Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2)

The Single-Use Digital Flexible Ureteroscope is a disposable endoscope used with an image processor to visualize and perform diagnostic or therapeutic procedures in the ureter and renal pelvis. It enters the body through the urethra and transmits video images to a monitor, allowing physicians to inspect or treat urinary tract pathology in adults.

The subject device uses a CMOS image sensor and LED cold light source at the distal tip, flexible insertion cord with user-controlled maneuverable tip, and is sterilized by ethylene oxide for single use. Compared to the predicate (K230200), it has a slightly wider field of view (120°±10% vs. 110°), similar bending angles (260°–300° vs. 285° up/down), a thinner insertion diameter (≤2.6 mm vs. 3.15 mm), and slightly shorter working length (670±3% mm vs. 700 mm).

ISO 8600 series (optical performance), ISO 10993 series (biocompatibility: cytotoxicity, sensitization, pyrogenicity, acute toxicity), ISO 11135:2014 (ethylene oxide sterilization validation), ISO 10993-7:2008 (residual gas testing), ASTM F1980-16 (accelerated aging), ISO 11607:2019 (package integrity), IEC 62471 (photobiological safety), and electrical safety standards ANSI/AAMI ES:60601-1 and IEC 60601-2-18.

The subject device is substantially equivalent because it employs identical fundamental technology (CMOS imaging, LED illumination, flexible scope design, single-use, EO sterilization) as the predicate and is intended for the same use in the same patient population by trained endoscopists. Minor dimensional differences (thinner diameter, shorter working length, slightly wider field of view) do not compromise safety or effectiveness, as all performance testing met applicable standards and comparative image quality testing confirmed equivalent optical performance. No clinical studies were required because the nonclinical testing adequately demonstrates safety and effectiveness parity.