SYNGO.VIA MI WORKFLOWS

K123577 · Siemens Medical Solutions USA, Inc. · LLZ · Jan 22, 2013 · Radiology

Device Facts

• Record ID: K123577
• Device Name: SYNGO.VIA MI WORKFLOWS
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Jan 22, 2013
• 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, 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. 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 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 unregistered images. syngo.via MI Workflows are a complement to these standard procedures.

Device Story

Software-only diagnostic application; installed on Siemens syngo.via platform. Inputs: multi-modality medical images (PET, SPECT, CT, MR). Transforms inputs via visualization/analytical tools; enables 3D visualization, MIP, and volume rendering; facilitates comparison of disjointed datasets. Used in clinical environments (Radiology, Nuclear Medicine, Cardiology) by healthcare professionals. Output: processed images and analytical documentation. Assists clinicians in assessing/documenting morphological or functional changes during diagnostic and therapy follow-up. Clinician retains ultimate diagnostic responsibility; device serves as a complement to standard practices.

Clinical Evidence

Bench testing only. Verification and validation activities performed to ensure software functions as designed and hazard mitigators are implemented. No clinical data presented.

Technological Characteristics

Software-only medical device; installed on Siemens syngo.via platform. Supports PET, SPECT, CT, and MR modalities. Features include 3D visualization, MIP, and volume rendering. Developed in compliance with ISO 14971:2007, ISO 13485, and IEC 62304 standards.

Indications for Use

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

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 (syngo.via MI Taskflows) (K113029)

Reference Devices

• Siemens syngo.via software platform (K123375)

Submission Summary (Full Text)

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# Siemens syngo.via MI Workflows

510(k) Premarket Notification

## 510(k) Summary

1235

as required by 21 CFR Part 807.87(h)

## JAN 2 2 2013

#### Identification of the Submitter

M. Alaine Medio, RAC Submitter: PET and PCS Regulatory Projects Manager Siemens Medical Solutions USA, Inc. Molecular Imaging 810 Innovation Drive Knoxville, TN 37932 Telephone Number: [phone] Fax Number: [phone] Siemens Medical Solutions USA, Inc Name / Address of Molecular Imaqing Manufacturer 2501 N. Barrington Road Hoffman Estates, IL 60192 USA Date of Submission: November 19, 2012 Identification of the product Device Proprietary Name: syngo.via MI Workflows Common Name: Image Processing Software Picture Archiving and Communication System per 21 Classification Name: CFR 892.2050 Product Code: LLZ

Radiology

Class II

Classification Panel:

Device Class:

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#### Siemens syngo.via MI Workflows 510(k) Premarket Notification

## Marketed Devices to which Equivalence is claimed

Device

#### Manufacturer

#### 510(k) Number

synqo.via Ml Workflows (syngo.via MI Taskflows)

Siemens Medical Solutions USA, Inc

K113029 (November 18, 2011)

### Device Description:

The syngo.via MI Workflows are software only medical devices 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 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. The images can be viewed in a number of output formats including MIP and volume rendering.

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 morpholoqical 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 synqo.via MI Workflows (K113029) are adding enhanced functionality to the commercially available Oncology workflow in this software. All changes are based on current commercially available software features and do not change the technological characteristics of the device.

syngo.via MI Workflows are intended to be run on the Siemens synqo.via software platform (K123375) either alone or with other advanced commercially cleared applications.

#### 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 14971:2007 to identify and provide mitigation to potential hazards beginning early in the design cycle and continuing throughout the development of the product. Siemens Medical Solutions, USA Inc. adheres to recognized and established industry standards for development including ISO 13485 and IEC 62304.

Verification and Validation activities have been successfully performed on the software package, including assurance that functions work as designed and that all hazard mitigators have been fully implemented.

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#### Indications for Use:

syngo.via MI Workflows are medical diagnostic applications for viewing, manipulation, 3Dvisualization and comparison of medical images from multiple imaginq 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 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 unregistered images. syngo.via MI Workflows are a complement to these standard procedures.

#### Conclusions:

There are no differences in the Indications for Use or Fundamental Technological Characteristics of the syngo via MI Workflows as compared to the currently commercially available software (K113029). 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.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a stylized human figure with three arms or extensions, representing health and human services.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -- WO66-G609 Silver Spring, MD 20993-0002

## January 22, 2013

Ms. Alaine Medio, RAC PET and PCS Regulatory Projects Manager Molecular Imaging 810 Innovation Drive KNOXVILLE TN 37934

Re: K123577

Trade/Device Name: syngo.via MI Workstaion Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 19, 2012 Received: November 20, 2012

Dear Ms. Medio:

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. Iisting 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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Page 2-Ms. Medio, RAC

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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. O'Hara for

Janine M. Morris 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):

K123577

syngo.via MI Workflows Device Name:

#### 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. 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 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 unregistered images. syngo.via MI Workflows are a complement to these standard procedures.

Prescription Use_ × (Part 21 CFR 801 Subpart D) Over the Counter Use_ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

OR

Division/Sign Off

Page 1 of

Division of Radiological Hea

Office of In Vitro Diagnostics and

Office of In Vitro Diag.
510(k) K123577.