syngo® Dynamics is an image and information system intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including review, analysis, quantification and reporting.

As a Cardiology PACS and information system, syngo® Dynamics supports the physician in interpretation and evaluation of examinations within healthcare institutions, in particular, in Cardiology, Obstetrics and Gynecology or other departments.

syngo® Dynamics is not intended to be used for displaying of digital mammography images for diagnosis in the U.S.

Device Description

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

syngo® Dynamics is a system that includes a DICOM Server which receives, stores, distributes, and archives images from digital image acquisition devices such as ultrasound, computer tomography, magnetic resonance and x-ray angiography machines. The system has workplaces that can be used to review, edit, and manipulate image data, as well as to generate quantitative data, qualitative data, and diagnostic reports.

syngo® Dynamics supports the physician in diagnosis and treatment planning. It also supports storage and archiving of DICOM Structured Reports. In a comprehensive imaging suite syngo® Dynamics integrates Hospital / Radiology / Cardiology Information Systems (HIS/RIS/CIS) to enable customer specific workflows.

syngo® Dynamics Version VA10A provides advanced reporting support for cardiology, OB/GYN, MFM (maternal fetal medicine), vascular ultrasound, including specific echo and cath lab oriented features for documentation support in the cardiology department.

AI/ML Overview

The provided 510(k) summary for syngo® Dynamics (Version VA10A) does not contain detailed information about specific acceptance criteria and a study proving the device meets those criteria in a quantitative sense with performance metrics like sensitivity, specificity, or accuracy.

The document states:
"Siemens conducts testing to verify the design output met the design input requirements and to validate the device conformance to the intended use. Predefined acceptance criteria was met and demonstrated that the device is as safe and effective as the predicate device."

However, it does not provide the specific acceptance criteria or the reported device performance metrics against those criteria. Instead, the focus of this 510(k) summary is on demonstrating substantial equivalence to a predicate device (syngo® Dynamics Version 9.0 (K102150)) based mainly on functional equivalence, technological characteristics, and risk management.

Here's a breakdown of the information that is available in the provided text, and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

Not provided in the document. The submission focuses on functional equivalence rather than quantitative performance metrics for a specific clinical task.

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

Not explicitly stated for any performance testing. The document mentions "Integration and System Testing were performed for verification and validation of The device," but does not specify the sample size of images, cases, or the origin (country, retrospective/prospective) of any data used for these tests.

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

Not applicable/Not provided. Since no specific clinical performance study with annotated ground truth for a diagnostic task is described, there's no mention of experts or their qualifications for establishing ground truth.

4. Adjudication Method for the Test Set

Not applicable/Not provided. Without a specific clinical performance study and expert-established ground truth, adjudication methods are not discussed.

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

No MRMC comparative effectiveness study is mentioned. The device, a PACS system, is not typically evaluated in this manner, as it's an infrastructure tool rather than a diagnostic algorithm that directly aids human readers in interpretation beyond displaying images. The submission focuses on its capabilities as an image and information system.

6. Standalone (Algorithm Only) Performance Study

No standalone performance study for an algorithm is mentioned. This device is described as a "software only" medical device, but its function is as an image and information system (PACS), not a standalone diagnostic algorithm with a specific output to be evaluated for accuracy.

7. Type of Ground Truth Used

Not applicable/Not provided in relation to a clinical performance study. The ground truth concept for this device's validation would likely revolve around functional correctness, data integrity, and adherence to standards (DICOM, HL7, etc.), rather than clinical diagnostic accuracy against pathology or outcomes data.

8. Sample Size for the Training Set

Not applicable/Not provided. As this is a PACS system and not a machine learning-based diagnostic algorithm, there isn't a "training set" in the sense of data used to train an AI model. Its development would involve software engineering and testing principles.

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

Not applicable/Not provided for the same reasons as #8.

In summary, the 510(k) for syngo® Dynamics (Version VA10A) focuses on establishing substantial equivalence through:

Identical Intended Use: The device shares the same intended use as its predicate.
Similar Technological Characteristics: The document provides a detailed table comparing functionalities, operating systems, image sources, display, data handling, and algorithms with the predicate device, highlighting minor enhancements (e.g., collaborative reporting, mobile device support) that do not raise new safety or effectiveness concerns.
Compliance with Voluntary Standards: DICOM, IEC/ISO, HL7, IEC 62366, SMPTE are listed.
Risk Management: Adherence to ISO 14971:2007 for risk analysis and control.
Verification and Validation Testing: General mention of "Integration and System Testing" to verify design output against input and validate conformance to intended use.

The submission confirms that "Predefined acceptance criteria was met" for these tests, but it does not specify what those criteria were in the context of clinical performance metrics, nor does it provide quantitative results from such a study. The nature of a PACS system's 510(k) often centers on functional validation and interoperability rather than diagnostic accuracy as would be required for an AI-powered diagnostic tool.

