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 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 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,

The syngo.via MI Workflows are based on the syngo.PET&CT Oncology package (K093621and are merely adding the ability to launch additional commercially available software such as Siemens Scenium product (K061545) on the syngo.via platform.

syngo.via MI Workflows are intended to be run on the Siemens syngo.via software platform (K092519) either alone or with other advanced commercially cleared applications.

AI/ML Overview

The provided document, K113029 for syngo.via MI Workflows, does not contain a study that proves the device meets specific acceptance criteria in the manner typically seen for performance evaluation of diagnostic algorithms.

This device is described as "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." Its primary function is for "viewing, manipulation, 3D-visualization and comparison of medical images...[providing] analytical tools to help the user assess, and document changes..."

The submission makes an equivalency claim to previously cleared Siemens devices (K092519 and K093621) and does not present new performance data or a clinical study for this specific 510(k) submission. Therefore, many of the requested elements regarding acceptance criteria, study design, and performance metrics are not applicable or not provided in this document.

Here's an assessment based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The document does not define specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for an AI algorithm or analytical tool, nor does it report device performance against such criteria. The device's clearance is based on substantial equivalence to existing predicate devices, implying its performance is comparable to or does not raise new questions of safety and effectiveness compared to those devices for its stated functions of image viewing, manipulation, visualization, and comparison.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. No new test set data or studies are presented.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. No new test set data or studies are presented.

4. Adjudication Method for the Test Set

Not applicable. No new test set data or studies are presented.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. An MRMC study was not conducted or reported for this submission. The device provides "analytical tools to help the user assess, and document changes," but there is no comparative effectiveness study on human readers with vs. without AI assistance described.

6. Standalone (Algorithm Only) Performance Study

Not applicable. A standalone performance study was not conducted or reported for this submission. The device is a software application designed for human review and analysis.

7. Type of Ground Truth Used

Not applicable. No new performance studies or ground truth establishment are detailed in this 510(k) summary.

8. Sample Size for the Training Set

Not applicable. No new training set or algorithm development data are detailed in this 510(k) summary.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No new training set or algorithm development data are detailed in this 510(k) summary.

Summary of Device Rationale for Clearance:

The K113029 submission for syngo.via MI Workflows primarily relies on demonstrating substantial equivalence to previously cleared Siemens products (syngo.via (syngo.x) K092519 and syngo.via MI Workflows (syngo.via PET&CT Oncology) K093621). The document states that the new device is "based on the syngo.PET&CT Oncology package (K093621) and are merely adding the ability to launch additional commercially available software such as Siemens Scenium product (K061545) on the syngo.via platform."

The safety and effectiveness argument is based on:

Risk Management via risk analyses in compliance with ISO 14971:2007.
Adherence to recognized and established industry standards for development.
The device labeling containing instructions for use and any necessary cautions and warnings.

In essence, this 510(k) is for updates and integration capabilities of existing, cleared functionalities, rather than for a novel diagnostic algorithm requiring a new performance study to establish its efficacy or accuracy with specific acceptance criteria.

Summary

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脚 1 8 2011

K113029

Strictly Confidential

510(k) Summary

as required by 21 CFR Part 807.87(h)

ldentification of the Submitter

Submitter:

M. Alaine Medio, RAC PET and PCS Regulatory Projects Manager Siemens Medical Solutions USA, Inc. Molecular Imaging 810 Innovation Drive Knoxville, TN 37932

Telephone Number:

Fax Number:

Name / Address of Manufacturer

(865)218-3019

(865)218-2703

Siemens Medical Solutions USA, Inc Molecular Imaging 2501 N. Barrington Road Hoffman Estates, IL 60192 USA

Date of Submission:

October 10, 2011

ldentification of the product

Device Proprietary Name:

syngo.via MI Workflows

Image Processing Software

Picture Archiving and Communication System per 21 Classification Name: CFR 892.2050

Product Code:

Classification Panel:

Common Name:

Device Class:

Radiology Class II

LLZ

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Marketed Devices to which Equivalence is claimed

Device	Manufacturer	510(k) Number
syngo.via (syngo.x)	Siemens Medical Solutions USA, Inc	K092519 (August 27, 2009)
syngo.via MIWorkflows(syngo.via PET&CTOncology)	Siemens Medical Solutions USA, Inc	K093621 (February 23, 2010)

Device Description:

syngo.via MI Workflows are intended to be run on the Siemens syngo.via software platform (K092519) 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 is 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.

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Indications for Use:

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle or bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird image.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Ms. Alaine Medio, RAC PET and PCS Regulatory Projects Manager Siemens Medical Solutions USA Inc. Molecular Imaging 810 Innovation Drive KNOXVILLE TN 37932

NOV 1 8 2011

Re: K113029

Trade/Device Name: Syngo.via MI Taskflows Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 10, 2011 Received: October 20, 2011

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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

{4}------------------------------------------------

Page 2

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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/ReportalProblem/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Mary Pastel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known):

K113029

Device Name: syngo.via MI Taskflows

Indications for Use:

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

syngo.via Ml 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 Ml workflows support the interpretation and evaluation of examinations and follow up documentation of findings within wellpreted.org the evaluation of 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.vio 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 Diagnostic Devices (OIVD)

__. (District/State/Zip)

(Division Sign-Off) Division of Radiological Device

610K K113029

Page 1 of

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).