(211 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: No". While it mentions image processing and intelligent work tools, there is no indication that these tools utilize AI or ML.
No
The device is a software intended for displaying, rendering, and post-processing medical data and images. Its purpose is to support medical professionals in reviewing and analyzing images, not to provide therapy or directly treat a disease.
Yes
The "Diagnostic Workspace" variant of the software is explicitly indicated for display, rendering, and post-processing of medical data, mostly medical images, within healthcare institutions for use in fields like Radiology, Nuclear Medicine, and Cardiology. This implies that the software provides tools to assist medical professionals in making a diagnosis based on these images and data.
Yes
The device description explicitly states "Syngo Carbon Space is a software only medical device which is intended to be installed on recommended common IT Hardware. The hardware is not seen as part of the medical device."
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is to display, review, and analyze medical images and data. This is focused on interpreting images and information from the patient, not on performing tests on samples taken from the patient.
- Device Description: The description emphasizes the software's role in displaying and processing medical images for review by healthcare professionals. It's a tool for interpreting existing data, not for generating new diagnostic data from biological samples.
- Lack of Mention of Biological Samples: There is no mention of the device being used with biological samples (blood, urine, tissue, etc.), which is a core characteristic of IVDs.
- Focus on Image Modalities: The input modalities are all imaging modalities (CR, CT, MR, etc.), which produce images, not results from in vitro tests.
In summary, the device is clearly described as a medical image viewing and analysis software, which falls under the category of medical devices but not specifically In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
Syngo Carbon Space is a software intended to display medical data and to support the review and analysis of medical images by trained medical professionals.
Syngo Carbon Space "Diagnostic Workspace" is indicated for display, rendering, post-processing of medical data (mostly medical images) within healthcare institutions, for example, in the field of Radiology, Nuclear Medicine and Cardiology.
Syngo Carbon Space "Physician Access" is indicated for display and rendering of medical data within healthcare institutions.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
Syngo Carbon Space is a software only medical device which is intended to be installed on recommended common IT Hardware. The hardware is not seen as part of the medical device. Syngo Carbon Space is intended to support reviews and analysis of medical images by trained medical practitioners. The software is used in Radiology for reading images and throughout the healthcare institutions for image & result distribution.
Syngo Carbon Space is a medical device, provided in two variants/options.
-Diagnostic Workspace (Fat/Thick Client)
-Physician Access (Thin/Web Client)
In any scenario, both the options can be installed/run on the same machine and be used simultaneously.
Syngo Carbon Space Diagnostic Workspace provides a reading workspace for Radiology that supports display of medical image data & documents and connects intelligent work tools (diagnostic and non-diagnostic software elements) to enable easy access to the data needed, easy access to external tools and creation of actionable results.
Syngo Carbon Space Physician Access provides a zero-footprint web application for enterprise-wide viewing of DICOM, non-DICOM, multimedia data and clinical documents to facilitate image and result distribution in the healthcare institution.
Since Syngo Carbon Space is a software only product, shelf-life is not applicable because of low likelihood of time-dependent product degradation. Hence performance data is not needed to establish maintenance of device performance characteristics over the shelf-life period
Syngo Carbon Space is a software only medical device, which is delivered by download only option to be installed on common IT hardware. This hardware must 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 and therefore not in the scope of this 510(k) submission.
Syngo Carbon Space provides tools and features to cover the radiological tasks reading images and support reporting through third party tools. It supports DICOM and Non-DICOM objects. In a comprehensive imaging suite, Syngo Carbon Space interoperates with a Radiology Information System (RIS) to enable customer specific workflows.
Syngo Carbon Space 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. The client provides the user interface for interactive image viewing and processing and can be installed and started on each workplace that has a network connection to the server.
Syngo Carbon Space 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 Carbon Space software version VA20A, as well as the predicate device, syngo.via, software version VB40A.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM image object display:
• CR Image
• CT Image
• DX Image
• ES Image
• GM Image
• MG Image
• MR Image
• NM Image
• PET Image
• OP/OPT Image
• RF Image
• RT IMAGE
• SM (WSI)
• XA Image
• US Image
• Secondary capture objects
DICOM non-image object display:
• ECG
• Encapsulated PDF
• PR
Non-DICOM file display:
• Images: BMP, GIF, JPEG (JFIF), JPEG 2000, JPEG-LE, JPEG-LS, PCX, PNG, PNM, TIFF, WBMP
• Video: FLV, H.264, H.265, INDEO2, INDEO3, INDEO4, MPEG1, MPEG2, MPEG4
• Text Documents: CDA (XML), PDF
Anatomical Site
No limitation concerning region of body or tissue type
Indicated Patient Age Range
No limitation concerning the patient population (e.g., age, weight, health, condition)
Intended User / Care Setting
Intended Users: Trained healthcare professionals
Care Setting Enviornment:
Syngo Carbon Space "Diagnostic Workspace" is used in Radiology, Nuclear Medicine and Cardiology environments (e.g., darkened/ shaded rooms).
