Endoscopic Video Image Processor (RP-IPD-V1000F)

The Endoscopic Video Image Processor (RP-IPD-V1000F) is a reusable video processing system that receives and processes image signals from compatible video endoscopes and produces live video images during endoscopic procedures. It also provides power supply to the endoscope and requires cleaning and disinfection before use. The device is intended for use with Single-Use Video Flexible Cysto-Nephroscope models RP-U-C01F and RP-U-C01FS.

The subject device has identical principles of operation, white balance, color tone adjustment, image enhancement, zoom, brightness adjustment, image freezing, and compatible endoscope functionality compared to the predicate device. Differences include product code (FET vs. FAJ), main configuration, video signal output, dimensions, and weight, but these differences do not raise new safety and effectiveness questions.

ISO 8600-1:2015 (Endoscopes—Medical endoscopes and endotherapy devices. General requirements) and ISO 8600-3:2019 (Endoscopes. Medical endoscopes and endotherapy devices. Part 3: Determination of field of view and direction of view of endoscopes with optics).

The subject device demonstrates substantial equivalence through nonclinical performance testing showing similar performance to the predicate device across nine parameters including resolution, signal-to-noise ratio, geometric distortion, and color performance. The indications for use are nearly identical, differing only by the addition of the compatible endoscope model names, and the technological principles are identical despite minor differences in configuration and dimensions that do not introduce new safety or effectiveness concerns.