(59 days)
No
The document describes standard image processing and management functions without mentioning AI or ML.
No
syngo Dynamics is described as an image and information system for medical image management and processing, intended for review, digital processing, manipulation, and quantification of medical images for disease detection, diagnosis, and patient management. It does not directly provide therapy.
Yes
syngo Dynamics is explicitly stated to support clinicians in "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 information, 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. They are used outside the body (in vitro).
- syngo Dynamics Function: syngo Dynamics is described as an image and information system for managing and processing medical images acquired from imaging modalities like ultrasound, X-ray angiography, CT, and MR. It focuses on post-image processing, manipulation, quantification, and reporting of these images.
- Lack of Biological Sample Analysis: The description of syngo Dynamics does not mention any analysis of biological samples. Its input is medical images, not biological specimens.
Therefore, syngo Dynamics falls under the category of medical imaging software or a Picture Archiving and Communication System (PACS) with advanced processing capabilities, rather than an In Vitro Diagnostic device.
N/A
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 (comma separated list FDA assigned to the subject device)
LLZ
Device Description
syngo Dynamics is a software only medical device which is used with common IT hardware. Recommended configurations are defined for the hardware required to run the device, and hardware is not considered as part of the medical device.
syngo Dynamics is intended to be used by trained healthcare professionals in a professional healthcare facility to review, edit, and manipulate image data, as well as to generate quantitative data, qualitative data, and diagnostic reports.
syngo Dynamics is a digital image display and reporting system with flexible deployment - it can function as a standalone medical device that includes a DICOM Server or as an integrated module within an Electronic Health Record (EHR) System with a DICOM Archive that receives images from digital image acquisition devices such as ultrasound and x-ray angiography machines. There are three deployments: Standalone, EHR/EHS Integrated, and Multi-Modality Cardiovascular (MMCV). MMCV deployment functions as a standalone medical device with capability of natively support 2D and 3D CT and MR image types.
The use of syngo Dynamics is focused on cardiac ultrasound (echocardiography), angiography (xray), cardiac nuclear medicine (NM), CT and MR studies that cover both adult and pediatric medicine. Also supported is vascular ultrasound and ultrasound in Obstetrics/Gynecology and Maternal Fetal Medicine (fetal echocardiography during pregnancy).
syngo Dynamics is based on a client-server architecture. The syngo Dynamics server processes the data from the connected imaging modalities, and stores data and images to a DICOM server and routes them for permanent storage, printing, and review. The client provides the user interface for interactive image viewing, reporting, and processing; and can be installed on network connected workstations.
syngo Dynamics offers multiple access strategies: A Workplace that provides full functionality for reading and reporting: A Remote Workplace that provides additionally compressed images with access to full fidelity images for reading and reporting; and a browser based WebViewer that provides access to additionally compressed images and reports from compatible devices (including mobile devices).
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
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.
Mentions AI, DNN, or ML
Not Found.
Input Imaging Modality
US XA DX CT MR SC NM
Anatomical Site
Not Found.
Indicated Patient Age Range
Adult and pediatric medicine.
Intended User / Care Setting
syngo Dynamics is intended to be used by trained healthcare professionals in a professional healthcare facility.
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 (Version VA40E). All performance testing was conducted in a non-clinical fashion as part of the verification and validation activities for the medical device. Nonclinical testing was conducted for the device syngo Dynamics (Version VA40E) during product development. The modifications described in this Premarket Notification were supported with verification and validation testing.
Performance tests were conducted to test the functionality of the device syngo Dynamics (Version VA40E). These tests have been performed to assess the functionality of the subject device. Results of all testing conducted were found acceptable in support to determine similarities to the predicate /previously cleared device.
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.
