SKOUT� system
Iterative Scopes, Inc.The SKOUT system is a medical software device that uses artificial intelligence to assist gastroenterologists in real-time detection of potential colorectal polyps during colonoscopy procedures. It provides visual markers on the endoscopic video feed to highlight suspected polyps, helping doctors identify these abnormalities more effectively during colorectal cancer screening or surveillance.
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. It is only intended to assist and not replace physician judgment, indicated for white light colonoscopy only.
Technology
The SKOUT system is comprised of a single-piece hardware and software design that processes high-definition endoscopic video in real time. It uses an artificial intelligence-based algorithm for polyp detection and tracking. It features a graphical user interface with a blue rectangular outline to mark detected polyps on the endoscopic video feed. The system also includes status indicators and disables polyp detection when surgical tools are present or lighting is inadequate. It is compatible with Olympus EVIS EXERA III and FUJI EC760 series endoscopes, and connects via Serial Digital Interface (SDI).
Performance
Non-clinical performance testing was performed to demonstrate safety and effectiveness, including software verification and validation per FDA guidelines, and additional bench testing for algorithm performance, pixel degradation, and video delays. The SKOUT system demonstrated passing results for all applicable testing. The software changes do not affect safety or effectiveness compared to its predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/28/2024
1 month - 2
FDA Approval
7/3/2024
Other devices from Iterative Scopes, Inc.
- SKOUT� system2024 • 510K
- SKOUT� system2023 • 510K
- SKOUT Software2022 • 510K
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