(28 days)
Yes
The device description explicitly states that it "runs deep machine learning and additional supporting algorithms" and mentions "The Al algorithm remains identical to the predicate device."
No.
The device is intended to assist endoscopists in identifying lesions (such as polyps) by highlighting regions with visual characteristics consistent with mucosal abnormalities. It is explicitly stated that the device is "not intended to be used for diagnosis or characterization of lesions, and does not replace clinical decision making," and it "is not intended to replace histopathological sampling as means of diagnosis." A therapeutic device would actively treat or cure a disease or condition, which this device does not do.
No
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state that the device is "not intended to replace histopathological sampling as means of diagnosis" and is "not intended to be used for diagnosis or characterization of lesions, and does not replace clinical decision making." It is described as an "adjunct" to assist in identifying lesions.
Yes
The device description explicitly states that the system "acquires the digital video output signal from the local endoscopy camera and processes the video frames" and "runs deep machine learning and additional supporting algorithms". It then presents the output on a "separate screen". This indicates the device is a software application that takes an existing video feed as input and provides a processed output, without including the endoscopy camera or the display hardware itself. The focus is on the software processing of the video data.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The definition of an IVD involves examining specimens such as blood, urine, tissue, etc., in vitro (outside the body) to provide information about a person's health.
- This device analyzes video images of the human body. The ME-APDS processes video output directly from an endoscopy camera during a procedure performed in vivo (inside the body). It's analyzing visual information from within the colon, not a sample taken from the colon.
- The intended use is to assist in identifying lesions during a procedure, not to diagnose based on sample analysis. The device highlights suspicious areas in real-time video to aid the endoscopist, but it explicitly states it's not intended for diagnosis or characterization of lesions and does not replace histopathological sampling (which is an IVD process).
Therefore, the ME-APDS 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 section for "Control Plan Authorized (PCCP) and relevant text" states "Not Found", which indicates no specific PCCP approval.
Intended Use / Indications for Use
ME-APDS (Magentig Eye's Automatic Polyp Detection System) is intended to be used by endoscopists as an adjunct to the common video colonoscopy procedure (screening and surveillance), aiming to assist the endoscopist in identifying lesions during colonoscopy procedure by highlighting reqions with visual characteristics consistent with different types of mucosal abnormalities that appear in the colonoscopy video during the procedure. Highlighted regions can be independently assessed by the endoscopist and appropriate action taken according to standard clinical practice.
ME-APDS is trained to process video images which may contain regions consistent with polyps.
ME-APDS is limited for use with standard white-light endoscopy imaging only.
ME-APDS is intended to be used as an adjunct to endoscopy procedures and is not intended to replace histopathological sampling as means of diagnosis.
Product codes
QNP
Device Description
ME-APDS™MAGENTIQ-COLO is intended to be used as an adjunct to the common video colonoscopy procedure. The system application aims to assist the endoscopist in identifying lesions, such as polyps, during the colonoscopy procedures in real time. The device is not intended to be used for diagnosis or characterization of lesions, and does not replace clinical decision making.
The system acquires the digital video output signal from the local endoscopy camera and processes the video frames. It runs deep machine learning and additional supporting algorithms in real time on the video frames in order to detect and identify regions having characteristics consistent with different types of mucosal abnormalities such as polyps. The output video with the detected lesions is presented on a separate screen, highlighting the suspicious areas on the original video. The user can also take snapshots of the videos, with and without the highlighting of the suspicious areas, record videos and view in full screen mode.
Mentions image processing
The system acquires the digital video output signal from the local endoscopy camera and processes the video frames.
Mentions AI, DNN, or ML
It runs deep machine learning and additional supporting algorithms in real time on the video frames in order to detect and identify regions having characteristics consistent with different types of mucosal abnormalities such as polyps. The AI algorithm remains identical to the predicate device.
Input Imaging Modality
standard white-light endoscopy imaging
Anatomical Site
Colon
Indicated Patient Age Range
Not Found
Intended User / Care Setting
endoscopists
Description of the training set, sample size, data source, and annotation protocol
ME-APDS™ is trained to process video images which may contain regions consistent with polyps.
Description of the test set, sample size, data source, and annotation protocol
The algorithm was tested offline on 212 unique full colonoscopy videos, containing 702 polyps. 16 videos contained no polyps. Of the 702 polyps, 586 were small (s≤5mm), 93 have medium size (5mm
§ 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.
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January 24, 2025
Magentiq Eye LTD % John J. Smith Partner Hogan Lovells US LLP Columbia Square 555 13th Street, NW Washington, District of Columbia 20004
Re: K244023
Trade/Device Name: MAGENTIQ-COLO (ME-APDS) Regulation Number: 21 CFR 876.1520 Regulation Name: Gastrointestinal Lesion Software Detection System Regulatory Class: Class II Product Code: QNP Dated: December 27, 2024 Received: December 27, 2024
Dear John J. Smith:
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.