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).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Siemens Medical Solutions USA, Inc. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k SAINT PAUL MN 55114
Re: K220832
May 20, 2022
Trade/Device Name: syngo Dynamics (Version VA40E) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: May 9, 2022 Received: May 10, 2022
Dear Prithul Bom:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
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, 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)
Device Name syngo Dynamics (version VA40E)
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) |
|---|---|
| ----------------------------------------------------------------------------------------------------- | ----------------------------------------------- |
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3
Image /page/3/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange. To the right of the word "Healthineers" is a graphic of orange dots arranged in a circular pattern.
510(k) Summary syngo Dynamics (Version VA40E)
In accordance with 21 CFR §807.92, the following summary of safety and effectiveness is provided.
I. SUBMITTER
21CFR § 807.92(a)(1)
Siemens Medical Solutions USA, Inc. 400 W. Morgan Road Ann Arbor, MI 48108
Contact Person : Abhineet Johri
Phone: +1 (484) 680-8723 Email: abhineet.johri(@siemens-healthineers.com
Date Prepared: May 03, 2022
DEVICE II.
21CFR § 807.92(a)(2)
| Device Trade Name | syngo Dynamics (version VA40E) |
|---|---|
| Common Name | Medical image management and processing system |
| Classification Name | System, Image Processing, Radiological |
| Classification Panel | Radiology |
| Regulation Number | 21 CFR §892.2050 |
| Product Code | LLZ |
| III. LEGALLY MARKETED PREDICATE DEVICES | 21CFR § 807.92(a)(3 |
|---|---|
| Predicate Device | |
| Device Trade Name | syngo Dynamics Version VA30 |
| 510(k) Number | K171053 |
| Product Code | LLZ |
| This predicate has not been subject to a design-related recall. | |
| Reference Device | |
| Device Trade Name | syngo.via (Version VB40A) |
| 510(k) Number | K191040 |
| Product Code | LLZ |
| This reference device has not been subject to a design-related recall. |
4
IV. DEVICE DESCRIPTION SUMMARY
This premarket notification addresses the Siemens Healthineers syngo Dynamics (Version VA40E) 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 (xray), cardiac nuclear medicine (NM), CT and MR studies that cover both adult and pediatric medicine. Also supported is vascular ultrasound and ultrasound in Obstetrics/Gynecology and Maternal Fetal Medicine (fetal echocardiography during pregnancy).
syngo Dynamics is based on a client-server architecture. The syngo Dynamics server processes the data from the connected imaging modalities, and stores data and images to a DICOM server and routes them for permanent storage, printing, and review. The client provides the user interface for interactive image viewing, reporting, and processing; and can be installed on network connected workstations.
syngo Dynamics offers multiple access strategies: A Workplace that provides full functionality for reading and reporting: A Remote Workplace that provides additionally compressed images with access to full fidelity images for reading and reporting; and a browser based WebViewer that provides access to additionally compressed images and reports from compatible devices (including mobile devices).
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.
Image /page/4/Picture/16 description: The image shows the text "21CFR § 807.92(a)(5)". This appears to be a reference to a section of the Code of Federal Regulations, specifically Title 21, which pertains to food and drugs. The section number is 807.92, subsection (a), paragraph (5). The text is presented in a clear, legible font.
Image /page/4/Picture/17 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in a salmon color. To the right of the words is a graphic of salmon-colored dots arranged in a circular pattern.
21CFR § 807.92(a)(4)
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| Subject Device
syngo Dynamics VA40E | Predicate Device
syngo Dynamics VA30
K171053 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 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. |
Indications for Use Comparison
The subject device, syngo Dynamics (Version VA40E) is a new version of the predicate device, syngo Dynamics VA30 (K171053). The Indications for Use for the subject device and the predicate device are equivalent. There were no fundamental changes to the device as a cardiology-focused information and imaging management software. The indications for use were updated to exclude functions such as "storage and display" of medical images as they are no longer fall within the definition of a medical device by the FDA.
Neither the subject nor the predicate device is indicated for any specific disease, condition, or patient population, and both are intended to support healthcare professionals in the healthcare institutions' environment.
Both the subject and predicate devices share the same contraindication that they are not intended to be used for display or diagnosis of digital mammography images in the U.S.
