(219 days)
Not Found
Yes.
The document explicitly mentions "AI/ML-based functions" and the "Auto EF algorithm" being re-trained and updated, which are clear indicators of an AI model.
No.
The device is described as a "software only medical device" that is intended for "medical image management and processing" for "interpretation and analysis of medical images for disease detection, diagnosis, and/or patient management." It does not directly provide therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use in the interpretation and analysis of medical images for disease detection, diagnosis, and/or patient management." This directly indicates its role as a diagnostic device.
Yes
The device explicitly states in its "Device Description" section that "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." This directly indicates it is a software-only device.
No.
This device is an image processing and information system that supports clinical interpretation of medical images. It does not perform tests on specimens derived from the human body.
Yes
The letter explicitly states, "FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP)." This language directly satisfies the condition of the Decision Rules for answering "Yes."
Intended Use / Indications for Use
syngo Dynamics is a multimodality, vendor agnostic Cardiology image and information system intended for medical image management and processing that provides capabilities relating to the review and digital processing of medical images.
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.
Product codes
QIH
Device Description
This premarket notification addresses the Siemens Healthineers syngo Dynamics (Version VA41D) Medical Image Management and Processing System (MIMPS).
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.
The use of syngo Dynamics is focused on cardiac ultrasound (echocardiography), angiography (x-ray), 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).
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 provides various semi-automated anatomical visualization tools.
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).
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
US, XA, DX, CT, MR, SC, NM, PT, ECG
Anatomical Site
Cardiac (echocardiography), angiography, vascular, Obstetrics/Gynecology and Maternal Fetal Medicine (fetal echocardiography during pregnancy)
Indicated Patient Age Range
Adult and pediatric medicine
Intended User / Care Setting
Trained healthcare professionals in a professional healthcare facility.
Description of the training set, sample size, data source, and annotation protocol
The LV auto contouring algorithm has been updated with pre-training and additional annotated training data with the goal to improve algorithm performance.
Description of the test set, sample size, data source, and annotation protocol
The test data (n = 150) represent 3 sites in the U.S. with geographic diversity from 2 different regions and are independent of the training data used for the training of the Auto EF algorithm. The test data are representative of the intended use population for Auto EF. They are balanced for gender and cover an age range from 21 to 93 years (average 64 years). The BMI ranges from 16.5 to 48.8 with an average of 27.9. Three ultrasound manufacturers (Philips, GE and Siemens) are included in the testing. Cases across the range of cardiac function are included.
The ground truth was established by 2 experienced sonographers using a conventional manual method to establish left ventricular volumes and ejection fraction with the "Method of Disks" (MOD) also known as the Modified Simpson's Rule. The 2 sonographers worked independently of each other and did not have access to Auto EF when establishing the ground truth.
Summary of Performance Studies
Study type: Validation Studies for AI/ML-enabled functions (Auto EF)
Sample size: n = 150
AUC: Not Found
MRMC: Not Found
Standalone performance: Not Found
Key results:
Acceptance of the statistical data is a Pearson's correlation coefficient r ≥ 0.800 between the biplane EF generated by Auto EF and the ground truth. This acceptance criterion has been previously used for the purpose of evaluating left ventricular ejection fraction in the predicate device (K222428). Additional acceptance criteria were defined with a total of 12 predetermined acceptance criteria.
The Auto EF results with the subject device are exceeding all 12 defined acceptance criteria. The Auto EF version in the predicate device has biplane results in 138 of 150 cases (92.0%) which is increased to 140 of 150 cases (93.3%) with the subject device. Biplane EF correlation between Auto EF and ground truth is 0.822 with the subject device compared to 0.826 with the predicate device which is on a similar level. The bias is minimal with -0.2% absolute EF which remains unchanged. The coverage plot shows that the absolute biplane EF delta between Auto EF and GT is ≤10% in 87.9% of cases with the subject device which is higher than 83.7% with the predicate device.
The results of clinical data-based software validation for the subject device demonstrated equivalent performance in comparison to the reference generated using conventional manual analysis.
Key Metrics
Pearson's correlation coefficient r: 0.822 (subject device) vs 0.826 (predicate device)
Bias: -0.2% absolute EF
Biplane results: 140 of 150 cases (93.3%) for subject device vs 138 of 150 cases (92.0%) for predicate device.
