EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)

The EVIS EXERA III Bronchovideoscope (three models: BF-Q190, BF-H190, BF-1TH190) is a flexible endoscope used for endoscopic diagnosis and treatment within the respiratory airways and tracheobronchial tree. It consists of a control section with angulation knobs, an insertion section with imaging and instrument channels, and a connector section that links to an external video system center and light source.

The subject devices have identical technological characteristics and design to their predicate devices with no modifications. Key specs include 120° field of view, 3-100mm depth of field, forward-viewing optics, dual focus capability (near and normal modes) via Voice Coil Motor actuator, instrument channels ranging from φ2.0mm to φ2.8mm depending on model, NBI observation capability, and water-resistant connectors.

Risk management was performed in accordance with ISO 14971:2019. The device is subject to the Quality Management System Regulation (QMSR) including ISO 13485 clauses 7.3 (design controls), 8.3 (nonconforming product), 8.5.2 (corrective action), and 8.5.3 (preventative action).

Substantial equivalence is established because the subject devices have identical indications for use, design, materials, sterilization methods, shelf life, reprocessing procedures, packaging, and software as the predicate device K121959. The only change is an update to the operation manual providing new instructions for proper use with laser, high-frequency, and APC systems, supported by bench testing for ignition factor safety and human factors validation.