Indications for Use/Intended Use Comparison Summary and Conclusion
The Indications for Use were assessed in accordance with the following FDA Guidance Documents:
- o The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]
- Food and Drug Administration Staff Guidance for Industry, General/Specific Intended Use 0
The results of this evaluation determined that the Indications for Use for the subject device and the predicate device are fundamentally the same, and only includes minor updates. As such, Siemens Healthineers is of the opinion that the Intended Use and Indications for Use are similar to the predicate device.
6
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
21CFR § 807.92(a)(6)
| Attribute | Subject Device
syngo Dynamics
VA40E | Predicate Device
syngo Dynamics
VA30
K171053 | Equivalency
Analysis |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Architecture | Client-server | Client-server | Same |
| Supported
modalities | US XA DX CT MR SC NM Additionally through
Corridor4DM: NM PET | US XA DX DR NM through
Corridor4DM | Subject device added
support for a few
DICOM modalities
compared to the
predicate device.
Note: The subject
device has the identical
natively supported
modalities as the
reference device,
syngo.via VB40A
(K191040).
The additionally
supported modalities by
the subject device only
enhances and extends
the conditions for use
and it does not impact
or change the purpose
or the actual use of the
device (intended use). |
| Image
Communication | 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 | 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 | Equivalent. All standard
protocols. |
| 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 with
higher compression rate. | Equivalent.
The only difference
between the subject
device and the predicate
device is the file format. |
| Attribute | Subject Device
syngo Dynamics
VA40E | Predicate Device
syngo Dynamics
VA30
K171053 | Equivalency
Analysis |
| Imaging
Algorithms | Window/Leveling Edge Enhancement Digital Subtraction Multiplanar reconstruction (MPR) Maximum and Minimum Intensity Projection (MIP/MinIP) Volume Rendering Technique (VRT) | Window/Leveling Edge Enhancement Digital Subtraction | The subject device uses
the same imaging
algorithm as the
predicate device, with
additional four imaging
algorithms.
Note: the additional
imaging algorithms
identical to that are
implemented in the
reference device,
syngo.via VB40A
(K191040). |
| Quantitative
algorithms | Pixel Size Evaluation Distance line Angle Volume | Pixel Size Evaluation | The subject device
added three quantitative
algorithms from the
predicate device.
Note: the additional
quantitative algorithms
identical to that are
implemented in the
reference device,
syngo.via VB40A
(K191040). |
| 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 provides
a trigger to pull in
previously stored
relevant data for a given
study. | Same with the predicate
device. |
| Attribute | Subject Device
syngo Dynamics
VA40E | Predicate Device
syngo Dynamics
VA30
K171053 | Equivalency
Analysis |
| Reporting | Customizable
DICOM Structured
Reporting Collaborative
reporting Remote reporting | Customizable
DICOM Structured
Reporting Collaborative
reporting Web reporting | Equivalent to the
predicate device. The
web reporting using
"Portal Image Review"
in the predicate device
was deprecated. In
VA40E, remote
reporting is
accomplished through
Remote Workplace. |
| 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. Portal - (Web
Client for reading
and reporting with
limited
functionality.) | Similar to the predicate
device. Instead of the
Portal Image Review in
the predicate device, the
subject device has the
Remote Workplace and
the WebViewer. |
| Mobile Device
Support | Yes - Through
WebViewer, Supports
iOS and Android
devices, but non-
diagnostic use. | Yes - Through the
Common Login and
Portal Image Review,
images can be viewed
on mobile devices, but
are non-diagnostic. | Equivalent. Both
devices use web client
for read-only access. |
| 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. | Same. |
| Attribute | Subject Device
syngo Dynamics
VA40E | Predicate Device
syngo Dynamics
VA30
K171053 | Equivalency
Analysis |
| 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) | Same. |
| Virtualization | Provides virtualization
of server and client
machines | Provides virtualization
of server and client
machines | Same. |
| 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) | Equivalent. Subject
device uses updated
versions of Microsoft
OS. |
| Attribute | Subject Device
syngo Dynamics
VA40E | Predicate Device
syngo Dynamics
VA30
K171053 | Equivalency
Analysis |
| Deployment
strategy | 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. | The use of syngo
Dynamics VA30
server/workplace in
the context of
cardiovascular
configuration. EHR/EHS
Integrated
configuration with
syngo Dynamics
server. | First two deployments
are equivalent to the
predicate device.