Absolute biplane EF delta ≤10%: 87.9% of cases for subject device vs 83.7% for predicate device.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP). Under section 515C(b)(1) of the Act, a new premarket notification is not required for a change to a device cleared under section 510(k) of the Act, if such change is consistent with an established PCCP granted pursuant to section 515C(b)(2) of the Act. Under 21 CFR 807.81(a)(3), a new premarket notification is required if there is a major change or modification in the intended use of a device, or if there is a change or modification in a device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process. Accordingly, if deviations from the established PCCP result in a major change or modification in the intended use of the device, or result in a change or modification in the device that could significantly affect the safety or effectiveness of the device, then a new premarket notification would be required consistent with section 515C(b)(1) of the Act and 21 CFR 807.81(a)(3). Failure to submit such a premarket submission would constitute adulteration and misbranding under sections 501(f)(1)(B) and 502(o) of the Act, respectively.
Siemens Healthineers will make future algorithm improvements under a Predetermined Change Control Plans (PCCPs) for Auto EF functions. The PCCP specifies anticipated modifications to the device software. The PCCP also specifies the methods to implement those modifications so that the device remains as safe and as effective as the predicate device.
Summary Predetermined Modifications for Auto EF:
Modification Group #1: Re-training Auto EF MLDSF with additional data. Test Methods and Validation Activities: Performance testing will be repeated using the same test methods and acceptance criteria as that used in syngo Dynamics VA41D. Communication to users, as needed: Labeling will be updated in accordance with the authorized PCCP to provide users with current information regarding the device's re-training process and performance capabilities.
Modification Group #2: Optimizations of the Auto EF ML-DSF core algorithms. Test Methods and Validation Activities: Performance testing will be repeated using the same test methods and acceptance criteria as that used in syngo Dynamics VA41D. Communication to users, as needed: Labeling will be updated in accordance with the authorized PCCP to provide users with current information regarding the device's re-training process and performance capabilities.
Modification Group #3: Auto EF ML-DSF with contrast support. Test Methods and Validation Activities: Performance testing will be repeated using the same test methods and acceptance criteria as that used in syngo Dynamics VA41D. Performance testing will be expanded to include contrast cases. Communication to users, as needed: Labeling will be updated in accordance with the authorized PCCP to provide users with current information regarding the device's capabilities with expanded input images including contrast.
§ 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).
FDA 510(k) Clearance Letter - syngo Dynamics (Version VA41D)
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
Siemens Healthcare GmbH
Jiayan Liu
Regulatory Affairs Manager
Henkestr. 127
ERLANGEN, 91052
GERMANY
Re: K242551
Trade/Device Name: syngo Dynamics (Version VA41D)
Regulation Number: 21 CFR 892.2050
Regulation Name: Medical Image Management And Processing System
Regulatory Class: Class II
Product Code: QIH
Dated: February 28, 2025
Received: March 3, 2025
Dear Jiayan Liu:
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 (the 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 available 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.
FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP). Under section 515C(b)(1) of the Act, a new premarket notification is not required for a change to a device cleared under section 510(k) of the Act, if such change is consistent with an
March 3, 2025
Page 2
Siemens Healthcare GmbH
Jiayan Liu
Regulatory Affairs Manager
Henkestr. 127
ERLANGEN, 91052
GERMANY
March 3, 2025
Re: K242551
Trade/Device Name: syngo Dynamics (Version VA41D)
Regulation Number: 21 CFR 892.2050
Regulation Name: Medical Image Management And Processing System
Regulatory Class: Class II
Product Code: QIH
Dated: February 28, 2025
Received: March 3, 2025
Dear Jiayan Liu:
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 (the 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 available 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.
FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP). Under section 515C(b)(1) of the Act, a new premarket notification is not required for a change to a device cleared under section 510(k) of the Act, if such change is consistent with an
K242551 - Jiayan Liu Page 2
established PCCP granted pursuant to section 515C(b)(2) of the Act. Under 21 CFR 807.81(a)(3), a new premarket notification is required if there is a major change or modification in the intended use of a device, or if there is a change or modification in a device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process. Accordingly, if deviations from the established PCCP result in a major change or modification in the intended use of the device, or result in a change or modification in the device that could significantly affect the safety or effectiveness of the device, then a new premarket notification would be required consistent with section 515C(b)(1) of the Act and 21 CFR 807.81(a)(3). Failure to submit such a premarket submission would constitute adulteration and misbranding under sections 501(f)(1)(B) and 502(o) of the Act, respectively.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Page 3
K242551 - Jiayan Liu Page 3
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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
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
Page 4
FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known)
K242551
Device Name
syngo Dynamics (Version VA41D)
Indications for Use (Describe)
syngo Dynamics is a multimodality, vendor agnostic Cardiology image and information system intended for medical image management and processing that provides capabilities relating to the review and digital processing of medical images.
