(36 days)
Yes
The document explicitly states, "The SKOUT system utilizes an artificial intelligence-based algorithm to perform the polyp detection function."
No.
The device is described as a "computer-aided detection tool" that assists gastroenterologists in identifying potential colorectal polyps. It explicitly states that it is not intended to provide a primary interpretation of procedures, medical diagnoses, or treatment recommendations, which are characteristics of therapeutic devices.
Yes.
The device is intended to assist in identifying potential colorectal polyps during colonoscopy examinations, which is a diagnostic purpose.
Yes
The device description explicitly states "The SKOUT system is a software-based computer aided detection (CADe) system". While it processes endoscopic video, the device itself is described solely as software providing a visual aid. There is no mention of accompanying hardware components that are part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- SKOUT System Function: The SKOUT system analyzes real-time endoscopic video during a colonoscopy. It does not analyze samples taken from the body. It processes visual information within the body during a procedure.
- Intended Use: The intended use clearly states it's a "computer-aided detection tool providing colorectal polyps location information to assist qualified and trained gastroenterologists in identifying potential colorectal polyps during colonoscopy examinations." This is a tool for assisting a medical professional during a procedure, not a diagnostic test performed on a sample.
Therefore, the SKOUT system falls under the category of a medical device that assists in a clinical procedure, rather than an in vitro diagnostic device.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The provided text indicates "Control Plan Authorized (PCCP) and relevant text Not Found", which does not meet the criteria for a "Yes" answer.
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.
Product codes
QNP
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
The SKOUT system utilizes an artificial intelligence-based algorithm to perform the polyp detection function.
Input Imaging Modality
High-definition endoscopic video (white light colonoscopy)
Anatomical Site
Colorectal
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Qualified and trained gastroenterologists. Not Found for care setting but implicitly in a clinical setting where colonoscopies are performed.
Description of the training set, sample size, data source, and annotation protocol
Refinement/retraining of polyp detection algorithm, including:
- Utilization of same system level and algorithm level architectures as predicate device
- Utilization of data from 30+ unique clinical sites, of which 27 were new compared to the predicate device, with new data representing 61% of the cumulative data
Annotation protocol: Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found. "Performance data demonstrates that the SKOUT system is as safe and effective as the predicate device."
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 algorithm performance, pixel degradation and video delays.
SKOUT system demonstrated passing results in all applicable testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
SKOUT® system, Iterative Scopes, K240781
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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July 3, 2024
Iterative Scopes, Inc. % Janice Hogan Partner Hogan Lovells US LLP 1735 Market St. Floor 23 Philadelphia, Pennsylvania 19103
Re: K241508
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: May 28, 2024 Received: May 28, 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.
1
2
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" (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 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.
2
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Sivakami Venkatachalam -S
for
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)
Device Name
SKOUT® system
Indications for Use (Describe)
The SKOUT® system is a software device designed to detect potential colorectal polyps in real time during colonoscopy examinations. It is indicated as a computer-aided detection tool providing colorectal polyps location information to assist qualified and trained gastroenterologists in identifying potential colorectal polyps during colonoscopy examinations in adult patients undergoing colorectal cancer screening or surveillance.
The SKOUT® system is only intended to assist the gastroenterologist in identifying suspected colorectal polyps and the gastroenterologist is responsible for reviewing SKOUT® suspected polyp areas and confirming the presence or absence of a polyp based on their own medical judgment. SKOUT® is not intended to replace a full patient evaluation, nor is it intended to be relied upon to make a primary interpretation of endoscopic procedures, medical diagnosis, or recommendations of treatment/course of action for patients. SKOUT® is indicated for white light colonoscopy only.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY
SKOUT® system
K241508
Submitter Contact Information:
Address: Iterative Health, Inc. (Iterative Scopes) 14 Arrow Street Floor 3 Cambridge. MA 02138
Phone: (617) 209-9773
Caitlyn Seidl, VP, Clinical, Regulatory and Medical Affairs Contact:
Date Prepared: May 27, 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, K240781
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.
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 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 19, 2024 (K240781). The key characteristics of the subject SKOUT system and the predicate SKOUT system are compared in the following table.
| | Subject Device:
SKOUT® system (K241508) | Predicate Device:
SKOUT® system (K240781) | Comparison |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product Code | QNP | QNP | Same |
| Regulation | 21 CFR 876.1520 | 21 CFR 876.1520 | Same |
| Device Class | Class II | Class II | Same |
| 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 | 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 | Same |
| | Subject Device:
SKOUT® system (K241508) | Predicate Device:
SKOUT® system (K240781) | Comparison |
| | gastroenterologists in identifying
potential colorectal polyps during
colonoscopy examinations in
adult patients undergoing
colorectal cancer screening or
surveillance. | 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 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. | |
| 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 |
| | Subject Device:
SKOUT® system (K241508) | Predicate Device:
SKOUT® system (K240781) | Comparison |
| 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
green box will be
replaced with a red X
and error message to
indicate an error has
occurred. | 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
green box will be
replaced with a red X
and error message to
indicate an error has
occurred. | Same |
| 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 | 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 | Same |
| | Subject Device:
SKOUT® system (K241508) | Predicate Device:
SKOUT® system (K240781) | Comparison |
| | obstruction of the area of interest
during intervention. | obstruction of the area of interest
during intervention. | |
| Video Input | Serial Digital Interface (SDI); de-
interlacing applied during pre-
processing | Serial Digital Interface (SDI); de-
interlacing applied during pre-
processing | Same |
| Compatible
Endoscopes | Olympus EVIS EXERA III and
FUJI EC760 series | Olympus EVIS EXERA III and
FUJI EC760 series | Same |
Table 1: Comparison of Key Characteristics
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The subject device includes the following minor changes to the technological characteristics compared to the predicate device:
- Refinement/retraining of polyp detection algorithm, including:
- Utilization of same system level and algorithm level architectures as predicate device O
- Utilization of data from 30+ unique clinical sites, of which 27 were new compared to o the predicate device, with new data representing 61% of the cumulative data
- Refinement of polyp tracking algorithm ●
- Update to current version of system operating system ●
- Update to current version of software libraries ●
- Bug fixes
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 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, 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 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.