EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-P190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XT190); BRONCHOVIDEOSCOPE (OLYMPUS BF-H1100); BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH1100)

These are flexible bronchovideoscopes (five models: BF-XP190, BF-P190, BF-XT190, BF-H1100, BF-1TH1100) used for endoscopic diagnosis and treatment within the airways and tracheobronchial tree. They are intended to be used with an Olympus video system center, light source, documentation equipment, and endotherapy accessories such as biopsy forceps.

The subject devices have identical technological characteristics and design to their predicate devices with no modifications to design, materials, sterilization, shelf life, reprocessing, packaging, or software. The BF-XP190, BF-P190, and BF-XT190 models are cleared for use with the newly cleared EVIS X1 VIDEO SYSTEM CENTER CV-1500 and support imaging modes WLI, NBI, RDI, TXI, and BAI-MAC. All subject devices have updated labeling regarding proper use with laser, high frequency, and APC systems.

Risk management was performed in accordance with ISO 14971:2019. The document does not cite other specific consensus standards such as IEC or ASTM.

The devices raise no new issues of safety and effectiveness because they are unchanged in all design, material, sterilization, and operational characteristics from their predicates. Bench testing confirmed thermal safety, photobiological safety, color performance, resolution, image quality, and safety factors for laser, high-frequency, and APC use. Animal testing validated imaging modes with the new video processor. Since there are no design or material changes, extensive testing categories (biocompatibility, sterilization, electrical safety) were appropriately not repeated.