Note: The third
deployment uses
identical technology to
the reference device,
syngo.via VB40A
(K191040). The
changes in the key
attributes due to the
addition of this
deployment is covered
above (Supported
modalities, Imaging
algorithms, Quantitative
algorithms).
Note: Multi-modality
cardiovascular
configuration
additionally uses
native/syngo software
(NS_Container and
NS_Frontend) in
native/syngo server and
workplace to support
viewing of CT and MR
studies. That's the same
technology which is
used in the reference
device syngo.via
VB40A (K191040) |
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8
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VII. PERFORMANCE DATA
The following performance data were provided in support to demonstarte similarities to the predicate /previously cleared device.
Clinical Testing
No clinical studies were carried out for syngo Dynamics (Version VA40E). All performance testing was conducted in a non-clinical fashion as part of the verification and validation activities for the medical device.
Summary of Non-Clinical Testing
No performance standards for MIMPS have been issued under the authority of Section 514. Nonclinical testing was conducted for the device syngo Dynamics (Version VA40E) during product development. The modifications described in this Premarket Notification were supported with verification and validation testing.
Siemens Healthineers claims conformance to the following recognized consensus standards:
- NEMA PS 3.1 3.20 (2016) ●
- o ISO IEC 10918-1 First edition 1994-02-15
- IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION 0
- ISO 14971 Third Edition 2019-12
- IEEE Std 3333.2.1-2015
- IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION 0
- IEC TR 80001-2-2 Edition 1.0 2012-07 0
- IEC 82304-1 Edition 1.0 2016-10 o
Software Verification and Validation
In accordance with the FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005, documentation is included within this submission for software of a Moderate Level of Concern. Non-clinical Testing was conducted during product development. Evidence provided within this submission demonstrates conformance with special controls for medical devices containing software.
Cybersecurity considerations related to syngo Dynamics are included within this submission. Siemens Healthineers conforms to cybersecurity requirementing a means to prevent unauthorized access, modification, misuse, denial of use or unauthorized use of information stored, accessed or transferred from a medical device to an external recipient.
Risk Analysis, in compliance with ISO 14971 Third Edition, for syngo Dynamics (Version VA40E) was completed and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation for the device was found acceptable in support to determine similarities to the predicate /previously cleared device.
21CFR § 807.92(b)(1)
21CFR § 807.92(b)(2)
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VIII. CONCLUSIONS
21CFR § 807.92(b)(3)
Performance tests were conducted to test the functionality of the device syngo Dynamics (Version VA40E). These tests have been performed to assess the functionality of the subject device. Results of all testing conducted were found acceptable in support to determine similarities to the predicate /previously cleared device.
Device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of this device. Risk management was implemented throughout the development process to control potential hazards.
The device does not come in contact with the patient and is only used by trained professionals. The output of the device is evaluated by clinicians, providing for sufficient review to identify and intervene in the event of a malfunction.
Siemens Healthineers believes that syngo Dynamics (Version VA40E) is safe and effective as the identified predicate device and does not introduce new safety and effectiveness concerns.
Substantial Equivalence Conclusion
The comparison of intended use, technological characteristics, performance specifications, device hazards as well as verification and validation results demonstrate that syngo Dynamics is safe, effective and performs as well as the predicate device.
In summary, Siemens Healthineers is of the opinion that syngo Dynamics (Version VA40E) does not introduce any new significant potential safety risks and is similar to the predicate device.