Endoscopic Camera System

The Endoscopic Camera System is a camera control unit (CCU) with a camera head designed to connect with optical endoscopes for visualization, image capture, processing, and documentation during general endoscopic and microscopic diagnostic and surgical procedures. It transmits images from inside the human body cavity to a monitor for real-time viewing.

The subject device has the same operational principles as the predicate but differs in minor specifications including horizontal resolution, spatial frequency response, field of view, focal length, camera head dimensions and weight, image delay, video output format, and USB port configuration of the CCU.

Electrical safety testing per IEC 60601-1 Edition 3.2 (2020-08); EMC testing per IEC 60601-1-2 Edition 4.1 (2020-09); Reprocessing validation per AAMI TIR 12:2020; Software verification testing per FDA Guidance on Device Software Functions; and bench performance testing for camera, CCU, and system-level functions.

Both the subject and predicate devices are camera systems with identical indications for use and operational principles for endoscopic and microscopic visualization and documentation. Although minor technology differences exist in specifications like resolution and dimensions, bench testing demonstrates the subject device meets all design specifications. These minor differences do not raise new safety or effectiveness concerns, making the devices substantially equivalent for their intended purpose.