(27 days)
No
The document describes standard image viewing, manipulation, and storage software with image processing capabilities, but there is no mention of AI, ML, or related concepts.
No
Explanation: The device is a software solution for viewing, manipulating, and storing medical images for interpretation and evaluation (diagnostic purposes), not for directly treating a disease or condition.
Yes
The "Intended Use / Indications for Use" section states that syngo.via "supports interpretation and evaluation of examinations within healthcare institutions," which implies assisting in making a diagnosis. The fact that it is "not intended for the displaying of digital mammography images for diagnosis in the U.S." for a specific type of image further implies that it is intended for diagnosis for other image types.
Yes
The device description explicitly states "syngo.via is a software only medical device, which is delivered by download to be installed on common IT hardware. This hardware has to fulfil the defined requirements. Any hardware platform that complies to the specified minimum hardware and software requirements and with successful installation verification and validation activities can be supported. The hardware itself is not seen as part of the medical device syngo.via and therefore not in the scope of this 510(k) submission."
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that syngo.via is for "viewing, manipulation, and storage of medical images" and supports "interpretation and evaluation of examinations." This describes a system for handling and displaying medical images, not for performing tests on biological samples to diagnose conditions.
- Device Description: The description focuses on the software's function in processing, rendering, and storing medical images from various modalities. It describes a Picture Archiving and Communications System (PACS) with advanced viewing and processing capabilities.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided text does not mention any interaction with biological samples or the analysis of such samples.
The device is a medical image viewing and processing software, which falls under a different regulatory category than IVD devices.
N/A
Intended Use / Indications for Use
syngo.via is a software solution intended to be used for viewing, manipulation, and storage of medical images.
It can be used as a stand-alone device or together with a variety of cleared and unmodified syngo based software options. syngo .via supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments.
The system is not intended for the displaying of digital mammography images for diagnosis in the U.S.
Product codes
LLZ
Device Description
Siemens Healthcare GmbH intends to market the Picture Archiving and Communications System, syngo.via. software version VB40A. This 510(k) submission describes several modifications to the previously cleared predicate device, syngo.via, software version VB10A.
syngo.via is a software only medical device, which is delivered by download to be installed on common IT hardware. This hardware has to fulfil the defined requirements. Any hardware platform that complies to the specified minimum hardware and software requirements and with successful installation verification and validation activities can be supported. The hardware itself is not seen as part of the medical device syngo.via and therefore not in the scope of this 510(k) submission.
syngo.via provides tools and features to cover the radiological tasks reading images and reporting. syngo.via supports DICOM formatted images and objects. syngo.via also supports storage of Structured DICOM Reports. In a comprehensive imaging suite, syngo.via interoperates with a Radiology Information System (RIS) to enable customer specific workflows.
syngo.via is based on a client-server architecture. The server processes and renders the data from the connected modalities. The server provides central services including image processing and temporary storage, and incorporates the local database. The client provides the user interface for interactive image viewing and can be installed and started on each workplace that has a network connection to the server.
The server's backend communication and storage solution is based on Microsoft Windows server operating systems. The client machines are based on Microsoft Windows operating systems.
syngo.via supports various monitor setups and can be adapted to a range of image types by connecting different monitor types.
The subject device and the predicate device share fundamental scientific technology. This device description holds true for the subject device, syngo.via, software version VB40A, as well as the predicate device, syngo.via, software version VB10A.
Mentions image processing
Yes, "syngo.via provides central services including image processing and temporary storage, and incorporates the local database."
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT Image (Computed Tomography)
MR Image (Magnetic Resonance)
NM Image (Nuclear Medicine)
XA Image (X-Ray Angiography)
US Image (Ultrasound)
DX Image (Digital Radiography)
DICOM secondary capture objects
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments.
