Uro-G HD Cystoscope (1520)

The Uro-G HD Flexible Cystoscope is a handheld, battery-operated cystoscope used for endoscopic diagnosis and infusion of irrigating fluids within the bladder and urethra. It consists of a disposable steerable cannula with a 2.2 mm working channel and a reusable handle with an integrated video monitor, allowing real-time visualization without a separate external display.

The device is identical to its predicate in all material respects: same cannula dimensions (380.2 mm working length, 5.6 mm max width, 2.2 mm channel), same optical specifications (0.7 MP CMOS camera, 100° ± 5° field of view, 3 lp/mm resolution), same tip angulation (210° ± 5° up, 130° ± 5° down), same biocompatible materials meeting ISO 10993, same electrical safety (IEC 60601-1 and IEC 60601-2-18 compliant), and same software version 4.1. The only change is the handle surface disinfection process: reduced contact time from 6 to 3 minutes with disinfectant and air-dry time from 20 to 5 minutes, with Super Sani-Cloth now accepted as an alternative to CaviWipe.

ISO 10993 (biocompatibility), IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC safety), IEC 60601-2-18 (endoscopic equipment safety and performance), USAF 1551 test chart (image resolution). Microbiology testing validated the modified disinfection protocol achieved log reductions ≥3 and ≥6 of tested pathogens.

The subject device is substantially equivalent because the modification addresses only the reusable handle's surface disinfection procedure—a process control change—while the device's intended use, indications, technological design, materials, and performance characteristics remain completely unchanged. Microbiology testing demonstrated the reduced contact time (3 minutes vs. 6 minutes) achieved sufficient pathogen reduction, and the shorter air-dry time (5 minutes vs. 20 minutes) does not compromise efficacy. Since this change affects only post-use cleaning and does not alter the device's clinical function, safety profile, or interaction with patients, no new safety or effectiveness issues are raised, supporting substantial equivalence to the predicate.