syngo.via WebViewer is intended to be a software-only solution for reviewing medical images from syngo.via. The system cannot be used as stand-alone device. It is intended to be an option for syngo.via system only. syngo.via WebViewer is not intended for storage or distribution of medical images from one medical device to another. syngo.via WebViewer is a client server architecture and the client is intended to run on web clients which are connected to the healthcare institution IT infrastructure where the customer has to ensure HIPPA compliance. syngo.via WebViewer supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments. The communication of syngo.via WebViewer with connected medical IT systems will be done via standard interfaces such as but not limited to DICOM. The system is not intended for the displaying of digital mammography images for diagnosis in the U.S.

Device Description

This premarket notification covers Siemens ' PACS syngo.via WebViewer. syngo.via WebViewer is intended to be a software-only solution for reviewing medical images from syngo.via. The system cannot be used as stand-alone device. It is intended to be an option for syngo via system only. syngo. via Web Viewer is not intended for storage or distribution of medical images from one medical device to another. syngo.via WebViewer is a client server architecture and the client is intended to run on web clients which are connected to the healthcare institution IT infrastructure where the customer has to ensure HIPPA compliance. syngo. via Web Viewer supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments. The communication of syngo.via WebViewer with connected medical IT systems will be done via standard interfaces such as but not limited to DICOM. The system is not intended for the displaying of digital mammography images for diagnosis in the U.S. The system is a software only medical device. It defines minimum requirements to the hardware it runs on. The hardware itself is not seen as a medical device and not in the scope of this 510(k) submission. It supports the physician in diagnosis and treatment planning.

AI/ML Overview

The provided text is a 510(k) Summary for the Siemens syngo.via WebViewer. This document describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain explicit acceptance criteria or a study demonstrating that the device meets such criteria.

The 510(k) submission process for a Picture Archiving and Communications System (PACS) like syngo.via WebViewer primarily focuses on establishing substantial equivalence to existing legally marketed devices, rather than conducting new clinical trials with specific statistical performance metrics and acceptance criteria as might be expected for an AI-powered diagnostic device.

Here's a breakdown of why the requested information is largely absent based solely on the provided text, and what could be inferred or is generally understood for this type of device:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in the document. For a PACS viewer, acceptance criteria would typically revolve around functional performance (e.g., image display accuracy, speed, compliance with DICOM standards, user interface usability, data integrity, security).
Reported Device Performance: Not quantitively reported in the document. The document affirms that the device "passed all necessary verification and validation steps to demonstrate safety and effectiveness" and "does not introduce any new significant potential safety risks and is substantially equivalent to and performs as well as the predicate devices." This is a qualitative statement of performance relative to predicates rather than a measured performance against specific criteria.

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

Test Set Sample Size: Not specified. Validation for a PACS viewer typically involves testing against various types of DICOM images and objects (CT, MR, SC, PDF) to ensure correct display and functionality. The "sample" here would be representative medical images, but the document doesn't quantify how many were used.
Data Provenance: Not specified. It's implied that various types of DICOM images would be used for testing, but their origin (country, retrospective/prospective) is not detailed.

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

Ground Truth Experts: Not applicable or specified. For a PACS viewer, "ground truth" isn't generally established by experts in the same way it would be for a diagnostic AI algorithm. The viewer's "ground truth" is adherence to DICOM standards for image display and manipulation, and the successful execution of its functions. The verification and validation would be conducted by software testers and engineers, likely with medical domain knowledge.

4. Adjudication method for the test set

Adjudication Method: Not applicable or specified. Again, for a PACS viewer, the "test set" isn't typically adjudicated like an AI diagnostic outcome. Functional and performance testing would involve objective checks against specifications and industry standards.

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

MRMC Study: No. The syngo.via WebViewer is a medical image viewing and management system, not an AI-assisted diagnostic tool designed to improve human reader performance. Therefore, an MRMC study and
"effect size of how much human readers improve with AI vs without AI assistance" are not relevant to this device as described.

