FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R

The FUJIFILM Processor EP-8000 is an endoscopic processor with integrated light source that provides illumination, processes electronic signals from video endoscopes, and enables image recording. The FUJIFILM Endoscope Model EG-860R is intended for visualization and endoscopic treatment of the upper digestive tract (esophagus, stomach, duodenum). Both devices work together as a system and include imaging modes like BLI, LCI, ACI, and FICE as adjunctive diagnostic tools.

The EP-8000 combines separate video processing and light sourcing functions into one integrated unit, compared to predicate devices VP-7000 and BL-7000 which were separate. It uses four LED lamps (violet, blue, green, amber) at 79.2W total power, modified power rating (2.0-1.1A), supports multiple endoscope system generations (800/700/600/500), includes new ACI imaging mode and Multi Observation option, tablet operation capability, and updated dimensions/weight (395×210×515mm, 18kg). The EG-860R has minor differences in objective lens F#, resolution, distal end diameter, and tube materials compared to predicates.

IEC testing was performed on the subject device for power rating validation. The document references engineering requirements and test protocols similar to those used for predicate devices but does not cite specific consensus standards (ISO, IEC, ASTM numbers) by designation.

Both devices demonstrated substantial equivalence because they share identical intended use with predicates, employ the same operational principles (light transmission through fiber bundles to CMOS sensors), and use the same four LED colors. For EP-8000, image performance testing (color reproduction, geometric distortion, resolution, depth of field, dynamic range, uniformity, field of view) showed equivalence across all imaging modes. For EG-860R, 19 performance parameters met predefined acceptance criteria identical to predicate testing. Minor differences in consolidation, power rating, compatibility, tablet control, and specifications do not raise new safety or effectiveness questions because they do not change the fundamental diagnostic function or introduce new procedures.