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

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 enhanced PACS system syngo.x.

syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a stand-alone device or together with a variety of cleared and unmodified syngo x based software options. syngo x supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments. 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.x also supports storage of Structured DICOM Reports.

In a comprehensive imaging suite syngo.x integrates Radiology Information Systems (RIS) to enable customer specific workflows.

syngo.x allows to use a variety of advanced applications (clinical applications) designed for syngo.x just as the predicate device syngo MultiModality Workplace (K072728, cleared on April 22, 2007). These applications are medical devices on their own rights and filed separately. They are not part of this 510(k) submission and not part of the syngo x medical device. syngo.x has a universal component called generic reader application which is part of this medical device and it allows no newly introduced imaging and postprocessing algorithms compared to the above mentioned predicate devices.

syngo.x is based on Windows. Due to special customer requirements and the clinical focus syngo.x can be configured in the same way as the syngo MultiModality Workplace with different combinations of syngo.x- or Windows -based software options and clinical applications which are intended to assist the physician in diagnosis and/or treatment planning. This includes commercially available post-processing software packages.

syngo.x 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 herewith described syngo.x supports DICOM formatted images and objects.

The syngo.x will be marketed as a software only solution for the end-user (with recommended hardware requirements). It 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.

AI/ML Overview

The provided text is a 510(k) summary for the syngo.x Picture Archiving and Communications System (PACS). This document focuses on demonstrating that the syngo.x device is substantially equivalent to previously cleared devices (syngo Imaging and syngo MultiModality Workplace), rather than presenting a study to prove meeting specific acceptance criteria for performance.

Therefore, much of the requested information (acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training data details) is not available in this specific 510(k) summary.

The document primarily states that "syngo.x does not introduce any new significant potential safety risks and is substantially equivalent to and performs as well as the predicate devices." This substantial equivalence argument is based on similar intended use and technical characteristics, not on a new clinical study with defined performance metrics.

Here's a breakdown of what can be extracted from the provided text, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated as quantifiable performance metrics for the syngo.x device itself. The acceptance criteria for this 510(k) submission are implicitly demonstrating substantial equivalence to predicate devices based on intended use and technological characteristics.
Reported Device Performance: No specific numerical performance metrics (e.g., accuracy, sensitivity, specificity, processing speed targets) are reported for syngo.x. The claim is that it "performs as well as the predicate devices," but no data from a performance study is included to substantiate this in a measurable way.

Missing Information: Specific KPIs, thresholds, and performance results of syngo.x.

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

Sample Size (Test Set): Not applicable or not specified. There is no mention of a test set being used for a performance study.
Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable or not specified.

Missing Information: Any details about a performance test set.

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

Number of Experts: Not applicable or not specified.
Qualifications of Experts: Not applicable or not specified.

Missing Information: Details about experts for ground truth establishment.

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

Adjudication Method: Not applicable or not specified.

Missing Information: Adjudication method.

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 Comparative Effectiveness Study: No, an MRMC study is not mentioned. The syngo.x is a PACS system for viewing, manipulation, communication, and storage of medical images, and its 510(k) is about demonstrating substantial equivalence to existing PACS systems, not about demonstrating improvement in human reader performance with AI assistance. The document explicitly states that "advanced applications (clinical applications) designed for syngo.x... are medical devices on their own rights and filed separately. They are not part of this 510(k) submission and not part of the syngo x medical device."

Missing Information: MRMC study details and effect size.

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

Standalone Study: No, a standalone algorithm performance study is not mentioned. This device is a PACS system intended for human use and interaction, not a standalone diagnostic algorithm.

Missing Information: Standalone study details.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Type of Ground Truth: Not applicable or not specified. No performance study data is presented.

Missing Information: Type of ground truth.

8. The sample size for the training set:

Sample Size (Training Set): Not applicable or not specified. No machine learning or AI algorithm development details are provided for syngo.x itself in this submission.

Missing Information: Training set details.

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

Ground Truth Establishment (Training Set): Not applicable or not specified.

Missing Information: Ground truth establishment for training set.

Summary of available information:

The 510(k) summary for syngo.x focuses on:

Device Description and Intended Use: Viewing, manipulation, communication, and storage of medical images (excluding digital mammography for diagnosis in the U.S.).
Regulatory Classification: Class II, Product Code LLZ, 21 CFR §892.2050 (Picture Archiving and Communications System).
Substantial Equivalence: Claimed based on similar intended use and technical characteristics to predicate devices:
- Siemens syngo Imaging (K081734)
- Siemens syngo MultiModality Workplace (K072728)
Safety and Effectiveness Concerns: Addressed through risk analysis, software development, verification and validation testing, and adherence to recognized industry practices and standards.
Software Only: The device is a software-only medical device, with hardware requirements specified, and installation performed by Siemens service engineers.

In essence, this 510(k) submission is a declaration of equivalence to existing PACS systems based on the functionalities and technological aspects of the software, not a report of a new performance study with specific acceptance criteria that the device had to meet through experimental data.

Summary

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K092519
Page 1 of 4

510(k) Summary

AUG 2 7 2009

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:

ਹ

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

3002808157 Registration Number:
Sven Knoke Contact Person: Regulatory Affairs Manager Telephone: +49 (9131) 84-4687 +49 (9131) 84-2792 Telefax:

Device Name and Classification:

. Trade Name: syngo.x
Picture Archiving and Communications Classification Name: System

Radiology Classification Panel:

21 CFR §892.2050
Device Class: .
Product Code: .

CFR Section:

Class II LLZ
510(k) for syngo®.x August 03, 2009

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K092519

Page 2 of 4

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

Device Description and Intended Use:

This premarket notification covers Siemens enhanced PACS system syngo.x.

It supports the physician in diagnosis and treatment planning. syngo.x also supports storage of Structured DICOM Reports.

In a comprehensive imaging suite syngo.x integrates Radiology Information Systems (RIS) to enable customer specific workflows.

Page K3

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K092519
Page 3 of 4

syngo.x 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, storage media and central system administration, to provide a flexible storage hierarchy.

Integration:

The Workflow Management enables by integration of any HL7- / DICOMcompatible RIS (IHE Year 5) to the syngo product family a consistent workflow - from patient registration to requirement scheduling to a personal work list and supports therefore reporting, documentation or administrative tasks.

Technological Characteristics:

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2008 operating system. The client machines are based on Windows XP. 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.x supports DICOM formatted images and objects.

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.

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K092519
Page 4 of 4

. Substantial Equivalence:

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

Manufacturer	Predicate Device Name	FDA ClearanceNumber
Siemens	syngo Imaging	K081734
Siemens	syngo MultiModality Workplace	K072728

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

In summary, Siemens is of the opinion that syngo.x 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 shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure.

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

Siemens AG Medical Solutions % Mr. Stefan Preiss TÜV SÜD America 1775 Old Hwy 8 NW. Ste 104 NEW BRIGHTON MN 55112-1891

AUG 2 7 2009

Re: K092519

Trade/Device Name: syngo®.x Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 12, 2009 Received: August 18, 2009

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 (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

{5}------------------------------------------------

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.

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/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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Lamur M. Mouk

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known):	K092519
Device Name:	syngo@.x

Indications For Use:

syngo.x is a software solution intended to be used for viewing, manipulation, and storage of medical images.

It can be used as a stand-alone device or together with a variety of cleared and unmodified syngo.x based software options.

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

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

Prescription Use	X
(Part 21 CFR 801 Subpart D)
AND/OR
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) Our (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number

510(k) for syngo®.x

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).