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 can perform harmonization of SUV (PET) across different PET systems or different reconstruction methods.

syngo via MI workflows support the interpretation and evaluation 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 Description

The SPECT Processing 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 synqo.via MI Workflows 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 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. 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 SPECT (Organ) Processing feature within the MI Reading workflow. This feature will integrate already existent functionality from Symbia 6.0, MI Applications (K142006) and provide the user additional organ-specific functionality for Nuclear Medicine (NM) and SPECT images within the syngo.SPECT Processing workflow.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria or a dedicated study proving the device syngo.via MI Workflows meets those criteria. Instead, it describes the device, its intended use, and its equivalence to a predicate device for the purpose of 510(k) clearance by the FDA.

The text states that "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 mitiqations have been fully implemented. All testing has met the predetermined acceptance values." However, it does not provide the specifics of these "predetermined acceptance values" or the "performance requirements and specifications."

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and the reported device performance. The document broadly states "All testing has met the predetermined acceptance values" but does not define these values or present specific performance data.
Sample size used for the test set and the data provenance. This information is not present.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts. This information is not present.
Adjudication method for the test set. This information is not present.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done. This information is not present. The document focuses on showing equivalence to a predicate device rather than comparative effectiveness.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done. This information is not present. The device is described as a tool to aid human interpretation ("The clinician retains the ultimate responsibility...").
The type of ground truth used. This information is not present.
The sample size for the training set. This information is not present.
How the ground truth for the training set was established. This information is not present.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed performance study results that would typically include the information you've requested.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, arranged in a cascading manner.

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

March 4, 2016

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

Re: K160426

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 10, 2016 Received: February 16, 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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

K160426

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.

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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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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 PadhariaRegulatory Affairs SpecialistSiemens Medical SolutionsUSA, Inc.Molecular Imaging2501 Barrington RoadHoffman Estates, IL 60192	M. Alaine Medio, RACPET and PCS RegulatoryProjects ManagerSiemens Medical SolutionsUSA, Inc.Molecular Imaging810 Innovation DriveKnoxville, TN 37932
Telephone Number:	(630) 877 – 5761	(865) 218 – 2703
Fax Number:	(847) 304 - 6023	(865) 218 - 3019
Name / Address ofManufacturer	Siemens Medical Solutions USA, IncMolecular Imaging2501 N. Barrington RoadHoffman Estates, IL 60192USA
Date of Submission:	February 10, 2016
Device Proprietary Name:	syngo.via MI Workflows – SPECT (Organ) Processing feature
Common Name:	Image Processing Software
Classification Name:	Picture Archiving and Communication System per 21 CFR892.2050
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	Type of Predicate
syngo.via MI WorkflowsVB10A	Siemens Medical SolutionsUSA, Inc	K151192 (June2015)	Primary Predicate
MI Applications, Symbia6.0	Siemens Medical SolutionsUSA, Inc	K142006 (July2014)	Reference Predicate

Device Description

Technological Characteristics

The syngo.via MI Workflows VB10B software modifications are based on the commercially available syngo.via VB10A software (K151192) as well as MI Applications software within Symbia 6.0 (K142006). The features introduced into syngo.via VB10B had no impact on the technoloqical 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.

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Performance Testinq / 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 continuing throughout the development of the product. Siemens Medical Solutions, USA Inc. adheres to recognized 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 mitiqations 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)
Recognition Number 5-40: ISO 14971 Second Edition 2007-03-01 o
o 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 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.

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.

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Statement Regarding Substantial Equivalence:

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 (K151192). Both devices are used for viewing, manipulation, 3Dvisualization and comparison of medical images from multiple imaging modalities and/or multiple time-points

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.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
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.(b)
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).