syngo®.via (version VB10A)

K150843 · Siemens AG · LLZ · Apr 24, 2015 · Radiology

Device Facts

• Record ID: K150843
• Device Name: syngo®.via (version VB10A)
• Applicant: Siemens AG
• Product Code: LLZ · Radiology
• Decision Date: Apr 24, 2015
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Indications for Use

syngo.via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a stand-alone device or together with a variety of cleared and unmodified syngo based software options. syngo.via supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments. The system is not intended for the displaying of digital mammography images for diagnosis in the U.S.

Device Story

syngo.via (VB10A) is a client-server software solution for viewing, manipulating, and storing DICOM medical images. It integrates with Radiology Information Systems (RIS) to support clinical workflows in Radiology, Nuclear Medicine, and Cardiology. The server processes and renders data from connected modalities; the client provides the user interface for interactive viewing and reporting. Healthcare providers use the system to interpret examinations, create reports, and manage patient data. Key features include Volume Rendering Technique (VRT) for image enhancement, automatic spine and rib labeling, and tools for image annotation, measurement, and printing. The device aims to improve diagnostic efficiency and workflow management within clinical environments.

Clinical Evidence

Bench testing only. Verification and validation testing confirmed that software specifications met acceptance criteria. No clinical data was required or provided.

Technological Characteristics

Client-server software architecture; supports DICOM and Structured DICOM Reports. Standards: NEMA PS3 (DICOM), ISO/IEC 10918-1 (JPEG), ISO/IEC 15444-1 (JPEG 2000), ISO 14971, ANSI/AAMI ES 60601-1, IEC 62304, IEC 62366, ISO/HL7 21731. Cybersecurity controls implemented to prevent unauthorized access/modification. Software level of concern: Moderate.

Indications for Use

Indicated for viewing, manipulation, communication, and storage of medical images in healthcare institutions, including Radiology, Nuclear Medicine, and Cardiology. Not for digital mammography diagnosis in the U.S.

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

• syngo.via (K123920)

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

April 24, 2015

Siemens AG % Ms. Dawn Tibodeau Third Party 510(k) Project Coordinator TUV SUD America, Inc. 1775 Old Highway 8 NW NEW BRIGHTON MN 55112-1891

Re: K150843

Trade/Device Name: syngo®.via (version VB10A) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 26, 2015 Received: March 30, 2015

Dear Ms. Tibodeau:

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,

Robert Ochs. Ph.D. Acting 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) K150843

Device Name syngo®.via (Version VB10A)

Indications for Use (Describe)

syngo.via is a software solution intended to be used for viewing, manipulation, and storage of medical images.

It can be used as a stand-alone device or together with a variety of cleared and unmodified syngo based software options.

syngo via supports interpretation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments.

The system is not intended for the displaying of digital mammography images for diagnosis in the U.S.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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### C Siemens AG, 2015

## 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

Date prepared: March 18, 2015

- 1. Submitter: Siemens AG Medical Solutions Henkestrasse 127
D-91052 Erlangen Germany

## Establishment Registration Number: 3002808157

## 2. Contact Person:

Mr. Martin Meyer Regulatory Affairs Manager Siemens AG, Healthcare Syngo Hartmann Str. 16 · D-91052 Erlangen Germany E-mail: [e-mail] Telephone: [phone] Fax: [phone]

## 3. Device Name and Classification:

| Trade Name: | syngo.via |
|-----------------------|---------------------------------------------|
| Classification Name: | Picture Archiving and Communications System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.2050 |
| - Device Class: | Class II |
| Product Code: | LLZ |

## 4. Legally Marketed Predicate Device:

| Trade Name: | syngo.via |
|-----------------------|-------------------------------------------------------------------------------|
| 510(k) Clearance: | K123920 |
| Clearance Date: | January 18, 2013 |
| Classification Name: | Picture Archiving and Communications System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.2050 |
| Device Class: | Class II |
| Product Code: | LLZ |
| Recall Information: | This predicate device has not been the subject of any design related recalls. |

510(k) for syngo®.via VB10A

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#### C Siemens AG. 2015

### 5. Device Description:

Siemens AG intends to market the Picture Archiving and Communications System, syngo.via, software version VB10A. This 510(k) submission describes several modifications to the previously cleared predicate device, syngo.via, software version VA20A.

syngo.via is a software only medical device, which is delivered on DVD to be installed on common IT hardware. This hardware has to fulfil the defined requirements. Any hardware platform that complies to the specified minimum hardware and software requirements and with successful installation verification and validation activities can be supported. The hardware itself is not seen as part of the medical device syngo.via and therefore not in the scope of this 510(k) submission.

syngo.via provides tools and features to cover the radiological tasks reading images and reporting. syngo.via supports DICOM formatted images and objects. syngo.via also supports storage of Structured DICOM Reports. In a comprehensive imaging suite, syngo. via interoperates with a Radiology Information System (RIS) to enable customer specific workflows.

syngo.via is based on a client-server architecture. The server processes and renders the data from the connected modalities. The server provides central services including image processing and temporary storage, and incorporates the local database. The client provides the user interface for interactive image viewing and processing and can be installed and started on each workplace that has a network connection to the server.

The server's backend communication and storage solution is based on Microsoft Windows server operating systems. The client machines are based on Microsoft Windows operating systems.

syngo.via supports various monitor setups and can be adapted to a range of image types by connecting different monitor types.

