Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11, BC-E1E12, BC-E1H10, BC-E1H11, BC-E1H12; Digital Video Monitor: DVM-D1, DVM-D2; Single-use sampler: S-20mL, S-30mL, S-50mL

The Video Bronchoscope System is a single-use flexible bronchoscope with integrated digital video monitor and sampler for endoscopic procedures within the airways and tracheobronchial tree. It enables visualization, diagnosis, treatment, and collection of fluid samples during bronchial alveolar lavage (BAL) or bronchial wash (BW) procedures in adult patients in healthcare facilities.

The proposed device has a 95° field of view (versus 85° in predicate), depth of view of 3-100mm (versus 6-50mm), working lengths of 560/580/600mm (versus 600mm), and a 15.6-inch display (versus 12.8-inch). Both use CMOS digital imaging with LED illumination, identical biocompatibility profiles, EO sterilization, and the same HDMI/SDI video outputs and Type A USB connections.

ISO 10993-1:2018 (biocompatibility), ISO 11135 (sterilization), IEC 60601-1 and IEC 60601-2-18 (electrical safety), IEC 60601-1-2 (electromagnetic compatibility), and FDA guidance on software verification and validation and cybersecurity.

The device has identical intended use, patient population (adults), and application field as the predicate Ambu aScope 4 Broncho systems. Despite minor differences in field of view, depth of view, and display size, these variations do not alter the fundamental functionality or safety profile. Biocompatibility, sterilization method, digital imaging technology, and safety/EMC compliance are substantially identical to predicate devices, demonstrating equivalent performance for the same clinical procedures.