Syngo Carbon Space "Physician Access" is used in departmental environments within healthcare institutions.
For reading images certified monitors are required (e.g., medical diagnostic displays).
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)
Bench Testing Evaluation Summary: The results of phantom and reader studies conducted on the Lesion Segmentation Algorithm were evaluated for fit for use in the subject device and it was concluded that the Algorithm can be integrated in the subject device with few design mitigations to overcome the drawbacks/limitations specified in these studies. These design mitigations were validated by Non-Clinical performance testing of the subject device and were found acceptable.
Non-clinical tests were conducted for the device Syngo Carbon Space during product development. The modifications described in this Premarket Notification were supported with verification and validation testing.
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" 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 Carbon Space 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.
Summary: Performance tests were conducted to test the functionality of the device Syngo Carbon Space. 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Siemens Healthcare GmbH % Vijay Ramadas Regulatory Affairs Manager Siemensstr. 1 Forchheim. Baveria 91301 GERMANY
June 21, 2022
Re: K213665
Trade/Device Name: Syngo Carbon Space VA20A Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: May 16, 2022 Received: May 19, 2022
Dear Vijay Ramadas:
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
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see 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
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Indications for Use
510(k) Number (if known) K213665
Device Name Syngo Carbon Space VA20A
Indications for Use (Describe)
Syngo Carbon Space is a software intended to display medical data and to support the review and analysis of medical images by trained medical professionals.
Syngo Carbon Space "Diagnostic Workspace" is indicated for display, rendering, post-processing of medical data (mostly medical images) within healthcare institutions, for example, in the field of Radiology, Nuclear Medicine and Cardiology.
Syngo Carbon Space "Physician Access" is indicated for display and rendering of medical data within healthcare institutions.
| 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 Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a graphic of orange dots.
Traditional 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.
-
- Submitter: Siemens Healthcare GmbH Henkestrasse 127 91052 Erlangen Germany
-
- Establishment Registration Number: 3004977335
3. Contact Person:
Mr. Vijay Ramadas Regulatory Affairs Manager Siemens Healthcare GmbH, Siemensstr. 1 91301 Forchheim Germany
E-mail: vijay.ramadas(@siemens-healthineers.com Telephone: +49 (172) 4324369 Fax: +49 (9191) 18-4404
4. Device Name and Classification
| Device/Trade Name: | Syngo Carbon Space (VA20A) |
|---|---|
| Classification Panel: | Radiology |
| Classification Number: | 21 CFR 892.2050 |
| Classification Name: | Medical Image Management and Processing System |
| Device Class: | Class II |
| Product Code: | LLZ |
5. Legally Marketed Predicate Device:
| Device/Trade Name: | syngo.via (VB40A) |
|---|---|
| 510(k) Clearance: | K191040 |
| Clearance Date: | May 16, 2019 |
| 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
6. Device Description:
Syngo Carbon Space is a software only medical device which is intended to be installed on recommended common IT Hardware. The hardware is not seen as part of the medical device. Syngo Carbon Space is intended to support reviews and analysis of medical images by trained medical practitioners. The software is used in Radiology for reading images and throughout the healthcare institutions for image & result distribution.
Syngo Carbon Space is a medical device, provided in two variants/options.
- Diagnostic Workspace (Fat/Thick Client) -
- -Physician Access (Thin/Web Client)
In any scenario, both the options can be installed/run on the same machine and be used simultaneously.
Syngo Carbon Space Diagnostic Workspace provides a reading workspace for Radiology that supports display of medical image data & documents and connects intelligent work tools (diagnostic and non-diagnostic software elements) to enable easy access to the data needed, easy access to external tools and creation of actionable results.
Syngo Carbon Space Physician Access provides a zero-footprint web application for enterprise-wide viewing of DICOM, non-DICOM, multimedia data and clinical documents to facilitate image and result distribution in the healthcare institution.
