Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3); Endoscopic Video Image Processor (RP-IPD-V2000EF); Endoscopic Video Image Processor (RP-IPD-V1000F)

The device is a single-use video flexible ureterorenoscope system used for endoscopy and endoscopic surgery within the urinary tract, ureter, and kidney. It consists of four ureterorenoscope models and two endoscopic video image processors that work together to provide visualization and surgical capability in urological procedures.

The proposed ureterorenoscopes have a smaller outer diameter (2.50 mm vs 2.85–2.9 mm), smaller maximum insertion width (2.75 mm vs 3.15–3.2 mm), and improved bending angle (up/down 285° vs 275°) compared to the predicate. The image processors differ in dimension, weight, video signal outputs (added DVI and SDI interfaces), and zoom range, but maintain the same white balance and brightness adjustment functionality.

ISO 8600 (endoscope testing), ISO 10993-1 (biocompatibility), ISO 11135:2014 (sterilization), ASTM F1980-21 (shelf life), ASTM F1886/F1886M-16, ASTM D4169-23, ASTM F1929-23, ASTM F88/F88-23 (packaging), IEC 60601-1:2005 and amendments, IEC 60601-2-18:2009, IEC 60601-1-2:2014 (electrical safety and EMC).

The proposed device is substantially equivalent to predicate K221158 because it performs the same intended function with identical principles of operation and target anatomy. Non-clinical performance testing demonstrates equivalent optical and mechanical performance; dimensional and design differences (smaller diameter, enhanced bending capability, additional video outputs) represent improvements or clarifications that do not raise new safety or effectiveness concerns.