EBM iDO Viewer 1.2.1

K162285 · Ebm Technologies Incorporated · LLZ · Jan 27, 2017 · Radiology

Device Facts

• Record ID: K162285
• Device Name: EBM iDO Viewer 1.2.1
• Applicant: Ebm Technologies Incorporated
• Product Code: LLZ · Radiology
• Decision Date: Jan 27, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

EBM iDO Viewer 1.2.1 software is intended to display images from CT. MR . CR. US. XA and SC for the trained physician 's diagnosis or referring purpose. EBM iDO Viewer 1.2.1 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

Software application installed on Apple iPad Pro; provides wireless, portable access to medical images (CT, MR, CR, US, XA, SC) stored on existing EBM PACS server. User logs in, queries, and displays images for diagnostic review or referral. Intended for use by trained physicians when access to a full diagnostic workstation is unavailable. Device facilitates remote image viewing; supports clinical decision-making by providing mobile access to patient imaging data. Performance depends on environmental lighting conditions; not intended to replace primary diagnostic workstations.

Clinical Evidence

Clinical evaluation performed by three board-certified radiologists. Radiologists reviewed images under varying environmental lighting conditions. All participants confirmed acceptable image quality for diagnostic and remote review purposes when operated within intended use parameters. No quantitative metrics (sensitivity/specificity) reported; qualitative assessment only.

Technological Characteristics

Software-based medical image viewer for iOS (iPad Pro). Connectivity via wireless network to EBM PACS server. Image processing functions for presentation and review. Display performance validated against AAPM Assessment of Display Performance for Medical Imaging Devices (2005). Software development follows IEC 62304 standards.

Indications for Use

Indicated for trained physicians to display and review CT, MR, CR, US, XA, and SC medical images for diagnostic or referring purposes. Not 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 27, 2017

EBM Technologies, Incorporated % Mr. John Su Quality Manager 5f., No. 516, Sec. 1, Neihu Rd. Taipei, 114 Taiwan REPUBLIC OF CHINA

Re: K162285

Trade/Device Name: EBM iDO Viewer 1.2.1 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 28, 2016 Received: January 5, 2017

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'Hara For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K162285

Device Name EBM iDO Viewer 1.2.1

#### Indications for Use (Describe)

EBM iDO Viewer 1.2.1 software is intended to display images from CT. MR . CR. US. XA and SC for the trained physician 's diagnosis or referring purpose. EBM iDO Viewer 1.2.1 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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## 510(k) Summary

### 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 Quality Manager Tel: [phone] [e-mail]

Date of Submission: Aug 15, 2016

### 5.2 Device Name

Device Trade Name: EBM iDO Viewer 1.2.1 Common/Classification Name: Picture Archiving and Communications System ( 21 CFR 892.2050, Product Code LLZ)

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

Device Trade Name: EBM iDO Viewer 510(k) Number: K140399 Manufacturer: EBM Technologies Incorporated

## 5.4 Device Description:

EBM iDO Viewer 1.2.1 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 EBM PACS server. The device can be installed in iOS 5.0 or later version platform such as iPad, but can't be installed in platforms other than iOS 5.0 or later version . It will be almost the same image quality of CT, MR , US, XA and SC as displayed on iPad Pro when it is used for diagnosis purpose. However, if it is used for CR diagnosis purpose, we will strongly suggest that users should adopt iPad

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Pro.

## 5.5 Indication for Use:

EBM iDO Viewer 1.2.1 software is intended to display images from CT, MR , CR, US, XA and SC for the trained physician 's diagnosis or referring purpose. EBM iDO Viewer 1.2.1 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.

## 5.6 Technical characteristics

EBM iDO Viewer 1.2.1 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 EBM PACS 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.

## 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.

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# 5.8 Performance data from clinical Testing

Clinical testing were conducted by a panel of three board-certified radiologists reading the same images under different environmental lightning conditions. Under the usage condition requested by the indications for use, they were comfortable with the diagnostic mode of EBM iDO Viewer 1.2.1 as a device.

All three radiologists agree that the software and devices provide acceptable quality for diagnostic or remote reviewing use if the device is operated within the intended use.

## 5.9 Conclusion

Based on all above evidence, EBM iDO Viewer 1.2.1 described in this 510(K) is, in our opinion, substantially equivalent to the predicate devices.