LumiRex Ureteroscope

The LumiRex Single-Use Digital Flexible Ureteroscope is a video endoscope designed for insertion through the urethra into the urinary tract and kidney. It contains a light source and camera to visualize the urinary tract and interior of the kidney, with a working channel allowing passage of instruments like biopsy forceps, brushes, and stone retrieval baskets for urology and urological procedures.

The device can operate both wirelessly and wired via Wireless or Wired Scope Adapters, unlike the predicate which only supports wired use. The video processor accepts both mains and lithium battery power, compared to the predicate's mains-only power. Comparative testing showed the subject device has a wider field of view but equivalent depth of view. The device features a built-in battery for wireless maneuverability.

ISO 11135:2014 (sterilization), ISO 11607:2-2019 (sterile barriers), ASTM F1980 (accelerated aging), ISO 8600-1:2015 and ISO 8600-3:2019 (endoscopes general requirements and field of view), ISO 8600-4:2014 (insertion portion width), IEC 62471:2006 (photobiological safety), IEC 60601-1:2005, IEC 60601-1-2:2014+A1:2020, IEC 60601-2-18 (electrical safety), and ISO 10993-1 series (biocompatibility).

The subject device and predicate share the same basic form factor, digital video and illumination sources, single-use construction, and video processing architecture. The differences—wireless capability, battery power option for the video processor, and wider field of view—do not raise different safety or effectiveness questions because wireless operation was validated to be acceptable, both devices perform equivalently in wired mode, and the wider field of view with same depth maintains clinical utility without introducing new risks.