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 document, an FDA 510(k) summary for the SKOUT® system (K240781), primarily focuses on demonstrating substantial equivalence to a predicate device (K230658) and does not contain the detailed acceptance criteria or the specific study results from a primary clinical performance study.

The document indicates that "the inference algorithms have remained the same, therefore clinical performance remains unchanged from the clinical performance submitted in K213686." This suggests that the clinical performance evaluation was conducted for a previous version or submission (K213686), and the current submission relies on that prior assessment.

Therefore, I cannot provide all the requested information using only the text you provided. The document explicitly states: "Performance data demonstrates that the SKOUT system is as safe and effective as the predicate device." However, it does not explicitly show the full performance data, acceptance criteria, sample sizes, or ground truth establishment details for that primary performance study (K213686).

Based on the provided text, here is what can be extracted and what information is missing:

Information Extracted from the Provided Text:

Device Performance Reported: The document states that "SKOUT system demonstrated passing results in all applicable testing." and "Performance data demonstrates that the SKOUT system is as safe and effective as the predicate device."
Adjudication Method: "None" is inferred for the listed "Performance Testing" which are non-clinical tests (Software verification and validation, bench software testing). For the clinical performance from K213686, the adjudication method is not described in this document.
Standalone Performance: The non-clinical testing described seems to be for algorithm-only performance ("bench software testing was performed to confirm the device meets the special controls in 21 CFR 876.1520 for true and false positives, pixel degradation and video delays."). However, the specific metrics (e.g., sensitivity, specificity for polyp detection) are not reported here.
Ground Truth Type: For the non-clinical testing, the "ground truth" seems to be defined by the design requirements and special controls for software (e.g., "true and false positives"). For the clinical performance (K213686), the type of ground truth is not specified.

Missing Information (Not Present in the Provided Text):

A table of acceptance criteria and the reported device performance: While it states "passing results," the specific numerical acceptance criteria and the corresponding numerical performance values are not provided.
Sample sized used for the test set and the data provenance: Not described for the underlying clinical performance study (K213686).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not described for the underlying clinical performance study (K213686).
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: Not described for the underlying clinical performance study (K213686). The device is a CADe system, which suggests human-in-the-loop, but specific MRMC study results are not here.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not described for the underlying clinical performance study (K213686).
The sample size for the training set: Not described.
How the ground truth for the training set was established: Not described.

Based on the provided document, here's a structured response (with noted limitations):

The provided document (FDA 510(k) Summary for SKOUT® system, K240781) primarily asserts substantial equivalence to a predicate device (K230658) and refers to prior performance data from K213686. It does not contain the detailed acceptance criteria or the specific study results from the primary clinical performance evaluation.

The document states: "Performance data demonstrates that the SKOUT system is as safe and effective as the predicate device. Thus, the SKOUT system is substantially equivalent." and "the inference algorithms have remained the same, therefore clinical performance remains unchanged from the clinical performance submitted in K213686." This implies that the definitive study proving device performance against acceptance criteria was conducted for the K213686 submission, not detailed within this current document.

Here's what can be gathered:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions "Additional bench software testing was performed to confirm the device meets the special controls in 21 CFR 876.1520 for true and false positives, pixel degradation and video delays." and "SKOUT system demonstrated passing results in all applicable testing." However, the specific numerical acceptance criteria (e.g., minimum sensitivity, maximum false positives per minute) and the quantified reported device performance values against these criteria are not provided in this document.

2. Sample Size and Data Provenance (for the test set):

Not explicitly stated for the underlying clinical performance study (K213686). The "Performance Testing" section describes non-clinical software verification and validation, which usually involves test cases rather than patient sample sizes.

3. Number of Experts and Qualifications for Ground Truth:

Not explicitly stated for the underlying clinical performance study (K213686).

4. Adjudication Method for the Test Set:

Not explicitly stated for the underlying clinical performance study (K213686). For the "Performance Testing" described in this document (non-clinical bench software testing), an adjudication method is not applicable in the human-reader sense.

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

The document does not provide information about an MRMC comparative effectiveness study or the effect size of human readers improving with AI vs. without AI assistance. While the device is a Computer-Aided Detection (CADe) tool, which inherently assists human readers, the details of such a study are absent here.

