syngo.via MI Workflows

K160317 · Siemens Medical Solutions USA, Inc. · LLZ · Feb 29, 2016 · Radiology

Device Facts

• Record ID: K160317
• Device Name: syngo.via MI Workflows
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Feb 29, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

syngo.via MI Workflows are medical diagnostic applications for viewing, manipulation, 3D- visualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR. syngo.via MI Workflows enable visualization of information that would otherwise have to be visually compared disjointedly. syngo.via MI Workflows provide analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations. syngo.via MI Workflows can perform harmonization of SUV (PET) across different PET systems or different reconstruction methods. syngo via MI workflows support the interpretation and evaluations and follow up documentation of findings within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments. Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unregistered images. syngo.via MI Workflows are a complement to these standard procedures.

Device Story

Software-only diagnostic application; installed on syngo.via platform. Inputs: multi-modality medical images (PET, SPECT, CT, MR). Function: enables 3D visualization, image comparison, and analytical tools for assessing morphological/functional activity changes; includes Total Lesion Glycolysis (TLG) calculation and Molecular Tumor Volume (MTV) trending. Output: visualized images (MIP, volume rendering) and quantitative data for clinical review. Used in radiology, nuclear medicine, and cardiology departments. Clinicians use output to support diagnostic and therapy follow-up decisions. Benefits: facilitates visualization of disjointed data; provides standardized quantitative metrics for longitudinal assessment.

Clinical Evidence

Bench testing only. Verification and validation activities confirmed that software functions perform as designed, specifications are met, and hazard mitigations are implemented. No clinical data provided.

Technological Characteristics

Software-only medical device; installed on Siemens syngo.via platform. Connectivity: standalone or networked within healthcare institutions. Standards: IEC 62304 (software lifecycle), ISO 14971 (risk management), NEMA PS 3.1-3.20 (DICOM), IEC 62366-1 (usability), ISO 15223-1 (labeling).

Indications for Use

Indicated for use by clinicians in Radiology, Nuclear Medicine, and Cardiology to view, manipulate, 3D-visualize, and compare medical images (PET, SPECT, CT, MR) from multiple modalities or time-points to assess and document morphological or functional activity changes.

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 MI Workflows VB10A (K151192)

Reference Devices

• Siemens syngo.via software platform (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

February 29, 2016

Siemens Medical Solutions USA, Inc. % Ms. Veronica Padharia Regulatory Affairs Specialist 2501 N. Barrington Road HOFFMAN ESTATES IL 60192

Re: K160317

Trade/Device Name: syngo.via MI Workflows Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 3, 2016 Received: February 5, 2016

Dear Ms. Padharia:

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)

K160317

Device Name syngo.via MI Workflows

#### Indications for Use (Describe)

syngo.via MI Workflows are medical diagnostic applications for viewing, manipulation, 3D- visualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR.

syngo.via MI Workflows enable visualization of information that would otherwise have to be visually compared disjointedly. syngo.via MI Workflows provide analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations. syngo.via MI Workflows can perform harmonization of SUV (PET) across different PET systems or different reconstruction methods.

syngo via MI workflows support the interpretation and evaluations and follow up documentation of findings within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments.

Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unregistered images. syngo.via MI Workflows are a complement to these standard procedures.

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

| <span></span> | Prescription Use (Part 21 CFR 801 Subpart D) |
|---------------|----------------------------------------------|
| <span></span> | Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary

as required by 21 CFR Part 807.87(h)

## Identification of the Submitter

| | Primary Contact: | Alternate Contact: | |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Submitter: | Veronica Padharia<br>Regulatory Affairs Specialist<br>Siemens Medical Solutions<br>USA, Inc.<br>Molecular Imaging<br>2501 Barrington Road<br>Hoffman Estates, IL 60192 | Cynthia Busch<br>Regulatory Technical Specialist<br>Siemens Medical Solutions<br>USA, Inc.<br>Molecular Imaging<br>2501 Barrington Road<br>Hoffman Estates, IL 60192 | |
| Telephone Number: | (630) 877 – 5761 | (847) 304 - 7095 | |
| Fax Number: | (847) 304 – 6023 | (847) 304 - 6023 | |
| Name / Address of<br>Manufacturer | Siemens Medical Solutions USA, Inc<br>Molecular Imaging<br>2501 N. Barrington Road<br>Hoffman Estates, IL 60192<br>USA | | |
| Date of Submission: | February 3, 2016 | | |
| Identification of the product | | | |
| Device Proprietary Name: | syngo.via MI Workflows – Total Lesion Glycolysis (TLG) feature | | |
| Common Name: | Image Processing Software | | |
| Classification Name: | Picture Archiving and Communication System per 21 CFR<br>892.2050 | | |
| Product Code: | LLZ | | |
| Classification Panel: | Radiology | | |
| Device Class: | Class II | | |

