(119 days)
Not Found
Yes
The intended use explicitly states the device uses "machine learning techniques".
No
The device aids in diagnosis by processing ultrasound images and providing tools for analysis and reporting; it does not provide any direct treatment or therapy.
Yes
The intended use explicitly states that the device is designed to "aid trained medical professionals in diagnosis of developmental dysplasia of the hip (DDH)."
Yes
The device description explicitly states that MEDO ARIA is a "cloud-based standalone software as a medical device (SaMD)". It takes DICOM images as input and provides tools for viewing, quantifying, and reporting, all within the software itself. There is no mention of accompanying hardware components that are part of the regulated device.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis.
- This device analyzes ultrasound images, which are generated by external energy applied to the body, not from a specimen taken from the body.
The device's function is to process and analyze medical images (ultrasound) to aid in diagnosis, which falls under the category of medical imaging software or medical image analysis software, not in vitro diagnostics.
No
The letter does not 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 ARIA is designed to view and quantify ultrasound image data using machine learning techniques to aid trained medical professionals in diagnosis of developmental dysplasia of the hip (DDH). The device is intended to be used on neonates and infants, aged 0 to 12 months.
Product codes (comma separated list FDA assigned to the subject device)
QIH
Device Description
MEDO ARIA is a cloud-based standalone software as a medical device (SaMD) that helps qualified users with image-based assessment of developmental hip dysplasia (DDH) of pediatric patients (e.g., ages 0 to 12 months). It is designed to support the workflow by helping the radiologist to evaluate, quantify, and generate reports for hip images.
MEDO ARIA 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 alpha angle and acetabular coverage, and manipulate 2D and 3D infant hip ultrasound images, as well as create and finalize examination reports. It provides users with a specific toolset for viewing pediatric ultrasound hip images, placing landmarks, and creating reports.
Key features of the software are:
- 2D image visualization including one or more image frames that may have a spatial . or temporal relationship
- Slice-scroll (frame scroll) ●
- Manual and semi-automatic landmark placements ●
- Alpha and coverage measurements 0
- Hip Graf classification ●
- Report generation ●
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Ultrasound
Anatomical Site
Hip
Indicated Patient Age Range
0 to 12 months
Intended User / Care Setting
Trained medical professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Safety and performance of MEDO ARIA 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."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized symbol. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
MEDO DX Pte. Ltd. (0/A MEDO.ai) % Dornoosh Zonoobi CEO and Co-founder 32 Carpenter Street 059911 SINGAPORE
June 11, 2020
Re: K200356
Trade/Device Name: MEDO ARIA Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: QIH Dated: May 7, 2020 Received: May 8, 2020
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/cfpmp/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 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
1
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 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-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) K200356
Device Name MEDO ARIA
Indications for Use (Describe)
MEDO ARIA is designed to view and quantify ultrasound image data using machine learning techniques to aid trained medical professionals in diagnosis of developmental dysplasia of the hip (DDH). The device is intended to be used on neonates and infants, aged 0 to 12 months.
| 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 | 32 CARPENTER STREET SINGAPORE 059911 |
| Correspondence Person | Dornoosh Zonoobi |
| Contact Information | 780-991-9462 |
| dornoosh@medo.ai | |
| Date Prepared | May 7, 2020 |
5.2 Proposed Device
| Proprietary Name | MEDO ARIA |
|---|---|
| Common Name | ARIA |
| 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 |
|---|---|
| Premarket Notification | 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 ARIA is a cloud-based standalone software as a medical device (SaMD) that helps qualified users with image-based assessment of developmental hip dysplasia (DDH) of pediatric patients (e.g., ages 0 to 12 months). It is designed to support the workflow by helping the radiologist to evaluate, quantify, and generate reports for hip images.
4
MEDO ARIA 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 alpha angle and acetabular coverage, and manipulate 2D and 3D infant hip ultrasound images, as well as create and finalize examination reports. It provides users with a specific toolset for viewing pediatric ultrasound hip images, placing landmarks, and creating reports.
Key features of the software are:
- 2D image visualization including one or more image frames that may have a spatial . or temporal relationship
- Slice-scroll (frame scroll) ●
- Manual and semi-automatic landmark placements ●
- Alpha and coverage measurements 0
- Hip Graf classification ●
- Report generation ●
5.5 Indications for Use
MEDO ARIA is designed to view and quantify ultrasound image data using machine learning techniques to aid trained medical professionals in diagnosis of developmental dysplasia of the hip (DDH). The device is intended to be used on neonates and infants, aged 0 to 12 months.
5.6 Comparison of Technological Characteristics with the Predicate Device
| Feature/
Function | Subject Device
MEDO ARIA | Predicate Device
QLAB Advanced
Quantification (K191647) |
|-----------------------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Image input | Complies with DICOM
Standard | Complies with DICOM
Standard |
| Scan type | 2D and 3D Ultrasound | 2D 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 |
5
| 2D image review | Yes, capable of reviewing all
frames of multi-frame
(multi-slice) image | Yes |
|-------------------------------------------|-------------------------------------------------------------------------------|----------------------|
| Manual landmark
placement | Yes | Yes |
| Semi-automatic
landmark
placement | Yes, user-modifiable | Yes, user-modifiable |
| Quantitative
analysis | • Angle (alpha angle)
• Distance ratio (coverage) | • Distance
• Area |
| Lookup-table-based
Graf Classification | Yes, user-modifiable | No |
| Report creation | Yes | No |
5.7 Performance Data
Safety and performance of MEDO ARIA 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."
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 ARIA raises no new questions of safety or effectiveness and is substantially equivalent to the predicate device in terms of safety, efficacy, and performance.