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)
Non-clinical tests were conducted for the device syngo.via 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.via. These tests have been performed to assess the functionality of the subject device. Results of all conducted testing were found acceptable in supporting the claim of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 16, 2019
Siemens Healthcare GmbH % Mr. Georg Bauer Responsible Third-Party Official TÜV SÜD America, Inc. 1775 Old Highway 8 NW, Suite 104 NEW BRIGHTON MN 55112
Re: K191040
Trade/Device Name: syngo.via (Version VB40A) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: April 17, 2019 Received: April 19, 2019
Dear Mr. Bauer:
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
1
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 https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191040
Device Name syngo.via (Version VB40A)
syngo.via is a software solution intended to be used for viewing, manipulation, and storage of medical images.
It can be used as a stand-alone device or together with a variety of cleared and unmodified syngo based software options. syngo .via supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments.
The system is not intended for the displaying of digital mammography images for diagnosis in the U.S.
| Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) | |
|---|---|
| --------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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3
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
Date prepared: April 03, 2019
-
- Submitter: Siemens Healthcare GmbH Henkestrasse 127 91052 Erlangen Germany
Establishment Registration Number: 3004977335
- Submitter: Siemens Healthcare GmbH Henkestrasse 127 91052 Erlangen Germany
2. Contact Person:
Mr. Elango Alampalayam Rangappan Regulatory Affairs Manager Siemens Healthcare GmbH, Siemensstr. 1 91301 Forchheim Germany E-mail: ar.elango@siemens-healthineers.com Telephone: +49 (9191) 18-4429 Fax: +49 (9191) 18-4404
3. Device Name and Classification:
| Trade Name: | syngo.via (Version VB40A) |
|---|---|
| Classification Name: | Picture Archiving and Communications System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.2050 |
| Device Class: | Class II |
| Product Code: | LLZ |
4. Legally Marketed Predicate Device:
| Trade Name: | syngo.via (Version VB10A) |
|---|---|
| 510(k) Clearance: | K150843 |
| Clearance Date: | April 25, 2015 |
| Classification Name: | Picture Archiving and Communications System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.2050 |
| Device Class: | Class II |
| Product Code: | LLZ |
| Recall Information: | This predicate device has not been the subject of any design related recalls. |
4
5. Device Description:
Siemens Healthcare GmbH intends to market the Picture Archiving and Communications System, syngo.via. software version VB40A. This 510(k) submission describes several modifications to the previously cleared predicate device, syngo.via, software version VB10A.
syngo.via is a software only medical device, which is delivered by download to be installed on common IT hardware. This hardware has to fulfil the defined requirements. Any hardware platform that complies to the specified minimum hardware and software requirements and with successful installation verification and validation activities can be supported. The hardware itself is not seen as part of the medical device syngo.via and therefore not in the scope of this 510(k) submission.
syngo.via provides tools and features to cover the radiological tasks reading images and reporting. syngo.via supports DICOM formatted images and objects. syngo.via also supports storage of Structured DICOM Reports. In a comprehensive imaging suite, syngo.via interoperates with a Radiology Information System (RIS) to enable customer specific workflows.
syngo.via is based on a client-server architecture. The server processes and renders the data from the connected modalities. The server provides central services including image processing and temporary storage, and incorporates the local database. The client provides the user interface for interactive image viewing and can be installed and started on each workplace that has a network connection to the server.
The server's backend communication and storage solution is based on Microsoft Windows server operating systems. The client machines are based on Microsoft Windows operating systems.
syngo.via supports various monitor setups and can be adapted to a range of image types by connecting different monitor types.
The subject device and the predicate device share fundamental scientific technology. This device description holds true for the subject device, syngo.via, software version VB40A, as well as the predicate device, syngo.via, software version VB10A.
6. Intended Use:
syngo.via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
It can be used as a stand-alone device or together with a variety of cleared and unmodified syngo based software options.
syngo. via supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments.
The system is not intended for the displaying of digital mammography images for diagnosis in the U.S.