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#### Marketed Devices to which Equivalence is claimed

| Device | Manufacturer | 510(k) Number |
|-----------------------------------------|------------------------------------|---------------------|
| <i>syngo</i> .via MI<br>Workflows VB10A | Siemens Medical Solutions USA, Inc | K151192 (June 2015) |

#### Device Description

The Total Lesion Glycolysis (TLG) feature resides within synqo.via MI Workflows and is a software only medical device which will be delivered on CD-ROM / DVD to be installed onto the commercially available Siemens syngo.via software platform by trained service personnel.

syngo.via MI Workflows is a medical diagnostic application for viewing, manipulation, 3Dvisualization and comparison of medical images from multiple imaqinq modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR. The images can be viewed in a number of output formats including MIP and volume rendering.

synqo.via MI Workflows enable visualization of information that would otherwise have to be visually compared disjointedly. synqo.via MI Workflows provide analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations. They additionally support the interpretation and evaluation of examinations and follow up documentation of findings within healthcare institutions, for example, in Radiology (Oncology), Nuclear Medicine and Cardiology environments.

The modifications to the syngo.via MI Workflows (K151192) include the addition of the Total Lesion Glycolysis (TLG) feature within the MM Oncology workflow. This feature will provide the ability for the user to calculate and display the TLG for a given volume of interest (VOI) in addition to calculating and trending the summed Molecular Tumor Volume (MTV) for all VOIs defined for the given PET series.

## Technological Characteristics

The syngo.via MI Workflows VB10B software modifications are based on the commercially available syngo.via MI Workflows VB10A software (K151192). The features introduced into syngo.via VB10B had no impact on the technological characteristics already present in the commercially available predicate system.

syngo.via MI Workflows is intended to be run on the Siemens syngo.via software platform (K150843) either alone or with other advanced commercially cleared applications.

## Performance Testing / Safety and Effectiveness

The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of the device.

Risk Management has been ensured via risk analyses in compliance with ISO 14971:2012 to identify and provide mitigation to potential hazards beginning early in the design cycle and

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continuing throughout the development of the product. Siemens Medical Solutions, USA Inc. adheres to recoqnized and established industry standards for development including EN ISO 13485 and IEC 62304.

Verification and Validation activities have been successfully performed on the software package, including assurance that functions work as designed, performance requirements and specifications have been met, and that all hazard mitigations have been fully implemented. All testing has met the predetermined acceptance values. Traceability of the requirements specified in the requirement specifications and functional specifications is ensured during component integration, software validation and system testing.

The device is designed and manufactured in accordance with Quality System Requlations as outlined in 21 CFR 820. The FDA recognized standards are listed as follows:

- Recognition Number 13-8: IEC 62304 First Edition 2006-05
- Recognition Number 12-238: NEMA PS 3.1 3.20 (2011) ●
- o Recognition Number 5-40: ISO 14971 Second Edition 2007-03-01
- Recognition Number 5-95: IEC 62366-1 Edition 1.0 2015-02
- o Recognition Number 5-90: ISO 15223-1 Second Edition 2012-07-01

#### Indications for Use

syngo.via MI Workflows are medical diagnostic applications for viewing, manipulation, 3Dvisualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR.

syngo.via MI Workflows enable visualization of information that would otherwise have to be visually compared disjointedly. synqo.via MI Workflows provide analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations. syngo.via MI Workflows can perform harmonization of SUV (PET) across different PET systems or different reconstruction methods.

syngo.via MI Workflows support the interpretation and evaluation of examinations and follow up documentation of findings within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments.

Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unreqistered images. syngo.via MI Workflows are a complement to these standard procedures.

## Statement Regarding Substantial Equivalence:

There are no differences in the Indications for Use or Fundamental Technological Characteristics of the synqo.via MI Workflows as compared to the currently commercially available software (K151192). Both devices are used for viewing, manipulation, 3Dvisualization and comparison of medical images from multiple imaging modalities and/or multiple time-points

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Additionally, there have been no changes that raise any new issues of safety and effectiveness as compared to the predicate device. Based on this information, as well as the documentation in support of the modifications, it is Siemens opinion that the syngo.via MI Workflows software with the modifications outlined in this application is substantially equivalent to the predicate device.