UDE

K202292 · Ebm Technologies, Inc. · LLZ · Oct 5, 2020 · Radiology

Device Facts

• Record ID: K202292
• Device Name: UDE
• Applicant: Ebm Technologies, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Oct 5, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

UDE software is intended to display images from CT, MR, CR, US, XA and SC for the trained physician 's diagnosis or referring purpose. UDE provides wireless and portable access to medical images. It is not intended to be used as, or to replace, a full diagnostic workstation or system and should be used only when there is no access to a workstation. This device is not to be used for mammography diagnosis.

Device Story

UDE is a software application for Apple iPad Pro; enables wireless, portable access to medical images stored on an existing UDE server. Operates by allowing trained physicians to query, retrieve, and display images (CT, MR, CR, US, XA, SC) for diagnostic or referral purposes. Features include distance calculation, window/level adjustment, pan, zoom, cine loop, and mammography hanging protocols. Used in clinical environments as a secondary viewing tool when primary workstations are inaccessible. Output is visual image presentation on the iPad Pro screen; assists physicians in clinical review and decision-making. Benefits include increased mobility and timely access to patient data.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, including software verification/validation per IEC 62304 and display performance testing per AAPM (2005) standards.

Technological Characteristics

Software-based PACS viewer for Apple iPad Pro (iOS 9, 11, 12, 13). Connectivity via wireless network to UDE server. Features include image processing (window/level, zoom, pan, distance measurement), user authentication, and FIFO image management. Display performance evaluated against AAPM 2005 standards. Software developed per IEC 62304.

Indications for Use

Indicated for trained physicians to display and review medical images (CT, MR, CR, US, XA, SC) for diagnostic or referring purposes when a primary workstation is unavailable. Contraindicated for mammography diagnosis.

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

• EBM iDO Viewer (K140399)

Submission Summary (Full Text)

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October 5, 2020

Image /page/0/Picture/1 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

EBM Technologies, Inc. % Mr. John Su Regulatory Affairs Manager 5F., No. 516, Sec. 1, Neihu Rd. Taipei. Taiwan 11493 REPUBLIC OF CHINA

Re: K202292

Trade/Device Name: UDE Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: May 27, 2020 Received: August 12, 2020

Dear Mr. Su:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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 (OS) 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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known)

K202292

Device Name UDE

#### Indications for Use (Describe)

UDE software is intended to display images from CT, MR, CR, US, XA and SC for the trained physician 's diagnosis or referring purpose. UDE provides wireless and portable access to medical images. It is not intended to be used as, or to replace, a full diagnostic workstation or system and should be used only when there is no access to a workstation. This device is not to be used for mammography 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)

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K202292

## 5.1 Device Submitter

EBM Technologies Incorporated 5F., No. 516, Sec. 1, Neihu Rd., Taipei, Taiwan, Republic of China Phone: [phone] Fax: [phone] Contact Person: John Su Regulation Affairs Manager Tel: [phone] [e-mail]

### 5.2 Device Name

Device Trade Name: UDE Device Class : Class 2 Product Code : LLZ Regulation name and number: Picture Archiving and Communications System , 21 CFR 892.2050

## 5.3 Substantially Equivalent (predicate) device(s)

Device Trade Name: EBM iDO Viewer 510(k) Number: K140399 Device Class : Class 2 Product Code : LLZ Regulation name and number: Picture Archiving and Communications System , 21 CFR 892.2050 Manufacturer: EBM Technologies Incorporated

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# 5.4 Device Description:

UDE is a software device that can be installed on Apple iPad Pro. Through wireless network, user can login, query and display the images which are stored in heir existing UDE server. The device can be installed in iOS 9, 11, 12 and 13 version platform such as iPad /iPhone, but can't be installed in platforms other than iOS 9, 11, 12 and 13 version . The image display quality on iPad /iPhone will be almost the same as on iPad Pro when it is used for diagnosis purpose of CT, MR, US, XA and SC. However, if it is used for CR diagnosis purpose, we will strongly suggest that users should adopt iPad Pro. because the screen size of iPad Pro is larger than those of Apple® iPad/iPhone.

Main features of UDE are listed below

- Receive, Store, Retrieve, Display, and Process Digital Images(CT, MR, US, CR, Full- Field . Mammography, XA,SC etc.)
- · The displayed CT, MR, CR,, US,XA and SC images can be diagnosed by the trained physicians.
- . The displayed CT, MR, CR, Full- Field Mammography, US, XA and SC images can be referred by the trained physicians. Mammography images are not for diagnostic use
- · Communication log file
- · Auto delete old images (FIFO)
- · Overlay labels
- · User Authentication
- Display of Clinical Patient Data .
- Distance Calculation
- · layout adjustment (1×1, 2×1, 1×2, 2×2)
- · Pan
- Zoom
- Window Level
- · Cine Loop
- Mammography hanging protocol

## 5.5 Indication for Use:

UDE software is intended to display images from CT, MR, CR, XA and SC for the trained physician 's diagnosis or referring purpose. UDE provides wireless and portable access to medical images. It is not intended to be used as, or to replace, a full diagnostic workstation or system and should be used only when there is no access to a workstation. This device is not to be used for mammography diagnosis.

