UE BRONCHO Single-Use Bronchoscopes (EBS-380C); UE BRONCHO Single-Use Bronchoscopes (EBS-500C); UE BRONCHO Single-Use Bronchoscopes (EBS-600C); UE Display (UE-M10S)

The UE BRONCHO Single-Use Bronchoscopes are sterile, single-use flexible video bronchoscopes available in three sizes (Slim 3.8mm, Regular 5.0mm, Large 5.8mm) designed for endoscopy within the airways and tracheobronchial tree in adult hospital patients. They connect to the UE Display, a reusable 10.1-inch digital monitor that shows live imaging data captured by a CMOS chip at the scope's distal end.

The subject device has a 90° field of view (vs. predicate's 85°), 1920×1200 maximum resolution (vs. 800×480), and 128 GB storage capacity (vs. 8 GB). The UE Display is larger (10.1 inches vs. 8.5 inches) with enhanced specifications. Both use LED illumination, CMOS imaging sensors, 600mm working length, 180° up/180° down deflection angles, and ethylene oxide sterilization. Physical dimensions of the insertion tubes and working channel diameters are equivalent or identical across all three size variants.

ISO 8600 series (optical performance), ISO 10993-1 (biocompatibility evaluation), ISO 11135:2014 (sterilization validation), ISO 10993-7 (EO/ECH residual testing), ASTM F1980 (accelerated aging), ISO 11607-1/2 (package validation), IEC 60601-1, IEC 60601-2-18 (electrical safety), and IEC 60601-1-2 (electromagnetic compatibility).

The subject device is substantially equivalent because it shares the same intended use (flexible bronchoscopy for airway visualization in adults), same anatomical sites, same product code (EOQ), and same underlying technology (single-use flexible scope with CMOS imaging and reusable display monitor). Performance specifications are identical or equivalent across all critical parameters including deflection angles, working lengths, channel diameters, and sterilization method. Higher resolution and storage capacity in the display represent non-significant improvements rather than new intended uses or safety/effectiveness risks. Bench testing demonstrates comparable optical performance, and compliance with the same consensus standards ensures equivalent safety and effectiveness.