(52 days)
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.
syngo Dynamics VA30, is a digital image display and reporting system. This system can function as a standalone medical device that includes a DICOM server or as an integrated module within and 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. The syngo Dynamics system provides components that can be used to review, edit and manipulate image data, as well as to generate quantitative data, qualitative date and diagnostic reports. syngo Dynamics VA30 also provides advanced reporting support for cardiology, OB/GYN, MFM (maternal fetal medicine) and vascular ultrasound studies.
syngo Dynamics is a software only medical device. Recommended configurations are defined for the hardware required to run the device. The hardware itself is not seen as a medical device and not in the scope of this 510(k) submission.
syngo Dynamics is based on a client-server architecture. The server processes the data from the connected imaging modalities. The client provides the user interface for interactive image viewing and processing and can be installed on remote, network connected, workstation machines or through industry standard virtualization software.
The provided document is a 510(k) summary for the medical device "syngo® Dynamics Version VA30," a Picture Archiving and Communication System (PACS). This document does not describe any quantitative acceptance criteria or a study proving that the device meets such criteria in terms of diagnostic performance (e.g., sensitivity, specificity, accuracy).
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (syngo® Dynamics VA10A) based on functional performance, technical characteristics, and adherence to relevant standards.
Here's a breakdown of why the requested information cannot be fully provided from the given text:
- No Diagnostic Performance Claims: The device is a PACS system designed for image management, review, analysis, quantification, and reporting. It is explicitly stated that "syngo Dynamics is not intended to be used for displaying of digital mammography images for diagnosis in the U.S." This implies that the device itself is not making diagnostic claims that would require clinical performance metrics like sensitivity or specificity.
- Focus on System Functionality and Safety: The "acceptance criteria" and "study" described are primarily related to software verification and validation, cybersecurity, and risk management, ensuring the system functions as intended and is safe within its defined scope.
However, based on the information provided, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance:
Since there are no diagnostic performance metrics (e.g., sensitivity, specificity) for this PACS device, the "acceptance criteria" can be inferred from the non-clinical testing and conformance to standards. The "reported device performance" refers to the successful completion of these tests and compliance.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate | The device has the "same fundamental technical characteristics" and offers similar functionalities (image display, data export, communication, algorithms, analysis, reporting) as the predicate (syngo Dynamics VA10A), with new features aligning with its intended use. Overall "performs as well as the predicate device." |
| Software Verification & Validation (V&V) | Documentation (for Moderate Level of Concern software per FDA Guidance) provided to demonstrate that "all software specifications have been implemented and met the defined acceptance criteria." |
| Compliance with Standards | Conformance claimed for: |
| - NEMA PS3 Digital Imaging and Communications in Medicine (DICOM) | |
| - ISO 14971:2007 (Risk Management) | |
| - ANSI/AAMI ES 60601-1. A1. clauses 14.11 and 14.13 | |
| - IEC 62304: 2006 (Software Life Cycle) | |
| - IEC 62366-1:2015 (Usability) | |
| - IEC 10918-1:1994 + Technical Corrigendum 1:2005 | |
| - ISO/HL7 21731:2014 | |
| Cybersecurity | Implemented means to prevent unauthorized access, modification, misuse, denial of use, or unauthorized use of information. Cybersecurity considerations are included in the submission. |
| Risk Management | A risk analysis (in compliance with ISO 14971:2007) was conducted, mitigation controls implemented, and V&V testing confirmed effectiveness. Labelling contains necessary cautions and warnings. |
| Safety and Effectiveness | "Does not introduce any new significant potential safety risks" and is "substantially equivalent to the predicate device." Output is evaluated by clinicians, providing sufficient review to identify and intervene in case of malfunction. (This is a general claim based on the overall V&V and risk management, not a specific performance metric). |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly mentioned. The document states "All performance testing was conducted in a non-clinical fashion as part of the verification and validation activities for the medical device." This implies internal testing with data relevant to PACS functionalities (e.g., various image formats, sizes, and data types to ensure proper storage, display, and manipulation).
- Data Provenance: Not explicitly mentioned. Given it's a PACS system for various medical images (Ultrasound, XA, DX, DR, PET, Nuclear Medicine), the test data would likely be representative medical images and related patient information used for internal V&V. The data used is almost certainly retrospective as it's for non-clinical V&V, not a prospective clinical study. No country of origin is specified for test data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. As no clinical diagnostic performance study was conducted where "ground truth" for disease states would be required, this information is not relevant or provided. The "truth" for this device's testing would be whether its software functions correctly, adheres to DICOM standards, correctly displays images, and performs specified manipulations/quantifications as per its design specifications.
4. Adjudication method for the test set:
- Not Applicable. Since there was no clinical diagnostic performance study requiring expert interpretation of medical images to establish a ground truth, no adjudication method (like 2+1 or 3+1) was applicable or mentioned.
