MAGENTIQ-COLO (ME-APDS)

K252178 · Magentiq Eye, Ltd. · QNP · Oct 3, 2025 · Gastroenterology, Urology

Device Facts

• Record ID: K252178
• Device Name: MAGENTIQ-COLO (ME-APDS)
• Applicant: Magentiq Eye, Ltd.
• Product Code: QNP · Gastroenterology, Urology
• Decision Date: Oct 3, 2025
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1520
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device

Intended 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), 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 is intended to be used as an adjunct to endoscopy procedures and is not intended to replace histopathological sampling as means of diagnosis.

Device Story

ME-APDS (MAGENTIQ-COLO) is a real-time computer-aided detection (CADe) software for colonoscopy. It acquires digital video output from endoscopy cameras; processes frames using deep machine learning to identify regions consistent with polyps; and presents highlighted areas on a separate screen. The system includes a tool-detection feature that suppresses bounding boxes when endoscopic tools (forceps, snares, pumps, shafts) are in the field of view. Used in clinical settings by endoscopists; the device assists in lesion identification during procedures. The physician independently assesses highlighted regions to guide clinical decisions. The device does not replace histopathological diagnosis.

Clinical Evidence

Bench-only testing. Evaluated on 252 unique full colonoscopy videos (806 polyps). Primary endpoints included polyp detection recall (frame-wise and polyp-wise) and tool detection reliability. Overall FRecall was 73.0% [70.58%, 75.65%]. Tool detection feature evaluated on a subset of videos containing forceps, pumps, shafts, and snares, achieving high recall (TRecall1 99.7% [99.15%, 100%]) and FPPF of 0.0118. All testing met pre-specified acceptance criteria.

Technological Characteristics

CADe engine using deep machine learning; processes real-time video frames from standard white-light endoscopy. Features include automated polyp detection and tool detection (forceps, snares, pumps, shafts) to suppress bounding boxes. Software-based; standalone application. No specific materials or energy sources listed as it is software-only.

Indications for Use

Indicated for use by endoscopists as an adjunct to standard white-light video colonoscopy (screening and surveillance) to assist in identifying mucosal abnormalities/polyps. Not for diagnosis or characterization; does not replace histopathological sampling.

Regulatory Classification

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.

Special Controls

In combination with the general controls of the FD&C Act, the gastrointestinal lesion software detection system is subject to the following special controls:

*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.

Predicate Devices

• Magentiq Eye's Automatic Polyp Detection System (K244023)

Submission Summary (Full Text)

{0}

FDA U.S. FOOD & DRUG ADMINISTRATION

October 3, 2025

Magentiq Eye LTD
% John J. Smith
Partner
Hogan Lovells US LLP
555 13th Street, NW
Washington, District of Columbia 20004

Re: K252178
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: July 11, 2025
Received: September 5, 2025

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.

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"

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

{1}

K252178 - John J. Smith
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 ([e-mail]) or phone [phone] or 301-796-7100).

{2}

K252178 - John J. Smith
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

{3}

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known)
K252178

Device Name
MAGENTIQ-COLO (ME-APDS)

Indications for Use (Describe)
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), 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 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
[e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]

{4}

510(k) Summary

Magentiq Eye's MAGENTIQ-COLO

Submitter:

Magentiq Eye Ltd.

6 Ben-Gurion Blvd. Haifa, 3541416, Israel

Phone: [phone] Contact Person: Dr. Dror Zur

Date Prepared: August 4, 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 (K244023)

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. The ME-APDS™ includes an additional feature that removes the presentation of the bounding box once the physician has inserted an endoscopic tool (e.g. snare or forceps) into the endoscopic field of view.

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),

{5}

K252178 Page 2 of 4

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 detection 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 a feature that removes the presentation of the bounding box once the physician has inserted an endoscopic tool (e.g. snare or forceps) into the endoscopic field of view. The AI Polyp detection algorithm remains identical to the predicate device.

## Performance Data:

Conducted Testing:

The additional compatible endoscopy system was evaluated on the standalone performance testing database. The following testing was conducted:

- Standalone algorithm performance testing was conducted to assess polyp detection frame-wise recall, polyp-wise recall, and median of polyp coverage. All testing met pre-specified acceptance criteria demonstrating that polyp detection performance is appropriately maintained when the tool detection is active
- Marker Annotation delay testing. Marker annotation delay was assessed which demonstrated adequate performance. All testing met pre-specified acceptance criteria.