5
7. Summary of Differences between the Subject Device and the Predicate Device:
The differences between the subject device in this premarket notification and the predicate device are summarized in the following comparison table:
| | Subject device | Predicate device | Comparison | Impact to Safety & Effec-
tiveness |
|------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name and
version (K number) | syngo.via (Version VB40A) | syngo.via (Version VB10A)
(K150843) | New product version | NA |
| Manufacturer | Siemens Healthcare GmbH | Siemens AG Medical Solutions | Legal manufacturer
change22. | NA |
| Intended use | syngo.via is a software solution in-
tended to be used for viewing, manipu-
lation, communication, and storage of
medical images.
It can be used as a stand-alone device
or together with a variety of cleared
and unmodified syngo based software
options.
syngo.via supports interpretation and
evaluation of examinations within
healthcare institutions, for example, in
Radiology, Nuclear Medicine and
Cardiology environments.
The system is not intended for the dis-
playing of digital mammography im-
ages for diagnosis in the U.S. | syngo.via is a software solution in-
tended to be used for viewing, manipu-
lation, communication, and storage of
medical images.
It can be used as a stand-alone device
or together with a variety of cleared
and unmodified syngo based software
options.
syngo.via supports interpretation and
evaluation of examinations within
healthcare institutions, for example, in
Radiology, Nuclear Medicine and
Cardiology environments.
The system is not intended for the dis-
playing of digital mammography im-
ages for diagnosis in the U.S. | Same | NA |
| | Subject device | Predicate device | Comparison | Impact to Safety & Effectiveness |
| Software architecture | Client-server architecture that is logically broken down to syngo.via subsystems. Subsystems are further broken down to syngo modules. | Client-server architecture that is logically broken down to syngo.via subsystems. Subsystems are further broken down to syngo modules. | Same | NA |
| Image communication | Standard network protocols like TCP/IP and standard communication protocol DICOM. Additional fast image transfer protocol for use inside syngo.via between the client and server. | Standard network protocols like TCP/IP and standard communication protocol DICOM. Additional fast image transfer protocol for use inside syngo.via between the client and server. | Same | NA |
| Imaging algorithms | Multiplanar reconstruction (MPR)
Maximum and Minimum Intensity Projection (MIP/MinIP)
Volume Rendering Technique (VRT) with additional technique
Cinematic VRT for photorealistic rendering
Shaded Surface Display (SSD)
Editor functionality (e.g. ClipBox)
Registration
Anatomical registration
Region growing with single click region growing
Organ segmentation based on existing ALPHA technology.
Change Visualization
Automatic Spine Labeling, also for ribs in CT thorax scans13 (“Rib labeling”) | Multiplanar reconstruction (MPR)
Maximum and Minimum Intensity Projection (MIP/MinIP)
Volume Rendering Technique (VRT)
Shaded Surface Display (SSD)
Editor functionality (e.g. ClipBox)
Registration
Anatomical registration
Region growing
Automatic Spine Labeling, also for ribs in CT thorax scans23 (“Rib labeling”) | There are enhancements to the existing algorithms in the subject device compared to the predicate device.
cVRT: Cinematic VRT is an extension to the standard VRT rendering algorithm to visualize the photorealistic images.
Organ Segmentation: Organ Segmentation is an enhancement based on the existing but improved ALPHA technology to visualize the anatomical regions Heart, Lung and Aorta.
Change Visualization: This algorithm helps to visualize the anatomical changes | The changes between the predicate device and the subject device doesn't impact the safety and effectiveness of the subject device as the necessary measures taken for the safety and effectiveness of the subject device. |
| | Subject device | Predicate device | Comparison | Impact to Safety & Effec-
tiveness |
| | | | in the lung region between
two series belonging to
different time points. | |
| Quantitative algo-
rithms | Distance and angle measurements | Distance and angle measurements | Same | NA |
| Supported Image
Generating Modali-
ties | The following Image types are sup-
ported by syngo.via:
- CT Image (Computed Tomogra-
phy) - MR Image (Magnetic Resonance)
- NM Image (Nuclear Medicine)
- XA Image (X-Ray Angiography)
- US Image (Ultrasound)
- DX Image (Digital Radiography)
- DICOM secondary capture objects | The following Image types are sup-
ported by syngo.via: - CT Image (Computed Tomogra-
phy) - MR Image (Magnetic Resonance)
- NM Image (Nuclear Medicine)
- XA Image (X-Ray Angiography)
- US Image (Ultrasound)
- DX Image (Digital Radiography)
- DICOM secondary capture objects | Same | NA |
| Image data Com-
pression | Receive & Store:
Images are received and stored as re-
ceived without any change in the com-
pression format.
