SKOUT system

The SKOUT system is a software-based computer-aided detection (CADe) device that analyzes high-definition endoscopic video during colonoscopy procedures in real time. It displays a blue rectangular outline around suspected colorectal polyps on the endoscopic monitor to assist gastroenterologists in identifying potential polyps during colorectal cancer screening or surveillance in adult patients. The gastroenterologist retains full responsibility for confirming polyp presence based on their medical judgment.

The subject device (v2.3) has the same hardware configurations (SKOUT 211 and 220), intended use, indications, and fundamental technology as the predicate (v2.2). Minor changes include retraining of inference algorithms for Endocuff device compatibility and improved performance on multiple polyps and sessile serrated lesions; refinement of software for optimized video edge detection and memory efficiency; and updated user interface icons and status indicators. The device maintains the same AI-based algorithm architecture, power source, safety features, video input/output specifications, and compatible endoscopes as the predicate.

Not stated in this summary.

The SKOUT system is substantially equivalent because it maintains identical intended use, indications for use, user population, and fundamental technological characteristics as its predicate device (K251126). The inference algorithms utilize the same architecture and meet the same performance requirements; minor software refinements do not affect safety or effectiveness when used as labeled. Non-clinical performance testing including software verification and validation, algorithm performance testing, and bench testing confirmed the device meets all applicable design requirements and special controls under 21 CFR 876.1520, demonstrating it is as safe and effective as the predicate device.