(144 days)
Not Found
Yes
The intended use statement explicitly mentions "using machine learning techniques" and the device name is listed as "MEDO Thyroid-AI".
No
This device is a diagnostic tool that aids in the analysis and quantification of thyroid ultrasound images; it does not provide any therapeutic benefit or treatment.
Yes
The device is designed to "view and quantify ultrasound thyroid image data using machine learning techniques to aid in analysis of thyroid lobes and identify thyroid nodules," and helps the radiologist to "evaluate, quantify, and generate reports for thyroid ultrasound images," which falls under the definition of a diagnostic device aiding in the diagnosis of thyroid conditions.
Yes
The device description explicitly states that MEDO-Thyroid is a "cloud-based standalone software as a medical device (SaMD)" and its function is to process and analyze imported DICOM images from ultrasound scanners. It does not include or require any specific hardware component for its intended use beyond the input images themselves.
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. They are used to examine these samples outside of the body.
- MEDO-Thyroid's Function: MEDO-Thyroid analyzes images of the thyroid gland obtained through ultrasound. It processes and quantifies data from these images to aid in the analysis of thyroid lobes and nodules. It does not perform any tests on biological samples.
- Input Data: The input data for MEDO-Thyroid is DICOM images from ultrasound scanners, not biological specimens.
- Intended Use: The intended use is to view and quantify ultrasound thyroid image data to aid in analysis, not to perform diagnostic tests on biological samples.
Therefore, MEDO-Thyroid falls under the category of medical imaging software or a SaMD (Software as a Medical Device) that assists in the interpretation of medical images, 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.
Intended Use / Indications for Use
MEDO-Thyroid is designed to view and quantify ultrasound thyroid image data using machine learning techniques to aid in analysis of thyroid lobes and identify thyroid nodules, including evaluation, quantification and documentation of any such nodule. The device is intended to be used on adult patient images of 18 years or older.
Product codes
QIH
Device Description
MEDO-Thyroid is a cloud-based standalone software as a medical device (SaMD) that helps qualified users with image-based assessment of thyroid ultrasound images in adult patients of 18 years and older. It is designed to support the workflow by helping the radiologist to evaluate, quantify, and generate reports for thyroid ultrasound images.
MEDO-Thyroid Software takes as an input imported Digital Imaging and Communications in Medicine (DICOM) images from ultrasound scanners and allows users to upload, browse, and view images, measure thyroid lobes and thyroid nodule volumes of single frame and multi-frame ultrasound images, as well as create and finalize examination reports. It provides users with a specific toolset for viewing ultrasound Thyroid images, placing landmarks, and creating reports.
Key features of the software are:
- Single and multi-frame visualization .
- Cross Referencing .
- . Manual and semi-automatic landmark placements
- Thyroid Lobes (left and right) and thyroid nodule volume measurements ●
- TI-RADS Score and Classification (based on user manual input) .
- Report generation ●
Mentions image processing
Not Found
Mentions AI, DNN, or ML
MEDO-Thyroid is designed to view and quantify ultrasound thyroid image data using machine learning techniques to aid in analysis of thyroid lobes and identify thyroid nodules, including evaluation, quantification and documentation of any such nodule. The device is intended to be used on adult patient images of 18 years or older.
Input Imaging Modality
ultrasound
Anatomical Site
thyroid
Indicated Patient Age Range
18 years or older.
Intended User / Care Setting
qualified users, radiologist
Description of the training set, sample size, data source, and annotation protocol
MEDO Thyroid-AI has been primarily trained and tested on the Philips, GE and Siemens ultrasound devices.
Description of the test set, sample size, data source, and annotation protocol
The device has been tested using images acquired from the following ultrasound machines using high frequency linear transducers as described in Table 5.7.1 (below):
| Ultrasound Manufacturer | Machine |
|---|---|
| Philips | EPIQ 5G |
| Philips | iU22 |
| Philips | CX50 |
| GE | LOGIQE9 |
| Siemens | S2000 |
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Safety and performance of MEDO-Thyroid have been evaluated and verified in accordance with software specifications and applicable performance standards through software verification and validation testing. Additionally, the software validation activities were performed in accordance with IEC 62304:2006/AC:2015 - Medical device software -Software life cycle processes, in addition to the FDA Guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
The performance of the MEDO-Thyroid device has been successfully assessed on a nodule size range between 0.13 cc and 36.5 cc, and is independent of the sizes of nodules being measured.
