Who is the manufacturer of SKOUT® system?

Iterative Scopes, Inc. filed the 510(k) submission for SKOUT® system (K230658).

What is the FDA product code for SKOUT® system?

QNP. It is classified under 21 CFR 876.1520 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for SKOUT® system?

510(k) clearance (submission type: Special).

Does SKOUT® system use AI or machine learning?

Yes. SKOUT® system (K230658) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like SKOUT® system?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like SKOUT® system get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

SKOUT® system

K230658 · Iterative Scopes, Inc. · QNP · Apr 7, 2023 · Gastroenterology, Urology

Device Facts

Record ID	K230658
Device Name	SKOUT® system
Applicant	Iterative Scopes, Inc.
Product Code	QNP · Gastroenterology, Urology
Decision Date	Apr 7, 2023
Decision	SESE
Submission Type	Special
Regulation	21 CFR 876.1520
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

AI Performance

Output	Algorithm	Acceptance	Observed	Dev DS	Dev Readers	Test DS	Test Readers
Colorectal polyp detection	Artificial intelligence-based algorithm	—	—	—	—	—	—

Indications for 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. The SKOUT system is only intended to assist the gastroenterologist in identifying suspected colorectal polyps and the gastroenterologist is responsible for reviewing SKOUT suspected polyp areas and confirming the presence or absence of a polyp based on their own medical judgment. SKOUT is not intended to replace a full patient evaluation, nor is it intended to be relied upon to make a primary interpretation of endoscopic procedures, medical diagnosis, or recommendations of treatment/course of action for patients. SKOUT is indicated for white light colonoscopy only.

Device Story

SKOUT system is a software-based computer-aided detection (CADe) device for real-time analysis of high-definition endoscopic video during colonoscopy. It processes video input to identify potential colorectal polyps; outputs visual markers (blue rectangular outlines) superimposed on the endoscopic monitor. Used in clinical settings by gastroenterologists; system pauses detection when surgical tools are detected or lighting is inadequate to prevent obstruction. Includes a GUI with status indicators (active, tool present, or error). The device assists clinicians in polyp identification; however, the clinician retains responsibility for final diagnosis and clinical decision-making. Benefits include potential improvement in polyp detection rates during screening or surveillance.

Clinical Evidence

No clinical data presented. Substantial equivalence supported by software verification and validation, electrical safety/EMC testing (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18), and human factors validation.

Technological Characteristics

Software-based CADe system; single-piece hardware architecture. Interfaces with endoscopes (Olympus EVIS EXERA III, FUJI EC760 series). Powered by hospital mains. Features real-time video processing with AI-based detection algorithm. GUI provides visual status indicators and polyp bounding boxes. Complies with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-18 standards.

Indications for Use

Indicated for adult patients undergoing colorectal cancer screening or surveillance colonoscopy. Assists trained gastroenterologists in identifying potential colorectal polyps in real time during white light colonoscopy.

Regulatory Classification

Identification

A gastrointestinal lesion software detection system is a computer-assisted detection device used in conjunction with endoscopy for the detection of abnormal lesions in the gastrointestinal tract. This device with advanced software algorithms brings attention to images to aid in the detection of lesions. The device may contain hardware to support interfacing with an endoscope.

Special Controls

In combination with the general controls of the FD&C Act, the gastrointestinal lesion software detection system is subject to the following special controls:

*Classification.* Class II (special controls). The special controls for this device are:(1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including detection of gastrointestinal lesions and evaluation of all adverse events. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must include: (i) Standalone algorithm performance testing; (ii) Pixel-level comparison of degradation of image quality due to the device; (iii) Assessment of video delay due to marker annotation; and (iv) Assessment of real-time endoscopic video delay due to the device. (3) Usability assessment must demonstrate that the intended user(s) can safely and correctly use the device. (4) Performance data must demonstrate electromagnetic compatibility and electrical safety, mechanical safety, and thermal safety testing for any hardware components of the device. (5) Software verification, validation, and hazard analysis must be provided. Software description must include a detailed, technical description including the impact of any software and hardware on the device's functions, the associated capabilities and limitations of each part, the associated inputs and outputs, mapping of the software architecture, and a description of the video signal pipeline. (6) Labeling must include: (i) Instructions for use, including a detailed description of the device and compatibility information; (ii) Warnings to avoid overreliance on the device, that the device is not intended to be used for diagnosis or characterization of lesions, and that the device does not replace clinical decision making; (iii) A summary of the clinical performance testing conducted with the device, including detailed definitions of the study endpoints and statistical confidence intervals; and (iv) A summary of the standalone performance testing and associated statistical analysis.

