Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)

The Single-Use Video Flexible Cysto-Nephroscope is a flexible endoscope used with an Endoscopic Video Image Processor for observation, diagnosis, photography, and treatment within the bladder, urethra, and kidney in professional healthcare settings such as hospitals and clinics.

The proposed device is identical to the predicate device in design, operating principle, and fundamental technology. Key differences include: addition of a detachable video cable in the package, increase of downward deflection angle from 135° to 225°, and change of immediate packaging material from DuPont Tyvek 2FS paper to DuPont Tyvek 1073B paper with adjusted middle and transportation packaging dimensions.

ISO 11135:2014 (sterilization validation), ASTM F1980-21 (accelerated aging of sterile barriers), ISO 11607-1:2019 and ISO 11607-2:2019 (packaging requirements), ASTM F1929-23 (seal leak detection), ASTM F88/F88M-23 (seal strength), ASTM F1886/F1886M-16 (seal integrity), and ASTM D4169-23 (shipping container performance testing).

The proposed device maintains identical indications for use, design, and fundamental technology as the predicate. Risk analysis identified and evaluated the three design modifications (detachable cable addition, deflection angle increase, and packaging material change), and verification testing using previously cleared methods and acceptance criteria demonstrated the device meets all performance standards. The device is therefore substantially equivalent because the modifications do not affect its fundamental safety and effectiveness for the same intended use.