:2020 (human factors/usability); FDA Guidance on Device Software Functions (June 2023).

The subject Navient system is substantially equivalent to the predicate NaviENT system because both are essentially identical surgical navigation platforms with the same intended use, indications, operating principles (optical tracking), imaging modalities (CT/MR), registration approach, accuracy performance, and instrumentation. Minor differences in hardware configuration (AIO vs. laptop, cart design) do not affect the fundamental function, safety, or effectiveness of the navigation system, as both achieve identical clinical performance and accuracy.