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.
Type of Use (Select one or both, as applicable)
☑ 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
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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."
Page 5
510(k) Summary
syngo Dynamics (Version VA41D)
K242551
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: Jiayan Liu
Phone: +1 (734) 604-7870
Email: jiayan.liu@siemens-healthineers.com
Date Prepared: August 27th, 2024
II. DEVICE 21CFR § 807.92(a)(2)
| Device Trade Name | syngo Dynamics (version VA41D) |
|---|---|
| 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 | QIH |
III. LEGALLY MARKETED PREDICATE DEVICES 21CFR § 807.92(a)(3)
Predicate Device
| Device Trade Name | syngo Dynamics (Version VA40F) |
|---|---|
| 510(k) Number | K222428 |
| Product Code | QIH |
This predicate has not been subject to a design-related recall.
Page 6
syngo Dynamics (Version VA41D)
Traditional 510(k) K242551
IV. DEVICE DESCRIPTION SUMMARY 21CFR § 807.92(a)(4)
This premarket notification addresses the Siemens Healthineers syngo Dynamics (Version VA41D) Medical Image Management and Processing System (MIMPS).
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.
The use of syngo Dynamics is focused on cardiac ultrasound (echocardiography), angiography (x-ray), 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).
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 provides various semi-automated anatomical visualization tools.
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).
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 21CFR § 807.92(a)(5)
syngo Dynamics is a multimodality, vendor agnostic Cardiology image and information system intended for medical image management and processing that provides capabilities relating to the review and digital processing of medical images.
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.
Page 7
Indications for Use Comparison
| Subject Device
syngo Dynamics VA41D
K242551 | Predicate Device
syngo Dynamics VA40F
K222428 |
|---|---|
| syngo Dynamics is a multimodality, vendor agnostic Cardiology image and information system intended for medical image management and processing that provides capabilities relating to the review and digital processing of medical images.
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. | syngo Dynamics is a multimodality, vendor agnostic Cardiology image and information system intended for medical image management and processing that provides capabilities relating to the review and digital processing of medical images.
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 displaying or diagnosis of digital mammography images in the U.S. |
The subject device, syngo Dynamics (Version VA41D) is a new version of the predicate device, syngo Dynamics VA40F (K222482). The Indications for Use for the subject device and the predicate device are identical. There were no fundamental changes to the device as a cardiology-focused information and imaging management software.
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:
- The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]
- Food and Drug Administration Staff Guidance for Industry, General/Specific Intended Use
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.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE 21CFR § 807.92(a)(6)
Page 8
| Attribute | Subject Device
syngo Dynamics VA41D
K242551 | Predicate Device
syngo Dynamics VA40F
K222428 | Equivalency Analysis |
|---|---|---|---|
| Architecture | Client-server | Client-server | Identical |
| Supported modalities | • US
• XA
• DX
• CT
• MR
• SC
• NM
• PT
• ECG | • US
• XA
• DX
• CT
• MR
• SC
• NM
• PT
• ECG | Identical |
| Supported deployment | • Standalone medical device including a DICOM Server
• Integrated model within an Electronic Health Record (EHR) System with a DICOM Archive
• Multimodality Cardiovascular (MMCV) deployment with native support of 2D/3D CT/MR image types | • Standalone medical device including a DICOM Server
• Integrated model within an Electronic Health Record (EHR) System with a DICOM Archive
• Multimodality Cardiovascular (MMCV) deployment with native support of 2D/3D CT/MR image types | Identical |