6. Standalone (Algorithm Only) Performance:

The document states "Additional bench software testing was performed to confirm the device meets the special controls in 21 CFR 876.1520 for true and false positives, pixel degradation and video delays." This indicates that the algorithm's performance in detecting polyps and managing system lags was tested independently. However, the specific metrics (e.g., standalone sensitivity, specificity, or FPs/min rate) from this testing are not numerically reported in this document.

7. Type of Ground Truth Used:

For the clinical performance (referred to as K213686), the type of ground truth (e.g., expert consensus, pathology, follow-up outcomes) is not specified in this document. For the non-clinical performance testing, the ground truth is defined by the design requirements and regulatory standards for "true and false positives, pixel degradation and video delays."

8. Sample Size for the Training Set:

Not provided in this document.

9. How the Ground Truth for the Training Set Was Established:

Not provided in this document.

Summary

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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 in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" on the bottom.

April 19, 2024

Iterative Scopes, Inc. % Janice Hogan Partner Hogan Lovells US LLP 1735 Market St. Floor 23 Philadelphia, Pennsylvania 19103

Re: K240781

Trade/Device Name: SKOUT® system Regulation Number: 21 CFR 876.1520 Regulation Name: Gastrointestinal Lesion Software Detection System Regulatory Class: Class II Product Code: ONP Dated: March 21, 2024 Received: March 21, 2024

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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(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 OS 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 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-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 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.

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-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).

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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

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Indications for Use

Submission Number (if known)

K240781

Device Name

SKOUT® system

Indications for Use (Describe)

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)

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510(K) SUMMARY

SKOUT® system

K240781

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, Clinical, Regulatory and Medical Affairs

Date Prepared: March 21, 2024

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, K230658

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 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.

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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

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 on April 7, 2023 (K230658). The key characteristics of the subject SKOUT system and the predicate SKOUT system are compared in the following table.