Summary

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K123922

SIEMENS

Healthcare

JAN 1 6 2013

510(k) Summary

svngo® Dvnamics (Version VA10A)

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.

General Information l.
Date of Summary Preparation: December 5, 2012

Establishment:

Address: .
Siemens Medical Solutions USA. Inc. 400 W. Morgan Road Ann Arbor, MI 48108
Registration Number: ●
1836549

Contact Person: ●

Yuri Ikeda Quality Engineer, Quality & Regulatory Phone: (734) 205-2442 Fax: (734) 205-2683 Email: yuri.ikeda@siemens.com

Device Name and Classification:

Trade Name: syngo® Dynamics Version VA10A
Picture Archiving and Communications System Classification Name: .
- Classification Panel: Radiology
21 CFR §892.2050 CFR Number: ●
Class II Device Class: .
. Product Code:

Safety and Effectiveness Information Supporting the Substantial ll. Equivalence Determination

LLZ

Intended Use:

Siemens Medical Solutions USA, Inc.

400 West Morgan Road Ann Arbor, MI 48108 USA

Tel .: +1-734-205-2400 www.usa.siemens.com/healthcare

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departments.

syngo® Dynamics is not intended to be used for displaying of digital mammography images for diagnosis in the U.S.

Device Description:

This premarket notification addresses the Siemens syngo® Dynamics Version VA10A Picture Archiving and Communication System.

Data Management:

syngo® Dynamics allows all authorized personnel fast and continuous access to data such as cardiovascular images and information. Its 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.

Technological Characteristics:

syngo® Dynamics is a "software only" system, which will be delivered on CD-ROM / DVD to be installed on common IT hardware. Hardware must meet the defined requirements. 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.

The backend communication and storage solution is based on Windows 2008 operating system. The client machines are based on Windows XP, and Windows 7. Any hardware platform, which meets the specified recommended hardware and software requirements and with successful installation verification and

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validation activities can be supported. syngo® Dynamics supports DICOM formatted images and objects.

syngo® Dynamics Version VA10A will be used to display, process, read, report, communicate, distribute and store digital medical images, much like its predicate, syngo® Dynamics Version 9.0 (K102150).

The difference between the syngo® Dynamics Version VA10A and the predicate device syngo® Dynamics Version 9.0 are to give the subject device greater capabilities than the predicate device. syngo® Dynamics Version VA10A has similar technological characteristics as the predicate device and is similar to the functionalities of the predicate device. The table below summarizes the similarities and the differences between the two devices.