Predicate Devices

SKOUT System (K213686)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. April 7, 2023 Iterative Scopes Inc. Dennis Francoeur Director of Regulatory Affairs 675 Massachusetts Ave 2nd Floor Cambridge, MA 02139 Re: K230658 Trade/Device Name: SKOUT® system Regulation Number: 21 CFR 876.1520 Regulation Name: Gastrointestinal Lesion Software Detection System Regulatory Class: Class II Product Code: QNP Dated: March 9, 2023 Received: March 9, 2023 Dear Dennis Francoeur: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. # Shanil P. Haugen -S Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ 510(k) Number (if known) K230658 Device Name #### SKOUT® System Indications for Use (Describe) 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. The SKOUT system is only intended to assist the gastroenterologist in identifying suspected colorectal polyps and the gastroenterologist is responsible for reviewing SKOUT suspected polyp areas and confirming the presence or absence of a polyp based on their own medical judgment. SKOUT is not intended to replace a full patient evaluation, nor is it intended to be relied upon to make a primary interpretation of endoscopic procedures, medical diagnosis, or recommendations of treatment/course of action for patients. SKOUT is indicated for white light colonoscopy only. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|-----------------------------------------------| | X Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) | # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.qov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number. {3}------------------------------------------------ #### VII. 510(K) SUMMARY #### 510(k) SUMMARY SKOUT® system ### Submitter: Iterative Health, Inc. (Iterative Scopes) 675 Massachusetts Ave Cambridge MA 02139 Phone: (603) 819-8387 Contact Person: Dennis Francoeur, Director of Regulatory Affairs Date Prepared: March 9, 2023 Name of Device: SKOUT® System Classification Name: Gastrointestinal Lesion Software Detection System Classification Panel: Gastroenterology and Urology Regulation Number: 876.1520 Product Code: QNP Predicate Device: SKOUT System, Iterative Scopes, K213686 # Device Description The SKOUT® system is a software-based computer aided detection (CADe) system for the analysis of highdefinition endoscopic video during colonoscopy procedures. The SKOUT system is intended to aid gastroenterologists with the detection of potential colorectal polyps during colonoscopy by providing an informational visual aid on the endoscopic monitor using trained software that processes the endoscopic video in real time. Users will primarily interact with the SKOUT system by observing the software display, including the polyp detection box and device status indicator signal. #### Polyp Detection Notification The SKOUT system has a main graphical user interface (GUI) feature of the polyp detection notification. The polyp detection notification is a two-dimensional blue rectanqular outline generated around any suspected polyps on the endoscopic video feed. If there is no polyp detected, the bounding box does not appear. SKOUT® system pauses polyp detection when an endoscopic tools are detected in the video feed to ensure that the bounding box does not hinder any surgical procedure, biopsy, or resection or this may also occur when lighting conditions are deemed to be inadequate. {4}------------------------------------------------ The polyp detection notification enables users to: - Detect potential colorectal polyps during colonoscopy examinations in adult patients undergoing a . colorectal cancer screeninq or surveillance procedure. - Utilize a tool that provides additional information for endoscopic observation. ● ### Device Status Indicator The SKOUT system has an additional GUI feature that notifies users of the current device status (active or error): - a two-dimensional green box with letter (S) when the device is powered on and actively processing ● video. - o a two-dimensional grav box with letter (S) when a surgical tool is present. - a red (X) with an error message: when there is an error with the video processing function of the ● SKOUT system, the green box will be replaced with a red X and error message to indicate an error has occurred. ### Intended Use / Indications for 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. The SKOUT system is only intended to assist the aastroenterologist in identifying suspected colorectal polyps and the gastroenterologist is responsible for reviewing SKOUT suspected polyp areas and confirming the presence or absence of a polyp based on their own medical judgment. SKOUT is not intended to replace a full patient evaluation, nor is it intended to be relied upon to make a primary interpretation of endoscopic procedures, medical diagnosis, or recommendations of