	Subject Device:SKOUT System (K240781)	Predicate Device:SKOUT System (K230658)	Comparison
Product Code	QNP	QNP	Same
Regulation	21 CFR 876.1520	21 CFR 876.1520	Same
Device Class	Class II	Class II	Same
Indications forUse	The SKOUT system is asoftware device designed todetect potential colorectal polypsin real time during colonoscopyexaminations. It is indicated as acomputer-aided detection toolproviding colorectal polypslocation information to assistqualified and trained	The SKOUT system is asoftware device designed todetect potential colorectal polypsin real time during colonoscopyexaminations. It is indicated as acomputer-aided detection toolproviding colorectal polypslocation information to assistqualified and trained	Same
	Subject Device:SKOUT System (K240781)	Predicate Device:SKOUT System (K230658)	Comparison
	gastroenterologists in identifyingpotential colorectal polyps duringcolonoscopy examinations inadult patients undergoingcolorectal cancer screening orsurveillance.	gastroenterologists in identifyingpotential colorectal polyps duringcolonoscopy examinations inadult patients undergoingcolorectal cancer screening orsurveillance.
	The SKOUT system is onlyintended to assist thegastroenterologist in identifyingsuspected colorectal polyps andthe gastroenterologist isresponsible for reviewingSKOUT suspected polyp areasand confirming the presence orabsence of a polyp based ontheir own medical judgment.SKOUT is not intended toreplace a full patient evaluation,nor is it intended to be reliedupon to make a primaryinterpretation of endoscopicprocedures, medical diagnosis,or recommendations oftreatment/course of action forpatients. SKOUT is indicated forwhite light colonoscopy only.	The SKOUT system is onlyintended to assist thegastroenterologist in identifyingsuspected colorectal polyps andthe gastroenterologist isresponsible for reviewingSKOUT suspected polyp areasand confirming the presence orabsence of a polyp based ontheir own medical judgment.SKOUT is not intended toreplace a full patient evaluation,nor is it intended to be reliedupon to make a primaryinterpretation of endoscopicprocedures, medical diagnosis,or recommendations oftreatment/course of action forpatients. SKOUT is indicated forwhite light colonoscopy only.
UserPopulation	Adult patients undergoingcolorectal cancer screening orsurveillance colonoscopy	Adult patients undergoingcolorectal cancer screening orsurveillance colonoscopy	Same
TechnologicalCharacteristics	The SKOUT system iscomposed of a single piecehardware design and softwaredesigned to highlight portions ofthe colon where the devicedetects potential colorectalpolyps.	The SKOUT system iscomposed of a single piecehardware design and softwaredesigned to highlight portions ofthe colon where the devicedetects potential colorectalpolyps.	Same
SoftwareAlgorithm	The SKOUT system utilizes anartificial intelligence-basedalgorithm to perform the polypdetection function.	The SKOUT system utilizes anartificial intelligence-basedalgorithm to perform the polypdetection function.	Same
Power Source	Hospital mains power	Hospital mains power	Same
	Subject Device:SKOUT System (K240781)	Predicate Device:SKOUT System (K230658)	Comparison
SafetyFeatures	The Mode Selection Buttonallows for instantaneous togglingbetween the SKOUT video feedand the bypass video feed in theevent of software error thataffects video quality.The polyp detection marker isdisabled if a biopsy tool entersthe field of view to preventobstruction of the area of interestduring intervention.SKOUT system GUI also has adevice status indicator thatnotifies users of the currentdevice status (active or error):a two-dimensional greenbox with letter (S) whenthe device is powered onand actively processingvideo.a two-dimensional graybox with letter (S) when asurgical tool is present.a red (X) with an errormessage; when there isan error with the videoprocessing function ofthe SKOUT system, thegreen box will bereplaced with a red Xand error message toindicate an error hasoccurred.	The Mode Selection Buttonallows for instantaneous togglingbetween the SKOUT video feedand the bypass video feed in theevent of software error thataffects video quality.The polyp detection marker isdisabled if a biopsy tool entersthe field of view to preventobstruction of the area of interestduring intervention.SKOUT system GUI also has adevice status indicator thatnotifies users of the currentdevice status (active or error):a two-dimensional greenbox with letter (S) whenthe device is powered onand actively processingvideo.a two-dimensional graybox with letter (S) when asurgical tool is present.a red (X) with an errormessage; when there isan error with the videoprocessing function ofthe SKOUT system, thegreen box will bereplaced with a red Xand error message toindicate an error hasoccurred.	Same
Video Input	Serial Digital Interface (SDI); de-interlacing applied during pre-processing	Serial Digital Interface (SDI); node-interlacing applied during pre-processing	Similar
Device Output	SKOUT system generatesmarkers in the form of bluerectangles superimposed on theendoscopic video when potentialcolorectal polyps are identified.SKOUT markers are notaccompanied by a sound.	SKOUT system generatesmarkers in the form of bluerectangles superimposed on theendoscopic video when potentialcolorectal polyps are identified.SKOUT markers are notaccompanied by a sound.	Same
	Subject Device:SKOUT System (K240781)	Predicate Device:SKOUT System (K230658)	Comparison
	The polyp detection marker isdisabled if a biopsy tool entersthe field of view to preventobstruction of the area of interestduring intervention.	The polyp detection marker isdisabled if a biopsy tool entersthe field of view to preventobstruction of the area of interestduring intervention.
CompatibleEndoscopes	Olympus EVIS EXERA III andFUJI EC760 series	Olympus EVIS EXERA III andFUJI EC760 series	Same
Video Delay	Video delay due to markerannotation = 0ms (no SE,minimum resolution 1.1ms)	Video delay due to markerannotation = 0.0ms (No SE,minimum resolution 1.1ms)	Same
	Video delay due to device = 0ms(no SE, minimum resolution1.1ms)	Video delay due to device =0.0ms (No SE, minimumresolution 1.1ms)
Pixel LevelDegradation	No pixel level degradation isintroduced by SKOUT to theEndoscopic System.	No pixel level degradation isintroduced by SKOUT to theEndoscopic System.	Same

Table 1: Comparison of Key Characteristics

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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.
Additional bench software testing was performed to confirm the device meets the special . controls in 21 CFR 876.1520 for true and false positives, 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 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 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.