The syngo MultiModality Workplace is a medical diagnostic workstation for viewing, manipulation, communication, and storage of medical images and data on exchange media.

The syngo MultiModality Workplace can be configured as a stand-alone diagnostic review and post-processing workplace with a variety of syngo- or Windows XP-based software options, that are intended to assist the physician in diagnosis, surgical planning, interventional procedures or treatment planning. These options include commercially available post-processing software.

The syngo MultiModality Workplace does not support the display of mammography images for diagnosis.

Device Description

This premarket notification covers Siemens syngo MultiModality Workplace (syngo MM WP), a syngo-based workplace that supports different modalities. syngo is a universal imaging platform based on Windows XP. syrgo MultiModality Workplace offers a comprehensive solution to view, optimize, process diagnostic information and aid the doctors in the evaluation of digital radiological examinations and patient information.

Due to special customer requirements based on the modality image type and the clinical focus, the syngo MultiModality Workplace can be configured with different combinations of clinical applications. syngo applications can be added to the multimodality workplace either individually or as clinically focused packages.

The syneo MultiModality Workplace is a medical diagnostic workplace for realtime viewing, manipulation, communication, and storage of medical images and data on exchange media.

The syrgo MultiModality Workplace can be configured as a stand-alone diagnostic review and post-processing workplace with a variety of syngo- or Windows XPbased software options, that are intended to assist the physician in diagnosis, surgical planning, interventional procedures or treatment planning. These options include commercially available post-processing software. The syngo MultiModality Workplace does not support the display of mammography images for diagnosis.

The syngo MultiModality Workplace will be marketed as a software only solution for the end-user (with recommended hardware requirements) or as a complete work station for the end-user (hardware and software package). It will be installed by Siemens service engineers. The syngo MultiModality Workplace described supports DICOM formatted images and information. The workplace is based on the Windows XP operating system.

AI/ML Overview

This 510(k) submission for the Siemens syngo MultiModality Workplace (syngo MMWP) does not include a study proving device performance against acceptance criteria in the typical sense of a clinical or performance study with metrics like sensitivity, specificity, or reader agreement.

Instead, this submission is centered on demonstrating substantial equivalence to a previously cleared predicate device (syngo MultiModality Workplac (K052775) and MAGNETOM Systems with Expert-i option (K052423)). For general PACS (Picture Archiving and Communications System) software like the syngo MMWP, the "acceptance criteria" are primarily related to conforming to established standards, ensuring proper image display and manipulation, and maintaining data integrity, rather than diagnostic performance metrics.

Therefore, many of the requested points below cannot be directly extracted from the provided text, as the focus is on safety, effectiveness, and equivalence to existing technology.

Here's an breakdown based on the information available and the nature of this type of device submission:

1. Table of Acceptance Criteria and Reported Device Performance

As a general PACS workstation for viewing, manipulating, communicating, and storing medical images, the “acceptance criteria” are primarily conformance to established standards and ensuring functional equivalence to the predicate. Specific quantitative diagnostic performance metrics are not typically required for a device of this classification.

Acceptance Criteria (Implied)	Reported Device Performance (Implied from Substantial Equivalence Claim)
Functional equivalence to predicate devices (K052775, K052423)	The syngo MultiModality Workplace has the "same intended use and similar technical characteristics" as the predicate devices and "performs as well."
Compliance with DICOM standards	The workplace "supports DICOM formatted images and information."
Risk management and safety	"Risk management is ensured via a risk analysis," with hazards controlled by software development, verification, and validation testing. Adheres to "recognized and established industry practice and standards" to minimize hazards.
Proper display, manipulation, communication, and storage of medical images	The device offers a "comprehensive solution to view, optimize, process diagnostic information and aid the doctors in the evaluation of digital radiological examinations and patient information." Supports "realtime viewing, manipulation, communication, and storage of medical images and data on exchange media."
Excludes mammography for diagnosis	Explicitly states: "The syngo MultiModality Workplace does not support the display of mammography images for diagnosis."