treatment/course of action for patients. SKOUT is indicated for white light colonoscopy only. # Design Changes Hardware architecture changes: The multi piece tethered system of the predicate to a single box containing all of the components. Some of the components included in the subject device have been updated to improve component longevity and image quality performance. Software architecture changes: To support the updated hardware design the software was updated in addition to improvements to image handling for image quality performance and error handling for improved usability performance. # Non-Clinical Testing - Software verification and validation was conducted on the SKQUT System software to validate it for its intended use per the design documentation in line with recommendations outlined in General Principles of Software Validation, Guidance for Industry and FDA Staff. The SKOUT software demonstrated passing results on all applicable testing. - . Electrical Safety Electromagnetic Compatibility the SKOUT system was evaluated for compliance to the following FDA-Recognized Consensus Standards: - IEC 60601-1:2005, AMD 1:2012 Medical electrical equipment Part 1: General о requirements for basic requirements for basic safety and essential performance {5}------------------------------------------------ - IEC 60601-1-2: 2014 Medical electrical equipment Part 1-2: General requirements for o basic requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility – Requirements and tests - IEC 60601-2-18: 2009 Medical electrical equipment Part 2-24: Particular requirements o for the basic safety and essential performance of endoscopic equipment - Human factors validation was performed following the FDA Guidance document Applying Human Factors and Usability Engineering to Medical Devices, Guidance for Industry and FDA Staff recommendations. The human factors validation demonstrated that the device functioned as intended, use-related risk has been mitigated, and the SKOUT system is safe for its intended use. # Summary of Technological Characteristics The predicate device represents a previous revision of the subject device, SKOUT System FDA cleared via K213686 on August 12, 2022. | | Subject Device SKOUT System | Predicate Device SKOUT System (K213686) | |----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | A gastrointestinal lesion software detection system is a computer- assisted detection device used in conjunction with endoscopy for the detection of abnormal lesions in the gastrointestinal tract. This device with advanced software algorithms brings attention to images to aid in the detection of lesions. The device has hardware components to support interfacing with an endoscope. | Same - A gastrointestinal lesion software detection system is a computer-assisted detection device used in conjunction with endoscopy for the detection of abnormal lesions in the gastrointestinal tract. This device with advanced software algorithms brings attention to images to aid in the detection of lesions. The device has hardware components to support interfacing with an endoscope. | | Indications for 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. The SKOUT system is only intended to assist the gastroenterologist in identifying suspected colorectal polyps and the gastroenterologist is responsible for reviewing SKOUT suspected polyp areas and confirming the presence or absence of a polyp based on their own medical judgment. SKOUT is not intended to replace a full patient evaluation, nor is it intended to be relied upon to make a primary | Same - 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. The SKOUT system is only intended to assist the gastroenterologist in identifying suspected colorectal polyps and the gastroenterologist is responsible for reviewing SKOUT suspected polyp areas and confirming the presence or absence of a polyp based on their own medical judgment. SKOUT is not intended to replace a full patient evaluation, nor is it intended to be relied upon to make a primary | | | Subject Device SKOUT System | Predicate Device SKOUT System (K213686) | | | interpretation of endoscopic procedures, medical diagnosis, or recommendations of treatment/course of action for patients. SKOUT is indicated for white light colonoscopy only. | interpretation of endoscopic procedures, medical diagnosis, or recommendations of treatment/course of action for patients. SKOUT is indicated for white light colonoscopy only. | | User Population | Adult patients undergoing colorectal cancer screening or surveillance colonoscopy. | Same - Adult patients undergoing colorectal cancer screening or surveillance colonoscopy. | | Technological Characteristics | The SKOUT system is composed of a single piece hardware design and software designed to highlight portions of the colon where the device detects potential colorectal