| K-number | K251126 |
| Device name | SKOUT system |
| Applicant | Iterative Health |
| Product code | QNP |
| Device class | Class II |
| Decision date | May 9, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 876.1520 |
The SKOUT system is a software-based computer-aided detection tool designed to assist gastroenterologists in identifying potential colorectal polyps in real time during colonoscopy procedures. It displays a blue rectangular outline around suspected polyps on the endoscopic video monitor to aid detection during colorectal cancer screening or surveillance in adult patients. The system pauses polyp detection when endoscopic tools are present to prevent obstruction of the surgical field.
The subject device introduces an alternate hardware configuration with a modified GPU and video bypass switch to improve supply chain stability and reduce power consumption, along with updates to system and back-end software for compatibility with both hardware configurations. An additional video processor (Olympus EVIS EXERA II) was validated as compatible and added to device labeling. The inference algorithms, intended use, indications for use, and fundamental principles of operation remain identical to the predicate device.
Electrical safety, usability, and electromagnetic compatibility testing per IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, and IEC 60601-1-6. Software verification and validation testing per General Principles of Software Validation guidance. Algorithm performance testing for true positives, false positives, and polyp detection time. Bench testing to confirm compliance with 21 CFR 876.1520 special controls for pixel degradation and video delays.
The SKOUT system maintains identical intended use, indications for use, and core inference algorithms as the predicate device (K241508), with only minor hardware and software modifications designed to improve supply chain stability and reduce power consumption. Non-clinical performance testing demonstrates the alternate hardware configuration meets the same electrical safety and compatibility standards as the predicate. The AI-based polyp detection algorithm is unchanged, preserving clinical performance from previous testing, and additional testing confirms the new video processor compatibility does not raise different safety or effectiveness questions.
View the full FDA submission: accessdata.fda.gov