Table 5.7.2: Performance Analysis of device on thyroid lobe volume measurement for Ultrasound Device Subgroups
| Subgroup | AI (cc) | Ref. data (cc) | ICC | Maximum % Volume Error |
|---|---|---|---|---|
| Siemens | 4.27 ± 2.61 | 4.35 ± 2.66 | 0.974 (95% CI 0.967-0.978) | 18.2% (95% CI 12.0-24.0) |
| Philips | 6.12 ± 3.73 | 5.95 ± 3.57 | 0.963 (95% CI 0.952-0.969) | 21.1% (95% CI 16.5-25.0) |
| GE | 8.08 ±10.02 | 7.73 ± 9.99 | 0.974 (95% CI 0.969-0.977) | 24.4% (95% CI 20.0-29.5) |
| All | 6.48 ± 6.54 | 6.29 ± 6.46 | 0.972 (95% CI 0.969-0.975) | 21.7% (95% CI 19.0-24.8) |
Table 5.7.3: Performance Analysis of device on nodule volume measurement for Ultrasound Device Subgroups
| Subgroup | AI (cc) | Ref. data (cc) | ICC | Maximum % Volume Error |
|---|---|---|---|---|
| Siemens | 0.85 ± 1.19 | 0.87 ± 1.22 | 0.978 (95% CI 0.975-0.979) | 17.4% (95% CI 12.0-24.0) |
| Philips | 1.76 ± 2.95 | 1.76 ± 3.07 | 0.972 (95% CI 0.967-0.975) | 23.5% (95% CI 16.5-25.0) |
| GE | 1.83 ± 5.71 | 1.93 ± 6.34 | 0.974 (95% CI 0.969-0.977) | 24.6% (95% CI 20.0-29.5) |
| All | 1.61 ± 3.71 | 1.64 ± 4.02 | 0.973 (95% CI 0.971-0.975) | 22.9% (95% CI 20.0-26.0) |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 23, 2021
MEDO DX Pte. Ltd. Dornoosh Zonoobi CEO and Co-founder 4560 TEC Centre, 10230 Jasper Avenue Edmonton, Alberta T5J4P6 Canada
Re: K203502
Trade/Device Name: MEDO-Thyroid Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: QIH Dated: March 22, 2021 Received: March 24, 2021
Dear Dornoosh Zonoobi:
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.
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
1
801and Part 809); 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
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203502
Device Name MEDO-Thyroid
Indications for Use (Describe)
MEDO-Thyroid is designed to view and quantify ultrasound thyroid image data using machine learning techniques to aid in analysis of thyroid lobes and identify thyroid nodules, including evaluation, quantification and documentation of any such nodule. The device is intended to be used on adult patient images of 18 years or older.
| 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 PRAStaff(@fda.hhs.gov
"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."
3
Section 5. 510(k) Summary
5.1. General Information
| 510(k) Sponsor | MEDO DX Pte. Ltd. (O/A MEDO.ai) |
|---|---|
| Address | MEDO DX Pte. Ltd. (O/A MEDO.ai) |
| 32 Carpenter Street, Singapore 059911 | |
| Correspondence | |
| Person | Dornoosh Zonoobi |
| Contact Information | 780-991-9462 |
| dornoosh@medo.ai | |
| Date Prepared | November 20, 2020 |
5.2. Proposed Device
| Proprietary Name | MEDO-Thyroid |
|---|---|
| Common Name | MEDO-Thyroid |
| Classification Name | Automated Radiological Image Processing Software |
| Regulation Number | 21 CFR 892.2050 |
| Product Code | QIH |
| Regulatory Class | II |
5.3. Predicate Device
| Proprietary Name | QLAB Advanced Quantification Software |
|---|---|
| Common Name | K191647 |
| Classification Name | Automated Radiological Image Processing Software |
| Regulation Number | 21 CFR 892.2050 |
| Product Code | QIH |
| Regulatory Class | II |
5.4. Device Description
MEDO-Thyroid is a cloud-based standalone software as a medical device (SaMD) that helps qualified users with image-based assessment of thyroid ultrasound images in adult patients of 18 years and older. It is designed to support the workflow by helping the radiologist to evaluate, quantify, and generate reports for thyroid ultrasound images.
MEDO-Thyroid Software takes as an input imported Digital Imaging and Communications in Medicine (DICOM) images from ultrasound scanners and allows users to upload, browse,
4
and view images, measure thyroid lobes and thyroid nodule volumes of single frame and multi-frame ultrasound images, as well as create and finalize examination reports. It provides users with a specific toolset for viewing ultrasound Thyroid images, placing landmarks, and creating reports.
Key features of the software are:
- Single and multi-frame visualization .
- Cross Referencing .
- . Manual and semi-automatic landmark placements
- Thyroid Lobes (left and right) and thyroid nodule volume measurements ●
- TI-RADS Score and Classification (based on user manual input) .
