(30 days)
Yes
The device description explicitly states it is an "artificial intelligence-based device" and mentions retraining of a "neural network."
No
The device is described as a "computer-assisted reading tool" and "computer-assisted detection device" designed to aid in the detection of lesions during endoscopy. It does not perform any therapeutic action.
Yes
The device is designed to aid in detecting colonic mucosal lesions and provides direct output to the endoscopist (superimposed markers on the display and sound), which are used for diagnostic decision-making.
No
The device description explicitly states, "The device includes hardware to support interfacing with video endoscopy systems." This indicates it is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, outside of the body to provide information for diagnosis, monitoring, or screening.
- GI Genius Function: The GI Genius System processes real-time video images from an endoscope inside the patient's body during a colonoscopy. It aids in the detection of lesions directly on the mucosal surface.
- No Specimen Analysis: The device does not analyze any biological specimens removed from the patient. It works directly with the live endoscopic video feed.
Therefore, based on the provided information, the GI Genius System is a medical device used in vivo (within the living body) to assist in visual examination and detection, not an in vitro diagnostic device.
No
The clearance letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / Indications for Use
The GI Genius System is a computer-assisted reading tool designed to aid endoscopists in detecting colonic mucosal lesions (such as polyps and adenomas) in real time during standard white-light endoscopy examinations of patients undergoing screening and surveillance endoscopic mucosal evaluations. The GI Genius computer-assisted detection device is limited for use with standard white-light endoscopy imaging only. This device is not intended to replace clinical decision making.
Product codes
QNP
Device Description
GI Genius is an artificial intelligence-based device that has been trained to process colonoscopy images containing regions consistent with colorectal lesions like polyps, including those with flat (non-polypoid) morphology.
GI Genius is compatible with the following Video Processors: Fujifilm VP-7000, Olympus CV-180 EXERA II, Olympus CV-190 EXERA III, Fujifilm VP-4450HD, and Pentax EPK-i7000 Video Processor.
GI Genius is connected between the video processor and the endoscopic display monitor. When first switched on, the endoscopic field of view is clearly identified by four corner markers, and a blinking green square indicator appears on the connected endoscopic display monitor to state that the system is ready to function.
During live video streaming of the endoscopic video image, GI Genius generates a video output on the endoscopic display monitor that contains the original live video together with superimposed green square markers that will appear when a polyp or other lesion of interest is detected, accompanied by a short sound. These markers will not be visible when no lesion detection occurs.
The operating principle of the subject device is identical to that of the predicate device, this being 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 includes hardware to support interfacing with video endoscopy systems.
Mentions image processing
Yes
Mentions AI, DNN, or ML
GI Genius is an artificial intelligence-based device that has been trained to process colonoscopy images containing regions consistent with colorectal lesions like polyps, including those with flat (non-polypoid) morphology.
The software design change includes an upgrade to the inference engine to optimize algorithm speed and improve energy efficiency, together with a retraining of the neural network with additional procedure videos, and improved data augmentation, to improve polyp detection capability robustness.
Input Imaging Modality
standard white-light endoscopy imaging
Anatomical Site
colonic mucosal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
endoscopists
Description of the training set, sample size, data source, and annotation protocol
retraining of the neural network with additional procedure videos, and improved data augmentation, to improve polyp detection capability robustness.
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-clinical testing:
- Verification of the revised software at the system level. Each element of the SRS was tested and found to meet specified requirements, testing 14 Units and 9 Items, encompassing 133 software requirements.
- Validation of the revised software at the user level, testing 14 Units and 9 Items, encompassing 133 software requirements.
- Protective measures identified by risk management have been verified during Installation Qualification and Operational Qualification.
- Electromagnetic Compatibility (EMC) and Electrical Safety compliance tests have been completed according to IEC 60601-1 and IEC 60601-1-2 requirements.
- Standalone Performance Testing has been carried out to assess the performance of the subject device in accordance with the same test protocol as that used for the predicate device, the results of which demonstrate substantial equivalence to the predicate device.
- Non-inferiority of performance of GI Genius with a new video processor has been established by means of a per-frame assessment on 40 pre-recorded procedures.