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

Standalone Performance: Not applicable as a diagnostic algorithm. The device itself is described as a "software-only solution for reviewing medical images" and "cannot be used as stand-alone device" meaning it requires the syngo.via system to function. It functions as a standalone software component (algorithm only in its specified role), but its "performance" is in displaying images and managing data, not making diagnoses without a human.

7. The type of ground truth used

Type of Ground Truth: Not applicable in the traditional sense of a diagnostic device (e.g., pathology, outcomes data). The "ground truth" for a PACS viewer essentially refers to the correct and accurate display of DICOM images as per specifications and standards, and the proper functioning of its features (e.g., measurements, windowing). This is verified through comparison against known correct outputs or adherence to technical specifications.

8. The sample size for the training set

Training Set Sample Size: Not applicable. The syngo.via WebViewer is not described as an AI/ML device that requires a "training set" in the context of machine learning model development. It's a traditional software application.

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

Ground Truth for Training Set: Not applicable, as there is no "training set."

Summary based on the provided document:

The 510(k) summary focuses on demonstrating the substantial equivalence of the syngo.via WebViewer to previously cleared predicate devices (Siemens syngo.x and Siemens InSpace 4D). It highlights similarities in intended use, technological characteristics (image communication, processing, supported image types, user interface, hardware), and adherence to relevant industry standards (IEC 62304 for software lifecycle, ISO 14971 for risk management, IEC 60601-1-1-6 for usability, DICOM, HL7, JPEG, JPEG2000 for communication and compression).

The "study" referenced implicitly is the verification and validation activities performed during the device's development cycle, which are stated to be compliant with QSR design processes, IEC 62304, ISO 14971, and IEC 60601-1-1-6. These activities would have ensured that the software functions as intended and meets its specifications, including accurate rendering of medical images and adherence to interface standards. However, direct evidence of specific acceptance criteria met through a formal study with statistical outcomes is not part of this 510(k) summary.

Summary

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MAY 1 3 2011

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

Establishment:

Address: .
- . Registration Number:
Contact Person:

Siemens AG, Medical Solutions Henkestrasse 127 D-91052 Erlangen Germany

3002808157

Sven Knoke Regulatory Affairs Manager Telephone: +49 (9131) 84-4687 +49 (9131) 84-2792 Telefax:

Device Name and Classification:

Trade Name:
Classification Name:
Classification Panel:
CFR Section:
Device Class:
Product Code:

Date of submission:

syngo.via WebViewer

Picture Archiving and Communications System

Radiology

21 CFR §892.2050

Class II

LLZ .

March 2011

510(k) for syngo®.via WebViewer

March 29, 2011

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.
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II. SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE SUB-STANTIAL EQUIVALENCE DETERMINATION

Device Description and Intended Use:

This premarket notification covers Siemens ' PACS syngo.via WebViewer.

syngo.via WebViewer is intended to be a software-only solution for reviewing medical images from syngo.via.

The system cannot be used as stand-alone device. It is intended to be an option for syngo via system only.

syngo. via Web Viewer is not intended for storage or distribution of medical images from one medical device to another.

syngo.via WebViewer is a client server architecture and the client is intended to run on web clients which are connected to the healthcare institution IT infrastructure where the customer has to ensure HIPPA compliance.

syngo. via Web Viewer supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments.

The communication of syngo.via WebViewer with connected medical IT systems will be done via standard interfaces such as but not limited to DICOM.

The system is not intended for the displaying of digital mammography images for diagnosis in the U.S

The system is a software only medical device. It defines minimum requirements to the hardware it runs on. The hardware itself is not seen as a medical device and not in the scope of this 510(k) submission.

It supports the physician in diagnosis and treatment planning.

syngo. via Web Viewer Data Management

... ensures all authorized personnel fast and continuous access to radiological data. It's main functionality ranges from availability of images with regard to data security, open interfaces.

Integration:

The Workflow Management enables by integration of any HL7- / DICOMcompatible RIS (IHE Year 5) to the syngo product family consistent workflow within the healthcare organization.

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Technological Characteristics:

syngo.via WebViewer server part is a "software only"-system, which will be delivered on CD-ROM / DVD to be installed on common IT hardware. This hardware has to fulfil the defined requirements. The Software will be installed by Siemens service engineers only.