| Image Communication | 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 images, MP4s and thumbnails | Within the network, the following communication protocols are used:
• TCP/IP for communication and transport
• DICOM and HL7 at application level
• HTTP(S) for communication and transport of images, MP4s and thumbnails | Identical |
| Image Data Compression | Lossless compression with compression factor 2 to 3 and lossy compression (JPEG and MP4) with higher compression rate. | Lossless compression with compression factor 2 to 3 and lossy compression (JPEG and MP4) with higher compression rate. | Identical |
Page 9
| Attribute | Subject Device
syngo Dynamics VA41D
K242551 | Predicate Device
syngo Dynamics VA40F
K222428 | Equivalency Analysis |
|---|---|---|---|
| Architecture | Client-server | Client-server | Identical |
| Supported modalities | • US
• XA
• DX
• CT
• MR
• SC
• NM
• PT
• ECG | • US
• XA
• DX
• CT
• MR
• SC
• NM
• PT
• ECG | Identical |
| Supported deployment | • Standalone medical device including a DICOM Server
• Integrated model within an Electronic Health Record (EHR) System with a DICOM Archive
• Multimodality Cardiovascular (MMCV) deployment with native support of 2D/3D CT/MR image types | • Standalone medical device including a DICOM Server
• Integrated model within an Electronic Health Record (EHR) System with a DICOM Archive
• Multimodality Cardiovascular (MMCV) deployment with native support of 2D/3D CT/MR image types | Identical |
| Image Communication | 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 images, MP4s and thumbnails | Within the network, the following communication protocols are used:
• TCP/IP for communication and transport
• DICOM and HL7 at application level
• HTTP(S) for communication and transport of images, MP4s and thumbnails | Identical |
| Image Data Compression | Lossless compression with compression factor 2 to 3 and lossy compression (JPEG and MP4) with higher compression rate. | Lossless compression with compression factor 2 to 3 and lossy compression (JPEG and MP4) with higher compression rate. | Identical |
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| Attribute | Subject Device
syngo Dynamics VA41D
K242551 | Predicate Device
syngo Dynamics VA40F
K222428 | Equivalency Analysis |
|---|---|---|---|
| Imaging Algorithms | • Window/Leveling
• Edge Enhancement
• Digital Subtraction
• Multiplanar reconstruction (MPR)
• Maximum and Minimum Intensity Projection (MIP/MinIP)
• Volume Rendering Technique (VRT)
• Gamma Correction
• Manual and semi-automated calculation for left ventricular ejection fraction (Auto EF, updated) | • Window/Leveling
• Edge Enhancement
• Digital Subtraction
• Multiplanar reconstruction (MPR)
• Maximum and Minimum Intensity Projection (MIP/MinIP)
• Volume Rendering Technique (VRT)
• Gamma Correction
• Manual and semi-automated calculation for left ventricular ejection fraction (Auto EF) | Enhanced. Rationale is provided below this table. |
| Quantitative algorithms | • Pixel Size Evaluation
• Distance line
• Angle
• volume | • Pixel Size Evaluation
• Distance line
• Angle
• Volume | Identical |
| Decision Support | 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 provide a trigger to pull in previously stored relevant data for a given study. | 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 provide a trigger to pull in previously stored relevant data for a given study. | Identical |
| Reporting | • Customizable DICOM Structured Reporting
• Collaborative reporting
• Web reporting | • Customizable DICOM Structured Reporting
• Collaborative reporting
• Remote reporting | Identical |
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| Attribute | Subject Device
syngo Dynamics VA41D
K242551 | Predicate Device
syngo Dynamics VA40F
K222428 | Equivalency Analysis |
|---|---|---|---|
| Access strategies for imaging and reporting | • Workplace (thick client)- access for reading and reporting.
• Remote Workplace (MP4 image display with access to full DICOM image for US/XA and full DICOM image for CT/MR) – access for reading and reporting
• WebViewer – (Web Client with MP4 Image display) – Access for review only | • Workplace (thick client) – access for reading and reporting.
• Remote Workplace (MP4 image display with access to full DICOM image for US/XA and full DICOM image for CT/MR) – access for reading and reporting.
