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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 consists of AI-based software integrated into a single hardware unit that analyzes high-definition endoscopic video in real time to highlight suspected colorectal polyps with on-screen visual markers (blue rectangular outlines). It pauses detection during surgical tool use to avoid interference and includes a status indicator to show device operation or errors.

Performance

The software underwent verification and validation per FDA guidelines for software in medical devices, showing passing results. Electrical safety and electromagnetic compatibility testing conformed to recognized IEC standards. Human factors validation demonstrated safe and effective use. The system maintains low video delay and image quality without pixel degradation.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    3/9/2023

    29 days
  • 2

    FDA Approval

    4/7/2023

Other devices from Iterative Scopes Inc.

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