Functionality	syngo® DynamicsVersion VA10A	syngo® DynamicsVersion 9.0
Manufacturer	Siemens Medical SolutionsUSA, Inc.	Siemens Medical SolutionsUSA, Inc.
Intended Use	syngo® Dynamics is an imageand information systemintended for acceptance,transfer, display, storage,archive and manipulation ofdigital medical images,including review, analysis,quantification and reporting.As a Cardiology PACS andinformation system, syngo®Dynamics supports the	syngo® Dynamics is a PictureArchiving and CommunicationSystem (PACS) intended foracceptance, transfer, display,storage, archive andmanipulation of digital medicalimages, including quantificationand report generation.syngo® Dynamics is notintended to be used for readingof mammography images.
	physician in interpretation andevaluation of examinationswithin healthcare institutions, inparticular, in Cardiology,Obstetrics and Gynecology orother departments.
	syngo Dynamics® is notintended to be used fordisplaying of digitalmammography images fordiagnosis in the U.S.
Functionality	syngo® DynamicsVersion VA10A	syngo® DynamicsVersion 9.0
OperatingSystems	ServerWindows 2008 R2 ServerStandard Edition R2 SP1 orSP2 (64-bit)WorkplaceMicrosoft Windows XP SP2 orhigher32-bit or 64-bit, orMicrosoft Windows 7 orWindows 7 SP1 or higher32-bit or 64-bitUltimate, Professional,Enterprise, Ultimate N,Professional N, orEnterprise NPortal Website HostWindows Server 2008 R1 32-bit or greater	ServerWindows Server 2008 R2 SP1Standard Edition (64-bit)WorkplaceWindows 2000, 2003, XP,Vista, 7 (32 or 64-bit)Portal Website HostWindows Server 2008 R1 32-bit or greater
Image Source	DICOM Ultrasound, XA, CT,MR, DX, DR and NuclearMedicine, including PET.	DICOM Ultrasound, XA, CT,MR, DX, DR and NuclearMedicine, including PET.
Image Display	Ultrasound, XA, CT, MR, DX,DR, PET and Nuclear Medicinethrough Corridor4DM	Ultrasound, XA, CT, MR, DX,DR, PET and Nuclear Medicinethrough MI Mobile orCorridor4DM
Data ExportImageCommunication	DICOM, bmp, aviWithin the network, thefollowing communicationprotocols are used:TCP/IP: for communicationand transportDICOM and HL7 atapplication levelHTTP for communicationand transport of thumbnails	DICOM, bmp, aviWithin the network, thefollowing communicationprotocols are used:TCP/IP: for communicationand transportDICOM and HL7 atapplication levelHTTP for communicationand transport of thumbnails
Image DataCompression	Lossless compression withcompression factor 2 to 3 andlossy compression with highercompression rate.	Lossless compression withcompression factor 2 to 3 andlossy compression with highercompression rate.
ImagingAlgorithms	Window/Leveling, EdgeEnhancement, and DigitalSubtraction	Window/Leveling, EdgeEnhancement, and DigitalSubtraction
QuantitativeAlgorithms	Pixel Size Evaluation	Pixel Size Evaluation
Network Access	Yes	Yes
Analysis	Yes	Yes
Reporting	Yes	Yes
Multimodalitystorage andreview	Yes	Yes
Functionality	syngo® DynamicsVersion VA10A	syngo® DynamicsVersion 9.0
Web Server forimages and clips	Yes	Yes
Report upload toInformationSystems	Yes, through broker orinterface engine	Yes, through broker orinterface engine
DICOM StructuredReporting	Yes	Yes
Export/ImportData Sets viaremovable mediaor network means	Yes	Yes
VascularQuantification	Yes, measurements andcalculations	Yes, measurements andcalculations
Data Mining	Yes	Yes
Discrete DataExport	Yes	Yes
CardiacMeasurements	Yes	Yes
Interactivegraphicaldocumentation forreporting	Yes, through SoarianCardiology, version 2.0 utilizingpatient/user context sharing	Yes, through SoarianCardiology, version 2.0 utilizingpatient/user context sharing
Hemodynamicdata import (thirdparty vendor)	Yes	Yes
Web Reporting	Yes	Yes
Hardware	Software-only option for serverWorkstation: software only(HW is not part of the medicaldevice, but needs to meetrecommended requirements asspecified by syngo Dynamics)	Software-only option for serverWorkstation: software only(HW is not part of the medicaldevice, but needs to meetrecommended requirements asspecified by syngo Dynamics)
CollaborativeReporting	Yes	No
Mobile DeviceSupport	Yes - Non-diagnostic, andread-only. Support AppleiPhone and iPad	No

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・

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Summary of Non-Clinical Tests:

Integration and System Testing were performed for verification and validation of The device. Siemens Medical Solutions USA, Inc. complies with voluntary standards DICOM Version 3.x (2011), IEC/ISO 10918-1:1994 + TC 1:2005 Standards DrOOm Version 6.X (2017) 1207 Version 2.3.1, IEC 62366:2007, and SMPTE.

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 this device.

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Risk management is ensured via a risk analysis in compliance with ISO 14971:2007 to identify potential hazards. These potential hazards are controlled via software development, labeling, and verification and validation testing.

The device has no patient contacting materials and is used only by trained professionals. The output of the device is evaluated by trained professionals allowing sufficient review for identification and intervention in the event of a malfunction.

Siemens believes that syngo® Dynamics Version VA10A is as safe and effective as its predicate device as it does not, raise new types of safety and effectiveness concerns, or introduce new technology.

Substantial Equivalence

The syngo® Dynamics Version VA10A, addressed in this premarket modification is substantially equivalent to the following commercially available device:

Manufacturer	Predicate Device Name	FDA ClearanceNumber
Siemens Medical SolutionsUSA, Inc.	syngo Dynamics Version 9.0	K102150

The potential hazards of modifications to the device have been evaluated and controlled as part of the product development process, including risk analysis and design considerations. Siemens conducts testing to verify the design output met the design input requirements and to validate the device conformance to the intended use. Predefined acceptance criteria was met and demonstrated that the device is as safe and effective as the predicate device.

In summary, Siemens is of the opinion that syngo® Dynamics Version VA10A does not introduce any new significant potential safety risks and is substantially equivalent to and performs as well as the predicate device.

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the logo.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

January 16. 2013

Siemens Medical Solutions USA, Inc. % Mr. Yuri Ikeda Ouality Engineer, Ouality & Regulatory TUV SUD America, Inc. 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891

Re: K123922

Trade/Device Name: syngo Dynamics (Version VA10A) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 17, 2012 Received: December 20, 2012

Dear Mr. Ikeda:

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. Iisting 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

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forth in the quality systems (OS) 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/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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Sean M.ABoyd -S for

Janine M. Morris 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): K123922

Device Name: syngo® Dynamics (Version VA10A)

Indications for Use:

syngo® Dynamics is not intended to be used for 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 (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Sean M. Boyd -S

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

K123922 510(k)

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).