Single-use Flexible Ureteroscope

The Single-use Flexible Ureteroscope is a sterile, single-use endoscope designed for diagnostic and therapeutic procedures in the urinary tract and kidneys in adults. It features a CMOS image sensor at its tip that converts reflected light into electrical signals transmitted to a Digital Video Monitor for display, enabling visualization during endoscopy and endoscopic surgery.

Compared to the predicate device (Uscope, K172098), the subject device has a larger bending angle (285° up/down vs. 270°), a smaller maximum outer diameter (2.8 mm vs. 3.2 mm), a longer working length (700 mm vs. 650 mm), and a larger minimum instrument channel diameter (1.2 mm vs. 1.0 mm). Both devices use CMOS digital video technology, LED illumination, are single-use, sterile (EO sterilized), and support flexible scope design with 120° field of view and 0° direction of view.

ISO 10993-1 (biocompatibility), ISO 11135 (EO sterilization), IEC 60601-1, IEC 60601-2-18, IEC 60601-1-2, IEC 60601-4-2 (electrical safety and EMC), ISO 8600-1 and ISO 8600-4 (mechanical performance), IEC 62471:2006 (photobiological safety), ASTM F1980-21 (accelerated aging), and ASTM D4169-22 (simulated transportation).

The subject device is substantially equivalent because it maintains the same intended use (endoscopy and endoscopic surgery in the urinary tract and kidney), operation principle (digital video endoscopy with CMOS sensor and LED illumination), and regulatory classification (Class II, 21 CFR 876.1500). The dimensional and performance differences (larger bending angle, smaller diameter, longer working length) represent engineering improvements that enhance clinical utility without altering the fundamental safety or effectiveness profile, and bench testing demonstrates the device meets design specifications and performs comparably to the predicate across mechanical, optical, and safety metrics.