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 MRMC study was done. The device is a PACS system, not an AI-powered diagnostic algorithm intended to assist human readers in interpretation or alter their diagnostic performance. It is a tool for image and information management. The document explicitly states: "No clinical studies were carried out for syngo Dynamics VA30."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. The device is a PACS system; it doesn't have a "standalone algorithm" in the sense of a diagnostic AI performing automated interpretations. Its performance is intrinsically linked to its functionality as an imaging and information management system, which supports human users. The "software verification and validation" tests its standalone functional capabilities.
7. The type of ground truth used:
- For this device, "ground truth" pertains to the correct functioning of the software according to its specifications and adherence to standards. It would involve comparing the system's output (e.g., displayed image, stored data, reported measurement) against expected, known correct values or behaviors established by engineering specifications, DICOM standards, or manual verification. It's not expert consensus, pathology, or outcomes data as it's not a diagnostic device making clinical claims.
8. The sample size for the training set:
- Not Applicable. This device is a PACS system, not a machine learning or AI algorithm that requires a "training set" of data for model development. Its development follows traditional software engineering principles.
9. How the ground truth for the training set was established:
- Not Applicable. As no training set is used for this type of software, this question is not relevant.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 1, 2017
Siemens Healthcare GmbH % Mr. Olaf Teichert Third Party Reviewer TUV SUD America Inc. 1775 Old Hwy 8 NW, Suite 104 NEW BRIGHTON MN 55112
Re: K171053
Trade/Device Name: syngo® Dynamics Version VA30 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 18, 2017 Received: May 25, 2017
Dear Mr. Teichert:
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. 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 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.
{1}------------------------------------------------
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D. O'Hara
For
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K171053
Device Name syngo Dynamics Version VA30
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots arranged in a triangular shape.
510(k) Summary
syngo® Dynamics (Version VA30)
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.
Date prepared: March 27, 2017
1. Submitter
Siemens Healthcare GmbH Henkestrasse 127 D-91052 Erlangen Germany
Establishment Registration Number 3002808157
2. Contact Person
Ms. Lauren Bentley Regulatory Affairs Manager Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Mailcode: 65-3 Malvern, PA 19355 USA Email: lauren.bentley@siemens.com Telephone: +1 (610) 448 - 6104 Fax: +1 (610) 448 – 6557
3. Device Name and Classification
| Trade Name: | syngo® Dynamics Version VA30 | |
|---|---|---|
| Classification Name: | Picture Archiving and Communication System | |
| Classification Panel: | Radiology | |
| CFR Section: | 21 CFR §892.2050 | |
| Device Class: | Class II | |
| Product Code: | LLZ |
4. Legally Marketed Predicate Device
| Trade Name: | syngo Dynamics |
|---|---|
| 510(k) Clearance: | K123922 |
{4}------------------------------------------------
| Clearance Date: | January 16, 2013 |
|---|---|
| Classification Name: | Picture Archiving and Communication System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.2050 |
| Device Class: | Class II |
| Product Code: | LLZ |
5. Device Description
This premarket submission addresses the Siemens syngo® Dynamics Version VA30 Picture Archiving and Communication System.
syngo Dynamics VA30, is a digital image display and reporting system. This system can function as a standalone medical device that includes a DICOM server or as an integrated module within and 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. The syngo Dynamics system provides components that can be used to review, edit and manipulate image data, as well as to generate quantitative data, qualitative date and diagnostic reports. syngo Dynamics VA30 also provides advanced reporting support for cardiology, OB/GYN, MFM (maternal fetal medicine) and vascular ultrasound studies.
syngo Dynamics is a software only medical device. Recommended configurations are defined for the hardware required to run the device. The hardware itself is not seen as a medical device and not in the scope of this 510(k) submission.
syngo Dynamics is based on a client-server architecture. The server processes the data from the connected imaging modalities. The client provides the user interface for interactive image viewing and processing and can be installed on remote, network connected, workstation machines or through industry standard virtualization software.
Since the majority of the data processing is performed by the server, the client can be installed on standard off-the-shelf computers with a variety of monitor types. The quality of displayed images highly depends on the quality and settings of monitors, graphics cards, and graphics drivers. It is the customer's responsibility that client monitors are compatible with graphics cards and graphics drivers. It is also the customer's responsibility to use suitable monitors for diagnostic purposes.
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.
syngo® Dynamics VA30 and its predicate device have the same fundamental technical characteristics.
{5}------------------------------------------------
6. Intended Use
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.
