Outlook Surgical Versa One System (8900139)

The Outlook Surgical Versa One System is a video nasopharyngoscopy system that provides illumination and live video visualization of a patient's internal anatomy during otolaryngology and head and neck procedures. It consists of a semi-flexible endoscope, connection cable, wireless-enabled display unit, and wireless HDMI receiver. Users attach accessory instruments to the endoscope shaft, which becomes rigid when an instrument is attached, functioning as a rigid endoscope for examination and visualization in operating rooms, healthcare clinics, or medical offices.

The Versa One System uses an integrated LED light source with a CMOS sensor at the distal tip to transmit images to an integrated handheld display with video processor, rather than rod lenses with an external camera. It features optional wireless video transmission between the handheld monitor and wireless receiver, whereas the predicate has no wireless capability. The subject device has a 120° field of view compared to the predicate's 80°–105°, and shorter working length of 102–105 mm versus 125–180 mm. Both devices are rigid endoscopes without articulation control or internal working channel, are reusable, and use similar manual cleaning and sterilization reprocessing methods.

ISO 8600-X, ISO 12233, ISO 15739 (optical performance); IEC 60601-1, IEC 60601-2-18 (electrical safety); IEC 60601-1-2 (EMC); IEC 63195-1, ANSI/IEEE C95.1-1 (RF safety); IEC 62471 (photobiological safety); ISO 10993-5, ISO 10993-10, ISO 10993-23 (biocompatibility); ISO 22441:2022 (low-temperature hydrogen peroxide sterilization); ISO 11135:2014 (ethylene oxide sterilization); AAMI TIR12, AAMI ST98 (cleaning validation); IEC 62366-1 (user validation).

The subject and predicate devices share the same intended use, indication, and use environment, both providing illumination and visualization as rigid endoscopes without articulation control or internal channels. Technical differences—integrated LED versus external light source, CMOS imaging versus rod lenses, optional wireless transmission, and different shaft dimensions and field of view—do not raise new safety or effectiveness questions because performance testing (optical, electrical, photobiological), user validation studies, and biocompatibility testing all passed acceptance criteria and demonstrated equivalent safety and functionality. Both devices are reusable, undergo similar manual cleaning and APS STERRAD sterilization, and the performance data confirms the subject device performs as safely and effectively as the predicate.