• WebViewer- (Web Client with MP4 Image display) – Access for review only | Identical |
| Mobile Device Support | Yes –Through the Common Login and Web Viewer, images can be viewed on mobile devices, WebViewer, supports iOS and Android devices, but are non-diagnostic use. | Yes –Through the Common Login and Web Viewer, images can be viewed on mobile devices, WebViewer, supports iOS and Android devices, but are non-diagnostic use. | Identical |
| Long Term Archive | Provide long term archive and retrieve of DICOM studies to/from either VNA (Vendor Neutral Archive) or HSM (Hierarchical Storage Management) archiving Systems. | Provide long term archive and retrieve of DICOM studies to/from either VNA (Vendor Neutral Archive) or HSM (Hierarchical Storage Management) archiving Systems. | Identical |
| Hardware | Software-only option for server Workstation: software only (HW is not part of the medical device, but needs to meet recommended requirements as specified by syngo Dynamics) | Software-only option for server Workstation: software only (HW is not part of the medical device, but needs to meet recommended requirements as specified by syngo Dynamics) | Identical |
| Virtualization | Provides virtualization of server and client machines | Provides virtualization of server and client machines | Identical |
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| Attribute | Subject Device
syngo Dynamics VA41D
K242551 | Predicate Device
syngo Dynamics VA40F
K222428 | Equivalency Analysis |
|---|---|---|---|
| Operating system | Server:
Microsoft Windows server 2016 Standard edition (64 bit)
Microsoft Windows Server 2019 Standard Edition (64 Bit)
Client Software: Microsoft Windows 10 x64 version 1803 or greater
Portal Website Host:
Microsoft Windows Server 2016 Standard edition (64-bit), Microsoft Windows Server 2019 Standard edition (64-bit) | Server:
Microsoft Windows server 2016 Standard edition (64 bit)
Microsoft Windows Server 2019 Standard Edition (64 Bit)
Client Software: Microsoft Windows 10 x64 version 1803 or greater
Portal Website Host:
Microsoft Windows Server 2016 Standard edition (64-bit), Microsoft Windows Server 2019 Standard edition (64-bit) | Identical |
| Deployment strategy | • The use of syngo Dynamics VA41D server/workplace in the context of cardiovascular configuration.
• EHR/EHS Integrated configuration with syngo Dynamics server.
• Multi-modality cardiovascular configuration with native/syngo server and syngo Dynamics workplace with native/syngo components. | • The use of syngo Dynamics VA40F server/workplace in the context of cardiovascular configuration.
• EHR/EHS Integrated configuration with syngo Dynamics server.
• Multi-modality cardiovascular configuration with native/syngo server and syngo Dynamics workplace with native/syngo components. | Identical |
The functionalities and technological characteristics of subject and predicate devices are fundamentally the same except for differences in AI/ML-enabled features. Comparing with the predicate, the Auto EF algorithm of the subject device is re-trained with more training data to enhance the performance of calculating left ventricle ejection fraction using ultrasound images. The re-trained algorithm passed the validation testing using the same testing datasets and acceptance criteria, and no new concerns were found with respect to safety and effectiveness compared to the predicate device.
The Auto EF algorithm allows users to review, edit or reject the results generated by the AI/ML-based functions. In addition, the Auto EF algorithms are locked before integrating into the syngo Dynamics system.
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Thus, the performance of the new or enhanced features to the subject device and associated risk mitigations were assessed in device verification and validation testing and found no new concerns for the safety and effectiveness.
Summary of Non-Clinical Testing 21CFR § 807.92(b)(2)
No performance standards for MIMPS have been issued under the authority of Section 514. Non-clinical testing was conducted for the device syngo Dynamics (Version VA41D) 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 (2023e)
- ISO IEC 10918-1 First edition 1994-02-15
- IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION
- ISO 14971 Third Edition 2019-12
- IEEE Std 3333.2.1-2015
- IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION
- IEC TR 80001-2-2 Edition 1.0 2012-07
- IEC 82304-1 Edition 1.0 2016-10
Software Verification and Validation
In accordance with the FDA's Guidance Document "Content of Premarket Submissions for Device Software Functions" issued on June 14, 2023, documentation is included within this submission for software of Basic Documentation Level. 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 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.
Risk Analysis, in compliance with ISO 14971 Third Edition, for syngo Dynamics (Version VA41D) was completed and risk control implemented to mitigate identified hazards. The testing results support that all the
VII. PERFORMANCE DATA
The following performance data were provided in support to demonstrate similarities to the predicate /previously cleared device.
Clinical Testing 21CFR § 807.92(b)(1)
No clinical studies were carried out for syngo Dynamics (Version VA41D). All performance testing was conducted in a non-clinical fashion as part of the verification and validation activities for the medical device.
