Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU, BS41H-12US, BS46H-17EU, BS50H-20EU, BS46H-17US, BS50H-20US, BS53H-22EU, BS53H-22US, BS55H-24EU, BS55H-24US, BS59H-28EU, BS59H-28US

This is a portable video processor (EA101) and multiple flexible bronchoscope models designed for use together as a system for visualizing and performing procedures within the airways and tracheobronchial tree in adults. The system operates in hospital environments where the video processor displays images captured by the bronchoscope on a built-in LCD screen or external monitor, powered by a lithium-ion battery or separate adapter.

The subject flexible bronchoscopes are identical to the predicate device (K211169) except for compatibility with the new portable video processor and package configuration changes. The portable video processor differs from its predicate (EOS-H-01) by being mountable on an IV pole, featuring a built-in LCD screen for standalone operation, offering lithium-ion battery power, and lacking USB data exchange functions.

Testing was conducted per ANSI/AAMI ES60601-1:2005, IEC 60601-2-18 Edition 3.0, IEC/TR 60601-4-2 Edition 1.0, IEC 62471:2006, ISO 8600, ISO 10993-1, ISO 11135:2014, ISO 11607:1-2019 and ISO 11607-2:2019, ASTM F88/F88M-21, ASTM F1929-15, ASTM D4169-22, IEC 62304:2006+A1:2015, and FDA guidance documents for software validation.

The flexible bronchoscopes maintain the same design, materials, indications for use, and performance characteristics as the predicate K211169, with only software/connectivity changes to support the new video processor. The portable video processor performs the same core function as its predicate (displaying live endoscopic video and controlling image brightness) with design modifications that do not alter fundamental safety or effectiveness. Comparative testing demonstrated equivalent optical performance and image quality between the subject device and predicate.