Since Syngo Carbon Space is a software only product, shelf-life is not applicable because of low likelihood of time-dependent product degradation. Hence performance data is not needed to establish maintenance of device performance characteristics over the shelf-life period
Syngo Carbon Space is a software only medical device, which is delivered by download only option to be installed on common IT hardware. This hardware must 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 and therefore not in the scope of this 510(k) submission.
Syngo Carbon Space provides tools and features to cover the radiological tasks reading images and support reporting through third party tools. It supports DICOM and Non-DICOM objects. In a comprehensive imaging suite, Syngo Carbon Space interoperates with a Radiology Information System (RIS) to enable customer specific workflows.
Syngo Carbon Space 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. The client provides the user interface for interactive image viewing and processing and can be installed and started on each workplace that has a network connection to the server.
Syngo Carbon Space 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 Carbon
5
Space software version VA20A, as well as the predicate device, syngo.via, software version VB40A.
7. Intended Use:
Syngo Carbon Space is a software intended to display medical data and to support the review and analysis of medical images by trained medical professionals.
8. Indications for Use:
Syngo Carbon Space is a software intended to display medical data and to support the review and analysis of medical images by trained medical professionals.
Syngo Carbon Space "Diagnostic Workspace" is indicated for display, rendering, postprocessing of medical data (mostly medical images) within healthcare institutions, for example, in the field of Radiology, Nuclear Medicine and Cardiology.
Syngo Carbon Space "Physician Access" is indicated for display and rendering of medical data within healthcare institutions.
6
9. 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:
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &
Effectiveness |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name
and version (K
number) | Syngo Carbon Space VA20A | syngo.via VB40A (K191040) | New product | NA |
| Manufacturer | Siemens Healthcare GmbH | Siemens Healthcare GmbH | Same | NA |
| Indications for
use | Syngo Carbon Space is a software
intended to display medical data and to
support the review and analysis of
medical images by trained medical
professionals.
Syngo Carbon Space "Diagnostic
Workspace" is indicated for display,
rendering, post-processing of medical
data (mostly medical images) within
healthcare institutions, for example, in
the field of Radiology,
Nuclear
Medicine and Cardiology.
Syngo Carbon Space "Physician
Access" is indicated for display and
rendering of medical data within
healthcare institutions. | 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. | Syngo Carbon Space is a
device available in two
options,
Diagnostic
Workspace
(Thick Client)
Physician Access
(Web Client)
with same intended use
and Indications to use.
Additionally, Syngo
Carbon Space displays
Non-DICOM Artifacts | Display of Non-
DICOM artifacts in
the subject device
doesn't impact the
safety and
effectiveness of the
device, as necessary
measures have been
taken |
7
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &
Effectiveness |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contraindications | Syngo Carbon Space "Diagnostic
Workspace" is not intended for
diagnosis of digital mammography
images.
Syngo Carbon Space "Diagnostic
Workspace" is not intended to be
used as a sole basis for clinical
decisions.
Syngo Carbon Space "Physician
Access" is not intended for diagnosis
of digital mammography images.
Syngo Carbon Space "Physician
Access" is not intended to be used
for diagnostic purpose on mobile
devices in the United States of
America (USA).
