Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope (U-Scope)(2.5/1.2) (OMI161-2F25-CH12-US); Images Systems (Camera-Controlled Unit) (OMI01M12)

The Flexible Ureteroscope (U-Scope) is a single-use, flexible digital video ureteroscope with a miniature CMOS camera and LED illumination, designed to visualize the urinary tract (urethra, bladder, ureter, calyces, renal papillae) via trans-urethral or percutaneous access to perform diagnostic and therapeutic procedures. It pairs with a reusable Images System (Camera-Controlled Unit) that processes and displays video images from the scope.

The subject device differs from the predicate (Uretero1™) in insertion tube outer diameter (2.5/2.8 mm vs. 2.98 mm), image sensor resolution (same 400×400), depth of field (5–50 mm vs. 2–50 mm), working hours (6 hours vs. 4 hours), and the Camera-Controlled Unit's LCD size (12.1 inches vs. 21.5 inches). Both share 400×400 resolution, 1.2 mm working channel, ethylene oxide sterilization, and compliance with IEC 60601 standards.

IEC 60601-1:2005, IEC 60601-1-2:2014, IEC 60601-2-18:2009 (electrical safety and EMC); IEC 62471:2006 (photobiological safety); ISO 8600-3:2019, ISO 8600-5:2020 (field of view, resolution); ISO 10993-5, -10, -11, -23 and USP46:2023 (biocompatibility); ISO 11135:2014 (sterilization validation); ASTM D4332-22, ASTM D4169-22 (environmental conditioning and shipping simulation).

Although the subject device differs from the predicate in insertion tube diameter, depth of field, working hours, and LCD size, these differences do not raise new safety or effectiveness questions because the subject device has demonstrated equivalent or superior performance through comprehensive mechanical, optical, electrical, biocompatibility, and sterilization testing. Both devices share the same indications for use, working channel diameter, image resolution, sterilization method, and regulatory compliance standards, establishing technological similarity sufficient for substantial equivalence.