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 Description

The SKOUT® system is a software-based computer aided detection (CADe) system for the analysis of high-definition 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.

AI/ML Overview

The provided FDA 510(k) clearance letter for the SKOUT® system (K251126) indicates that this submission is for a modified version of a previously cleared device (K241508) and asserts that the "inference algorithms have remained the same, therefore clinical performance remains unchanged from the clinical testing submitted in K213686." This means the detailed clinical performance data and ground truth establishment would likely reside in the K213686 submission, which is not provided in this document.

However, based on the information present in the K251126 clearance letter, we can describe the non-clinical performance testing that was conducted to demonstrate substantial equivalence to the predicate device. The letter explicitly states:

"Algorithm performance testing was performed for evaluation of true positives, false positives, and polyp detection time, with an expanded dataset for the added video processing tower."

This indicates that some form of performance evaluation was done for the algorithm, even if the core clinical performance from K213686 is simply being referenced.

Given the limitations of the provided document, here's a structured response based on the available information, with clear indications where information is not provided in K251126 and would require reviewing K213686:

Acceptance Criteria and Device Performance for SKOUT® System (K251126)

The SKOUT® system (K251126) is a modified version of a predicate device (K241508). The clearance letter explicitly states that "the inference algorithms have remained the same, therefore clinical performance remains unchanged from the clinical testing submitted in K213686." This implies that the core clinical performance metrics and their acceptance criteria were established and met in the K213686 submission.

For the K251126 submission, non-clinical performance testing was conducted to demonstrate substantial equivalence. This included "Algorithm performance testing... for evaluation of true positives, false positives, and polyp detection time, with an expanded dataset for the added video processing tower." However, the specific quantitative acceptance criteria and the reported performance metrics (true positives, false positives, detection time) are NOT provided in this document.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The specific quantitative acceptance criteria and reported device performance (True Positives, False Positives, Polyp Detection Time) for the algorithm from the K251126 submission are NOT explicitly provided in this document. The document refers to the unchanged clinical performance from K213686. The table below represents the types of metrics that would have been evaluated, as stated in the document, but the actual numerical values are missing.

Performance Metric (Non-Clinical, for K251126)	Acceptance Criteria (Not Explicitly Stated in Doc)	Reported Device Performance (Not Explicitly Stated in Doc)
True Positives (Algorithm)	Conformance with predicate performance from K213686	"Passing results" (qualitative confirmation)
False Positives (Algorithm)	Conformance with predicate performance from K213686	"Passing results" (qualitative confirmation)
Polyp Detection Time (Algorithm)	Conformance with predicate performance from K213686	"Passing results" (qualitative confirmation)
Video Delay (Marker Annotation)	0 ms	0 ms (no standard error, minimum resolution 1.1ms)
Video Delay (Device)	0 ms	0 ms (no standard error, minimum resolution 1.1ms)
Pixel Level Degradation	No degradation introduced to Endoscopic System	No pixel level degradation

2. Sample Size and Data Provenance for Test Set

Sample Size Used for Test Set: The document mentions "an expanded dataset for the added video processing tower" for algorithm performance testing. However, the specific sample size (number of cases, images, or polyps) is NOT provided in this document for either the K251126 testing or the referenced K213686 clinical testing.
Data Provenance: Not explicitly stated in this document. For K251126, it implies additional video data for specific hardware validation. For the core clinical performance (K213686), this information would be detailed in that submission. It is generally assumed, for FDA clearance, that data would represent diverse patient populations.
Retrospective or Prospective: Not explicitly stated in this document for the algorithm performance testing in K251126. Clinical studies underpinning K213686 might have been retrospective or prospective, but this is not discussed in the provided text.

3. Number and Qualifications of Experts for Ground Truth

Number of Experts: Not provided in this document for either the K251126 testing or the referenced K213686 clinical testing.
Qualifications of Experts: Not provided in this document. For ground truth in medical imaging, experts are typically board-certified specialists (e.g., gastroenterologists or pathologists) with significant experience.

4. Adjudication Method for Test Set

Adjudication Method: Not provided in this document. For K251126, the performance testing was focused on validating the algorithm with expanded data, not necessarily re-establishing clinical ground truth for a human-in-the-loop study. For K213686, the adjudication method for ground truth establishment for polyp detection would be detailed in that submission. Common methods include consensus reading (e.g., 2+1, where two readers agree, or a third adjudicates disagreement) or pathology correlation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Conducted: The document for K251126 does not describe an MRMC comparative effectiveness study directly for this submission. It states that "clinical performance remains unchanged from the clinical testing submitted in K213686." An MRMC study would be common for a device that assists human readers (CADe), and such a study would likely have been part of the original K213686 submission to demonstrate clinical benefit.
Effect Size of Human Reader Improvement: Since an MRMC study is not detailed for K251126, the effect size is not provided here. If such a study was performed for K213686, the effect size (e.g., improvement in adenoma detection rate, per-lesion sensitivity) would be reported in that submission.

