FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit

This submission covers two devices: the FUJIFILM Endoscope Model EG-S100XT, a sterile single-use upper gastrointestinal endoscope for visualization, observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum; and the FUJIFILM Processor Model VS-1000, a non-sterile reusable display device that processes and displays live image data from the endoscope.

The EG-S100XT uses LED illumination at the tip with a CMOS image sensor to capture images transmitted to the processor, which converts signals to video for display. The VS-1000 provides image processing, light source control, automatic exposure control, and connectivity for display units and network devices. Both devices have minor differences from predicates in optical characteristics, LED method, insertion diameter, forceps channel diameter, materials, and processor type, but these differences do not affect safety or efficacy.

Not stated in this summary.

The proposed devices are substantially equivalent because they perform the same intended use and function on the same principles of operation as predicate devices. Although there are minor differences in optical characteristics, LED illumination method, physical dimensions, materials, and processor specifications, bench testing and biocompatibility testing confirmed these differences do not raise new or additional questions about safety or effectiveness. The VS-1000's upgrade to Class II electrical protection (versus predicate Class I) is equivalent to or better than the predicate device.