syngo Dynamics supports clinicians by providing post image processing functions for image manipulation, and/or quantification that are intended for use in the interpretation and analysis of medical images for disease detection, diagnosis, and/or patient management within the healthcare institution's network.

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

Device Description

syngo Dynamics is a software only medical device which is used with common IT hardware. Recommended configurations are defined for the hardware required to run the device, and hardware is not considered as part of the medical device.

syngo Dynamics is intended to be used by trained healthcare professionals in a professional healthcare facility to review, edit, and manipulate image data, as well as to generate quantitative data, qualitative data, and diagnostic reports.

syngo Dynamics is a digital image display and reporting system with flexible deployment - it can function as a standalone medical device that includes a DICOM Server or as an integrated module within an Electronic Health Record (EHR) System with a DICOM Archive that receives images from digital image acquisition devices such as ultrasound and x-ray angiography machines. There are three deployments: Standalone, EHR/EHS Integrated, and Multi-Modality Cardiovascular (MMCV). MMCV deployment functions as a standalone medical device with capability of natively support 2D and 3D CT and MR image types.

syngo Dynamics is based on a client-server architecture. The syngo Dynamics server processes the data from the connected imaging modalities, and stores data and images to a DICOM server and routes them for permanent storage, printing, and review. The client provides the user interface for interactive image viewing, reporting, and processing; and can be installed on network connected workstations.

syngo Dynamics offers multiple access strategies: A Workplace that provides full functionality for reading and reporting: A Remote Workplace that provides additionally compressed images with access to full fidelity images for reading and reporting; and a browser based WebViewer that provides access to additionally compressed images and reports from compatible devices (including mobile devices).

AI/ML Overview

The provided document describes a 510(k) premarket notification for syngo Dynamics (Version VA40E), a medical image management and processing system. The submission aims to demonstrate substantial equivalence to a predicate device, syngo Dynamics VA30 (K171053).

Based on the document, here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

It is important to note that the document does not explicitly state "acceptance criteria" in a quantitative, measurable sense for specific performance metrics (e.g., sensitivity, specificity, accuracy) because it is a substantial equivalence submission for a software update rather than a new device that needs to establish clinical efficacy from scratch. The acceptance criteria are implicitly met by demonstrating that the new version performs as well as or better than the predicate device, or that any changes do not introduce new safety or effectiveness concerns.

The performance is primarily evaluated through non-clinical testing (verification and validation) to confirm that the updated software continues to function as intended and maintains the performance of the predicate device, especially considering the added functionalities.