Syngo Carbon Space "Physician
Access" is not intended to be used as
a sole basis for clinical decisions. | The system is not intended for the
displaying of digital mammography
images for diagnosis in the U.S. | The subject device
includes additional
contraindication
statements which acts as
a caution to the user
about the usage of the
device while making a
clinical decision from
medical images or
clinical documents. | The difference in
'contra-Indications'
between the
predicate device and
the subject device
doesn't impact the
safety and
effectiveness of the
subject device as
necessary measures
have been taken |
| Software
architecture | Syngo Carbon Space is based on a
client-server architecture | syngo.via is based on a client-server
architecture | Same | NA |
8
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &
Effectiveness |
|----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Image
communication | Standard network protocols like
TCP/IP and standard communication
protocol including DICOM (2016a)
and non-DICOM objects. Supports
interfacing with HL7 (v2.5 / v2.3.1 /
v2.3 / FHIR R4). | Standard network protocols like
TCP/IP and standard communication
protocol including DICOM (2016a)
objects. Allows interfacing with
HL7 (v2.5 / v2.3.1 / v2.3). | Syngo Carbon Space
additionally allows
communication with
non-DICOM artefacts
and FHIR interface | The difference in
image
communication
between the
predicate device and
the subject device
doesn't impact the
safety and
effectiveness of the
subject device as
necessary measures
have been taken |
| Image display
algorithms | MPR: MPR, MPR Thick, MPR/MPR* MIP: MIP, MIP Thin MinIP View VRT*: Plain VRT, Adapt VRT, VRT Thin, Cinematic VRT Fused View * Invert Image * available in in Diagnostic
Workspace only | MPR: MPR, MPR Thick, MPR/MPR MIP: MIP, MIP Thin MinIP View VRT: Plain VRT, Adapt VRT, VRT Thin, Cinematic VRT Fused View Invert Image | Same | NA |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &
Effectiveness |
| Measurement,
Evaluation/Inte
rpretation
Tools | • Distance (Distance line, Distance
Polyline)
• Angle
• 2D ROI (Circle, Freehand,
Polygonal, Auto Contour) *
• 3D VOI (Sphere, Freehand) *
• Pixel Lens
• Ranges (Parallel, Radial, Radial
Sliced, Curved, Spine) *
• Lesion Quantification *
• Assisted Perpendicular Tool*
• Automatic Organ Segmentation*
• Interactive Tissue Segmentation*
• Time Curve, Time ROI*
• SUV Measurement*
• Automatic Anatomy Labeling (rib,
spine) *
• Next Study/ Previous Study*
• Time Curve, Time ROI*
- available in in Diagnostic
Workspace only | • Distance (Distance Line,
Distance Polyline)
• Angle
• 2D ROI (Circle, Freehand,
Polygonal)
• 3D VOI (Sphere, Freehand)
• Pixel Lens
• Ranges (Parallel, Radial, Radial
Sliced, Curved, Spine, Vascular)
• Assisted Perpendicular Tool
• Automatic Organ Segmentation
• Interactive Tissue Segmentation
• Time Curve, Time ROI
• Define Vessel
• SUV Measurement
• Automatic Anatomy Labeling
(rib, spine)
• Basic Onco Tool (Assisted
Perpendicular Tool)
• Change Visualization
• Next Study/ Previous Study | The
evaluation/interpretation
functionalities in the
subject device are
enhanced.
Lesion Quantification
Enables the user to
perform diameter
measurements and to
create segmentation
objects of suspect lesions
in lung parenchyma. This
is a non-Deep learning
algorithm | This differences
between the
predicate device and
the subject device
doesn't impact the
safety and
effectiveness of the
subject device as the
necessary measures
taken |
| Supported
objects
for display | DICOM image object display: | DICOM image object display: | The subject device
supports additional
image object types for
display: | This difference in
supported DICOM
modality and Non-
DICOM object types
between the
predicate device and
the subject device
doesn't impact the
safety and
effectiveness of the
subject device as
necessary measures
have been taken |
| | DICOM image object display:
• CR Image
• CT Image
• DX Image
• ES Image
• GM Image
• MG Image
• MR Image
• NM Image
• PET Image
• OP/OPT Image
• RF Image
• RT IMAGE
• SM (WSI)
• XA Image
• US Image
• Secondary capture objects | DICOM image object display:
• CR Image
• CT Image
• DX Image
• MG Image
• MR Image
• NM Image
• PET Image
• XA Image
• US Image
• Secondary capture objects | DICOM image object
display:
• ES Image
• GM Image
• OP/OPT Image
• SM (WSI)
DICOM non-image
object display:
• ECG
• Encapsulated PDF
• PR
Non-DICOM file
display:
• Images: BMP, GIF,
JPEG (JFIF), JPEG
2000, JPEG-LE,
JPEG-LS, PCX,
PNG, PNM, TIFF,
WBMP
• Video: FLV, H.264,
H.265, INDEO2,
INDEO3, INDEO4,
MPEG1, MPEG2,
MPEG4, VP8, VP9, | |
| | DICOM non-image object display:
• ECG
• Encapsulated PDF
• PR
Non-DICOM file display:
• Images: BMP, GIF, JPEG
(JFIF), JPEG 2000, JPEG-LE,
JPEG-LS, PCX, PNG, PNM,
TIFF, WBMP
• Video: FLV, H.264, H.265,
INDEO2, INDEO3, INDEO4,
MPEG1, MPEG2, MPEG4 | | | |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety & Effectiveness |
| | VP8, VP9, WMV1, WMV2, WMV3
• Text Documents: CDA (XML), PDF | | WMV1, WMV2, WMV3
• Text Documents: CDA (XML), PDF | |
| Operating