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# 5.6 Technical characteristics

UDE is a software device that can be installed on Apple iPad Pro. Through wireless network, user can login, query and display the images which are stored in heir existing UDE server. It has functions related to the medical image presentation and processing. These functions can help the trained physician to perform the medical images review and diagnosis if environment lighting condition has been evaluated and in opportune setting.

| Device | Subject device | Predicate device | Comparison and<br>Explanation of<br>Differences |
|-------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Topic | UDE | EBM iDO Viewer | |
| 510k number | N/A | K140399 | |
| Intended Use /<br>Indications for Use | UDE software is intended<br>to display images from<br>CT, MR , CR, US, XA<br>and SC for the trained<br>physician 's diagnosis or<br>referring purpose. UDE<br>provides wireless and<br>portable access to<br>medical images. It is not<br>intended to be used as, or<br>to replace, a full<br>diagnostic workstation or<br>system and should be<br>used only when there is<br>no access to a<br>workstation. This device<br>is not to be used for<br>mammography diagnosis. | EBM iDO Viewer software is<br>intended to display images from<br>CT/MR for the trained physician 's<br>diagnosis or referring purpose.<br>EBM iDO Viewer provides<br>wireless and portable access to<br>medical images. It is not intended<br>to be used as, or to replace, a full<br>diagnostic workstation or system<br>and should be used only when there<br>is no access to a workstation. This<br>device is not to be used for<br>mammography. | The images displayed by<br>subject device have extended<br>to CR and Full-Field<br>Mammography , US, XA and<br>SC. It leads to the change of<br>intended use. It raises no new<br>issues of safety or<br>effectiveness |
| Receive, Store,<br>Retrieve, Display,<br>and Process Digital<br>Medical Images | Yes | Yes | No difference |
| Display of Clinical<br>Patient Data When<br>No Access to a<br>Workstation | Yes | Yes | No difference |
| Distance Calculation | Yes | Yes | No difference |
| layout adjustment (1<br>×1,2×1,1×2,2<br>×2) | Yes | Yes | No difference |
| Window / Level | Yes | Yes | No difference |
| Zoom, Pan | Yes | Yes | No difference |
| User Authentication | Yes | Yes | No difference |
| Modality images for<br>diagnosis | CT, MRI, CR, US,<br>XA,SC | CT, MRI | The images displayed by<br>subject device has extended to<br>CR, US, XA, and SC. It raises<br>no new issues of safety or<br>effectiveness |
| Modality images for<br>reference.<br>Mammography<br>images are not for<br>diagnostic use. | CT, MRI, CR, Full-Field<br>Digital<br>Mammography, US,<br>XA,SC | CT, MRI ,US, CR,XA,SC | The modalities connected<br>with subject device has<br>extended to Full-Field<br>Mammography. It raises no<br>new issues of safety or<br>effectiveness |
| Mammography<br>hanging protocol | Yes | No | Subject device has added a<br>new image process function<br>which raise no new issues of<br>safety or effectiveness |
| Communication log<br>file | Yes | No | Subject device has added a<br>new image process function<br>which raise no new issues of<br>safety or effectiveness |
| Auto delete old<br>images (FIFO) | Yes | No | Subject device has added a<br>new image process function<br>which raise no new issues of<br>safety or effectiveness |
| Overlay labels | Yes | No | Subject device has added a<br>new image process function<br>which raise no new issues of<br>safety or effectiveness |
| Remote Handheld<br>Viewing | Yes | Yes | No difference |
| Operating Platform | Apple® iOS | Apple® iOS | No difference |
| Hardware<br>Requirements | Apple® iPad Pro | Apple® iPad/iPhone | The hardware to be installed is<br>different. It raises no new<br>issues of safety or<br>effectiveness |
| Screen technology | 12.9"/11"TFT Color<br>LCD Panel | 9.7"TFT Color LCD Panel<br>(Apple® iPad)<br>3.5"TFT Color LCD Panel<br>(Apple® iPhone) | The screen size of iPad Pro is<br>larger than those of Apple®<br>iPad/iPhone. It raises no new<br>issues of safety or<br>effectiveness |
| Screen resolution in<br>pixels/square inch | 264 ppi | 264 ppi (Apple® iPad)<br>326 ppi (Apple® iPhone) | The screen of iPad Pro has the<br>same resolution as that of<br>Apple® iPad, but is different<br>that of iPhone. It raises no new<br>issues of safety or<br>effectiveness |

Device Comparison between subject and predicate

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# 5.7 Performance data from non-clinical Testing

The software verification testing and validation testing based on IEC 62304 workflows have been performed by designed engineer or professional personnel. These testing include unit, integration and system tests. The test results of software verification and validation had all met and passed the acceptance criteria referred to medical image software quality request.

The non-clinical performance of display had been conducted according to the description and requirements described in the AAPM Assessment of Display Performance for Medical Imaging Devices (2005) document by a third party to ensure high quality laboratory results. All tests had passed successfully.

# 5.8 Performance data from clinical Testing

Given the differences from the predicate device iDO Viewer (K140399), no clinical testing of the UDE software is necessary for this submission. The subject software is based on the cleared predicate. Moreover, bench testing results are showing adequate performance of the iPad Pro display used in combination with the UDE software.

# 5.9 Conclusion

Based on all above evidence, UDE described in this 510(K) is, in our opinion, substantially equivalent to the predicate devices.