polyps. | Similar - The SKOUT system is composed of a multi piece hardware design and software designed to highlight portions of the colon where the device detects potential colorectal polyps. | | Software Algorithm | The SKOUT system utilizes an artificial intelligence-based algorithm to perform the polyp detection function. | Same - The SKOUT system utilizes an artificial intelligence-based algorithm to perform the polyp detection function. | | Power Source | Hospital mains power | Same - Hospital mains power | | Safety Features | The Mode Selection Button allows for instantaneous toggling between the SKOUT video feed and the bypass video feed in the event of software error that affects video quality. | Similar - The Video Display Switch allows for instantaneous toggling between the SKOUT video feed and the standard video feed in the event of software error that affects video quality. | | | The polyp detection marker is disabled if a biopsy tool enters the field of view to prevent obstruction of the area of interest during intervention. | The polyp detection marker is disabled if a biopsy tool enters the field of view to prevent obstruction of the area of interest during intervention. | | | SKOUT system GUI also has a device status indicator, the subject device has an additional GUI feature that notifies users of the current device status (active or error): a two-dimensional green box with letter (S) when the device is powered on and actively processing video. a two-dimensional gray box with letter (S) when a surgical tool is present. a red (X) with an error message; when there is an error with the video processing function of the SKOUT® system, the green box will be replaced with a red X and error message to indicate an error | SKOUT system GUI also has a device status indicator, a green square, located in the top left corner of the SKOUT video feed. This GUI feature is an additional check to the user that the SKOUT system is on and in use, even when polyp detection notifications are not on the screen to prevent undesired use of the AI. | | | Subject Device SKOUT System | Predicate Device SKOUT System (K213686) | | Device Output | SKOUT system generates markers in the form of blue rectangles superimposed on the endoscopic video when potential colorectal polyps are identified. SKOUT markers are not accompanied by a sound. | Same - SKOUT system generates markers in the form of blue rectangles superimposed on the endoscopic video when potential colorectal polyps are identified. SKOUT markers are not accompanied by a sound. | | | The polyp detection marker is disabled if a biopsy tool enters the field of view to prevent obstruction of the area of interest during intervention. | The polyp detection marker is disabled if a biopsy tool enters the field of view to prevent obstruction of the area of interest during intervention. | | Compatible Endoscopes | Olympus EVIS EXERA III and FUJI EC760 series | Same - Olympus EVIS EXERA III and FUJI EC760 series | | Video Delay | Assessment of video delay due to marker annotation; SDI 0.0ms (error 1.1ms ) Assessment of video delay due to device; SDI 0.0ms (error 1.1ms) Subject device does not have DVI input. | Similar - Assessment of video delay due to marker annotation; 56.00ms (95% CI: 50.54, 61.46) and 3.25 (95% CI: 2.93, 3.56) frame delay for Serial Digital Interface (SDI) and 62.33ms (95% CI: 60.76, 63.90) and 3.74 (95% CI: 3.65, 3.83) frame delay for Digital Visual Interface (DVI). Assessment of real-time endoscopic video delay due to the device; 56.67ms (95% CI: 51.01, 62.33) and 3.28 (95% CI: 2.96, 3.62) frame delay for SDI and 60.67ms (95% CI: 57.72, 63.61) and 3.64 (95% CI: 3.46, 3.81) frame delay for DVI. | | Pixel Level Degradation | No pixel level degradation is introduced by SKOUT to the Endoscopic System. | Similar - No visually detectable differences between images were found with the introduction of the SKOUT system @ | #### Table 1: Technological Characteristics Comparison {6}------------------------------------------------ {7}------------------------------------------------ The hardware and software differences to the subject device that result in improved performance, these differences do not introduce new questions of safety or effectiveness. # Conclusions The SKOUT system has the same intended use, indications for use, technological characteristics, and principles of operation as its predicate device. The minor differences in hardware design and software do not affect its safety and effectiveness when used as labeled. The algorithm between the two devices remains the same, therefore clinical performance remains unchanged. Performance data demonstrates that the SKOUT system is as safe and effective as the predicate device. Thus, the SKOUT system can be considered substantially equivalent.

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