Digital Video Processor

The Digital Video Processor (model DVP-C10) is an endoscopic image processing device that receives and processes video signals from digital endoscopes and transfers the processed signals to a connected monitor. It is designed for use with Vathin medical endoscopes and other ancillary equipment to support endoscopic diagnosis, treatment, and video observation in professional healthcare facility environments.

The proposed device offers higher maximum resolution (1920×1080 for HDMI/SDI/DVI outputs and 720×576 for CVBS/S-Video) compared to the predicate's 1280×800. It includes a 12.1-inch touch screen display, USB 3.0 and USB 2.0 connections, and multiple video output formats (HDMI, SDI, CVBS, S-VIDEO, DVI), versus the predicate's HDMI and USB 2.0 outputs. Both devices perform image/video capture and serve the same classification and intended use in professional healthcare settings.

The device was tested for electrical safety and electromagnetic compatibility (EMC) in accordance with IEC 60601-1, IEC 60601-2-18 (safety), and IEC 60601-1-2 (EMC). Software verification and validation testing was conducted following FDA guidance on device software functions and cybersecurity. Performance testing evaluated field of view, depth of field, geometric distortion, image intensity uniformity, and color performance.

The device is substantially equivalent because it shares the same intended use, classification (Class II, 21 CFR 876.1500, product code FGB), regulatory designation, and fundamental function as the predicate—both process endoscopic video signals for display. Although the proposed device has enhanced technical specifications (higher resolution outputs and additional connectivity options), these improvements do not create new risks or change the fundamental safety and effectiveness profile. The non-clinical testing demonstrates equivalent or superior performance in critical imaging parameters, and compliance with the same international safety and EMC standards confirms equivalence to the legally marketed predicate device.