FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000

The FUJIFILM Endoscope Models ED-S100TP and ED-S100XP are sterile, single-use side-viewing endoscopes designed for endoscopy and endoscopic surgery within the duodenum. The FUJIFILM Processor Model VS-1000 is a non-sterile, reusable display device that processes and displays live image data from the FUJIFILM single-use endoscopes for observation, diagnosis, photography, and treatment.

The proposed endoscope models feature LED illumination at the tip, a CMOS image sensor, a flexible tube with a bending part allowing four-directional movement, and a forceps channel for trans-endoscopic treatment. The VS-1000 processor provides image processing, light source control, AE (shutter) control, and connectivity for endoscopes and display units. Minor differences exist in optical characteristics, LED method, field of view, distal/flexible portion diameter, and materials compared to predicates, but these do not affect safety or efficacy.

Testing was performed according to engineering requirements including Image Geometric Distortion, Image Resolution Performance, Depth of Field Performance, ISO-SNR & Dynamic Range Performance, Image Intensity Uniformity, Color Performance, and evaluations of bending capability, working length, forceps channel diameter, air/water volume, suction rate, field of view, resolution, brightness, color reproducibility, guidewire lock, and elevator angulation.

Although minor differences exist in optical characteristics, LED illumination method, field of view, distal diameter, and materials compared to predicate devices, the proposed devices are substantially equivalent because these differences do not raise new safety or efficacy concerns. Bench testing and biocompatibility testing confirmed no impact on safety or effectiveness, and the proposed devices share the same intended use and core technical functionalities as the legally marketed predicates.