Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US)

The Flexible Bronchoscope is a single-use endoscope designed for visualization and therapeutic procedures within the airways and tracheobronchial tree in adult patients in hospital settings. It consists of a handle with deflection controls, an insertion section with a working channel, and a distal tip containing a CMOS image sensor and LED-powered illumination delivered via optical fibers. The device connects to a portable video processor to display images on a monitor.

The subject device shares fundamental technology with the predicate in deflection, field of view, direction of view, imager type, single-use design, and ethylene oxide sterilization. Key differences are the distal end outer diameter and patient-contacting materials. A significant design difference is that the subject device uses an LED in the handle transmitted via optical fibers to the distal tip, whereas the predicate uses LEDs at the distal tip. Optical performance testing confirmed the subject device achieves comparable optical parameters to the predicate and reference devices.

ANSI AAMI ES60601-1, ANSI AAMI IEC 60601-1-2, IEC 60601-2-18, IEC/TS 60601-4-2, IEC 62471 (photobiological safety), ISO 8600 (mechanical and optical), ISO 10993-1 (biocompatibility), ISO 11135:2014 (sterilization validation), ISO 10993-7:2008 (residual gas testing), ASTM F1980-21 (shelf life aging), ISO 11607 and ASTM standards (package validation).

The subject device is substantially equivalent because it has identical indications for use, the same fundamental technology and performance characteristics as the predicate, and differences in outer diameter, materials, and LED placement do not raise new safety or effectiveness questions. Optical performance testing demonstrated the subject device's LED-delivered-via-fiber illumination design produces equivalent optical quality to the predicate's distal-tip LEDs. Comprehensive nonclinical testing across electrical safety, photobiological safety, mechanical performance, biocompatibility, sterilization, and packaging confirmed the device is as safe and effective as the predicate.