UV5000 Handle

The UV5000 Handle is a reusable, battery-operated cystoscope handle with an integrated 5-inch LCD display that allows physicians to visualize the urethra, bladder, cervical canal, and uterine cavity for diagnostic purposes. It connects to disposable UroViu cannulas (Uro-G HD, Uro-G, Uro-V, Uro-N, and Hystero-V) and features video capture, adjustable LED brightness, and charging via USB cable.

The UV5000 Handle is slightly larger and heavier than the predicate 4500 Handle (178 mm vs. 176 mm length; 345 g vs. 264 g weight) to accommodate a higher-capacity 21700 lithium-ion battery (5000 mA vs. 3100 mA) powering an upgraded 5-inch LCD display (1024×768 resolution vs. 800×480). Operating time, charging time, and core functionality remain identical. Software version differs (1.0 vs. 4.1) but performs the same general functions.

ISO 60601-1 (electrical safety), ISO 60601-1-2 (EMC), IEC 60601-2-18 (particular requirements for endoscopic equipment including thermal safety). Performance testing included field of view accuracy, depth of field, noise and dynamic range, image distortion, resolution, uniformity, and color performance.

The UV5000 Handle is substantially equivalent because it has identical intended use, same regulatory classification (Class II, FAJ product code, 21 CFR 876.1500), and performs the same mechanism of action—integrating an LCD monitor into the handle body rather than requiring a separate monitor cable. The differences are minor: modest increases in handle dimensions and weight accommodate only a larger battery and higher-resolution display that improve visualization without introducing new safety or effectiveness concerns. All electrical safety and EMC testing compliance is maintained, and bench testing demonstrated equivalent performance across all critical imaging parameters.