Feature/Attribute Tested	Acceptance/Equivalency Standard	Reported Device Performance/Conclusion
Indications for Use	Equivalent to predicate device (syngo Dynamics VA30), with minor updates not fundamentally changing the device's purpose.	The Indications for Use for syngo Dynamics (Version VA40E) are fundamentally the same as the predicate device. Updates primarily exclude functions like "storage and display" which no longer fall under FDA's medical device definition. No new specific disease or patient population indications. Shared contraindication (not for digital mammography in U.S.).
Architecture	Same as predicate (Client-server).	Same (Client-server).
Supported Modalities	Supported modalities should not introduce new safety/effectiveness concerns compared to predicate, and ideally enhance/extend usability without changing the intended purpose.	Subject device added support for a few DICOM modalities (CT, MR, SC, PET via Corridor4DM) compared to the predicate. These additions enhance and extend conditions for use but do not impact the purpose or actual use of the device. (Note: These are identical to those in the reference device syngo.via VB40A, K191040).
Image Communication	Standard communication protocols, equivalent to predicate.	Equivalent. Uses TCP/IP, DICOM, HL7, HTTP(S). The predicate used HTTP, the subject uses HTTP(S). All are standard protocols.
Image Data Compression	Lossless and lossy compression methods, equivalent to predicate.	Equivalent. Both use lossless (factor 2-3) and lossy (JPEG/MP4) compression. The only difference is the file format for lossy compression (MP4 explicitly mentioned for subject device).
Imaging Algorithms	Equivalent or improved without introducing new safety/effectiveness concerns.	Subject device uses the same imaging algorithms as the predicate, with additional four algorithms (Multiplanar reconstruction (MPR), Maximum and Minimum Intensity Projection (MIP/MinIP), Volume Rendering Technique (VRT)). These additions are identical to those in the reference device syngo.via VB40A.
Quantitative Algorithms	Equivalent or improved without introducing new safety/effectiveness concerns.	Subject device added three quantitative algorithms (Distance line, Angle, Volume) from the predicate device (which only had Pixel Size Evaluation). These additions are identical to those in the reference device syngo.via VB40A.
Decision Support	Same as predicate (ability to interface with third-party rules engine).	Same with the predicate device.
Reporting	Equivalent to predicate's reporting capabilities.	Equivalent. Both offer customizable DICOM Structured Reporting and Collaborative reporting. "Web reporting" in predicate was replaced with "Remote reporting" via Remote Workplace in the subject device, which is considered equivalent.
Access Strategies	Similar to predicate's access methods.	Similar. "Portal Image Review" in predicate replaced by "Remote Workplace" and "WebViewer" in subject.
Mobile Device Support	Equivalent web-client for non-diagnostic read-only access.	Equivalent. Both use web client for read-only access (WebViewer for subject, Common Login/Portal Image Review for predicate) on mobile devices for non-diagnostic use.
Long Term Archive	Same archiving capabilities.	Same. Both provide long-term archive and retrieval of DICOM studies to/from VNA or HSM systems.
Hardware	Software-only option for server/workstation, with recommended requirements.	Same. Software-only. Hardware not part of medical device, but must meet recommended requirements.
Virtualization	Same virtualization capabilities.	Same. Provides virtualization of server and client machines.
Operating System	Updated OS versions without introducing new safety/effectiveness concerns.	Equivalent. Subject device uses updated versions of Microsoft Windows Server and Windows 10 client OS compared to older versions in the predicate.
Deployment Strategy	Similar to predicate, potentially with added configurations that are equivalent to reference device.	First two deployments (standalone and EHR/EHS Integrated) are equivalent. The third deployment (Multi-modality cardiovascular) uses technology identical to the reference device syngo.via VB40A (K191040), particularly for CT/MR viewing, ensuring equivalency.
Conformance to Standards	Adherence to recognized consensus standards.	Claims conformance to NEMA PS 3.1-3.20 (2016), ISO IEC 10918-1 (1994), IEC 62366-1 (2020), ISO 14971 (2019), IEEE Std 3333.2.1-2015, IEC 62304 (2015), IEC TR 80001-2-2 (2012), IEC 82304-1 (2016).
Software Verification & Validation	Conformance to FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Moderate Level of Concern) and cybersecurity requirements.	Documentation included for software of a Moderate Level of Concern. Non-clinical testing conducted. Evidence demonstrates conformance with special controls. Cybersecurity considerations addressed to prevent unauthorized access, modification, misuse, etc. Risk Analysis (ISO 14971) completed, risk control implemented, and testing results support that all software specifications met acceptance criteria. Testing for verification and validation was found acceptable in support of determining similarities to the predicate/previously cleared device.
Overall Safety and Effectiveness	Safe and effective as the predicate, introducing no new safety or effectiveness concerns.	The device is safe, effective, and performs as well as the predicate device. It does not introduce any new significant potential safety risks and is similar to the predicate device. The output is evaluated by clinicians, providing for sufficient review to identify and intervene in case of malfunction.

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

Sample Size: Not explicitly mentioned in terms of number of cases or studies. The submission states that "All performance testing was conducted in a non-clinical fashion as part of the verification and validation activities for the medical device." This implies functional testing, integration testing, and performance testing against defined specifications rather than testing with a "test set" of patient data in a clinical trial context.
Data Provenance: Not applicable, as no clinical studies with patient data were conducted. The testing involved non-clinical verification and validation.

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

This information is not provided because no clinical studies were conducted, and therefore, no "ground truth" was established by experts for a test set of clinical cases. The device is for image management and processing, and its performance is assessed through technical verification and validation, ensuring it functions correctly and aligns with the predicate device.

4. Adjudication Method for the Test Set

Not applicable as no clinical test set requiring expert adjudication was used.

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, an MRMC comparative effectiveness study was not done. The device, syngo Dynamics (Version VA40E), is a medical image management and processing system, not an AI-assisted diagnostic tool designed to directly improve human reader performance in interpreting images. It provides functionalities for image manipulation, quantification, review, and reporting.