The Tool Detection feature was evaluated on a subset of the standalone performance testing database videos containing forceps, pumps, shafts, cold snares, and hot snares. The following testing was conducted:

- Standalone algorithm performance testing was conducted to assess polyp detection frame-wise recall, polyp-wise recall, and median of polyp coverage. All testing met pre-specified acceptance criteria demonstrating that polyp detection performance is appropriately maintained when the tool detection is active.

{6}

K252178 Page 3 of 4

- Standalone algorithm performance testing was conducted to assess tool detection frame-wise recall, tool-wise recall, and median tool coverage. All testing met pre-specified acceptance criteria demonstrating tool detection reliability.

Marker annotation delay testing. Marker annotation delay was assessed including cases from new compatible endoscopy systems, with and without tool detection, which demonstrated adequate performance. All testing met pre-specified acceptance criteria.

- Software verification and validation. All testing was as expected.

# Detailed Summary of Standalone Performance Testing:

The algorithm was tested offline on 252 unique full colonoscopy videos, containing 806 polyps. 24 videos contained no polyps. Of the 806 polyps, 660 were small (s≤5mm), 111 have medium size (5mm<s<10mm), (270="" (precall1="" (s≥10mm).="" 3,="" 302="" 35="" 5="" 50-60="" 7="" 98.1%="" 99.7%="" 99.7%<="" 99.7%<)="" 100.0%="" 100.0%$,="" 111="" 133="" 170="" 3,="" 357unknown),="" 366="" 5="" 50-60="" 5,="" 7="" <table="" a="" ability="" additional="" adequadr="" adequately="" additional.="" additional.="" after="" algorithm="" algorithm,="" and="" are="" as="" assessed.="" at="" be="" by="" caucasian,="" csp.="" csp.256="" csp.3,="" csp.343="" csp.4,="" data="" data,="" defined="" details="" detected,="" detection="" detected,="" detection,="" details.="" details.="" detected,="" detection="" different="" different,="" each="" easily="" each.="" e-cal1="" evaluation="" evaluation.="" evaluation.="" evaluation.,="" f="" fame="" fame,="" fmcall1="" fmcall3,="" fmcall5,="" fmcall7)="" fmcall7)="" fmcall5,="" fmcall7)="" fmcall5,="" fpcall5,="" fpcall7)="" fpcall7)="" fpcall5,="" fpcall5,="" fpcall7)="" fpcall1="" fpcall1,="" fpcall5,="" fpcall7)="" fpcall5,="" fpcall7)="" fpcall1,="" fpcall5,="" fpcall5,="" fpcall7)="" fpcall1,="" fpcall5,="" fpcall7)="" fpcall1,="" fpcall5,="" fpcall5,="" fpcall7)="" fpcall1,="" fpcall5,="" fpcall7)="" fpcall1,="" fpcall5,="" fpcall5,="" fpcall7)="" fpcall1,="" fpcall5,="" fpcall5,=""

{7}

K252178 Page 4 of 4

# Results on the Entire Testing Dataset

| FRecall | CI | MPC | PRecall1 | CI | PRecall3 | CI | PRecall5 | CI | PRecall7 | CI |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 73.0% | [70.58%, 75.65%] | 72.0% | 98.1% | [97.0%, 99.06%] | 95.8% | [94.12%, 97.24%] | 93.8% | [91.81%, 95.46%] | 91.2% | [89.02%, 93.14%] |

As specified above, the Tool Detection feature was assessed and verified on a subset of this standalone performance testing database. The following results demonstrated performance of the tool detection on videos containing the following tool types: e.g. forceps, pumps, shafts, cold snares, and hot snares. The False Positives Per Frame (FPPF) of 0.0118 was calculated with the following results:

| FRecall | CI | MTC | TRecall1 | CI | TRecall3 | CI | TRecall5 | CI | TRecall7 | CI |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 85.9% | [83.21%, 88.83%] | 96.5% | 99.7% | [99.15%, 100%] | 99.7% | [99.07%, 100%] | 99.7% | [99.11%, 100%] | 99.7% | [99.14%, 100%] |

All testing met pre-specified acceptance criteria demonstrating tool detection reliability.

In summary, the testing results discussed above were observed to be as expected and support that the device has similar performance to the predicate device.

# Conclusions:

The modified ME-APDS/MAGENTIQ-COLO™ is as safe and effective as the company's prior cleared ME-APDS. The modified ME-APDS has the same intended uses and indications, similar technological characteristics, and principles of operation as its predicate device. The minor differences do not alter the intended use and raise no new issues of safety or effectiveness. Performance data demonstrate that the modified ME-APDS is as safe and effective as the cleared ME-APDS. Thus, the modified ME-APDS /MAGENTIQ-COLO™ is substantially equivalent.