system | Diagnostic Workspace | Windows client | In the subject device | This Operating |
| | Server | | client supports Microsoft | System difference |
| | Microsoft Windows Server 2019 Windows 10 IoT Red Hat Enterprise Linux 8.4 | Microsoft Windows 7 SP1 Microsoft Windows 8 (8.1 Pro, 8.1 Enterprise) Microsoft Windows 10 (Home, Pro, Education, Enterprise) | Windows 10 Operating
system and Server
supports Microsoft
Windows Server 2019,
Windows 10 IoT, and
Red Hat Enterprise
Linux 8.4 compared to
the predicate device. | between the |
| | Client | | | predicate device and |
| | Microsoft Windows 10
(Pro, Pro-Education, Enterprise) | Windows Server | | the subject device |
| | | Microsoft Windows Server
2008 R2 Microsoft Windows Server
2012 R2 Microsoft Windows Server
2016 | | doesn't impact the |
| | Physician Access | | | safety and |
| | Server | | | effectiveness of the |
| | Red Hat Enterprise Linux 8.4 | | | subject device as |
| | Client - Workplace
All operating systems that with
support for the following HTML5-
and JavaScript enabled browsers: | | | necessary measures
have been taken |
| | Google Chrome ≥ 83
(tested and recommended) Microsoft Internet Explorer ≥
11
(not recommended) Microsoft Edge ≥ 83
(tested and recommended:
Edge 89) Mozilla Firefox ≥ 78 Mozilla Firefox ESR ≥ 78 Apple Safari ≥ 13 | | | |
| | Client - Mobile device
iPadOS > 14, Safari web browser | | | |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety & Effectiveness |
| Impact on
Image
Acquisition
Devices | None
Syngo Carbon Space is a pure viewing and/or post-processing software and it has no influence on the image acquisition devices. | None
syngo.via is a pure viewing and/or post-processing software and it has no influence on the image acquisition devices. | Same | NA |
| CAD
Functionalities | None
No automated diagnostic interpretation capabilities like CAD are included. All image data are to be interpreted by trained personnel. | None
No automated diagnostic interpretation capabilities like CAD are included. All image data are to be interpreted by trained personnel. | Same | NA |
| Clinical
condition the
device is
intended to
diagnose, treat,
or manage | No limitation on the clinical condition of the patient. | No limitation on the clinical condition of the patient. | Same | NA |
| Intended
patient
population | No limitation concerning the patient population (e.g., age, weight, health, condition) | No limitation concerning the patient population (e.g., age, weight, health, condition) | Same | NA |
| Site of the body
the device is
intended to be
used | No limitation concerning region of body or tissue type | No limitation concerning region of body or tissue type | Same | NA |
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| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &
Effectiveness |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use
environment | Syngo Carbon Space "Diagnostic
Workspace" is used in Radiology,
Nuclear Medicine and Cardiology
environments (e.g., darkened/ shaded
rooms).
Syngo Carbon Space "Physician
Access" is used in departmental
environments within healthcare
institutions.
For reading images certified monitors
are required (e.g., medical diagnostic
displays). | syngo.via is used in Radiology,
Nuclear Medicine, and Cardiology
environments (e.g., darkened/
shaded rooms).
For reading images certified
monitors are required (e.g. medical
diagnostic displays). | Same | NA |
| Intended
user(s) | Trained healthcare professionals | Trained healthcare professionals | Same | NA |
| Device Type | Software application | Software application | Same | NA |
| Software
architecture | Syngo Carbon Space is based on a
client-server architecture | syngo.via is based on a client-server
architecture | Same | NA |
| Software self-
test / checks | | | Same | NA |
| | Client installation is prevented
automatically in case if the system
doesn't have the recommended
operating system. Also during the
launch of the client every time, the
compatibility to the server version is
checked and request to
update/upgrade to client in case of
mismatch. | 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
incorrect 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
automatically in case if the system
doesn't have the recommended
operating system. Also during the
launch of the client every time, the
compatibility to the server version is
checked and request 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 | | |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &
Effectiveness |
| | | modification is performed on the
DICOM Object (e.g. Lossy
compression, reduction of color
depth, resampling of image matrix,
etc.) | | |
| Cyber Security | • User access control
• Audit Trail
• Documentation of system
security information, Network
traffic & Firewall control
• Support of virus / malware
protection
• System Hardening (OS level and
Network level) | • User access control
• Audit Trail
• Documentation of system
security information, Network
traffic & Firewall control
• Support of virus / malware
protection.
