Vathin® Video Bronchoscope System

The Vathin® Video Bronchoscope System is a single-use flexible video bronchoscope (models BCV1-02 for ages 6 months to 6 years, BCV1-C2 for ages 6 years and older, plus adult models) used with a reusable digital video monitor for endoscopy within the airways and tracheobronchial tree in hospital settings. It enables visualization and therapeutic interventions in the respiratory tract.

The subject device has insertion shaft outer diameters of 2.2 mm (BCV1-02) and 3.2 mm (BCV1-C2), a field of view of 110° horizontal/vertical, depth of field 3-100 mm, working length 600/700 mm, CMOS digital video technology, LED illumination, and is sterilized by ethylene oxide. These specifications are identical to the primary predicate device (K223836) and comparable to secondary predicates.

IEC 60601-1 and IEC 60601-1-2 for electrical safety; IEC 60601-2-18 for endoscopic equipment; ISO 10993 series for biocompatibility; ISO 8600 series for optical performance; ISO 80369-7 for Luer taper compatibility; ISO 11135 for ethylene oxide sterilization validation; IEC 62366-1 for usability engineering.

The subject device is substantially equivalent because it is identical in intended use, indications for use, operating principle, and technological characteristics to the primary predicate (K223836), which is the manufacturer's own legally marketed device. The insertion pressure of the subject device's smaller (2.2 mm) scope tip is no greater than the secondary predicate's 2.8 mm version despite the size difference, supporting safe pediatric use. All performance testing, including electrical safety, biocompatibility, mechanical characteristics, and optical performance, demonstrates no new safety or effectiveness issues compared to predicate devices.