FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000

The FUJIFILM Endoscope Model EB-710P is a flexible bronchoscope for observation, diagnosis, and endoscopic treatment of the trachea and bronchus. The FUJIFILM Processor EP-8000 is an endoscopic processor with integrated light source that processes video signals from the endoscope, provides illumination via four LED lamps, and enables image recording for use with compatible endoscopes, monitors, and peripherals.

The EB-710P shares identical principles and product code (EOQ) with its predicate. The EP-8000 combines video processing and light sourcing into a single unit (versus separate VP-7000 and BL-7000 units), uses identical LED colors (violet, blue, green, amber), supports compatible 700 and 500 series endoscopes, has modified power ratings (2.0-1.1A versus separate ratings), larger dimensions (395×210×515mm), and increased weight (18kg), but retains the same four-color LED configuration and fundamental operational principles.

ANSI/AAMI ES 60601-1:2012, IEC 60601-1-2:2020, IEC 60601-1-6:2020, IEC 60601-2-18:2009 (electrical safety); IEC 62304:2015 (software); bench testing of color reproduction, image geometric distortion, resolution, depth of field, ISO-SNR dynamic range, image intensity uniformity, and field of view performance.

Both devices use identical LED lamp configurations and produce no difference in color performance. Bench testing demonstrated the EP-8000's image performance is substantially equivalent to the predicate VP-7000/BL-7000 across all imaging modes. Consolidating two separate units into one, modifying dimensions and power ratings, and adding tablet operation do not introduce new safety or efficacy concerns because the core light delivery, image processing, and clinical functionality remain unchanged. Risk analysis confirmed these modifications do not affect the device's intended use or safety profile.