syngo® Dynamics is a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation.

Device Description

This premarket notification covers Siemens' enhanced system syngo® Dynamics, version 5.0.

syngo® Dynamics is a digital image management system that includes a DICOM server. This system receives, stores, distributes, and archives images from digital image acquisition devices such as ultrasound 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.

synad® Dynamics provides advanced reporting features, including cardiology oriented features for review and analysis of x-ray angiographic images, and the capability to host additional 3rd party software applications.

syngo® Dynamics is a software device that is shipped as a turn key system with pre-installed software on common, off-the-shelf OEM computer hardware. syngo® Dynamics is installed by Siemens service engineers.

Version 5.0 contains extended reporting features to address a broader range of diagnostic imaging needs and other added capabilities for Radiology and Obstetric imaging, while continuing to provide special focus on Cardiology needs including echocardiography, x-ray anqiography, and image storage for nuclear medicine.

synqo® Dynamics, version 5.0 also offers an optional "software only" workplace with full viewing and report generation, which will be delivered on CD-ROM and installed by the end user on his own computer hardware.

AI/ML Overview

Here's an analysis of the provided 510(k) summary for syngo® Dynamics (version 5.0), focusing on acceptance criteria and supporting study details:

1. Acceptance Criteria and Reported Device Performance

The provided 510(k) summary for syngo® Dynamics (version 5.0) does not explicitly state specific acceptance criteria or report direct device performance metrics in a quantitative manner.

Instead, the submission relies on demonstrating substantial equivalence to predicate devices. The core argument for safety and effectiveness is that syngo® Dynamics does not introduce any new potential safety risks and performs as well as the commercially available predicate devices.

Therefore, for this particular submission, the "acceptance criteria" can be implicitly understood as:

Functional Equivalence: The device performs the same intended functions (acceptance, transfer, display, storage, archive, manipulation of digital medical images, quantification, and report generation) as the predicate devices.
Safety Equivalence: The device does not introduce new safety risks compared to the predicate devices.
Compliance with Standards: The device adheres to recognized and established industry practices and standards.

Since no specific performance metrics (e.g., accuracy, speed, uptime) are provided in the summary, a table of reported device performance is not possible to generate from this document.

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

The 510(k) summary does not mention a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The submission relies on establishing substantial equivalence through a comparison of technological characteristics with predicate devices and adherence to risk management processes, rather than reporting on a specific performance study with a test dataset.

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

Since no specific test set or performance study is detailed, there is no information provided regarding the number of experts, their qualifications, or their role in establishing ground truth.

4. Adjudication Method for the Test Set

As no specific test set or performance study is described, there is no information about any adjudication method.

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

The 510(k) summary does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed. The focus is on substantial equivalence to predicate devices, not on direct comparison of human reader performance with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

The 510(k) summary describes syngo® Dynamics as a "digital image management system," a "software device" that includes features like review, editing, manipulation, quantitative/qualitative data generation, and diagnostic reports. It also mentions an "optional 'software only' workplace with full viewing and report generation."

However, it does not contain information about a standalone (algorithm only) performance study. The device itself is a PACS system designed to be used by humans for managing and interpreting medical images. There's no mention of an embedded AI algorithm whose standalone performance was evaluated independently of human interaction.

7. Type of Ground Truth Used

Given the nature of the submission (substantial equivalence for a PACS system), and the lack of a detailed performance study with a test set, no specific "ground truth" (e.g., expert consensus, pathology, outcomes data) is mentioned as being used for validation. The validation hinges on functional equivalence to predicates and adherence to safety standards.

8. Sample Size for the Training Set

The 510(k) summary does not specify any training set size as it does not describe a machine learning or AI algorithm development that would typically involve a training phase.

9. How Ground Truth for the Training Set was Established

Since no training set is mentioned in the context of an algorithm, there is no information on how ground truth was established for a training set.

Summary

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K053133

510(k) Summary

syngo® Dynamics (version 5.0)

Date of Summary Preparation: [Date]

This summary of 510(k) safety and effectiveness information is being This Submitted in accordance with the requirements of 21 CFR §807.92.

General Information 1.

Specification Developer and Manufacturer Name and Address

Siemens Medical Solutions, Inc. 400 W. Morgan Road, Suite 100 Ann Arbor, MI 48108

Establishment Registration Number

1836549

Contact Person 2.

Ludmilla Foubert Sr. Manager, Regulatory Affairs and Quality

Telephone:	(610) 219-5373
Fax:	(610) 219-1521
email Address:	ludmilla.foubert@siemens.com

Device Name and Classification 3.

Trade Name:	syngo® DynamicsVersion 5.0
Classification Name:	Picture Archiving and Communications System
Classification Panel:	Radiology
CFR Number:	21 CFR §892.2050
Device Class:	Class II
Product Code:	LLZ

.. . .

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4. Device Description

This premarket notification covers Siemens' enhanced system syngo® Dynamics, version 5.0.

5. Intended Use

svngo® Dynamics is a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation.

