(95 days)
Yes
The document explicitly mentions "Validation Studies for AI/ML-enabled functions" and describes the training and testing of an "Auto EF algorithm," which is a strong indicator of AI/ML usage.
No.
This device is an image management and processing system used for disease detection, diagnosis, and patient management, not for direct therapy.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device provides functions "intended for use in the interpretation and analysis of medical images for disease detection, diagnosis, and/or patient management."
Yes
The device description explicitly states "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."
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: syngo Dynamics is described as an "image and information system" that manages and processes medical images acquired from imaging modalities like ultrasound, angiography, CT, and MR. It provides tools for reviewing, manipulating, quantifying, and reporting on these images.
- Lack of Biological Sample Analysis: The text explicitly states that the device works with images from imaging machines. There is no mention of analyzing biological samples from the patient.
Therefore, syngo Dynamics falls under the category of a medical image processing and management system, not an In Vitro Diagnostic device.
No
The letter does not state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
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 VA40F) 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 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).
Mentions image processing
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.
Mentions AI, DNN, or ML
To validate the syngo Dynamics (Version VA40F) Intended Use, standalone performance testing for Auto EF was conducted to assess the performance of Auto EF compared to the ground truth (reference standard) established using conventional methods.
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 ventriular 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 FDA cleared products (K210053). Additional acceptance criteria were defined with a total of 12 predetermined acceptance criteria.
The Auto EF results are exceeding all 12 defined acceptance criteria. Biplane EF correlation was 0.827 between Auto EF and ground truth (P
§ 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).
0
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Siemens Medical Solutions USA, Inc. % Jiayan Liu Regulatory Affairs Manager 400 W. Morgan Road ANN ARBOR MI 48108
Re: K222428
November 14, 2022
Trade/Device Name: syngo Dynamics (Version VA40F) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QIH Dated: September 29, 2022 Received: October 4, 2022
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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica Lamb
Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K222428
Device Name syngo Dynamics (version VA40F)
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) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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K222428
510(k) Summary
syngo Dynamics (Version VA40F)
In accordance with 21 CFR §807.92, the following summary of safety and effectiveness is provided.
SUBMITTER I.
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: November 7, 2022
DEVICE II.
21CFR § 807.92(a)(2)
| Device Trade Name | syngo Dynamics (version VA40F) |
|---|---|
| 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 VA40E) |
| 510(k) Number | K220832 |
| Product Code | LLZ |
This predicate has not been subject to a design-related recall.
IV. DEVICE DESCRIPTION SUMMARY
21CFR § 807.92(a)(4)
4
This premarket notification addresses the Siemens Healthineers syngo Dynamics (Version VA40F) 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 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
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.
Indications for Use Comparison
21CFR § 807.92(a)(5)
5
| Subject Device
syngo Dynamics VA40F | Predicate Device
syngo Dynamics VA40E
K220832 |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 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 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 not intended to be used for
displaying of digital mammography images for
diagnosis in the U.S. |
The subject device, syngo Dynamics (Version VA40F) is a new version of the predicate device, syngo Dynamics VA40E (K220832). 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 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)
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| Attribute | Subject Device
syngo Dynamics VA40F | Predicate Device
syngo Dynamics VA40E
K220832 | Equivalency
Analysis |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Architecture | Client-server | Client-server | Identical |
| Supported
modalities | US XA DX CT MR SC NM PT | US XA DX CT MR SC NM PT | 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 |
| Attribute | Subject Device
syngo Dynamics VA40F | Predicate Device
syngo Dynamics VA40E
K220832 | 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) | Window/Leveling Edge Enhancement Digital Subtraction Multiplanar reconstruction (MPR) Maximum and Minimum Intensity Projection (MIP/MinIP) Volume Rendering Technique (VRT) Gamma Correction Manual calculation for left ventricular ejection fraction | Updated by
adding semi-
automated
ejection
fraction |
| 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 |
| Attribute | Subject Device
syngo Dynamics VA40F | Predicate Device
syngo Dynamics VA40E
K220832 | 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 reportingWebViewer – (Web Client
with MP4 Image display) -
Access for review onlyPortal – (Web Client for
reading and reporting with
limited functionality.) | 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 | Similar.
Additional
portal access
for review and
limited
functionality
in subject
device. |
| Mobile Device
Support | Yes –Through the Common
Login and Portal Image
Review, images can be viewed
on mobile devices, WebViewer,
supports iOS and Android
devices, but are non-diagnostic
use. | Yes - Through WebViewer,
Supports iOS and Android
devices, but non-diagnostic use. | Similar.
Additional
portal access
for review and
limited
functionality
in subject
device. |
| 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 |
| Attribute | Subject Device
syngo Dynamics VA40F | Predicate Device
syngo Dynamics VA40E
K220832 | 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:
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:
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: 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) | Identical |
| Deployment
strategy | The use of syngo Dynamics VA30 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 VA40E 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 |
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Image /page/8/Picture/0 description: The image contains the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots.
9
Image /page/9/Picture/0 description: The image contains 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 circular pattern.
The functionalities of subject and predicate devices are fundamentally the same except for differences in image review features. Comparing with the predicate, the subject device is supplied with AVML algorithm that enable an optional semi-automated method (Auto EF) to calculate left ventricle ejection fraction using ultrasound images. Both subject and predicate devices have identical manual calculations
10
of left ventricular ejection fraction (LV EF). The subject device has an additional capability for semiautomated calculation of LV EF on images selected by the user and under full control of the user including possible manual intervention, performing equivalently to the manual measurement with no new concerns for the safety and effectiveness.
VII. PERFORMANCE DATA
The following performance data were provided in support to demonstarte similarities to the predicate /previously cleared device.
Clinical Testing
No clinical studies were carried out for syngo Dynamics (Version VA40F). All performance testing was conducted in a non-clinical fashion as part of the verification and validation activities for the medical device.
Summary of Non-Clinical Testing
No performance standards for MIMPS have been issued under the authority of Section 514. Nonclinical testing was conducted for the device syngo Dynamics (Version VA40F) during product development. The modifications described in this Premarket Notification were supported with verification and validation testing.
Siemens Healthineers claims conformance to the following recognized consensus standards:
- NEMA PS 3.1 3.20 (2016) ●
- 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 "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005, documentation is included within this submission for software of a Moderate Level of Concern. Non-clinical Testing was conducted during product development. Evidence provided within this submission demonstrates conformance with special controls for medical devices containing software.
Cybersecurity considerations related to syngo Dynamics are included within this submission. Siemens Healthineers conforms to cybersecurity 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 VA40F) was completed and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and
21CFR § 807.92(b)(2)
21CFR § 807.92(b)(1)
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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
To validate the syngo Dynamics (Version VA40F) Intended Use, standalone performance testing for Auto EF was conducted to assess the performance of Auto EF compared to the ground truth (reference standard) established using conventional methods.
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 ventriular 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 FDA cleared products (K210053). Additional acceptance criteria were defined with a total of 12 predetermined acceptance criteria.
The Auto EF results are exceeding all 12 defined acceptance criteria. Biplane EF correlation was 0.827 between Auto EF and ground truth (P