• System Hardening
• Device guard (Whitelisting) | The security of the
subject device was
improved by enhancing
the System Hardening at
OS level as well as
Network Level.
OS level: The
technologies (operating
system, browser, web
server etc.) used in IT
systems attached to the
network are hardened
(configured securely)
according to the IASE
DISA standard.
Network level: Provides
protection to the system
from malicious network
traffic. | The improved
security function
doesn't impact the
safety and
effectiveness of the
subject device as the
necessary measures
taken |
| Hardware | Hardware is not understood as part of
the medical device but needs to
comply with the minimum
requirements as specified by Syngo
Carbon Space. | Hardware is not understood as part
of the medical device but needs to
comply with the minimum
requirements as specified by
syngo.via. | Same | NA |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &
Effectiveness |
| Graphical user
interface | Yes, with reduced color palette,
clearer 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,
clearer structure, and text labels on
icons. Floating panels increases the
user friendliness as the user can
move the panels wherever they are
convenient with. | Same | NA |
| Patient
Browser | Search, browse & open data for
display from syngo.share core &
remote DICOM nodes Search, browse & open data for
display from external XDS(-I)
repository) ** Archive functionality (upload
medical data to syngo.share core
for archive) Document properties functions
(metadata modification and
tagging) Correct & re-arrange functions Restore (trigger fetch from
archive) functions Distribution, export & sharing
functions Inbox - access to medical data
shared by other users ** *available in Physician Access only | Simplified search functionality,
clearer structure of search results,
unlimited search results, periodic
updates of search results, image
preview, Correct & re-arrange and
flexible floating patient browser
window. | Syngo Carbon Space has
an additional feature
"Inbox" | The Inbox feature in
the subject device
doesn't impact the
safety and
effectiveness of the
device as necessary
measures have been
taken |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &
Effectiveness |
| Series
navigator /
Document
Preview | Yes, with a fast overview of the
displayed and not displayed data
(series, images) of the loaded studies,
identify not yet seen series/images,
quickly identify the relevant
series/images for reading, and bring
data (timepoints/series/images) into
display in an efficient manner
(Drag&Drop).
Study / Timepoints are marked with
individual colors for better
identification.
The Series Navigator is called
Document Preview for Physician
Access.
- available in in Diagnostic
Workspace only | 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. | The functionality is
enhanced in the subject
device. | This series navigator
difference between
the predicate device
and the subject
device doesn't
impact the safety and
effectiveness of the
subject device as
necessary measures
have been taken |
| Findings panel | Findings panel collects
measurements, annotations, and
graphical objects. Additionally, the
user can create new findings, edit
findings. It also allows creation of
automatic findings. | Findings Navigator collects
measurements, annotations, and
graphical objects. Additionally, the
user can create new findings, edit
findings, trend findings over time,
cluster findings based on body
region. | The functionality is
enhanced in the subject
device.
The Findings panel in the
subject device
additionally provides
automatic findings
creation option to create
structured findings. | This difference in
findings assistant
between the
predicate device and
the subject device
doesn't impact the
safety and
effectiveness of the
subject device as
necessary measures
have been taken |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &
Effectiveness |
| Reporting | No dedicated report creation
functionality supported in Syngo
Carbon Space.
Structured findings can be
automatically transferred to external
third-party reporting system via FHIR
interface for creation of structured
report content [e.g. (Powerscribe [by
Nuance], SmartReports [by Smart
Reporting)] | Findings and measurements are
automatically sent to the syngo.via
short Term Storage (STS) tracked
and listed by the syngo.via. The
radiologist can save or print a report,
or send it to a connected information
system, such as a HIS or RIS. | The reporting
functionality in the
subject device is
modified and connected
to third-party reporting
solutions when compared
to the predicate device. | This difference in
reporting
functionality
between the
predicate device and
the subject device
doesn't impact the
safety and
effectiveness of the
subject device as
necessary measures
have been taken |
| Image
Archiving | Diagnostic Workspace:
Syngo Carbon Space Diagnostic
Workspace does not store data or
images.
