SKOUT� system
Iterative Scopes, Inc.The SKOUT system is a computer-aided detection software designed to assist gastroenterologists during colonoscopy by identifying potential colorectal polyps in real time. It highlights suspected polyps on endoscopic video to aid in colorectal cancer screening or surveillance, supporting clinicians in making more accurate evaluations.
Intended Use
The SKOUT system is a software device designed to detect potential colorectal polyps in real time during colonoscopy examinations. It provides colorectal polyp location information to assist trained gastroenterologists during colorectal cancer screening or surveillance in adult patients using white light colonoscopy.
Technology
The SKOUT system is a software-based AI algorithm that processes high-definition endoscopic video in real time during colonoscopies. It detects potential colorectal polyps and highlights them on the video with a blue rectangular outline. It includes a GUI with device status indicators and temporarily pauses detection when surgical tools are present to avoid obstructing the view.
Performance
Non-clinical performance testing including software verification, validation, and bench testing demonstrated that the SKOUT system meets design requirements for safety and effectiveness. The device passed special controls for false positives, pixel degradation, and video delays, showing performance equivalent to its predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/21/2024
29 days - 2
FDA Approval
4/19/2024
Other devices from Iterative Scopes, Inc.
- SKOUT� system2024 • 510K
- SKOUT� system2023 • 510K
- SKOUT Software2022 • 510K
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