Display:
The images are displayed as received
without any change in the compres-
sion.
Lossy compression images are dis-
played with an indication to the user
with the compression ratio.
Export:
To DICOM node and Exchangeable
media: Images are sent as per the DI- | Receive & Store:
Images are received and stored as re-
ceived without any change in the com-
pression format.
Display:
The images are displayed as received
without any change in the compres-
sion.
Lossy compression images are dis-
played with an indication to the user
with the compression ratio.
Export:
To DICOM node and Exchangeable
media: Images are sent as per the DI- | Same | NA |
| | Subject device | Predicate device | Comparison | Impact to Safety & Effectiveness |
| | COM negotiation and depending on
Compression settings. Lossy compres-
sion is not supported. | COM negotiation and depending on
Compression settings. Lossy compres-
sion is not supported. | | |
| | Supported Compressions for export:
lossless compression algorithms,
JPEG, JPEG 2000 and RLE. | Supported Compressions for export:
lossless compression algorithms,
JPEG, JPEG 2000 and RLE. | | |
| Operating system | Client:
Microsoft Windows 7 SP1 or Mi-
crosoft Windows 8.1 or Microsoft
Windows 10
Server:
Microsoft Windows Server 2008 R2 or
Microsoft Windows Server 2012 R2.
or Microsoft Server 2016 | Client:
Microsoft Windows 7 SP1 or Mi-
crosoft Windows 8.1
Server:
Microsoft Windows Server 2008 R2 or
Microsoft Windows Server 2012 R2 | In the subject device client
supports the Microsoft
Windows 10 Operating
system and Server supports
Microsoft Windows Server
2016 additionally com-
pared to the predicate de-
vice. | This Operating System dif-
ference between the predi-
cate device and the subject
device doesn't impact the
safety and effectiveness of
the subject device as the
necessary measures taken for
the safety and effectiveness
of the subject device. |
| Impact on Image
Generating Devices | None
syngo.via is a pure post processing
software and no influence on the im-
age generating devices. | None
syngo.via is a pure post processing
software and no influence on the im-
age generating devices. | NA as both the devices do
not impact the Image gen-
erating devices. | NA |
| CAD Functionali-
ties | None.
No automated diagnostic interpretation
capabilities like CAD are included. All
image data are to be interpreted by
trained personnel.
Note: The LungCAD Navigation Tool
provides the user interface to visualize
the results of the external LungCAD
algorithm which is cleared with syn-
go.CT LungCAD as an accessory
(K143196). | None.
No automated diagnostic interpretation
capabilities like CAD are included. All
image data are to be interpreted by
trained personnel. | NA as both the devices
don't support any CAD
functionalities.
Note for Subject device:
The LungCAD Navigation
tool doesn't provide any
CAD Functionality rather
only provides the user in-
terface to view the results
generated by external
LungCAD algorithm. | NA |
| | Subject device | Predicate device | Comparison | Impact to Safety & Effec-
tiveness |
| Software self-test /
checks | Indicates the user in case that data
coming from an interface cannot be
assigned to a task flow to assign it
manually.
In case of a data mismatch due to in-
correct or inconsistent use of DICOM
rules the administrator can change the
data transfer protocol and patient
identification rules (DICOM Parser
Tool).
When the audit trail folder exceeds the
configured level of storage, a warning
message is sent to the administrator by
e-mail, if configured.