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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.
Validation Studies for AI/ML-enabled functions
Auto EF
Compared to Auto EF in syngo Dynamics VA40F (K222428), the algorithms for view classification and image image-based cardiac phase detection are unchanged while the LV auto contouring algorithm has been updated with pre-training and additional annotated training data with the goal to improve algorithm performance. The user interface for Auto EF in syngo Dynamics remains unchanged.
Performance of the updated Auto EF in syngo Dynamics VA41D was validated applying the same methodology including test data and ground truth as that used for syngo Dynamics VA40F.
The test data (n = 150) represent 3 sites in the U.S. with geographic diversity from 2 different regions and are independent of the training data used for the training of the Auto EF algorithm. The test data are representative of the intended use population for Auto EF. They are balanced for gender and cover an age range from 21 to 93 years (average 64 years). The BMI ranges from 16.5 to 48.8 with an average of 27.9. Three ultrasound manufacturers (Philips, GE and Siemens) are included in the testing. Cases across the range of cardiac function are included.
The ground truth was established by 2 experienced sonographers using a conventional manual method to establish left ventricular volumes and ejection fraction with the "Method of Disks" (MOD) also known as the Modified Simpson's Rule. The 2 sonographers worked independently of each other and did not have access to Auto EF when establishing the ground truth.
Acceptance of the statistical data is a Pearson's correlation coefficient r ≥ 0.800 between the biplane EF generated by Auto EF and the ground truth. This acceptance criterion has been previously used for the purpose of evaluating left ventricular ejection fraction in the predicate device (K222428). Additional acceptance criteria were defined with a total of 12 predetermined acceptance criteria.
The Auto EF results with the subject device are exceeding all 12 defined acceptance criteria. The Auto EF version in the predicate device has biplane results in 138 of 150 cases (92.0%) which is increased to 140 of 150 cases (93.3%) with the subject device. Biplane EF correlation between Auto EF and ground truth is 0.822 with the subject device compared to 0.826 with the predicate device which is on a similar level. The bias is minimal with -0.2% absolute EF which remains unchanged. The coverage plot shows that the absolute biplane EF delta between Auto EF and GT is ≤10% in 87.9% of cases with the subject device which is higher than 83.7% with the predicate device.
The results of clinical data-based software validation for the subject device demonstrated equivalent performance in comparison to the reference generated using conventional manual analysis.
VIII. Predetermined Change Control Plan
Siemens Healthineers will make future algorithm improvements under a Predetermined Change Control Plans (PCCPs) for Auto EF functions. The PCCP specifies anticipated modifications to the device software. The PCCP also specifies the methods to implement those modifications so that the device remains as safe and as effective as the predicate device.
The detailed description of the modifications, testing methods, validation activities, performance requirements, and communication to users are summarized in the tables below for Auto EF.
Summary Predetermined Modifications for Auto EF
| Planned Modifications | Test Methods and Validation Activities | Communication to users, as needed |
|---|---|---|
| Modification Group #1: | ||
| Re-training Auto EF MLDSF with additional data | Performance testing will be repeated using the same test methods and acceptance criteria as that used in syngo Dynamics VA41D. | Labeling will be updated in accordance with the authorized PCCP to provide users with current information regarding the device's re-training process and performance capabilities |
| Modification Group #2: | ||
| Optimizations of the Auto EF ML-DSF core algorithms | Performance testing will be repeated using the same test methods and acceptance criteria as that used in syngo Dynamics VA41D. | Labeling will be updated in accordance with the authorized PCCP to provide users with current information regarding the device's re-training process and performance capabilities |
| Modification Group #3: | ||
| Auto EF ML-DSF with contrast support | Performance testing will be repeated using the same test methods and acceptance criteria as that used in syngo Dynamics VA41D. Performance testing will be expanded to include contrast cases. | Labeling will be updated in accordance with the authorized PCCP to provide users with current information regarding the device's capabilities with expanded input images including contrast. |
IX. CONCLUSIONS 21CFR § 807.92(b)(3)
Performance tests were conducted to test the functionality of the device syngo Dynamics (Version VA41D). 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 VA41D) 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 VA41D) does not introduce any new significant potential safety risks and is similar to the predicate device.