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

The document implies that standalone software verification and validation were performed for the syngo Dynamics (Version VA40E) software, as it is a "software only medical device." The tests assessed the functionality of the device itself (e.g., image processing algorithms, communication protocols, reporting features) to ensure it meets specifications, which is a form of standalone performance assessment. However, it's not a standalone diagnostic performance study in the sense of a deep learning algorithm detecting disease.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Again, this is not explicitly stated as no clinical studies establishing diagnostic performance with a ground truth were conducted. For non-clinical software testing, the "ground truth" would likely be the expected output or behavior validated against established functional requirements, design specifications, and relevant industry standards (e.g., DICOM standard conformance for image handling).

8. The Sample Size for the Training Set

Not applicable. The device is a software system for image management and processing, not a machine learning model that requires a training set of data.

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

Not applicable, as there is no training set for this type of software.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Siemens Medical Solutions USA, Inc. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k SAINT PAUL MN 55114

Re: K220832

May 20, 2022

Trade/Device Name: syngo Dynamics (Version VA40E) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: May 9, 2022 Received: May 10, 2022

Dear Prithul Bom:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name syngo Dynamics (version VA40E)

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)
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☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange. To the right of the word "Healthineers" is a graphic of orange dots arranged in a circular pattern.

510(k) Summary syngo Dynamics (Version VA40E)

In accordance with 21 CFR §807.92, the following summary of safety and effectiveness is provided.

I. SUBMITTER

21CFR § 807.92(a)(1)

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

Contact Person : Abhineet Johri

Phone: +1 (484) 680-8723 Email: abhineet.johri(@siemens-healthineers.com

Date Prepared: May 03, 2022

DEVICE II.

21CFR § 807.92(a)(2)

Device Trade Name	syngo Dynamics (version VA40E)
Common Name	Medical image management and processing system
Classification Name	System, Image Processing, Radiological
Classification Panel	Radiology
Regulation Number	21 CFR §892.2050
Product Code	LLZ

III. LEGALLY MARKETED PREDICATE DEVICES	21CFR § 807.92(a)(3
Predicate Device
Device Trade Name	syngo Dynamics Version VA30
510(k) Number	K171053
Product Code	LLZ
	This predicate has not been subject to a design-related recall.
Reference Device
Device Trade Name	syngo.via (Version VB40A)
510(k) Number	K191040
Product Code	LLZ
	This reference device has not been subject to a design-related recall.

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IV. DEVICE DESCRIPTION SUMMARY

This premarket notification addresses the Siemens Healthineers syngo Dynamics (Version VA40E) Medical Image Management and Processing System (MIMPS).

The use of syngo Dynamics is focused on cardiac ultrasound (echocardiography), angiography (xray), cardiac nuclear medicine (NM), CT and MR studies that cover both adult and pediatric medicine. Also supported is vascular ultrasound and ultrasound in Obstetrics/Gynecology and Maternal Fetal Medicine (fetal echocardiography during pregnancy).

In the United States, monitors (displays) should not be used for diagnosis, unless the monitor (display) has specifically received 510(k) clearance for this purpose.

V. INTENDED USE/INDICATIONS FOR USE

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

Image /page/4/Picture/16 description: The image shows the text "21CFR § 807.92(a)(5)". This appears to be a reference to a section of the Code of Federal Regulations, specifically Title 21, which pertains to food and drugs. The section number is 807.92, subsection (a), paragraph (5). The text is presented in a clear, legible font.

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21CFR § 807.92(a)(4)

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Subject Devicesyngo Dynamics VA40E	Predicate Devicesyngo Dynamics VA30K171053
syngo Dynamics is a multimodality, vendoragnostic Cardiology image and informationsystem intended for medical image managementand processing that provides capabilities relatingto the review and digital processing of medicalimages.syngo Dynamics supports clinicians byproviding post image processing functions forimage manipulation, and/or quantification thatare intended for use in the interpretation andanalysis of medical images for disease detection,diagnosis, and/or patient management within thehealthcare institution's network.syngo Dynamics is not intended to be used fordisplay or diagnosis of digital mammographyimages in the U.S.	syngo Dynamics is an image and informationsystem intended for acceptance, transfer,display, storage, archive and manipulation ofdigital medical images, including review,analysis, quantification and reporting.As a Cardiology PACS and information system,syngo Dynamics supports the physician ininterpretation and evaluation of examinationswithin healthcare institutions, in particular, inCardiology, Obstetrics and Gynecology or otherdepartments.syngo Dynamics is not intended to be used fordisplaying of digital mammography images fordiagnosis in the U.S.

