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 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 describes the SKOUT system, a software device designed to detect potential colorectal polyps in real-time during colonoscopy examinations. The document outlines acceptance criteria and summarizes performance testing.

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly list "acceptance criteria" in a table format with numerical targets. Instead, it refers to performance objectives implicitly through comparisons to the predicate device and mentions passing results in applicable testing. Based on the "Performance Testing" section, the following can be inferred as the general performance areas that were assessed:

Acceptance Criteria Category	Reported Device Performance
Software Verification and Validation	SKOUT® system software meets design requirements for its intended use, in line with recommendations outlined in "General Principles of Software Validation, Guidance for Industry and FDA Staff."
Algorithm Performance (True Positives, False Positives, Polyp Detection Time)	Standalone and on-device algorithm performance testing was conducted, with passing results. Optimized performance with Endocuff, multiple polyps, and/or sessile serrated lesions, and reduced false positive rate.
Pixel Degradation	No pixel level degradation is introduced by SKOUT® to the Endoscopic System.
Video Delay (due to marker annotation)	Video delay due to marker annotation = 0ms (no standard error; all results were 0, minimum resolution 1.1ms).
Video Delay (due to device)	Video delay due to device = 0ms (no standard error; all results were 0, minimum resolution 1.1ms).
Endocuff Compatibility	Optimized performance in videos with Endocuff.
Multiple Polyps and Sessile Serrated Lesions	Optimized performance for multiple polyps and/or sessile serrated lesions.
Reduced False Positive Rate	Reduced false positive rate.

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: The document mentions "an expanded dataset for the added Endocuff compatibility" for standalone and on-device algorithm performance testing. However, it does not specify the exact numerical sample size (e.g., number of videos, number of polyps, or number of patients) of this expanded dataset.
Data Provenance: The document does not specify the country of origin of the data used for testing, nor whether the data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document does not provide information on the number of experts used to establish ground truth or their specific qualifications.

4. Adjudication method for the test set:

The document does not specify the adjudication method used for the test set (e.g., 2+1, 3+1, none).

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

The document explicitly states that the "clinical performance remains unchanged from the clinical performance submitted in K213686." This implies that a new MRMC comparative effectiveness study was not conducted for this submission (K253664). The existing clinical performance from K213686 was relied upon. Therefore, no new effect size for human reader improvement with AI vs. without AI assistance is reported here.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Yes, a standalone algorithm performance study was done. The "Performance Testing" section states: "Standalone and on-device algorithm performance testing was conducted for evaluation of true positives, false positives, and polyp detection time, with an expanded dataset for the added Endocuff compatibility."

7. The type of ground truth used:

The type of ground truth used is not explicitly specified in this document. Given it's a device for detecting polyps, it would typically be based on expert consensus (e.g., gastroenterologists reviewing videos and annotating polyps) or pathology (histopathological confirmation of removed lesions). However, the document does not confirm this.

8. The sample size for the training set:

The document does not specify the sample size used for the training set. It mentions "Retraining and refinement of inference algorithms... optimized performance," which indicates that a training process occurred, but details on the training set size are absent.

9. How the ground truth for the training set was established:

The document does not provide information on how the ground truth for the training set was established.

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 # 04017.08.02

December 22, 2025

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

Re: K253664
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: November 20, 2025
Received: November 20, 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"

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).

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

Indications for Use

Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions.
K253664

Please provide the device trade name(s).
SKOUT system

Please provide your Indications for Use below.

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.

Please select the types of uses (select one or both, as applicable).
☑ Prescription Use (21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

Page 5

510(K) SUMMARY

SKOUT® system

Submitter Contact Information:

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

Phone: (617) 209-9773

Contact: Caitlyn Seidl, VP, Commercial and Scientific Affairs

Date Prepared: November 20, 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 Health, K251126

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 surgical 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.