The backend communication and storage solution is based on Windows 2008 operating system. The client machines are based on standard computer (Mac / Windows PC / Linux PC). The client application runs in a standard webbrowser - such as but not limited to Internet Explorer, Firefox. Safari - please refer to the specification for the complete list of supported web browsers.

Any hardware platform, which complies to the specified minimum hardware and software requirements and with successful installation verification and validation activities, can be supported.

The herewith described syngo. via Web Viewer supports DICOM formatted images (CT, MR) and objects (SC, pdf).

The syngo.via WebViewer will be marketed as a software only solution for the end-user (with recommended hardware requirements). The server part will be installed by trained service engineers only. Any special needs such as integration in a specific environment and updates / upgrades will be covered by individual service contract and fulfilled by special trained service technicians.

General Safety and Effectiveness Concerns:

The device labelling contains instructions for use and any necessary cautions and warning, 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 hazards, Siemens adheres to recognized and established industry practice and standards.

Substantial Equivalence:

The syngo. via Web Viewer, addressed in this premarket notification, is substantially equivalent to the following commercially available devices: .

Manufacturer	Predicate Device Name	FDA Clearance.Number
Siemens	syngo.x	K092519
Siemens	InSpace 4D	K062673

510(k) for syngo®.via WebViewer

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The syngo.via WebViewer described in this 510(k) has similar intended use and similar technical characteristics as the devices listed above in regard to the specific functionalities.

Functionality	Syngo. Web Viewer
Manufacturer	identical
Intended use	identical to meaning of syngo.x
Image communication	Subset of syngo.x,Subset of InSpace 4D
Image Processing and Evaluation	Identical to InSpace 4D,Subset of syngo.x
Supported Image Types	Superset of InSpace 4D,Subset of syngo.x
Image data compression .	Identical to syngo.x,Similar to InSpace 4D
User administration	identical
User Interface	Identical to InSpace 4D,Similar to syngo.x
Hardware	similar to InSpace 4D,Similar to syngo.x

The device was designed according to the QSR compliant design process and passed all necessary verification and validation steps to demonstrate safety and effectiveness.

All software lifecycle aspects are done according to IEC 62304. Safety and hazard considerations are performed according to ISO 14971 and IEC 60601-1-4.

Usability aspects are implemented, verified and validated according to IEC 60601-1-1-6.

Communication with connected medical devices is done via DICOM and HL7 where appropriate.

To ensure proper image quality compression is done according to ISO 109019-1 (JPEG) and ISO 154444-1 (JPEG2000). Furthermore SMPTE Pattern according SMPTE: 1995 is used for verification and validation activities.

In summary, Siemens is of the opinion that syngo.via WebViewer does not introduce any new significant potential safety risks and is substantially equivalent to and performs as well as the predicate devices.

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Image /page/4/Picture/0 description: The image is a black and white seal for the Department of Health & Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized symbol that resembles a person embracing another person, or a symbol representing health and human services.

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

MAY 1 3 2011

Siemens AG Medical Solutions % Mr. Norbert Stuiber Responsible Third Party Official TÜV SÜD America 1775 Old Hwy 8 NW, Ste 104 NEW BRIGHTON MN 55112-1891

Re: K111079

Trade/Device Name: syngo®, via WebViewer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 13, 2011 Received: April 18, 2011

Dear Mr. Stuiber:

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

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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/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 (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):

Device Name: syngo®.via WebViewer

Indications For Use:

syngo.via WebViewer is intended to be a software-only solution for reviewing medical images from syngo.via.

The system cannot be used as stand-alone device. It is intended to be an option for syngo.via system only.

syngo.via WebViewer is not intended for storage or distribution of medical images from one medical device to another.

syngo.via WebViewer supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicins within
environments environments.

The communication of syngo.via WebViewer with connected medical IT systems will be done via standard interfaces such as but not limited to DICOM.

The system is not intended for the limited to DrOOM.
The U S the U.S

X Prescription Use AND / OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use_ (Part 21 CFR 801 Subpart C)

(Please do not write below this line - continue on another page if needed)

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

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) for syngo®.via WebViewer

510K
March 29, 2011

Page A 3

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).