Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200)

The Single Use Digital Flexible Ureteroscope (7.5F) is a sterile, single-use endoscope designed to visualize organs and cavities in the urinary tract (urethra, bladder, ureter, calyces, and renal papillae) via transurethral or percutaneous access. It works with the Videoscope Imaging Processor (Model HV-200), a reusable processor that provides illumination, processes video signals, and outputs images to external monitors, enabling diagnostic and therapeutic procedures in the urinary tract.

The subject device has a 7.5Fr flexible insertion portion with CMOS digital video technology and LED illumination, offering a 110° field of view, 2-50mm depth of field, and ≥3.6Fr working channel. It differs from the predicate in having 285° up/down deflection (vs. 270°), powered by line power (vs. battery or line power), and lacking suction capability that the predicate provides. The subject device uses the HV-200 processor versus the predicate's PV300 processor.

Testing compliance includes ISO 10993 series (biocompatibility: cytotoxicity, sensitization, irritation, pyrogenicity, acute systemic toxicity); IEC 60601-1:2005/AMD2:2020 and IEC 60601-1-2:2020 (electrical and EMC safety); IEC 60601-2-18:2009 (endoscopic equipment); IEC 62471:2006 (photobiological safety); ISO 80369-7:2021 (Luer taper connectors); ISO 11135:2014 (sterilization validation); ISO 10993-7:2008 (EO/ECH residuals); ASTM D4169-23 (shipping simulation); ASTM F1980-21 (shelf-life aging); and ISO 11607 (packaging validation).

The subject device is substantially equivalent to the predicate (Pusen Single Use Flexible Video Ureteroscope, K233778) because both are flexible, single-use digital ureteroscopes with CMOS and LED technology intended for the same urinary tract procedures. Comparative bench testing demonstrated equivalent mechanical, optical, and image quality performance, and comprehensive testing confirmed compliance with applicable biocompatibility, electrical safety, and performance standards. The device differs only in minor design specifications (deflection angles, working channel size, imaging processor model) while maintaining the same fundamental intended use and safety profile as the predicate.