Page 6

Device Status Indicator

The SKOUT® system has an additional GUI feature that notifies users of the current device status (active, surgical tool, bypass, or error) in the bottom-right corner of the screen:

a concentric green circle within a larger ring and the "SKOUT" label below, when the device is powered on and actively processing video.
a concentric gray solid circle within a larger dashed ring and the "SKOUT" label below, when a surgical tool is present.
a concentric amber solid circle within a larger ring, intersected with a diagonal slash across, and the "SKOUT" label below, when displaying the unaltered endoscope processor feed.
a concentric red solid circle within a larger ring, intersected with a diagonal slash across, and the "SKOUT" label below. A red (X) error icon with an error code and message is overlaid on the center of the screen over a dimmed endoscope feed.

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 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.

Summary of Technological Characteristics

The subject device is a modified version of the predicate device, which was FDA-cleared in K251126. 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

	Subject Device: SKOUT® system	Predicate Device: SKOUT® system (K251126)	Comparison
Device Name	SKOUT® system v2.3	SKOUT® system v2.2	N/A
Hardware Configuration(s)	SKOUT 211, SKOUT 220	SKOUT 211, SKOUT 220	Same
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	A gastrointestinal lesion software detection system is a computer-assisted detection device used in	Same

Page 7

	Subject Device: SKOUT® system	Predicate Device: SKOUT® system (K251126)	Comparison
	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.	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 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

Page 8

	Subject Device: SKOUT® system	Predicate Device: SKOUT® system (K251126)	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, tool, bypass, or error): • Active: a concentric green solid circle within a larger ring, and the "SKOUT" label below, when the device is powered on and actively processing video. • Tool: a concentric grey solid circle within a larger dashed ring and the "SKOUT" label below, when a surgical tool is present. • Bypass: a concentric amber solid circle within a larger ring, intersected with a diagonal slash across, and the "SKOUT" label below, when displaying 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, tool, or error): • Active: a two-dimensional green box with letter (S) when the device is powered on and actively processing video. • Tool: a two-dimensional gray box with letter (S) when a surgical tool is present. • Error: 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.	Same, except minor changes to status indicators. This does not raise different questions because the indicators communicate the same information with the same intent.

Page 9

	Subject Device: SKOUT® system	Predicate Device: SKOUT® system (K251126)	Comparison
	unaltered endoscope processor feed. • Error: a concentric red solid circle within a larger ring, intersected with a diagonal slash across, and the "SKOUT" label below. A red (X) error icon with an error code and message is overlaid on the center of the screen over a dimmed endoscope feed.
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 preprocessing	Serial Digital Interface (SDI); de-interlacing applied during preprocessing	Same
Compatible Endoscopes	Olympus EVIS EXERA II, Olympus EVIS EXERA III, and FUJI Eluxeo VP-7000 with compatible HD output	Olympus EVIS EXERA II, Olympus EVIS EXERA III, and FUJI Eluxeo VP-7000 with compatible HD output	Same
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

Page 10

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

Retraining and refinement of inference algorithms for compatibility with Endocuff devices, optimized performance in videos with Endocuff, multiple polyps, and/or sessile serrated lesions, and reduced false positive rate. No change to the system-level or algorithm-level architectures compared to the predicate device.
Refinement of device software for optimized detection of the edges of the active video feed for Fujifilm Eluxeo VP-7000 video processor, improved computer memory efficiency, and optimized tracking of polyps across video frames.
Updated appearance of power-up screen, power-down screen, and system status icons and notifications.
Updates to back-end software (non-user facing).
Routine updates to software packages and libraries.

Performance Testing

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

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.
Standalone and on-device algorithm performance testing was conducted for evaluation of true positives, false positives, and polyp detection time, with an expanded dataset for the added Endocuff compatibility.
Additional bench software testing was performed to confirm the device meets the special controls in 21 CFR 876.1520 for algorithm performance, 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, key technological characteristics, and principles of operation as its predicate device. The minor differences in software do not affect its safety and effectiveness when used as labeled. The inference algorithms utilize the same architecture and meet the same performance requirements as the predicate device, therefore clinical performance remains unchanged from the clinical performance 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.

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.