The results of the above testing aid in demonstration of substantial equivalence of the subject device with the predicate device, as the same test protocols have been used.
Key Results (Subject Device vs. Predicate Device):
- Video delay, signal in to signal out: 1.52 μs (Same)
- Lesion-based sensitivity: 86.5 % (Improved performance)
- Frame level performance (150 videos / 338 polyps):
- True positive: 269,223 (Improved performance)
- True negative: 5,239,128 (Improved performance)
- False positive: 104,669 (Improved performance)
- False negative: 192,567 (Improved performance)
- True positive rate per frame: Mean: 58.30 % (Improved performance) % of polyps: 100 % (Improved performance)
- False positive rate per frame: Mean: 1.96 % (Improved performance)
- Frame-Based TPr/FPr ROC curve, AOC: 0.796 (Improved performance)
- False positive clusters per patient: 500 ms: 1 more than baseline (Improved/Similar)
- Additional video processor: Yes: Fujifilm VP-7000 (Improved performance)
- Electrical safety: IEC 60601-1 (Same)
- Electromagnetic compatibility: IEC 60601-1-2 (Same)
- LAN port: Yes, non-functional to user (Different)
Key Metrics
- Lesion-based sensitivity: 86.5 %
- True positive: 269,223
- True negative: 5,239,128
- False positive: 104,669
- False negative: 192,567
- True positive rate per frame: Mean: 58.30 %; % of polyps: 100 %
- False positive rate per frame: Mean: 1.96 %
- Frame-Based TPr/FPr ROC curve, AOC: 0.796
- False positive clusters per patient: 500 ms: 1 more than baseline
Predicate Device(s)
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.
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July 23, 2021
Cosmo Artificial Intelligence - AI Ltd % Roger Gray VP Quality and Regulatory Donawa Lifescience Consulting Srl Piazza Albania 10 Rome, 00153 Italy
Re: K211951
Trade/Device Name: GI Genius Regulation Number: 21 CFR 876.1520 Regulation Name: Gastrointestinal Lesion Software Detection System Regulatory Class: Class II Product Code: QNP Dated: June 18, 2021 Received: June 23, 2021
Dear Roger Gray:
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 (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 located 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.
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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).
Sincerely.
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
510(k) Number (if known) K211951
Device Name GI Genius
Indications for Use (Describe)
The GI Genius System is a computer-assisted reading tool designed to aid endoscopists in detecting colonic mucosal lesions (such as polyps and adenomas) in real time during standard white-light endoscopy examinations of patients undergoing screening and surveillance endoscopic mucosal evaluations. The GI Genius computer-assisted detection device is limited for use with standard white-light endoscopy imaging only. This device is not intended to replace clinical decision making.
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
| 510(k) Reference: | K211951 |
|---|---|
| Device Name: | GI Genius |
| Type of 510(k) submission: | Special |
| Date of submission: | 18 June 2021 |
| 510(k) Owner and Submitter: | Cosmo Artificial Intelligence - Al Ltd |
| Riverside II, Sir John Rogerson's Quay | |
| Dublin D02 KV60 | |
| Ireland | |
| FDA Establishment Reg. Number: | 3018899987 |
| Specification Developer: | Linkverse Srl |
| via Ostiense 131/L | |
| 00154 Rome | |
| Italy | |
| Owner/Operator Reg. Number: | 3018901422 |
| 510(k) Application Correspondent: | Roger Gray |
| VP Quality and Regulatory | |
| Donawa Lifescience Consulting | |
| Piazza Albania 10 | |
| 00153 Rome, Italy | |
| Phone: | |
| Fax: | |
| Email: | +39 06 578 2665 |
| +39 06 574 3786 | |
| rgray@donawa.com | |
| FDA Product Code: | QNP |
| FDA Regulation Number: | 21 CFR 876.1520 |
| FDA Classification Name: | Gastrointestinal lesion software detection system |
| Classification Panel: | Gastroenterology and Urology |
| FDA Classification: | Class II |
Indications for Use:
The GI Genius System is a computer-assisted reading tool designed to aid endoscopists in detecting colonic mucosal lesions (such as polyps and adenomas) in real time during standard white-light endoscopy examinations of patients undergoing screening and surveillance endoscopic mucosal evaluations. The GI Genius computer-assisted detection device is limited for use with standard white-light endoscopy imaging only. This device is not intended to replace clinical decision making.