Subject Devicesyngo Dynamics VA40E

Predicate Devicesyngo Dynamics VA30K171053

syngo Dynamics is a multimodality, vendoragnostic Cardiology image and informationsystem intended for medical image managementand processing that provides capabilities relatingto the review and digital processing of medicalimages.syngo Dynamics supports clinicians byproviding post image processing functions forimage manipulation, and/or quantification thatare intended for use in the interpretation andanalysis of medical images for disease detection,diagnosis, and/or patient management within thehealthcare institution's network.syngo Dynamics is not intended to be used fordisplay or diagnosis of digital mammographyimages in the U.S.

syngo Dynamics is an image and informationsystem intended for acceptance, transfer,display, storage, archive and manipulation ofdigital medical images, including review,analysis, quantification and reporting.As a Cardiology PACS and information system,syngo Dynamics supports the physician ininterpretation and evaluation of examinationswithin healthcare institutions, in particular, inCardiology, Obstetrics and Gynecology or otherdepartments.syngo Dynamics is not intended to be used fordisplaying of digital mammography images fordiagnosis in the U.S.

Indications for Use Comparison

The subject device, syngo Dynamics (Version VA40E) is a new version of the predicate device, syngo Dynamics VA30 (K171053). The Indications for Use for the subject device and the predicate device are equivalent. There were no fundamental changes to the device as a cardiology-focused information and imaging management software. The indications for use were updated to exclude functions such as "storage and display" of medical images as they are no longer fall within the definition of a medical device by the FDA.

Neither the subject nor the predicate device is indicated for any specific disease, condition, or patient population, and both are intended to support healthcare professionals in the healthcare institutions' environment.

Both the subject and predicate devices share the same contraindication that they are not intended to be used for display or diagnosis of digital mammography images in the U.S.

Indications for Use/Intended Use Comparison Summary and Conclusion

The Indications for Use were assessed in accordance with the following FDA Guidance Documents:

o The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]
Food and Drug Administration Staff Guidance for Industry, General/Specific Intended Use 0

The results of this evaluation determined that the Indications for Use for the subject device and the predicate device are fundamentally the same, and only includes minor updates. As such, Siemens Healthineers is of the opinion that the Intended Use and Indications for Use are similar to the predicate device.

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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

21CFR § 807.92(a)(6)