Client installation is prevented auto-
matically in case if the system doesn't
have the recommended operating sys-
tem. Also during the launch of the
client every time, the compatibility to
the server version is checked and re-
quest to update/upgrade to client in
case of mismatch.
Database recovery tool restores the
data if the integrity checks between
the Short term Storage and syngo.via
database fails.
A new instance of DICOM object is
created in case of any non-reversible
modification is performed on the DI-
COM Object (e.g. Lossy compres-
sion, reduction of color depth. | Indicates the user in case that data
coming from an interface cannot be
assigned to a task flow to assign it
manually.
In case of a data mismatch due to in-
correct or inconsistent use of DICOM
rules the administrator can change the
data transfer protocol and patient
identification rules (DICOM Parser
Tool).
When the audit trail folder exceeds the
configured level of storage, a warning
message is sent to the administrator by
e-mail, if configured.
Client installation is prevented auto-
matically in case if the system doesn't
have the recommended operating sys-
tem. Also during the launch of the
client every time, the compatibility to
the server version is checked and re-
quest to update/upgrade to client in
case of mismatch.
Database recovery tool restores the
data if the integrity checks between
the Short term Storage and syngo.via
database fails.
A new instance of DICOM object is
created in case of any non-reversible
modification is performed on the DI-
COM Object (e.g. Lossy compres-
sion, reduction of color depth. | Same | NA |
| | Subject device | Predicate device | Comparison | Impact to Safety & Effec-
tiveness |
| | resampling of image matrix, etc.) | resampling of image matrix, etc.) | | |
| Cyber Security | - User access control
- Audit trails
- Documentation of system security
information, Network traffic &
Firewall control - Support of virus / malware protec-
tion. - System Hardening
- Device guard | - User access control
- Audit trails
- Documentation of system security
information, Network traffic &
Firewall control - Support of virus / malware protec-
tion. | The security of the system
was increased over the
years by introducing the
System Hardening and the
Device Guard. | The new security functions
don't impact the safety and
effectiveness of the subject
device as the necessary
measures taken for the safety
and effectiveness of the sub-
ject device. |
| Hardware | Hardware is not understood as part of
the medical device, but needs to com-
ply with the minimum requirements as
specified by syngo.via. | Hardware is not understood as part of
the medical device, but needs to com-
ply with the minimum requirements as
specified by syngo.via. | Same | NA |
| Software functionalities | | | | |
| Workflow control | Workflows support the user in prepar-
ing images for examination. Based on
information such as modality and
body part, syngo.via assigns work-
flows to studies. | Workflows support the user in prepar-
ing images for examination. Based on
information such as modality and
body part, syngo.via assigns work-
flows to studies. | Same | NA |
| Graphical user in-
terface | Yes, with reduced color palette, clear-
er structure and text labels on icons.
Floating panels increases the user
friendliness as the user can move the
panels wherever they are convenient
with. | Yes, with reduced color palette, clear-
er structure and text labels on icons | In compared to the predi-
cate device, the subject
device has the option to
move certain panels (e.g.
Favorite Tools) wherever
he/she wants to. This
gives greater flexibility to
the user. | This difference between the
predicate device and the
subject device doesn't im-
pact the safety and effec-
tiveness of the subject de-
vice as the necessary
measures taken for the safe-
ty and effectiveness of the
subject device. |
| | Subject device | Predicate device | Comparison | Impact to Safety & Effectiveness |
| Image text | Yes, with Interactive Image text and configurable settings. | Yes, with additional configurable settings. | In the subject device there is an additional functionality that the selective image texts can be manipulated with mouse click and scroll. | This difference between the predicate device and the subject device doesn't impact the safety and effectiveness of the subject device as the necessary measures taken for the safety and effectiveness of the subject device. |
| Patient Browser | Yes, with simplified search functionality, clearer structure of search results, unlimited search results, periodic updates of search results, image preview and flexible floating patient browser window. | Yes, with simplified search functionality, clearer structure of search results, unlimited search results, periodic updates of search results, image preview and flexible floating patient browser window. | Same. | This difference between the predicate device and the subject device doesn't impact the safety and effectiveness of the subject device as the necessary measures taken for the safety and effectiveness of the subject device. |
| Series navigator | Yes, the Series Navigator lists all currently loaded data within a workflow.
