MEDO ARIA

K200356 · Medo.Ai · QIH · Jun 11, 2020 · Radiology

Device Facts

• Record ID: K200356
• Device Name: MEDO ARIA
• Applicant: Medo.Ai
• Product Code: QIH · Radiology
• Decision Date: Jun 11, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device, Pediatric

Intended 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.

Device Story

MEDO ARIA is a cloud-based standalone software as a medical device (SaMD) for pediatric hip ultrasound assessment. It accepts DICOM-compliant 2D/3D ultrasound images as input. The software utilizes machine learning techniques to assist in landmark placement, alpha angle calculation, and acetabular coverage measurement. It provides tools for image visualization, slice-scrolling, and Graf classification. Operated by trained medical professionals (e.g., radiologists) in a clinical setting, the device supports the diagnostic workflow by generating examination reports. The output allows clinicians to evaluate hip dysplasia, potentially improving diagnostic accuracy and patient management for infants.

Clinical Evidence

No clinical data. Safety and performance were established through bench testing, including software verification and validation in accordance with IEC 62304:2006/AC:2015 and FDA guidance for software in medical devices.

Technological Characteristics

Cloud-based standalone SaMD. Inputs: DICOM-compliant 2D/3D ultrasound images. Features: image visualization, slice-scrolling, manual/semi-automatic landmark placement, alpha angle/coverage measurement, and Graf classification. Software lifecycle processes follow IEC 62304:2006/AC:2015.

Indications for Use

Indicated for neonates and infants aged 0 to 12 months to aid trained medical professionals in the diagnosis of developmental dysplasia of the hip (DDH) via viewing and quantification of ultrasound image data.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• QLAB Advanced Quantification Software (K191647)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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) | | |
|-------------------------------------------------|--|--|
| <table><tr><td></td><td></td></tr></table> | | |
| | | |

|× Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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K200356

# 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<br>[e-mail] |
| 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.

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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/<br>Function | Subject Device<br>MEDO ARIA | Predicate Device<br>QLAB Advanced<br>Quantification (K191647) |
|-----------------------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Image input | Complies with DICOM<br>Standard | Complies with DICOM<br>Standard |
| Scan type | 2D and 3D Ultrasound | 2D and 3D Ultrasound |
| Image display<br>mode | Static | Static |
| Image navigation<br>and manipulation<br>tools | Adjust image brightness and<br>contrast, slice-scroll, pane<br>layout, reset | Adjust image brightness<br>and contrast, slice-scroll,<br>pane layout, reset |

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| 2D image review | Yes, capable of reviewing all<br>frames of multi-frame<br>(multi-slice) image | Yes |
|-------------------------------------------|-------------------------------------------------------------------------------|----------------------|
| Manual landmark<br>placement | Yes | Yes |
| Semi-automatic<br>landmark<br>placement | Yes, user-modifiable | Yes, user-modifiable |
| Quantitative<br>analysis | • Angle (alpha angle)<br>• Distance ratio (coverage) | • Distance<br>• Area |
| Lookup-table-based<br>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.