6. Standalone (Algorithm Only) Performance

Standalone Performance Done: Yes, "Algorithm performance testing was performed for evaluation of true positives, false positives, and polyp detection time." This indicates a standalone evaluation of the algorithm's detection capabilities. However, the specific quantitative metrics (e.g., sensitivity, specificity, FROC curves) are NOT provided in this document. It only states that the testing demonstrated "passing results." The document also notes that "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," reinforcing its role as a CADe tool for human assistance.

7. Type of Ground Truth Used

Type of Ground Truth: The document implies that ground truth for "potential colorectal polyps" was established for the algorithm performance testing. For a device detecting polyps, the most robust ground truth would generally be histopathology (pathology results) from biopsied/resected lesions. Clinical consensus from expert endoscopists is also commonly used, especially for cases where biopsy might not be performed. The document does not explicitly state the type of ground truth used, but for polyp detection, pathology is gold standard.

8. Sample Size for Training Set

Sample Size for Training Set: Not provided in this document. The document primarily focuses on the substantial equivalence and validation of changes rather than a full re-description of the training process for the core AI algorithm, as the algorithm itself is stated to be unchanged from K213686.

9. How Ground Truth for Training Set Was Established

Ground Truth Establishment for Training Set: Not provided in this document. Similar to the test set, the methods for establishing ground truth for the training data (e.g., expert annotations, pathology reports, adjudicated consensus) would have been detailed in the original K213686 submission.

In summary, the provided FDA clearance letter for K251126 confirms that algorithm performance testing (for true positives, false positives, and detection time) was conducted for this submission, particularly with an "expanded dataset for the added video processing tower." However, it relies on the clinical performance established in the predicate's prior submission (K213686) because the core inference algorithms are unchanged. Therefore, many details regarding the clinical acceptance criteria, sample sizes, expert qualifications, and ground truth establishment for the clinical performance aspect are referred to the previous submission and are not present in this document.

Summary

FDA 510(k) Clearance Letter - SKOUT System

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

May 9, 2025

Iterative Health
℅ Janice Hogan
Partner
Hogan Lovells US LLP
1735 Market Street, Floor 23
Philadelphia, Pennsylvania 19103

Re: K251126
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: April 11, 2025
Received: April 11, 2025

Dear Janice Hogan:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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K251126 - Janice Hogan Page 2

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).

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K251126 - Janice Hogan Page 3

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

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Indications for Use

Submission Number (if known)
K251126

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)
☒ 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:

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"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."

Page 5

510(K) SUMMARY

SKOUT® system

K251126

Submitter Contact Information:

Address: Iterative Health, Inc. (Iterative Scopes)
14 Arrow Street Floor 3
Cambridge, MA 02138

Phone: (617) 209-9773

Contact: Caitlyn Seidl, VP, Scientific and Commercial Affairs

Date Prepared: April 29, 2025

Name of Device: SKOUT® system

Classification Name: Gastrointestinal lesion software detection system (21 CFR 876.1520, Product Code QNP)

Predicate Device: SKOUT® system, Iterative Scopes, K240781

Device Description

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 rectangular 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.

The polyp detection notification enables users to:

Detect potential colorectal polyps during colonoscopy examinations in adult patients undergoing a colorectal cancer screening or surveillance procedure.
Utilize a tool that provides additional information for endoscopic observation.

K251126
Page 1 of 6

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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.
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 has occurred.

Intended Use / Indications for Use

Summary of Technological Characteristics

The subject device is a modified version of the predicate device, which was cleared on July 3, 2024 (K241508). The key characteristics of the subject SKOUT® system and the predicate SKOUT® system are compared in the following table.