Attribute	Subject Devicesyngo DynamicsVA40E	Predicate Devicesyngo DynamicsVA30K171053	EquivalencyAnalysis
Architecture	Client-server	Client-server	Same
Supportedmodalities	US XA DX CT MR SC NM Additionally throughCorridor4DM: NM PET	US XA DX DR NM throughCorridor4DM	Subject device addedsupport for a fewDICOM modalitiescompared to thepredicate device.Note: The subjectdevice has the identicalnatively supportedmodalities as thereference device,syngo.via VB40A(K191040).The additionallysupported modalities bythe subject device onlyenhances and extendsthe conditions for useand it does not impactor change the purposeor the actual use of thedevice (intended use).
ImageCommunication	Within the network, thefollowingcommunicationprotocols are used:TCP/IP forcommunication andtransport DICOM and HL7 atapplication level HTTP(S) forcommunication andtransport of images,MP4s andthumbnails	Within the network, thefollowingcommunicationprotocols are used:TCP/IP: forcommunication andtransport DICOM and HL7 atapplication level HTTP forcommunication andtransport ofthumbnails	Equivalent. All standardprotocols.
Image DataCompression	Lossless compressionwith compression factor2 to 3 and lossycompression (JPEG andMP4) with highercompression rate.	Lossless compressionwith compression factor2 to 3 and lossycompression withhigher compression rate.	Equivalent.The only differencebetween the subjectdevice and the predicatedevice is the file format.
Attribute	Subject Devicesyngo DynamicsVA40E	Predicate Devicesyngo DynamicsVA30K171053	EquivalencyAnalysis
ImagingAlgorithms	Window/Leveling Edge Enhancement Digital Subtraction Multiplanar reconstruction (MPR) Maximum and Minimum Intensity Projection (MIP/MinIP) Volume Rendering Technique (VRT)	Window/Leveling Edge Enhancement Digital Subtraction	The subject device usesthe same imagingalgorithm as thepredicate device, withadditional four imagingalgorithms.Note: the additionalimaging algorithmsidentical to that areimplemented in thereference device,syngo.via VB40A(K191040).
Quantitativealgorithms	Pixel Size Evaluation Distance line Angle Volume	Pixel Size Evaluation	The subject deviceadded three quantitativealgorithms from thepredicate device.Note: the additionalquantitative algorithmsidentical to that areimplemented in thereference device,syngo.via VB40A(K191040).
Decision Support	Ability to interface witha third-party rulesengine (BizTalk), whererules are configured bythe end customer todetermine clinicalrelevance of selectedobservations.Customers identify andstore selected patientdata.Orchestrations provide atrigger to pull inpreviously storedrelevant data for a givenstudy.	Ability to interface witha third-party rulesengine (BizTalk), whererules are configured bythe end customer todetermine clinicalrelevance of selectedobservations.Customers identify andstore selected patientdata.Orchestrations providesa trigger to pull inpreviously storedrelevant data for a givenstudy.	Same with the predicatedevice.
Attribute	Subject Devicesyngo DynamicsVA40E	Predicate Devicesyngo DynamicsVA30K171053	EquivalencyAnalysis
Reporting	CustomizableDICOM StructuredReporting Collaborativereporting Remote reporting	CustomizableDICOM StructuredReporting Collaborativereporting Web reporting	Equivalent to thepredicate device. Theweb reporting using"Portal Image Review"in the predicate devicewas deprecated. InVA40E, remotereporting isaccomplished throughRemote Workplace.
Access strategiesfor imaging andreporting	Workplace (thickclient) - access forreading andreporting. Remote Workplace(MP4 image displaywith access to fullDICOM image forUS/XA and fullDICOM image forCT/MR) - accessfor reading andreporting. WebViewer- (WebClient with MP4Image display) -Access for reviewonly	Workplace (thickclient)- access forreading andreporting. Portal - (WebClient for readingand reporting withlimitedfunctionality.)	Similar to the predicatedevice. Instead of thePortal Image Review inthe predicate device, thesubject device has theRemote Workplace andthe WebViewer.
Mobile DeviceSupport	Yes - ThroughWebViewer, SupportsiOS and Androiddevices, but non-diagnostic use.	Yes - Through theCommon Login andPortal Image Review,images can be viewedon mobile devices, butare non-diagnostic.	Equivalent. Bothdevices use web clientfor read-only access.
Long TermArchive	Provide long termarchive and retrieve ofDICOM studies to/fromeither VNA (VendorNeutral Archive) orHSM (HierarchicalStorage Management)archiving Systems.	Provide long termarchive and retrieve ofDICOM studies to/fromeither VNA (VendorNeutral Archive) orHSM (HierarchicalStorage Management)archiving Systems.	Same.
Attribute	Subject Devicesyngo DynamicsVA40E	Predicate Devicesyngo DynamicsVA30K171053	EquivalencyAnalysis
Hardware	Software-only optionfor server Workstation:software only (HW isnot part of the medicaldevice, but needs tomeet recommendedrequirements asspecified by syngoDynamics)	Software-only optionfor server Workstation:software only (HW isnot part of the medicaldevice, but needs tomeet recommendedrequirements asspecified by syngoDynamics)	Same.
Virtualization	Provides virtualizationof server and clientmachines	Provides virtualizationof server and clientmachines	Same.
Operatingsystem	Server:Microsoft Windowsserver 2016 Standardedition (64bit)Microsoft WindowsServer 2019 StandardEdition (64Bit)Client Software:Microsoft Windows 10x64 version1803 or greaterPortal Website Host:Microsoft WindowsServer 2016 Standardedition (64-bit),Microsoft WindowsServer 2019 Standardedition (64-bit)	Server:Windows 2012 R2ServerStandard Edition R2(64-bit)Portal Client:Windows 7 SP1 orhigher (64-bit)Portal Website Host:Windows 2012 R2ServerStandard Edition R2(64-bit)	Equivalent. Subjectdevice uses updatedversions of MicrosoftOS.
Attribute	Subject Devicesyngo DynamicsVA40E	Predicate Devicesyngo DynamicsVA30K171053	EquivalencyAnalysis
Deploymentstrategy	The use of syngoDynamics VA40Eserver/workplace inthe context ofcardiovascularconfiguration. EHR/EHSIntegratedconfiguration withsyngo Dynamicsserver. Multi-modalitycardiovascularconfiguration withnative/syngo serverand syngoDynamicsworkplace withnative/syngocomponents.	The use of syngoDynamics VA30server/workplace inthe context ofcardiovascularconfiguration. EHR/EHSIntegratedconfiguration withsyngo Dynamicsserver.	First two deploymentsare equivalent to thepredicate device.Note: The thirddeployment usesidentical technology tothe reference device,syngo.via VB40A(K191040). Thechanges in the keyattributes due to theaddition of thisdeployment is coveredabove (Supportedmodalities, Imagingalgorithms, Quantitativealgorithms).Note: Multi-modalitycardiovascularconfigurationadditionally usesnative/syngo software(NS_Container andNS_Frontend) innative/syngo server andworkplace to supportviewing of CT and MRstudies. That's the sametechnology which isused in the referencedevice syngo.viaVB40A (K191040)

