UroNav 4

UroNav 4 is a stereotaxic image-guided system that assists clinicians in planning and performing minimally invasive diagnostic and therapeutic procedures on the prostate gland. It fuses pre-procedural imaging (such as MRI) with real-time ultrasound to help guide biopsy needles, guidewires, and ablation tools to precise targets while displaying the tracked instrument path on a monitor.

UroNav 4 retains the same core features as its predicate: multi-modality image support, 2D/3D ultrasound visualization, image fusion and registration (both rigid and elastic), multi-planar reformatting, gland segmentation, and electromagnetic tracking. The primary new addition is advanced annotation tools for measurement and planning; the system also adds explicit disclaimers that it does not predict ablation volumes or outcomes.

IEC 62304 (Medical Device Software Lifecycle Processes), IEC 62366-1 (Usability Engineering), and HIPAA compliance testing. The submission references FDA-recognized consensus standards but does not cite specific mechanical, electrical, or imaging performance standards.

UroNav 4 targets the same prostate anatomy, uses identical access routes (transrectal and transperineal), operates on the same software platform (Microsoft Windows), and implements the same image fusion and registration workflow as the predicate K193403. The minor addition of advanced annotation tools and EM tracking enhancements are refinements to existing functionality rather than new mechanisms of action. Non-clinical testing confirmed all functions meet predefined acceptance criteria without raising new safety or effectiveness concerns, and the removal of the fiducial marker indication narrows rather than expands the scope of use.