- Report generation ●
5.5. Indications for Use
MEDO-Thyroid is designed to view and quantify ultrasound thyroid image data using machine learning techniques to aid in analysis of thyroid lobes and identify thyroid nodules, including evaluation, quantification and documentation of any such nodule. The device is intended to be used on adult patient images of 18 years or older.
| 5.6. Comparison of Technological Characteristics with the Predicate Device | |||||
|---|---|---|---|---|---|
| ---------------------------------------------------------------------------- | -- | -- | -- | -- | -- |
| Feature /
Function | Subject Device
MEDO-Thyroid | Predicate Device
QLAB Advanced
Quantification (K191647) |
|-----------------------------------------------|-------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Image input | Complies with DICOM
Standard | Complies with DICOM
Standard |
| Scan type | 2D, 2D Cine, and 3D
Ultrasound (Sing and Multi
frame images) | 2D, 2D Cine, and 3D
Ultrasound |
| Image display
mode | Static | Static |
| Image navigation
and manipulation
tools | Adjust image brightness and
contrast, slice-scroll, pane
layout, reset | Adjust image brightness and
contrast, slice-scroll, pane
layout, reset |
| Image review | Yes, capable of reviewing all
frames of multi-frame
(multi-slice) image | Yes |
5
| Manual landmark
| placement | Yes | Yes |
|---|---|---|
| Semi-automatic | ||
| landmark placement | Yes, user-modifiable | Yes, user-modifiable |
| Quantitative | ||
| analysis | • Volume (thyroid lobes and | |
| user-identified thyroid | ||
| nodules | ||
| • Distance | • Distance | |
| • Area | ||
| TI-RADS | ||
| Classification | ||
| (based on user | ||
| manual input) | Yes, based on ACR Standard | |
| guidelines and user manual | ||
| input | No | |
| Cross Referencing | Yes | No |
| Report creation | Yes | No |
5.7. Performance Data
Safety and performance of MEDO-Thyroid have been evaluated and verified in accordance with software specifications and applicable performance standards through software verification and validation testing. Additionally, the software validation activities were performed in accordance with IEC 62304:2006/AC:2015 - Medical device software -Software life cycle processes, in addition to the FDA Guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
MEDO Thyroid-AI has been primarily trained and tested on the Philips, GE and Siemens ultrasound devices. The device has been tested using images acquired from the following ultrasound machines using high frequency linear transducers as described in Table 5.7.1 (below):
| Ultrasound Manufacturer | Machine |
|---|---|
| Philips | EPIQ 5G |
| Philips | iU22 |
| Philips | CX50 |
| GE | LOGIQE9 |
| Siemens | S2000 |
Table 5.7.1: Breakdown of ultrasound machines used for testing
6
Tables 5.7.2 and 5.7.3 (below) provide detailed breakdowns of device performance by ultrasound device subgroups:
| Thyroid Lobe Volume (cc) | |||||
|---|---|---|---|---|---|
| Subgroup | AI | Ref. data | ICC | Maximum % Volume Error | |
| Siemens | 4.27 ± 2.61 | 4.35 ± 2.66 | 0.974 (95% CI 0.967-0.978) | 18.2% (95% CI 12.0-24.0) | |
| Philips | 6.12 ± 3.73 | 5.95 ± 3.57 | 0.963 (95% CI 0.952-0.969) | 21.1% (95% CI 16.5-25.0) | |
| GE | 8.08 ±10.02 | 7.73 ± 9.99 | 0.974 (95% CI 0.969-0.977) | 24.4% (95% CI 20.0-29.5) | |
| All | 6.48 ± 6.54 | 6.29 ± 6.46 | 0.972 (95% CI 0.969-0.975) | 21.7% (95% CI 19.0-24.8) |
Table 5.7.2: Performance Analysis of device on thyroid lobe volume measurement for Ultrasound Device Subgroups
Table 5.7.3: Performance Analysis of device on nodule volume measurement for Ultrasound Device Subgroups
| Thyroid Nodule Volume (cc) | ||||
|---|---|---|---|---|
| Subgroup | AI | Ref. data | ICC | Maximum % Volume Error |
| Siemens | 0.85 ± 1.19 | 0.87 ± 1.22 | 0.978 (95% CI 0.975-0.979) | 17.4% (95% CI 12.0-24.0) |
| Philips | 1.76 ± 2.95 | 1.76 ± 3.07 | 0.972 (95% CI 0.967-0.975) | 23.5% (95% CI 16.5-25.0) |
| GE | 1.83 ± 5.71 | 1.93 ± 6.34 | 0.974 (95% CI 0.969-0.977) | 24.6% (95% CI 20.0-29.5) |
| All | 1.61 ± 3.71 | 1.64 ± 4.02 | 0.973 (95% CI 0.971-0.975) | 22.9% (95% CI 20.0-26.0) |
The performance of the MEDO-Thyroid device has been successfully assessed on a nodule size range between 0.13 cc and 36.5 cc, and is independent of the sizes of nodules being measured.
5.8. Conclusion
Based on the information submitted in this premarket notification, and based on the indications for use, technological characteristics, and performance testing, MEDO-Thyroid raises no new questions of safety or effectiveness and is substantially equivalent to the predicate device in terms of safety, efficacy, and performance.