Table 1: Comparison of Key Characteristics

	SKOUT® system (Subject Device, K251126)	SKOUT® system (Predicate Device, K241508)	Comparison
Device Version	SKOUT® system v2.2	SKOUT® system v2.1	N/A
Hardware Configuration(s)	SKOUT211 SKOUT220	SKOUT210	N/A
Regulation	21 CFR 876.1520	21 CFR 876.1520	Same
Product Code	QNP	QNP	Same
Device Class	Class II	Class II	Same
Intended Use	A gastrointestinal lesion software detection system is a computer-assisted detection device used in conjunction with endoscopy for	A gastrointestinal lesion software detection system is a computer-assisted detection device used in conjunction with endoscopy for	Same

K251126
Page 2 of 6

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	SKOUT® system (Subject Device, K251126)	SKOUT® system (Predicate Device, K241508)	Comparison
	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.	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 interpretation of endoscopic procedures, medical diagnosis, or recommendations of treatment/course of action for patients. SKOUT® is indicated for white light colonoscopy only.	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.	Same

K251126
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	SKOUT® system (Subject Device, K251126)	SKOUT® system (Predicate Device, K241508)	Comparison
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.	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.	Same
User Population	Adult patients undergoing colorectal cancer screening or surveillance colonoscopy.	Adult patients undergoing colorectal cancer screening or surveillance colonoscopy.	Same
Fundamental 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.	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.	Same
Software Algorithm	The SKOUT® system utilizes an artificial intelligence-based algorithm to perform the polyp detection function.	The SKOUT® system utilizes an artificial intelligence-based algorithm to perform the polyp detection function.	Same
Power Source	Hospital mains power	Hospital mains power	Same
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.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 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	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.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 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	Same, except for minor change in internal hardware components for the video bypass switch. This change does not raise different questions of safety or effectiveness.

K251126
Page 4 of 6

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	SKOUT® system (Subject Device, K251126)	SKOUT® system (Predicate Device, K241508)	Comparison
	green box will be replaced with a red X and error message to indicate an error has occurred.	green box will be replaced with a red X and error message to indicate an error has occurred.
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.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 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.	Same
Video Input	Serial Digital Interface (SDI); de-interlacing applied during pre-processing	Serial Digital Interface (SDI); de-interlacing applied during pre-processing	Same
Compatible Video Processors	Olympus EVIS EXERA II, Olympus EVIS EXERA III, and FUJIFILM Eluxeo VP-7000 with compatible HD output	Olympus EVIS EXERA III and FUJIFILM Eluxeo VP-7000 with compatible HD output	Addition of Olympus EVIS EXERA II video processor was validated in testing and does not raise different questions.
Video Delay	Video delay due to marker annotation = 0ms (no standard error; all results were 0, minimum resolution 1.1ms)Video delay due to device = 0ms (no standard error; all results were 0, minimum resolution 1.1ms)	Video delay due to marker annotation = 0ms (no standard error, all results were 0, minimum resolution 1.1ms)Video delay due to device = 0ms (no standard error, all results were 0, minimum resolution 1.1ms)	Same
Pixel Level Degradation	No pixel level degradation is introduced by SKOUT® to the Endoscopic System.	No pixel level degradation is introduced by SKOUT® to the Endoscopic System.	Same

K251126
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Page 10

The subject device includes the following minor changes to the technological characteristics compared to the predicate device:

Introduction of alternate hardware configuration with modified GPU and video bypass switch to improve supply chain stability, reduce power consumption by the GPU, and reduce risk of hardware-related failure for bypass switch;
Updates to system software to be compatible with both hardware configurations;
Updates to back-end software (non-user facing);
Update to the overheating warning message performance;
Routine software updates to address bugs, cybersecurity, and code optimization identified by software maintenance activities;
Additional video processing tower validated as compatible and added to the device labeling.

Performance Testing

Non-clinical performance testing was conducted to demonstrate that the SKOUT® system is as safe and effective as the predicate device.

Electrical safety, usability and electromagnetic compatibility testing was conducted for the alternate hardware configuration per IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, and IEC 60601-1-6.
Software verification and validation testing was conducted to confirm the SKOUT® system software meets design requirements for its intended use, per the device's design documentation in line with recommendations outlined in General Principles of Software Validation, Guidance for Industry and FDA Staff.
Algorithm performance testing was performed for evaluation of true positives, false positives, and polyp detection time, with an expanded dataset for the added video processing tower.
Additional bench software testing was performed to confirm the device meets the special controls in 21 CFR 876.1520 for pixel degradation and video delays.

SKOUT® system demonstrated passing results in all applicable testing.

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 and software do not affect its safety and effectiveness when used as labeled. The inference algorithms have remained the same, therefore clinical performance remains unchanged from the clinical testing submitted in K213686. Performance data demonstrates that the SKOUT® system is as safe and effective as the predicate device. Thus, the SKOUT® system is substantially equivalent.

K251126
Page 6 of 6

Regulation Number and Section

§ 876.1520 Gastrointestinal lesion software detection system.

(a)
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.(b)
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.