The subject device and the predicate device share the same fundamental scientific technology. This device description holds true for the subject device, syngo.via, software version VB10A; as well as the predicate device, syngo.via, software version VA20A.

#### 6. Intended Use:

syngo. via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.

It can be used as a stand-alone device or together with a variety of cleared and unmodified syngo based software options.

syngo. via supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments.

The system is not intended for the displaying of digital mammography images for diagnosis in the U.S.

510(k) for syngo®.via VB10A

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# 7. Summary of Differences between the Subject Device and the Predicate Device:

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The differences between the subject device described in this premarket notification and the predicate device are summarized in the following comparison table:

| | Subject device<br>syngo.via VB10A | Predicate device<br>syngo.via VA20A |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Software architecture | Client-server architecture that is logically broken down to syngo.via subsystems. Subsystems are further broken down to syngo modules. | Client-server architecture that is logically broken down to syngo.via subsystems |
| Operating systems | Client:<br>Microsoft Windows 7 SP1 or Microsoft<br>Windows 8.1<br>Server:<br>Microsoft Windows Server 2008 R2, or<br>Microsoft Windows Server 2012 R2 | Client:<br>Microsoft Windows XP, Microsoft<br>Windows Vista, or Microsoft Windows 7<br>Server:<br>Microsoft Windows Server 2008 R2 |
| Imaging algorithms | Volume Rendering Technique (VRT) with additional input parameters, for edge and surface enhancement and control over rendering parameters<br>Automatic Spine Labeling, also for ribs in CT thorax scans | Volume Rendering Technique (VRT)<br>Automatic Spine Labeling |
| Software functionality | Graphical user interface with reduced color palette, clearer structure and text labels on icons. | Graphical user interface with a defined color palette and iconic buttons. |
| | Online help system with improved search, indexing, filtering, library function, document collections, and user-generated content. | Online help system with basic search functionality. |
| | Reporting with additional functionality to create one page reports, insert snapshot images, customize reports, and data export in various formats. | Reporting with basic report templates and basic data export functionality. |
| | Patient browser with simplified search functionality, clearer structure of search results, unlimited search results, periodic updates of search results, image preview and flexible floating patient browser window. | Patient browser with search functionality across a variety of data, results list showing study and procedure information. |
| | Correct and rearrange of data | Correct and rearrange not available. |
| | Added anatomical range presets, support for spine ranges, and annotations as graphical overlays. | Basic functionality to create a series (range) of images and export a range. |
| Suggested spine labels to be confirmed<br>by user, and additional smart place-<br>ment of labels, also in inter-vertebra<br>regions, support of 2D images, support<br>of multi-series studies, and added sup-<br>port for rib labels. | Suggested spine labels to be confirmed<br>by user. | |
| Printing with additional options for<br>rearranging images, adding annota-<br>tions, full/customized image text, print<br>size and orientation. | Printing with image text on DICOM<br>printer or paper printer. | |
| Configurable settings for image text. | Show or hide image text. | |
| Added textual and graphical annota-<br>tions, improved placement of meas-<br>urement text, and changed numbering<br>of markers. | Marking a position on an image and<br>textual annotations. | |

510(k) for syngo®.via VB10A

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C Siemens AG, 2015

## 8. Non-clinical Performance Testing:

Non-clinical tests were conducted for the device syngo.via during product development. The modifications described in this Premarket Notification were supported with verification and validation testing.

Siemens claims conformance to the following standards:

- NEMA PS3 Digital Imaging and Communications in Medicine (DICOM)
- ISO IEC 10918-1:1994 + Technical Corrigendum 1:2005 (JPEG)
- ISO IEC 15444-1:2005 + Technical Corrigendum 1:2007 (JPEG 2000)
- ISO 14971:2007
- ANSI/AAMI ES 60601-1, A 1, clauses 14.11 and 14.13
- IEC 62304:2006
- IEC 62366:2007, clauses 4, 5.1 through 5.9, 6 and 7
- ISO/HL7 21731:2006

## Software Verification and Validation:

Software documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 is also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software. Non-clinical tests were conducted on the device syngo.via during product development.

The Risk Analysis was completed and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence.

510(k) for syngo®.via VB10A

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#### C Siemens AG. 2015

Siemens conforms to the Cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient. Contained in Section B of this submission are our cybersecurity considerations as they relate to the device symgo.via.

#### Summary:

Performance tests were conducted to test the functionality of the device syngo.via. These tests have been performed to assess the functionality of the subject device. Results of all conducted testing were found acceptable in supporting the claim of substantial equivalence.

## 9. Safety and Effectiveness Information:

Software specifications, design descriptions, hazard analysis, and labeling information are submitted in support of this premarket notification. The device labeling contains instructions for use with cautions to provide for safe and effective use of the device.

The results of the hazard analysis combined with the appropriate preventive measures taken indicate the device is of moderate level of concern, as per the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005).

## 10. Conclusion as to Substantial Equivalence:

The predicate device was cleared based on non-clinical supportive information. The comparison of technological characteristics, device hazards, non-clinical performance data, and software validation data demonstrates that the subject device performs comparably to and is as safe and effective as the predicate device that is currently marketed for the same intended use.

In summary, we are of the opinion that the subject device syngo. via, software version VB10A, does not introduce any new significant potential safety risks and is substantially equivalent to and performs as well as the predicate device. .