F88 URE-SD/RD Flexible Ureteroscope

The F88 URE-SD/RD Flexible Ureteroscope is a handheld flexible endoscope used for examining the urinary tract and kidney interior. It has a 670 mm insertion tube with a 1.2 mm working channel, CMOS imaging sensor, LED light source, and deflection capability of at least 270° in both directions. It is reusable and works with the F88 Flexible Camera Control Unit to perform diagnostic and therapeutic urological procedures.

The subject device is substantially similar to the predicate Karl Storz Flexible Video-Uretero-Renoscope across most characteristics including working channel diameter, deflection angles, CMOS sensor, LED light source, and sterilization method. Minor differences include: outer diameter of distal tip (9.15 Fr vs 8.5 Fr), insertion tube outer diameter (2.85 mm vs 2.9 mm), working channel length (670 mm vs 675 mm), field of view (106° vs 90°), and depth of view (2–50 mm vs 4–60 mm). The subject device lacks image/video capture and memory card recording capabilities that the predicate possesses.

ISO 10993-1 (biocompatibility), IEC 60601-1 (electrical safety), IEC 60601-1-2 (electromagnetic compatibility), ASTM D4169-23e1 (simulated transportation validation), IEC TR 60601-4-2, and FDA guidance on device software and cybersecurity.

Both devices share identical indications for use, device classification, FDA regulations, and product codes. Performance testing—including biocompatibility, reprocessing validation, electrical safety, EMC, software verification, and comparative testing with the predicate—demonstrated that the F88 device meets its specifications and performs as well as or better than the predicate. The minor dimensional and optical differences (slightly wider field of view, narrower distal tip diameter, shorter working length) do not raise different safety or effectiveness questions and fall within acceptable ranges for 510(k)-cleared ureteroscopes. The absence of image storage features does not affect the core diagnostic and therapeutic function.