Navigo Workstation 2.3 (FPRMC00039)

The Navigo Workstation 2.3 is a software-based adjunctive tool for ultrasound-guided prostate procedures. It displays 2D and 3D ultrasound images, fuses them with DICOM-sourced medical imaging (MRI/CT), tracks insertion tools such as needles in real-time, enables treatment planning with virtual ablation zones, and manages patient data and procedure reports. It is intended for use by physicians in diagnostic and interventional clinical procedures of the prostate.

The Navigo 2.3 shares core technological features with its predicate (Navigo 2.0): electromagnetic tracking system with identical sensors, 3D prostate model building and manipulation, DICOM data retrieval and fusion with ultrasound, needle trajectory tracking and recording, and comprehensive procedure data management. Key differences include expanded software features (anatomic ROI labeling, margin addition to ROIs, distance measurements to anatomical structures, virtual ablation zone display) and hardware updates (smaller cart form factor, updated computer/touchscreen/frame grabber components due to end-of-life parts).

Software verification and validation per IEC 62304 (medical device software lifecycle), electrical safety per IEC 60601-1, electromagnetic compatibility per IEC 60601-1-2 and IEC TR 60601-4-2, risk management per ISO 14971, and usability per IEC 60601-1-6. Bench testing validated mesh proximity calculations, ROI margin algorithms, virtual ablation zone accuracy, and mechanical performance of updated components.

Navigo 2.3 maintains identical indications for use and regulatory classification (Class II, 21 CFR 892.2050) as the predicate Navigo 2.0. Both devices employ the same electromagnetic tracking architecture, interface identically with standard ultrasound systems, and provide the same core functionality for 3D prostate visualization, DICOM fusion, and needle guidance. The software expansions (ROI labeling, margin tools, ablation zone display, proximity measurements) are extensions of existing capabilities evaluated through standard bench testing methods, and hardware changes preserve functionality while improving portability. No new safety or effectiveness concerns arise from these modifications, and performance testing demonstrates equivalent accuracy to the predicate device.