syngo®.via protoNeo (Version VA10A)

K161685 · Siemens Healthcare GmbH · LLZ · Jul 11, 2016 · Radiology

Device Facts

• Record ID: K161685
• Device Name: syngo®.via protoNeo (Version VA10A)
• Applicant: Siemens Healthcare GmbH
• Product Code: LLZ · Radiology
• Decision Date: Jul 11, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended Use

syngo.via protoNeo 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 protoNeo 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 protoNeo is a client-server medical software system for radiological image management. It receives, stores, and distributes images from modalities like CT and MR scanners. The server performs central image processing and temporary storage; the client provides a user interface for interactive viewing, editing, and manipulation. Clinicians use the system to generate quantitative and qualitative data for diagnosis and treatment planning. The device is operated by trained professionals within healthcare institutions. Output is displayed on client monitors, where clinicians evaluate the processed images to inform clinical decision-making. The system benefits patients by providing tools for efficient image review and interpretation.

Clinical Evidence

Bench testing only. Verification and validation testing confirmed that all software specifications were met and risk mitigations were implemented. No clinical data was required or provided.

Technological Characteristics

Software-only medical device; client-server architecture. Standards: NEMA PS3 (DICOM), ISO 14971:2007, ANSI/AAMI ES 60601-1, IEC 62304:2006, IEC 62366-1:2015, IEC 10918-1, IEC 15444-1. Connectivity: Networked (minimum 3 Mbits/s). Image processing: Multiplanar reconstruction (MPR), Maximum Intensity Projection (MIP), Volume Rendering Technique (VRT) with edge/surface enhancements, Curved Planar Reformat (CPR), and region growing.

Indications for Use

Indicated for use by trained healthcare professionals in Radiology, Nuclear Medicine, and Cardiology environments for viewing, manipulating, communicating, and storing medical images. Not indicated 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 (K150843)

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

July 11, 2016

Siemens Healthcare GmbH % Mr. Georg Bauer Responsible Third Party Official 510(k) TPR Deputy Program Manager TÜV SÜD America, Inc. 1775 old highway 8 NW, Suite 104 NEW BRIGHTON MN 55112-1891

Re: K161685

Trade/Device Name: syngo®.via protoNeo (Version VA10A) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 14, 2016 Received: June 17, 2016

Dear Mr. Bauer:

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/ResourcesforYou/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) K161685

Device Name syngo®.via protoNeo (Version VA10A)

#### Indications for Use (Describe)

syngo via protoNeo is a software solution intended to be used for viewing, 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 protoNeo 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.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CER 801 Subpart D) | <span style="text-decoration: overline;">☐</span> Over-The-Counter Use (21 CER 801 Subpart C) |
|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|

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# 510(k) Summary

## syngo®.via protoNeo (Version VA10A)

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: June 1, 2016

### 1. Submitter

Siemens Healthcare GmbH Henkestrasse 127 D-91052 Erlangen Germany

## Establishment Registration Number 3002808157

### 2. Contact Person

Ms. Lauren Bentley Regulatory Affairs Manager Siemens Healthcare GmbH 40 Liberty Boulevard Mailcode: 65-3 Malvern, PA 19355 USA Email: [e-mail] Telephone: [phone] - 6104 Fax: [phone] – 6557

#### 3. Device Name and Classification

| Trade Name: | syngo®.via protoNeo (Version VA10A) |
|-----------------------|--------------------------------------------|
| Classification Name: | Picture Archiving and Communication 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: | K150843 |
| Clearance Date: | April 24, 2015 |

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| Classification Name: | Picture Archiving and Communication 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<br>design related recalls. |

### 5. Device Description

This premarket submission addresses the Siemens syngo®.via protoNeo Version VA10A Picture Archiving and Communication System.

syngo®.via protoNeo, version VA10A, is a medical software system that provides tools and features to cover the radiological tasks of reading images. The system receives, stores and distributes images from digital image acquisition devices such as computer tomography and magnetic resonance scanners. The system has workplaces which can be used to review, edit, and manipulate imaqe data, as well as generate quantitative and qualitative data to support an authorized user in diagnosis and treatment planning.

syngo®.via protoNeo version VA10A is a software only medical device. It defines recommended configurations for the hardware to run on. The hardware itself is not seen as a medical device and is not within the scope of this 510(k) submission.

syngo®.via protoNeo 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 while incorporating the local database. The client provides the user interface for interactive image viewing and processing and can be installed and stored on each workplace that has a network connection to the server.