6. Substantial Equivalence

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

Predicate Device Name and	510(k)	Clearance	Product
Manufacturer	Number	Date	Code
KinetDxSiemens Medical Solutions, Inc	K041029	07/05/2004	LLZ

CONE:DENTIAL

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Predicate Device Name andManufacturer	510(k)Number	ClearanceDate	ProductCode
VERICIS Cardiovascular Image andInformation SystemCamtronics Medical Systems	K051649	08/02/2005	LLZ
AscentiaTM (formally EncompassTM)Heartlab Inc	K050228	02/18/2005	LLZ

Summary of Technological Characteristics of the Principal Device as 7. Compared with the predicate Device

syngo® Dynamics is a software device that is shipped as a turnkey system with syngo@ Dynamics is a bonthan off-the-shelf OEM computer hardware. syngo® Dynamics is installed by Siemens service engineers.

syngo® Dynamics, version 5.0 also offers an optional "software only" workplace Syngo® Dynamics, version 3.0 also on on will be delivered on CD-ROM and with full viewing and report generation, when computer hardware. This software-only installed by the cha ason on his the customer's computer hardware meet defined requirements.

synqo® Dynamics servers use the Microsoft Windows 2003 Server operating syngo® Dynamics Servere ase the Microsoft Windows XP operating system.

The herewith described syngo® Dynamics supports DICOM-formatted images and structured report objects.

General Safety and Effectiveness Concerns 8.

The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of this device.

Risk management is ensured via a risk analysis, which is used to identify potential hisk management to onsared have are controlled via software development and hazards. Those potonial hazarsa To minimize electrical, mechanical and vellication and valiation toot.hg. To recognized and established industry practices and standards.

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Conclusion as to Substantial Equivalence ರು.

In summary, Siemens is of the opinion that syngo@ Dynamics does not introduce In summary, Slemens is of the opinion that Syngos Bynamouth.
any new potential safety risks and is substantially equivalent to and performs as well as the predicate devices.

R, L, L,

11/04/2005

Date

Ludmilla Foubert Eudmilla Foubox
Sr. Manage, Regulatory Affairs and Quality

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" written around it. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 5 2005

Ms. Judith Campbell Regulatory Technical Specialist Regulatory Submissions Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway, E-50 MALVERN PA 19355

K053133 Re.: Trade/Device Name: syngo® Dynamics (version 5.0) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system. Regulatory Class: II Product Code: LLZ Dated: November 4, 2005 Received: November 8, 2005

Dear Ms. Campbell:

We have reviewed your Section 510(k) premarket notification of intent to market the device estated in we have reviewed your Section 510(ts) premaintially equivalent (for the indications for use tated in above and have decemined the devices marketed in interstate commerce prior to the enclosure) to regally marketed productions accessful with a mendments or to devices that have been May 26, 1978, the claculibilit dato of the Federal Food, Drug, and Cosmetic Act (Act) that reclassified in accordance with the provide of therefore, market the device, do not require approval of a provisions of the Act. The general controls provisions of the Act include subject to the general confors provisions of affects, 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 II your device is classified (see above) into exist regulations affecting your device can be found in the be subject to additional connolis. Entrolling in addition, FDA may publish further Oode of Peachar concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised mar 127 's issualled on a saceaanna sight other requirements of the Act or any
FDA has made a determination that your device complies with other requirement Federal statutes and regulations administered by other Federal agencies. You must comply with all the line Federal statues and tegulations administered of other Fration and listing (2) CFR Part 807); tabeling Act sTequirements, melading, but not minication requirements as set forth in the quality systems (QS) (ZT CFR Part 801); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k)
Children and consideration TRAC Coliner of unction of your device to a legally This letter will allow you to begin marketing your actives of your device of your device of your device to a legally
premarket notification. The FDA innder if your device an premarket notification. The FDA finding of substantial equivalion of your device to procced to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
r in the regulation of the filler following pumbers, based on the regulat If you desire specific advice for your device on our labeling regaration (1) vol
contact the Office of Compliance at one of the following numbers, based on the regulation num the top of this letter:

21 CFR 876.xxxx21 CFR 884.xxxx21 CFR 892.xxxxOther	(Gastroenterology/Renal/Urology)(Obstetrics/Gynecology)(Radiology)	240-276-0115240-276-0115240-276-0120240-276-0100
----------------------------------------------------------------	----------------------------------------------------------------------------	--------------------------------------------------------------

Also, please note the regulation while be reference to prematic notification" (21 CFR Also, please note the regulation entitled, " Misoralians on your responsibilities under the Act from the 807.97). You may obtain other general information on your responsible in toll-free number (800)
Division of Small Manufacturers, International deco DIVISION of Binan 1443-6597 or at its Internet address 038-2041 of (2017) · 1301) · 1301) · 1301 · 1000 · 11:11 · 1

Sincerely yours,

Nancy C. Hogdon

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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Indications for Use

510(k) Number (if known): _ Ko23133 _______________________________________________________________________________________

Device Name: syngo® Dynamics (version 5.0)

Indications for Use:

syngo® Dynamics is a Picture Archiving and Communication System (PACS) Syngo® Dynamios is a Protate Kranker, display, storage, archive and manipulation informou for doosplanes, including quantification and report generation.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

David G. Ingram

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K053133

Page 1 of 1

CONFIDENTIA!

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).