FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L

These three FUJIFILM endoscope models (EC-860P/M, EC-860P/L, EC-860S/L) are flexible colonoscopes intended for visualization, observation, diagnosis, and endoscopic treatment of the rectum and large intestine. They use a CMOS image sensor and fiber optic light guides to transmit images to a monitor for clinical evaluation.

The devices feature a bending portion controlled by knobs to angulate the distal end, a flexible insertion portion containing light guides, air/water channels, and a forceps channel. Compared to the predicate EC-760R-V/L, the proposed models have differences in objective lens F# and resolution, distal end diameter, total length, flexible portion diameter, and material composition, though these differences remain within specifications consistent with reference devices.

Electrical safety tested to ANSI/AAMI ES 60601-1:2012, IEC 60601-1-2:2020, IEC 60601-1-6:2020, and IEC 60601-2-18:2009. Biocompatibility per ISO 10993-1:2018, ISO 10993-5:2009, and ISO 10993-10:2021. Endoscope-specific testing per ISO 8600-1:2015, ISO 8600-3:2019, and ISO 8600-4:2014. Software testing per IEC 62304:2015. Reprocessing validation followed FDA 2015 guidance.

The proposed devices have identical indications for use and same principles of operation as the predicate EC-760R-V/L. Although optical characteristics and dimensional parameters differ, bench testing demonstrated substantially equivalent performance. Material differences were validated through biocompatibility testing showing no new safety or efficacy concerns. All measured parameters (field of view, resolution, bending capability, suction rate, illumination, etc.) met specifications, establishing substantial equivalence despite minor design variations.