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Image /page/4/Picture/1 description: The image shows the logo for Cosmo Pharmaceuticals. The logo features a stylized human figure in blue with an orange circle above its head. To the right of the figure is the word "COSMO" in blue, with the word "Pharmaceuticals" in a smaller font size underneath.
The indications for use statement is identical to that for the original unmodified (predicate) device, as cleared under DEN200055.
Device Description:
GI Genius is an artificial intelligence-based device that has been trained to process colonoscopy images containing regions consistent with colorectal lesions like polyps, including those with flat (non-polypoid) morphology.
GI Genius is compatible with the following Video Processors: Fujifilm VP-7000, Olympus CV-180 EXERA II, Olympus CV-190 EXERA III, Fujifilm VP-4450HD, and Pentax EPK-i7000 Video Processor.
GI Genius is connected between the video processor and the endoscopic display monitor. When first switched on, the endoscopic field of view is clearly identified by four corner markers, and a blinking green square indicator appears on the connected endoscopic display monitor to state that the system is ready to function.
During live video streaming of the endoscopic video image, GI Genius generates a video output on the endoscopic display monitor that contains the original live video together with superimposed green square markers that will appear when a polyp or other lesion of interest is detected, accompanied by a short sound. These markers will not be visible when no lesion detection occurs.
The operating principle of the subject device is identical to that of the predicate device, this being 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 includes hardware to support interfacing with video endoscopy systems.
Design changes:
This Special 510(k) describes the design changes incorporated into GI Genius following its FDA clearance under DEN200055. The device software version number as cleared under DEN 2000555 was 1.0.2; the device software version that is the subject of this Special 510(k) is 2.0.0.
The design changes include a single software design change that falls within the FDA guideline for submittal of a new 510(k). A labeling change is also planned, to add non-clinical performance data of the new software version and to include one additional video processor type in the list of compatible units in the User Manual. Other minor design changes have been the subject of internal documentation and are being advised to FDA for information only.
The software design change includes an upgrade to the inference engine to optimize algorithm speed and improve energy efficiency, together with a retraining of the neural network with additional procedure videos, and improved data augmentation, to improve polyp detection capability robustness.
Non-clinical testing:
The following non-clinical verification/ validation activities have been completed:
- Verification of the revised software at the system level. Each element of the SRS was tested and found to meet specified requirements, testing 14 Units and 9 Items, encompassing 133 software requirements.
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- · Validation of the revised software at the user level, testing 14 Units and 9 Items, encompassing 133 software requirements.
- · Protective measures identified by risk management have been verified during Installation Qualification and Operational Qualification.
- Electromagnetic Compatibility (EMC) and Electrical Safety compliance tests have been completed according to IEC 60601-1 and IEC 60601-1-2 requirements.
- Standalone Performance Testing has been carried out to assess the performance of the subject device in accordance with the same test protocol as that used for the predicate device, the results of which demonstrate substantial equivalence to the predicate device.
- Non-inferiority of performance of GI Genius with a new video processor has been established by means of a per-frame assessment on 40 pre-recorded procedures.
The results of the above testing aid in demonstration of substantial equivalence of the subject device with the predicate device, as the same test protocols have been used.
Substantial equivalence
The predicate device for the subject device is the pre-modification version of the same device, Gl Genius, FDA-cleared under DEN200055 on 9 April 2021:
| Predicate Device: | GI Genius |
|---|---|
| Sponsor: | Cosmo Artificial Intelligence - Al Ltd |
| De Novo Number: | DEN200055 |
| Clearance Date: | 9 April 2021 |
| FDA Product Code: | QNP |
| Classification Name: | Gastrointestinal lesion software detection syster |
| Regulation No: | 21 CFR 876.1520 |
| Class: | II |
Predicate device comparison table:
Table 1 provides evidence of substantial equivalence of the subject device with the predicate device.
