(52 days)
Not Found
No
The document describes a standard PACS and image processing system without mentioning AI, ML, or related concepts like deep learning, neural networks, or specific algorithms typically associated with AI/ML for image analysis or diagnosis.
No
The device is described as an "image and information system" and a "digital image display and reporting system" for medical images. Its functions include acceptance, transfer, display, storage, archive, manipulation, review, analysis, quantification, and reporting, which are all related to image management and evaluation, not direct treatment or therapy.
Yes
The device 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." It is explicitly stated that "syngo Dynamics supports the physician in interpretation and evaluation of examinations" and 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." These functions directly contribute to the diagnostic process by assisting physicians in making diagnoses based on medical images and generated reports.
Yes
The device description explicitly states "syngo Dynamics is a software only medical device." and clarifies that the required hardware is not considered a medical device and is outside the scope of the 510(k).
Based on the provided text, syngo Dynamics is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that syngo Dynamics is an image and information system for managing and analyzing medical images. It supports physicians in interpreting and evaluating examinations from imaging modalities like ultrasound and x-ray angiography. This is focused on in vivo imaging data, not in vitro analysis of biological samples.
- Device Description: The description reinforces that it's a digital image display and reporting system that receives images from digital image acquisition devices. It's a software-only device for image processing and reporting.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
IVD devices are specifically designed to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. Syngo Dynamics deals with images acquired directly from the patient's body.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM Ultrasound, XA, DX, DR and Nuclear Medicine, including PET.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician in interpretation and evaluation of examinations within healthcare institutions, in particular, in Cardiology, Obstetrics and Gynecology or other departments.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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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)
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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 |
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| 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.
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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 Device
syngo Dynamics VA30 | Predicate Device
syngo Dynamics VA10A |
|-----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Siemens Healthcare GmbH | Siemens Medical Solutions USA, Inc. |
| Software Architecture | Client-server architecture | Client-server architecture |
| Operating System | Server
Windows 2012 R2 Server
Standard Edition R2 (64-bit)
Portal Client
Windows 7 SP1 or higher
64-bit
Portal Website Host
Windows 2012 R2 Server
Standard Edition R2 (64-bit) | Server
Windows 2008 R2 Server
Standard Edition R2 SP1 or
SP2 (64-bit)
Workplace
Microsoft Windows 7 or
Windows 7 SP1 or higher
· 32-bit or 64-bit
· Ultimate, Professional,
Enterprise, Ultimate N,
Professional N, or
Enterprise N
Portal Website Host
Windows Server 2008 R1 32-bit or greater |
| Image Source | DICOM Ultrasound, XA, DX, DR
and Nuclear Medicine, including
PET. | DICOM Ultrasound, XA, DX, DR and
Nuclear Medicine, including PET. |
| Image Display | Ultrasound, XA, DX,
DR, PET and Nuclear Medicine
through Corridor4DM | Ultrasound, XA, MR, DX,
DR, PET and Nuclear Medicine
through Corridor4DM |
| Data Export | DICOM, bmp, avi | DICOM, bmp, avi |
| Image
Communication | Within the network, the
following communication
protocols are used:
· TCP/IP: for communication
and transport
· DICOM and HL7 at | Within the network, the
following communication
protocols are used:
· TCP/IP: for communication
and transport
· DICOM and HL7 at |
| | application level
- HTTP for communication
and transport of thumbnails | application level - HTTP for communication
and transport of thumbnails |
| Image Data
Compression | Lossless compression with
compression factor 2 to 3 and
lossy compression with higher
compression rate. | Lossless compression with
compression factor 2 to 3 and
lossy compression with higher
compression rate. |
| Imaging
Algorithms | Window/Leveling, Edge
Enhancement, and Digital
Subtraction | Window/Leveling, Edge
Enhancement, and Digital
Subtraction |
| Quantitative
Algorithms | Pixel Size Evaluation | Pixel Size Evaluation |
| Network Access | Yes | Yes |
| Analysis | Yes | Yes |
| Reporting | Yes | Yes |
| Decision Support
Interface to Rules
Engine | Ability to interface with a third party
rules engine (BizTalk), where rules
are configured by the end
customer to determine clinical
relevance of selected
observations.
Customers identify and store
selected patient data.
Orchestrations provides a trigger
to pull in previously stored relevant
data for a given study. | n/a |
| Send Critical Results | End user, identified critical Results
are sent to the EHR quickly | n/a |
| Multimodality
storage and
review | Yes | Yes |
| Web Server for
images and clips | Yes | Yes |
| Report upload to
Information
Systems | Yes, through broker or
interface engine | Yes, through broker or
interface engine |
| DICOM Structured
Reporting | Yes | Yes |
| Export/Import
Data Sets via
removable media
or network means | n/a | Yes |
| Vascular
Quantification | Yes, measurements and
calculations | Yes, measurements and
calculations |
| Data Mining | Yes | Yes |
| Discrete Data
Export | Yes | Yes |
| Cardiac
Measurements | Yes | Yes |
| Interactive
graphical
documentation for
reporting | Coronary Tree Diagrams are the
same in VA30. Congenital Heart
Diagrams and Vascular Diagrams
have been added in the Common
Reporting 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. |
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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.
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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.