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VII. PERFORMANCE DATA

The following performance data were provided in support to demonstarte similarities to the predicate /previously cleared device.

Clinical Testing

No clinical studies were carried out for syngo Dynamics (Version VA40E). All performance testing was conducted in a non-clinical fashion as part of the verification and validation activities for the medical device.

Summary of Non-Clinical Testing

No performance standards for MIMPS have been issued under the authority of Section 514. Nonclinical testing was conducted for the device syngo Dynamics (Version VA40E) during product development. The modifications described in this Premarket Notification were supported with verification and validation testing.

Siemens Healthineers claims conformance to the following recognized consensus standards:

NEMA PS 3.1 3.20 (2016) ●
o ISO IEC 10918-1 First edition 1994-02-15
IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION 0
ISO 14971 Third Edition 2019-12
IEEE Std 3333.2.1-2015
IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION 0
IEC TR 80001-2-2 Edition 1.0 2012-07 0
IEC 82304-1 Edition 1.0 2016-10 o

Software Verification and Validation

In accordance with the FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005, documentation is included within this submission for software of a Moderate Level of Concern. Non-clinical Testing was conducted during product development. Evidence provided within this submission demonstrates conformance with special controls for medical devices containing software.

Cybersecurity considerations related to syngo Dynamics are included within this submission. Siemens Healthineers conforms to cybersecurity requirementing a means to prevent unauthorized access, modification, misuse, denial of use or unauthorized use of information stored, accessed or transferred from a medical device to an external recipient.

Risk Analysis, in compliance with ISO 14971 Third Edition, for syngo Dynamics (Version VA40E) was completed and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation for the device was found acceptable in support to determine similarities to the predicate /previously cleared device.

21CFR § 807.92(b)(1)

21CFR § 807.92(b)(2)

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VIII. CONCLUSIONS

21CFR § 807.92(b)(3)

Performance tests were conducted to test the functionality of the device syngo Dynamics (Version VA40E). These tests have been performed to assess the functionality of the subject device. Results of all testing conducted were found acceptable in support to determine similarities to the predicate /previously cleared device.

Device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of this device. Risk management was implemented throughout the development process to control potential hazards.

The device does not come in contact with the patient and is only used by trained professionals. The output of the device is evaluated by clinicians, providing for sufficient review to identify and intervene in the event of a malfunction.

Siemens Healthineers believes that syngo Dynamics (Version VA40E) is safe and effective as the identified predicate device and does not introduce new safety and effectiveness concerns.

Substantial Equivalence Conclusion

The comparison of intended use, technological characteristics, performance specifications, device hazards as well as verification and validation results demonstrate that syngo Dynamics is safe, effective and performs as well as the predicate device.

In summary, Siemens Healthineers is of the opinion that syngo Dynamics (Version VA40E) does not introduce any new significant potential safety risks and is similar to the predicate device.

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).