2. Sample size used for the test set and the data provenance

Sample Size: Not specified. Performance testing for a PACS workstation typically involves extensive internal verification and validation with a wide variety of anonymized clinical images rather than a single "test set" with a defined sample size for a specific clinical endpoint.
Data Provenance: Not specified. Given it's a Siemens product developed in Germany, it's highly likely that testing data would include a mix of internal, international, and potentially U.S. clinical data, if specific clinical data were used, but the document does not elaborate. This type of submission relies more on functional testing and adherence to standards than a specific clinical dataset.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not a diagnostic AI/CAD device requiring expert-established ground truth for clinical performance evaluation. The "ground truth" for a PACS workstation is determined by its ability to accurately display, process, and transmit medical images as per DICOM standards and clinical requirements, which relies on engineering and software validation, not expert medical adjudication of diagnoses.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. See point 3.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This is not an AI-assisted diagnostic device. It is a general PACS workstation. Therefore, an MRMC study and AI assistance effect size are not relevant to this submission.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

No specific "standalone algorithm performance" study is described because the device is an interactive workstation designed for human users. The performance is assessed in terms of its functionality in supporting human users, not as an autonomous diagnostic algorithm.

7. The type of ground truth used

Not applicable in the sense of expert consensus, pathology, or outcomes data for a diagnostic performance evaluation. The "ground truth" for this device relates to the fidelity and accuracy of image display, processing, and storage according to technical specifications and DICOM standards. This is verified through technical validation, not clinical ground truth.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a "training set" in the context of machine learning model development. This is a conventional software application (PACS).

9. How the ground truth for the training set was established

Not applicable. See point 8.

Summary

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Siemens Medical Solutions, Inc 510(k) for syngo MultiModality Workplace_

510(k) Summary

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.

I. GENERAL INFORMATION

JUL 27 2006

Establishment: . Address:

Siemens AG
Medical Solutions
Henkestrasse 127
D-91052 Erlangen
Germany

3002808157 Registration Number: .
- Ms. Sieglinde West Regulatory Affairs Manager Phone: +49 (9131) 84-3144 Fax: +49 (9131) 84-2792

Device Name:

syngo MultiModality Workplace (syngo MM WP) Trade Name: . Picture Archiving and Communications System (PACS)
. Classification:
Classification Panel: .

Contact Person:

21 CFR §892.2050 CFR Section: .
. Device Class: Class Hass H 1902

Radiology

. Product Code:

Date of Preparation of Summary: June 24th, 2006

II. SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE SUBSTANTIAL EQUIVALENCE DETERMINATION

. Device Description and Intended Use:

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The syneo MultiModality Workplace is a medical diagnostic workplace for realtime viewing, manipulation, communication, and storage of medical images and data on exchange media.

Technological Characteristics: .

General Safety and Effectiveness Concerns: .

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 a risk analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing. To minimize electrical, mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.

. Substantial Equivalence:

The syngo Multimodality Workplace, addressed in this premarket notification, is substantially equivalent to the following commercially available device:

syngo MultiModality Workplac (K052775) MAGNETOM Systems with Expert-i option (K052423)

The syngo MultiModality Workplace described in this premarket notification has the same intended use and similar technical characteristics as the devices listed above.

In summary, Siemens is of the opinion that the syngo MultiModality Workplace does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate device.

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Image /page/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUL 27 2006

Siemens AG Medical Solutions % Mr. Stefan Preiss Responsible Third Party Official TÜV America, Inc., TÜV Product Service 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891

Re: K061964

Trade/Device Name: syngo MultiModality Workplace (MMWP) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 5, 2006 Received: July 12, 2006

Dear Mr. Preiss:

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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.

Image /page/2/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top. Below the text is the letters "FDA" in a bold, sans-serif font. Underneath the letters is the word "Centennial" in a cursive font. There are three stars below the word "Centennial". The logo is surrounded by a dotted border.

oting Public .

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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); 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.

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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150

or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 1: Indications for Use

Indications for Use

510(k) Number (if known):	K06 1964
Device Name:	syngo MultiModality Workplace (MMWP)

Indications for Use

The syngo MultiModality Workplace is a medical diagnostic workstation for viewing, manipulation, communication, and storage of medical images and data on exchange media.

The syngo MultiModality Workplace does not support the display of mammography images for diagnosis.

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Concurrence of the CDRH, Office of Device Evaluation (ODE)

Prescription Use _ V OR Over-The-Counter Use (Per 21 CFR 801.109)

June 24th, 2006	CONFIDENTIAL	Page 6
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(Division Sign)

Division

and

510(k) Number	KC61964
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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).