OPTOVISION Endoscopic Light Source Unit

The OPTOVISION Endoscopic Light Source Unit is a medical device that provides real-time endoscopic visible light and near-infrared fluorescence imaging during minimally invasive surgical procedures. When used with indocyanine green (ICG) dye administered intravenously, it enables surgeons to visualize blood vessels, tissue perfusion, and bile ducts; when ICG is administered interstitially, it visualizes the lymphatic system including lymph nodes and vessels.

The subject device uses RGB LEDs and an 808nm infrared laser diode combined through dichroic mirrors and projected onto an output light collimator, with fiber coupling to an endoscope. The predicate uses the same RGB LEDs and infrared laser approach but at 806nm and 830nm wavelengths. Both employ electronic drivers for light control. The subject device offers imaging modes (NIR, VIS, FUSION) where the FUSION mode functionally equates to the predicate's Overlay mode and NIR mode equates to Contrast mode, though the subject lacks the ENV mode.

IEC 60601-1 (electrical safety), IEC 60601-2-18 (endoscope standards), IEC 60601-1-2 (electromagnetic compatibility), IEC 62471 (photobiological safety), IEC 62366-1 (usability), and IEC 62304 (software validation and verification).

Both devices share identical intended use for ICG-based near-infrared fluorescence imaging of vessels, bile ducts, and lymphatic structures during endoscopic surgery. The minor technological differences—808nm versus 806nm/830nm wavelengths and different imaging mode nomenclature—do not affect primary function since both wavelengths perform equivalent NIR fluorescence imaging with ICG, and the subject's imaging modes functionally replicate the predicate's capabilities. All performance testing demonstrated compliance with applicable safety standards with no safety concerns identified, establishing that the devices are functionally equivalent despite minor technical variations.