Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2)

The AmaKris SR1-A-2 is a minimally invasive prostate surgery navigation system that guides trained urologists in planning and positioning insertion tools during trans-perineal prostate biopsies and interventional procedures under ultrasound guidance. It integrates real-time 2D ultrasound imaging with pre-operative MRI data to create 3D models, helping surgeons plan puncture paths while avoiding the urethra and pubic bones, and includes 3D simulation showing current and planned needle trajectories accounting for patient movement.

The subject device differs from its predicate in several ways: it adds software functions for ablation planning and needle puncture procedures; the robotic arm construction was redesigned (comprising guider, control arm, and support arm instead of guider, manipulator, moving arm, and rotating arm); a new robotic arm bracket was added to lower working height and expand operating space; the modeling algorithm was upgraded; and it requires use with specified ultrasound equipment (SmartUs EXT-1M/3M) rather than generic third-party ultrasound machines. All other core features including image processing, segmentation, registration, and navigation principles remain substantially the same.

IEC 60601-1:2005+AMD1:2012+AMD2:2020 (electrical safety); IEC 60601-1-2:2014+A1:2020 (electromagnetic compatibility); verification of accuracy and precision via 25-point test, egg phantom test, metal needle phantom test, and ICP algorithm for model fusion accuracy; software verification and validation testing.

The device is substantially equivalent because it shares the same intended use, target anatomy (prostate), access route (transperineal), and core operational principles with the predicate (K221499). Both employ mechanical navigation, MRI-TRUS fusion, 3D modeling, and similar software features for image processing and planning. The hardware modifications (robotic arm redesign, bracket addition) and software updates (ablation planning function) do not raise new safety risks—they represent incremental improvements to the same platform. Performance testing demonstrates navigation accuracy within 1.0 mm radius, model fusion accuracy within design specifications, and all safety testing meets applicable standards, matching the predicate's safety and effectiveness profile.