Series Navigator supports the Thumbnail view and switching between Preview, List and Thumbnail views for both series and instances level. | Yes, the Series Navigator lists all currently loaded data within a workflow. | The subject device supports the Thumbnail views for Series and Instances and the user can switch between the List, Preview and Thumbnail views. | NA |
| Findings navigator / Findings Assistant | Yes, Findings Assistant lists all measurements, graphical objects, annotations, and snapshots. Additionally the user can create new findings, edit findings, trend findings over time, | The Findings Navigator lists all measurements, graphical objects, annotations, and snapshots. | Findings Navigator from the predicate device is renamed with Findings Assistant with the improvements like create findings, edit findings | This difference between the predicate device and the subject device doesn't impact the safety and effectiveness of the subject device as the necessary |
| | Subject device | Predicate device | Comparison | Impact to Safety & Effectiveness |
| | cluster findings based on body region. | | findings trending, and
cluster findings. | measures taken for the safety and effectiveness of the subject device. |
| Reporting | Yes, with functionality to create one
page reports, insert snapshot images,
customize reports, and data export in
various formats. Also with edit option
of the attributes of findings in the report editor & trend findings over time.
The automation of the supported
guidelines is filled on its own for easy
reference of the user. The integration
of the findings export with Nuance
Powerscribe 360 is enabled. | Yes, with functionality to create one
page reports, insert snapshot images,
customize reports, and data export in
various formats. | There are some minor improvements to the existing
reporting functionality
like standard guideline
automation based on user
entries, interfacing with
external reporting applications, findings trending. | This difference between the
predicate device and the
subject device doesn't impact the safety and effectiveness of the subject device as the necessary
measures taken for the safety and effectiveness of the subject device. |
| Correct and rearrange | Yes, for administrative users, correction capabilities and rearranging of data are added. | Yes, for administrative users, correction capabilities and rearranging of data are added. | Same | NA |
| Import and export
of data | Import of DICOM data from network
nodes or external media, and of DI-COM-compliant or non DICOM-
compliant data from external media
and Windows file system.
Export to CD/DVD, Windows file
system, or other DICOM nodes. | Import of DICOM data from network
nodes or external media, and of DI-COM-compliant or non DICOM-
compliant data from external media
and Windows file system.
Export to CD/DVD, Windows file
system, or other DICOM nodes. | Same | NA |
| Archiving data | Data can be sent to an archive if syn-go.via is connected to a PACS or corresponding DICOM node. | Data can be sent to an archive if syn-go.via is connected to a PACS or corresponding DICOM node. | Same | NA |
| Ranges | Yes, parallel, radial, Radial sliced,
Curved and Spine ranges are support | Yes, parallel, radial, Radial sliced,
Curved and Spine ranges are support | Same | NA |
| | Subject device | Predicate device | Comparison | Impact to Safety & Effec-
tiveness |
| | ed. Additionally supported all the
Ranges with anatomical range presets
for CT and MR images. | ed. Additionally supported all the
Ranges with anatomical range presets
for CT and MR images. | | |
| Spine/Rib labeling | Yes, with suggested spine labels to be
confirmed by the user, and additional
smart placement of labels, also in in-
ter-vertebra regions, support of 2D
images, support of multi-series stud-
ies, and added support for rib labels. | Yes, with suggested spine labels to be
confirmed by the user, and additional
smart placement of labels, also in in-
ter-vertebra regions, support of 2D
images, support of multi-series stud-
ies, and added support for rib labels. | Same | NA |
| Communication | Yes, Interface with DICOM, HL7 is
possible. | Yes, Interface with DICOM, HL7 is
possible. | Same | NA |
| Printing | Yes, with support to print image text,
apply same zoom factor for all select-
ed images and selection of DICOM
printer or paper printer. Also the di-
rect printing from Patient browser is
possible now and the administrator
can configure a default printer for the
client instead of user. | Yes, with support to print image text