Created results for a study (e.g.
DICOM PR, SR objects) are stored in
syngo.share core in context of the
original study. syngo.share core is
responsible for long term archiving of
the original study and created results.
Physician Access:
Not applicable since Syngo Carbon
Space Physician Access does not
create data or images that is
transferred/stored | Data can be sent to an archive if
syngo.via is connected to a PACS or
corresponding DICOM node. | New option in the
functionality of the
subject device.
The image archiving in
the subject device takes
place via syngo.share
core option. | This difference of
image archiving
between the
predicate device and
the subject device
doesn't impact the
safety and
effectiveness of the
subject device as
necessary measures
have been taken |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &
Effectiveness |
| Patient Jacket | Provides access to patient history –
other studies of patient stored in
syngo.share core or
remote DICOM nodes. Also provides
a study content preview. | The Add study dialog allows to
query and retrieve studies from
remote DICOM nodes for same
patient | The Patient Jacket is
enhanced with the
feature, study content
preview (thumbnail
image for image series) | This difference of
patient jacket
between the
predicate device and
the subject device
doesn't impact the
safety and
effectiveness of the
subject device as
necessary measures
have been taken |
| Optimization &
preparation/
Spatial
Operation tools | Image Preview Zoom/Pan Fit to Segment*, Fit to
Acquisition Size* Synch, Align Windowing Rotate (2D image or 3D
Volume*) Flip (Horizontal, Vertical) Shutters On/Off* Blow-up Scroll Movie Clipping* Punching and Masking* Magnifier * available in in Diagnostic
Workspace only | Image Preview Zoom/Pan Fit to Segment, Fit to
Acquisition Size Synch, Align Windowing Rotate (2D image or 3D
Volume) Flip (Horizontal, Vertical) Shutters On/Off Blow-up Scroll Movie Clipping Punching and Masking | There are enhancements
to the interaction tool
algorithm in the subject
device compared to the
predicate device.
Magnifier
The Magnifier tool
allows the user to
magnify a section of the
image in order to get a
closer view of the
section. | This difference in
interaction tool
between the
predicate device and
the subject device
doesn't impact the
safety and
effectiveness of the
subject device as
necessary measures
have been taken |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety & Effectiveness |
| Annotation Tool | Arrow* Marker* Text * available in in Diagnostic Workspace only | Arrow Marker Text | Same | NA |
| Printing | Diagnostic workspace:
Structured findings can be printed on a paper printer.
Physician Access:
Provides printing functionality on a paper printer. | Provides printing functionality at a DICOM printer or on paper printer.
User may preview and re-arrange the images on the print sheet printing. The print sheet supports basic manipulations like zoom/pan and windowing. | Both the subject and predicate devices have the option for paper printing. | This difference in printing between the predicate device and the subject device doesn't impact the safety and effectiveness of the subject device as necessary measures have been taken |
| Online help system | Yes, with search, indexing, filtering, library function and document collections. | Yes, with search, indexing, filtering, library function, document collections, and user-generated content. | Same | NA |
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10. Clinical Testing
No clinical studies were carried out for the product, all performance testing was conducted in a non-clinical fashion as part of verification and validation activities of the medical device
11. Bench Testing Evaluation Summary
The results of phantom and reader studies conducted on the Lesion Segmentation Algorithm were evaluated for fit for use in the subject device and it was concluded that the Algorithm can be integrated in the subject device with few design mitigations to overcome the drawbacks/limitations specified in these studies. These design mitigations were validated by Non-Clinical performance testing of the subject device and were found acceptable.
12. Non-clinical Performance Testing:
Non-clinical tests were conducted for the device Syngo Carbon Space 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 -(DICOM) Set
- ISO/IEC 10918-1 First edition 1994-02-15 + Technical Corrigendum 1 (2005) -(JPEG)
- ISO 14971 Third Edition 2019-12 -
- -IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION
- IEC 82304-1 Edition 1.0 2016-10 -
- IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION -
- -IEEE Std 3333.2.1-2015
13. 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" 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 Carbon Space 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 Carbon Space.
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14. Summary:
Performance tests were conducted to test the functionality of the device Syngo Carbon Space. 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.
15. Safety and Effectiveness Information:
Software specifications, 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
16. 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 Carbon Space, software version VA20A, does not introduce any new significant potential safety risks and is substantially equivalent to and performs as well as the predicate device syngo.via VB40A.