Since the majority of the data processing is performed by the server, the client can be installed on standard off-the-shelf computers with a variety of monitor types. The quality of displayed images highly depends on the quality and settings of monitors, graphics cards, and graphics drivers. It is the customer's responsibility that client monitors are compatible with graphics cards and graphics drivers. It is also the customer's responsibility to use suitable monitors for diagnostic purposes.

In the United States, monitors (displays) should not be used for diagnosis, unless the monitor (display) has specifically received 510(k) clearance for this purpose.

syngo®.via protoNeo and its predicate device have the same fundamental technical characteristics.

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### 6. Intended Use

syngo.via protoNeo 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 synqo based software options.

syngo.via protoNeo 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

### 7. Summary of Differences Between the Subject Device and the Predicate Device

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 protoNeo VA10A | Predicate Device<br>syngo.via VB10A |
|--------------------------|------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Siemens Healthcare GmbH | Siemens AG |
| Software<br>Architecture | Client-server architecture with<br>enhanced business logic on the<br>client side. | Client-server architecture |
| Network Bandwidth | Minimum:<br>3 Mbits/second, 50 ms round-trip | Minimum:<br>1 Gbit ethernet3 |
| Operating System | Client:<br>Microsoft Windows 7<br><br>Server:<br>Microsoft Windows<br>Server 2012 R2 | Client:<br>Microsoft Windows 7 SP1 or<br>Microsoft Windows 8.1<br><br>Server:<br>Microsoft Windows Server<br>2008 R2, or Microsoft Windows<br>Server 2012 R2 |
| Patient Browser | Yes, with simplified search<br>functionality and clearer<br>structure of search results | Yes |
| Ranges | Yes, with a simplified ranges<br>control panel. | Yes |
| Image Display | CT and MR | DICOM Ultrasound, XA, CT,<br>MR, DX, DR and Nuclear<br>Medicine, including PET. |
| Imaging Algorithms | - Multiplanar reconstruction<br>(MPR)<br>- Maximum Intensity Projection<br>(MIP)<br>- Volume Rendering Technique | - Multiplanar reconstruction<br>(MPR)<br>- Maximum Intensity Projection<br>(MIP)<br>- Volume Rendering Technique |

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| | (VRT) with edge and surface<br>enhancements and control<br>over rendering parameters<br>- MPR Curved (Curved Planar<br>Reformat, CPR)<br>- Region growing | (VRT) with edge and surface<br>enhancements and control over<br>rendering parameters<br>- MPR Curved<br>- Region growing |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Export Data Sets via<br>Network Means | Export to other DICOM nodes. | Export to Windows file system, or<br>other DICOM nodes. |

# 8. Non-Clinical Performance Testing

Non-clinical testing was conducted for the device syngo.via protoNeo 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 14971:2007 ●
- ANSI/AAMI ES 60601-1, A1, clauses 14.11 and 14.13 .
- IEC 62304: 2006
- IEC 62366-1:2015
- IEC 10918-1:1994 + Technical Corrigendum 1:2005 ●
- IEC 15444-1:2005 + Technical Corrigendum 1:2007

# Software Verification and Validation

In accordance with the FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005, documentation is included within this submission for software of a Moderate Level of Concern. Non-clinical Testing was conducted during product development. Evidence provided within this submission demonstrates conformance with special controls for medical devices containing software.

Cybersecurity considerations related to syngo.via protoNeo are included within this submission. Siemens conforms to cybersecurity requirements by implementing a means to prevent unauthorized access, modification, misuse, denial of use or unauthorized use of information stored, accessed or transferred from a medical device to an external recipient.

A risk analysis, in compliance with ISO 14971:2007, for syngo.via protoNeo was conducted and mitigation controls were implemented for identified hazards. Verification and validation testing confirms that all software specifications have been implemented met the defined acceptance criteria. Further, documentation is provided to support the claim of substantial equivalence.

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### 9. Safety and Effectiveness Information

Device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of this device. Risk management was implemented throughout the development process to control potential hazards.

The device does not come into contact with the patient and is only used by trained professionals. The output of the device is evaluated by clinicians, providing for sufficient review to identify and intervene in the event of a malfunction.

Siemens believes that syngo.via protoNeo version VA10A is safe and effective as the identified predicate device and does not introduce new safety and effectiveness concerns.

## 10. Conclusion as to Substantial Equivalence

The comparison of intended use, technological characteristics, performance specifications, device hazards as well as verification and validation results demonstrate that syngo.via protoNeo is safe, effective and performs as well as the predicate device.

In summary. Siemens is of the opinion that syngo.via protoNeo version VA10A does not introduce any new significant potential safety risks and is substantially equivalent to the predicate device.