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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.
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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-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/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-regulatory
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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).
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)
Device Name
MAGENTIQ-COLO (ME-APDS)
Indications for Use (Describe)
ME-APDS (Magentig Eye's Automatic Polyp Detection System) is intended to be used by endoscopists as an adjunct to the common video colonoscopy procedure (screening and surveillance), aiming to assist the endoscopist in identifying lesions during colonoscopy procedure by highlighting reqions with visual characteristics consistent with different types of mucosal abnormalities that appear in the colonoscopy video during the procedure. Highlighted regions can be independently assessed by the endoscopist and appropriate action taken according to standard clinical practice.
ME-APDS is trained to process video images which may contain regions consistent with polyps.
ME-APDS is limited for use with standard white-light endoscopy imaging only.
ME-APDS is intended to be used as an adjunct to endoscopy procedures and is not intended to replace histopathological sampling as means of diagnosis.
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 Magentig Eye's MAGENTIQ-COLO
Submitter:
Magentiq Eye Ltd. 6 Ben-Gurion Blvd.. Haifa, 3541416, Israel
Phone: +972 (77) 2018838
Contact Person: Dr. Dror Zur
Date Prepared: January 14th, 2025
Name of Device: Magentiq Eye's Automatic Polyp Detection System (ME-APDS™)
Trade Name: MAGENTIQ-COLO™
Common or Usual Name: Computer aided detection software for colorectal polyps
Classification Name: Gastrointestinal Lesion Software Detection System
Regulatory Class: II
Product Code: QNP
Predicate Device: Magentiq Eye's Automatic Polyp Detection System (K223473)
Device Description:
ME-APDS™MAGENTIQ-COLO is intended to be used as an adjunct to the common video colonoscopy procedure. The system application aims to assist the endoscopist in identifying lesions, such as polyps, during the colonoscopy procedures in real time. The device is not intended to be used for diagnosis or characterization of lesions, and does not replace clinical decision making.
The system acquires the digital video output signal from the local endoscopy camera and processes the video frames. It runs deep machine learning and additional supporting algorithms in real time on the video frames in order to detect and identify regions having characteristics consistent with different types of mucosal abnormalities such as polyps. The output video with the detected lesions is presented on a separate screen, highlighting the suspicious areas on the original video. The user can also take snapshots of the videos, with and without the highlighting of the suspicious areas, record videos and view in full screen mode.
Intended Use / Indications for Use:
ME-APDS™ (Magentiq Eye's Automatic Polyp Detection System) is intended to be used by endoscopists as an adjunct to the common video colonoscopy procedure (screening and surveillance),
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aiming to assist the endoscopist in identifying lesions during colonoscopy procedure by highlighting regions with visual characteristics consistent with different types of mucosal abnormalities that appear in the colonoscopy video during the procedure. Highlighted regions can be independently assessed by the endoscopist and appropriate action taken according to standard clinical practice.
ME-APDS™ is trained to process video images which may contain regions consistent with polyps.
ME-APDS™ is limited for use with standard white-light endoscopy imaging only.
ME-APDS™ intended to be used as an adjunct to endoscopy procedures and is not intended to replace histopathological sampling as means of diagnosis.
Summary of Technological Characteristics:
Computer-Aided Polyp Detection (CADe) engine is the technological principle for both the subject and predicate devices. The major roles of CADe engine during colonoscopy is to process a video frame and to indicate the presence and location of detected lesions (such as polyps) in real time during colonoscopy procedure in order to improve mucosal lesion rates, thus improving the performance of the endoscopist.
The proposed device is a modification to the company cleared device. The proposed device labeling has been updated to identify an additional compatible endoscopy systems, and the system includes modifications to the devices hardware and software. The Al algorithm remains identical to the predicate device.
Performance Data:
Non-Clinical Testing:
The non-clinical performance studies of the subject device included:
- . Pixel-level comparison of degradation of image quality
- . Software validation
- EMC testing in accordance with the requirements of IEC 60601-1-2:2014 [Including AMD . 1:2021] and TR 60601-4-2 Edition 1.0 2016-05
- . Electrical safety testing in accordance with IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION
In all instances, the ME-APDS functioned as intended and all tests' results observed were as expected.
Assessment of Marker Annotation Delay:
Marker annotation delay was assessed for all polyps from the standalone performance testing dataset. The marker annotation latency's median, calculated over all the polyps, is 133 msec for FHD and 157 msec for 4K.
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Standalone Performance Testing:
The algorithm was tested offline on 212 unique full colonoscopy videos, containing 702 polyps. 16 videos contained no polyps. Of the 702 polyps, 586 were small (s≤5mm), 93 have medium size (5mm