VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)

The VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 is a video processing unit that receives electronic signals from video endoscopes and camera heads, then outputs processed images to a monitor. It is also compatible with rhino-laryngeal stroboscopes to observe vocal cord movement and diagnose voice disorders during endoscopic procedures.

The subject device offers similar functions to the predicate including stroboscopy capability, front panel operation, white balance adjustment, color tone adjustment, contrast enhancement, freeze/pre-freeze functions, and switching enhancement modes. Key differences include digital signal outputs (SDI, HDMI) versus the predicate's analog outputs; the subject uses LED lighting while the predicate uses xenon; the subject is smaller (308×157×461mm vs 350×180×485mm) and lighter (10.6kg vs 13.0kg); and the subject includes a color bar output feature not present in the predicate.

ISO 8600-3:2019 (field of view), ISO 15739:2017 (image noise and dynamic range), ANSI AAMI ES60601-1:2005/(R)2012 (electrical safety), ANSI AAMI IEC 60601-1-2 (EMC), IEC 60601-2-18 Edition 3.0, IEC 60601-4-2 Edition 1.0, IEC 60601-1-6 Edition 3.2, IEC 62304 Edition 1.1 (software), ISO 14971:2019 (risk management).

The subject device performs the same essential function as the predicate—receiving and processing video signals from endoscopes and outputting images for clinical observation—with equivalent safety and performance. Non-clinical testing of optical, image quality, and electrical safety parameters yielded results comparable to the predicate and reference devices. Technological differences (digital vs. analog outputs, LED vs. xenon lighting, compact design) represent refinements rather than new safety or effectiveness concerns, as both devices are designed for the same ENT endoscopic observation applications including stroboscopy.