and selection of DICOM printer or
paper printer. | The improvements include
the interactive zoom, di-
rect printing from Patient
browser and local printer
configuration in clients. | This difference between the
predicate device and the
subject device doesn't im-
pact the safety and effec-
tiveness of the subject de-
vice as the necessary
measures taken for the safe-
ty and effectiveness of the
subject device. |
| Online help system | Yes, with search, indexing, filtering,
library function, document collec-
tions, and user-generated content. | Yes, with search, indexing, filtering,
library function, document collec-
tions, and user-generated content. | Same | NA |
| Markers and anno-
tations | Yes,
with support for marking a posi-
tion on an image and textual an- | Yes,
with support for marking a posi-
tion on an image and textual an- | Same | NA |
| Subject device | Predicate device | Comparison | Impact to Safety & Effec-
tiveness | |
| notations. | notations. | | | |
| - with added textual and graphical
annotations, improved placement
of measurement text, and
changed numbering of markers. | - with added textual and graphical
annotations, improved placement
of measurement text, and
changed numbering of markers. | | | |
22 syngo via VB (0A was manufactured by Siement Solutions during the time of its filing. Late-on legal manufacturer change was performed to Siemens Healthcare GmbH. So finally, the legal manufacturer is identical for both devices.
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23 Rib Labeling as a functionality was already covered by a 510(k) clearance with device syngo.CT Bone Reading, K123584.
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8
9
10
11
12
13
14
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8. Non-clinical Performance Testing:
Non-clinical tests were conducted for the device syngo.via during product development. The modifications described in this Premarket Notification were supported with verification and validation testing.
Siemens Healthcare GmbH claims conformance to the following standards:
- NEMA PS 3.1 3.20 (2016) Digital Imaging and Communications in Medicine (DI--COM) Set
- ISO/IEC 10918-1 First edition 1994-02-15 + Technical Corrigendum 1 (2005) -(JPEG)
- ISO/IEC 15444-1:2016 (JPEG2000) -
- ISO 14971 Second edition 2007-03-01 -
- IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION -
- -IEC 82304-1 Edition 1.0 2016-10
- IEC 62366-1 Edition 1.0 2015-02 -
- IEEE Std 3333.2.1-2015 -
- ISO/HL7 21731:2014 (Version 2.x) -
Software Verification and Validation:
Software documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 is also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software. Non-clinical tests were conducted on the device syngo.via during product development.
The Risk Analysis 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 to support the claims of substantial equivalence.
Siemens Healthcare GmbH conforms to the Cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient. Contained in Section B of this submission are our cybersecurity considerations as they relate to the device syngo.via.
Summary:
Performance tests were conducted to test the functionality of the device syngo.via. These tests have been performed to assess the functionality of the subject device. Results of all conducted testing were found acceptable in supporting the claim of substantial equivalence.
16
9. Safety and Effectiveness Information:
Software specifications, design descriptions, hazard analysis, and labeling information are submitted in support of this premarket notification. The device labeling contains instructions for use with cautions to provide for safe and effective use of the device.
The results of the hazard analysis combined with the appropriate preventive measures taken indicate the device is of moderate level of concern, as per the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005).
10. Conclusion as to Substantial Equivalence:
The predicate device was cleared based on non-clinical supportive information. The comparison of technological characteristics, device hazards, non-clinical performance data, and software validation data demonstrates that the subject device performs comparably to and is as safe and effective as the predicate device that is currently marketed for the same intended use.
In summary, we are of the opinion that the subject device syngo.via, software version VB40A, does not introduce any new significant potential safety risks and is substantially equivalent to and performs as well as the predicate device.