7. Summary of Differences Between the Subject Device and the Predicate Device
The differences between the subject device described in this premarket notification and the predicate device are summarized in the following comparison table:
| Subject Devicesyngo Dynamics VA30 | Predicate Devicesyngo Dynamics VA10A | |
|---|---|---|
| Manufacturer | Siemens Healthcare GmbH | Siemens Medical Solutions USA, Inc. |
| Software Architecture | Client-server architecture | Client-server architecture |
| Operating System | ServerWindows 2012 R2 ServerStandard Edition R2 (64-bit)Portal ClientWindows 7 SP1 or higher64-bitPortal Website HostWindows 2012 R2 ServerStandard Edition R2 (64-bit) | ServerWindows 2008 R2 ServerStandard Edition R2 SP1 orSP2 (64-bit)WorkplaceMicrosoft Windows 7 orWindows 7 SP1 or higher· 32-bit or 64-bit· Ultimate, Professional,Enterprise, Ultimate N,Professional N, orEnterprise NPortal Website HostWindows Server 2008 R1 32-bit or greater |
| Image Source | DICOM Ultrasound, XA, DX, DRand Nuclear Medicine, includingPET. | DICOM Ultrasound, XA, DX, DR andNuclear Medicine, including PET. |
| Image Display | Ultrasound, XA, DX,DR, PET and Nuclear Medicinethrough Corridor4DM | Ultrasound, XA, MR, DX,DR, PET and Nuclear Medicinethrough Corridor4DM |
| Data Export | DICOM, bmp, avi | DICOM, bmp, avi |
| ImageCommunication | Within the network, thefollowing communicationprotocols are used:· TCP/IP: for communicationand transport· DICOM and HL7 at | Within the network, thefollowing communicationprotocols are used:· TCP/IP: for communicationand transport· DICOM and HL7 at |
| application level- HTTP for communicationand transport of thumbnails | application level- HTTP 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 |
| Decision SupportInterface to RulesEngine | Ability to interface with a third partyrules engine (BizTalk), where rulesare configured by the endcustomer to determine clinicalrelevance of selectedobservations.Customers identify and storeselected patient data.Orchestrations provides a triggerto pull in previously stored relevantdata for a given study. | n/a |
| Send Critical Results | End user, identified critical Resultsare sent to the EHR quickly | n/a |
| Multimodalitystorage andreview | Yes | Yes |
| 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 | n/a | Yes |
| VascularQuantification | Yes, measurements andcalculations | Yes, measurements andcalculations |
| Data Mining | Yes | Yes |
| Discrete DataExport | Yes | Yes |
| CardiacMeasurements | Yes | Yes |
| Interactivegraphicaldocumentation forreporting | Coronary Tree Diagrams are thesame in VA30. Congenital HeartDiagrams and Vascular Diagramshave been added in the CommonReporting Component. | Coronary Tree Diagrams |
| Hemodynamic | Yes | Yes |
| data import (third | ||
| party vendor) | ||
| Web Reporting | Yes | Yes |
| Electronic Health | Basic report and discrete data | Basic report and discrete data upload to |
| Record (EHR) | upload to EHR. | EHR |
| Interfacinq | ||
| Ability to integrate DICOM Image | ||
| Review and Common Reporting | ||
| Component with Cerner Electronic | ||
| Health Record System and PACS. | ||
| Collaborative | Yes | Yes |
| Reporting | ||
| Mobile Device | Images can be viewed on mobile | Yes - Non-diagnostic, and |
| Support | devices, but are still non- | read-only. Support Apple |
| diagnostic. | iPhone and iPad. |
{6}------------------------------------------------
{7}------------------------------------------------
8. Clinical Testing
No clinical studies were carried out for syngo Dynamics VA30. All performance testing was conducted in a non-clinical fashion as part of the verification and validation activities for the medical device.
9. Non-Clinical Performance Testing
Non-clinical testing was conducted for the device syngo Dynamics during product development. The modifications described in this Premarket Notification were supported with verification and validation testing.
Siemens claims conformance to the following standards:
- NEMA PS3 Digital Imaging and Communications in Medicine (DICOM)
- ISO 14971:2007
- ANSI/AAMI ES 60601-1. A1. clauses 14.11 and 14.13 ●
- IEC 62304: 2006 ●
- IEC 62366-1:2015 .
- IEC 10918-1:1994 + Technical Corrigendum 1:2005
- . ISO/HL7 21731:2014
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.
{8}------------------------------------------------
Cybersecurity considerations related to syngo Dynamics are included within this submission. Siemens conforms to cybersecurity requirements by implementing 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.
A risk analysis, in compliance with ISO 14971:2007, for syngo Dyanamics was conducted and mitigation controls were implemented for identified hazards. Verification and validation testing confirms that all software specifications have been implemented and met the defined acceptance criteria. Further, documentation is provided to support the claim of substantial equivalence.
10. Safety and Effectiveness Information
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 into 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 believes that syngo Dynamics version VA30 is safe and effective as the identified predicate device and does not introduce new safety and effectiveness concerns.
11. Conclusion as to Substantial Equivalence
The comparison of intended use, technological characteristics, performance specifications, device hazards as well as verification and validation results demonstrate that synqo Dynamics is safe, effective and performs as well as the predicate device.
In summary, Siemens is of the opinion that syngo Dynamics version VA30 does not introduce any new significant potential safety risks and is substantially equivalent to the predicate device.
§ 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).