SKOUT system
Iterative HealthThe SKOUT system is an AI-powered software device that helps gastroenterologists detect potential colorectal polyps in real-time during colonoscopy procedures. It highlights suspected polyps on the endoscopic video feed to assist doctors in colorectal cancer screening and surveillance, improving detection accuracy without replacing clinical judgment.
Intended Use
The SKOUT system is a software device designed to detect potential colorectal polyps in real time during colonoscopy examinations. It is indicated as a computer-aided detection tool providing colorectal polyps location information to assist qualified and trained gastroenterologists in identifying potential colorectal polyps during colonoscopy examinations in adult patients undergoing colorectal cancer screening or surveillance.
Technology
The SKOUT system is a software-based CADe tool using an AI algorithm to detect colorectal polyps in high-definition endoscopic video during colonoscopy. It highlights polyps by drawing a blue rectangular outline on the live video feed, and has a device status indicator. It incorporates video processing compatible with specific endoscopic video processors, utilizes hospital mains power, and includes safety features like pausing detection when surgical tools are detected in the video. Minor hardware and software updates improve performance and stability compared to the predicate device.
Performance
Non-clinical performance testing including electrical safety, usability, electromagnetic compatibility, software verification and validation, and algorithm performance testing was conducted. Testing demonstrated that the SKOUT system is as safe and effective as its predicate device, with reliable polyp detection accuracy and no pixel degradation or video delays. The device met all required special controls and showed unchanged clinical performance from prior submissions.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/11/2025
28 days - 2
FDA Approval
5/9/2025
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