| Table 1: Predicate device comparison table | |||
|---|---|---|---|
| Characteristic | Subject device | Predicate device | Comparison |
| Device name | GI Genius v.2.0.0 | GI Genus v.1.0.2 | N/A |
| Manufacturer | Linkverse Srl, Italy | Linkverse Srl, Italy | Same |
| FDA clearance | K211951 | DEN200055 | N/A |
| FDA Reg name | Gastrointestinal lesion software | ||
| detection system | Gastrointestinal lesion software | ||
| detection system | Same | ||
| FDA Reg # | 21 CFR 876.1520 | 21 CFR 876.1520 | Same |
| FDA Product Code | QNP | QNP | Same |
| Table 1: Predicate device comparison table | |||
| Characteristic | Subject device | Predicate device | Comparison |
| Indications for Use | The GI Genius System is a | ||
| computer-assisted reading tool | |||
| designed to aid endoscopists in | |||
| detecting colonic mucosal | |||
| lesions (such as polyps and | |||
| adenomas) in real time during | |||
| standard white-light endoscopy | |||
| examinations of patients | |||
| undergoing screening and | |||
| surveillance endoscopic mucosal | |||
| evaluations. The GI Genius | |||
| computer-assisted detection | |||
| device is limited for use with | |||
| standard white-light endoscopy | |||
| imaging only. This device is not | |||
| intended to replace clinical | |||
| decision making. | The GI Genius System is a | ||
| computer-assisted reading tool | |||
| designed to aid endoscopists in | |||
| detecting colonic mucosal | |||
| lesions (such as polyps and | |||
| adenomas) in real time during | |||
| standard white-light endoscopy | |||
| examinations of patients | |||
| undergoing screening and | |||
| surveillance endoscopic mucosal | |||
| evaluations. The Gl Genius | |||
| computer-assisted detection | |||
| device is limited for use with | |||
| standard white-light endoscopy | |||
| imaging only. This device is not | |||
| intended to replace clinical | |||
| decision making. | Same | ||
| Video delay, signal in | |||
| to signal out | 1.52 μs | 1.52 μs | Same |
| Lesion-based | |||
| sensitivity | 86.5 % | 82.0 % | Improved |
| performance | |||
| Frame level | |||
| performance | |||
| (150 videos / 338 | |||
| polyps) | True positive: 269,223 | ||
| True negative: 5,239,128 | |||
| False positive: 104,669 | |||
| False negative: 192,567 | True positive: 228,929 | ||
| True negative: 5,235,682 | |||
| False positive: 108,115 | |||
| False negative: 232,861 | Improved | ||
| performance | |||
| True positive rate per | |||
| frame | Mean: 58.30 % | ||
| % of polyps: 100 % | Mean: 49.57 % | ||
| % of polyps: 99.7 % | Improved | ||
| performance | |||
| False positive rate per | |||
| frame | Mean: 1.96 % | Mean: 2.02 % | Improved |
| performance | |||
| Frame-Based TPr/FPr | |||
| ROC curve, AOC | 0.796 | 0.723 | Improved |
| performance | |||
| False positive clusters | |||
| per patient | 500 ms: 1 more than baseline | 500 ms: Baseline | Improved |
| Similar | |||
| Additional video | |||
| processor | Yes: Fujifilm VP-7000 | N/A | Improved |
| performance | |||
| Electrical safety | IEC 60601-1 | IEC 60601-1 | Same |
| Electromagnetic | |||
| compatibility | IEC 60601-1-2 | IEC 60601-1-2 | Same |
| LAN port | Yes, non-functional to user | No | Different |
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The subject device and the predicate device have many identical or similar characteristics. None of the identified differences introduce new aspects of safety or effectiveness.
Conclusion
The subject and predicate devices have identical indications for use and fundamental technological characteristics. Any differences in performance between the subject and predicate devices do not raise different questions of safety and effectiveness. The performance data demonstrate that the subject device is substantially equivalent to the predicate device, which is already in interstate commerce within the USA. Therefore, the subject device is as safe, as effective, and performs better than the predicate device.