KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC)

The KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC) is a flexible video endoscope used for visualization and examination of the upper urinary tract (ureters and kidneys). It includes a luer with two ports for instrumentation access and irrigation, and can be used to perform various diagnostic and therapeutic procedures with additional accessories.

The subject device is a flexible CMOS video endoscope with 285° up/down deflection (270° with instruments in the working channel), 675mm working length, 1.2mm working channel diameter, 2.9mm outer diameter, internal LED light source, 0° direction of view, and 80–110° field of view. The predicate device has the same specifications except field of view is 80–95° and deflection is 270° up/down. Two models (11278VSE and 11278VSUE) differ only in distal tip deflection direction.

ISO 10993 series (biocompatibility: cytotoxicity, skin sensitization, systemic toxicity, irritation, chemical characterization); ISO 14937, ISO 17665-1, ISO 22441:2022 (sterilization); ANSI/AAMI ST98, ASTM F3208-20, ISO 17664-1, ANSI/AAMI ST77 (reprocessing and cleaning); ISO 8600-1, ISO 8600-3, IEC 62471 (bench performance and photobiological safety).

The subject device has substantially identical design, materials, and function to the predicate K141250—both are flexible CMOS video endoscopes for upper urinary tract visualization with the same working length, channel diameter, outer diameter, light source, and direction of view. The subject's expanded field of view (80–110° vs. 80–95°) and improved deflection capability (285° vs. 270°) represent enhancements that do not raise new safety or effectiveness concerns; non-clinical bench testing demonstrates the modifications maintain safety and performance parity with the predicate. No clinical testing was required because non-clinical data sufficiently established substantial equivalence.