LumiRex Bronchoscope

The LumiRex Bronchoscope is a single-use flexible video endoscope designed for insertion through the mouth or nose into the trachea and bronchial tubes to visualize the airways during diagnostic and therapeutic procedures. It features a light source, camera, and working channel for passage of instruments such as biopsy forceps and brushes, and can be operated in both wired and wireless modes through respective adapters connected to a video processor unit.

Compared to the predicate Vathin Video Bronchoscope System, the LumiRex adds wireless capability via a battery-powered wireless adapter, has a smaller insertion tube bend radius for improved flexibility, incorporates automated white balance without image enhancement controls, and demonstrates wider field of view and greater depth of field. The wired mode operates identically to the predicate device.

ISO 11135:2014 (sterilization), ISO 11607-2:2019 (sterile barrier), ISO 10993 series (biocompatibility), IEC 62304 (software), IEC 60601-1/1-2/2-18 (electrical safety and EMC), ISO 8600 series (endoscope general requirements and optics), ISO 80369-7:2021 (connectors), IEC 62471:2006 (photobiological safety), and FDA guidance on software validation, cybersecurity, and wireless technology.

The device shares the same intended use and indications as the predicate (flexible bronchoscopy in hospital settings). While it introduces wireless operation and optical improvements (wider field of view, better depth), the wired adapter functions identically to the predicate and comprehensive testing demonstrates that the wireless mode's latency remains acceptable and comparable between wired and wireless operation. Design differences in insertion tube bend radius and image controls do not introduce new risks or impair clinical function. All performance characteristics and safety testing met applicable standards or matched predicate performance.