Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.)

The Urology Videoscope System is a single-use flexible ureteroscope and cystoscope designed to be used with an endoscopic image processor to provide video visualization of the urinary system (urethra, bladder, ureter, and renal pelvis) for observation, diagnosis, photography, and treatment. The system includes multiple ureteroscope and cystoscope models with varying insertion portion widths and working lengths, plus a reusable image processor with two models that display endoscope images on a monitor.

The subject device shares similar technological characteristics with the predicate, including one CMOS image sensor, two LED illumination modules, and a working channel in the distal end. Differences exist only in dimensions (depth of field, outer diameter, working length, inner diameter of instrument channel), which do not raise different safety or effectiveness questions. The image processor differs from the predicate only in video signal output interface, which does not affect safety or effectiveness.

IEC 60601-1:2005+A1:2012+A2:2020; IEC 60601-2-18:2009; IEC 60601-1-2:2014+A1:2020; ISO 10993-1 and FDA guidance (Cytotoxicity ISO 10993-5:2009, Sensitization ISO 10993-10:2021, Irritation ISO 10993-23:2021, Acute Systemic Toxicity ISO 10993-11:2017, Pyrogen ISO 10993-11:2017); ISO 8600-1:2015, ISO 8600-3:2019, ISO 8600-4:2014; IEC 62471:2006.

Both the subject and predicate devices are ureteroscopes and cystoscopes used for endoscopic diagnosis and therapy within the urinary system with visualization via an image processor. They contain no differences in intended use and share the same technological characteristics (CMOS sensor, LED modules, single working channel). The dimensional differences between subject and predicate do not raise different questions regarding safety and effectiveness. Performance testing (electrical safety, biocompatibility, optical/mechanical performance, shelf life, photobiological safety, software/cybersecurity) demonstrated the subject device is as safe and effective as the predicate.