(21 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on image display, rendering, and post-processing tools without mentioning any AI/ML capabilities.
No
The device is a software intended to display and process medical data and images for review and analysis by trained medical professionals, not to directly treat or cure a disease or condition.
Yes
This device explicitly states that its "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." It also mentions supporting the review and analysis of medical images by trained medical professionals for reading, which are key aspects of diagnostic processes.
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 text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description of Syngo Carbon Space clearly states its purpose is to "display medical data and to support the review and analysis of medical images." It focuses on processing and presenting existing medical images and data, not on analyzing biological samples.
- Input Data: The input modalities listed are primarily imaging modalities (CR, CT, MR, etc.) and non-image data like ECGs and documents. There is no mention of analyzing biological samples.
- Intended Use: The intended use is for trained medical professionals to review and analyze medical images within healthcare institutions. This is consistent with image viewing and analysis software, not IVD testing.
Therefore, Syngo Carbon Space is a medical device for image viewing and analysis, not an In Vitro Diagnostic device.
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
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 the 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 and the predicate device.
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, VP8, VP9, WMV1, WMV2, WMV3
• 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
Trained healthcare professionals
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
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.
The results of phantom and reader studies conducted on the Lesion Quantification Algorithm, in the predicate device, 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 were found acceptable.
There are no changes to the algorithm and its performance that requires a new bench testing for the subject device. The results/summary from the predicate device is still applicable for the subject device.
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 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.
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
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 two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Siemens Healthcare GmBH % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k SAINT PAUL MN 55114
March 21, 2023
Re: K230561
Trade/Device Name: Syngo Carbon Space VA30A Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: II Product Code: LLZ Dated: February 28, 2023 Received: February 28, 2023
Dear Prithul Bom:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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/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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Jessica Lamb
Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K230561
Device Name Syngo Carbon Space (VA30A)
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) | |
|---|---|
| ------------------------------------------------- | -- |
X 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/0 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. Below the logo is the date "December 09, 2022".
Traditional 510(k) Summary
K230561
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.
1. Submitter:
Siemens Healthcare GmbH Henkestrasse 127 91052 Erlangen Germany
2. Establishment Registration Number: 3004977335
3. Contact Person:
Mr. Vijay Ramadas Regulatory Affairs Manager Siemens Healthcare GmbH, Siemensstr. 3 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 (VA30A) |
|---|---|
| Classification Panel: | Radiology Devices |
| Classification Number: | 21 CFR 892.2050 |
| Classification Name: | Medical Image Management and Processing System |
| Device Class: | Class II |
| Product Code: | LLZ |
5. Predicate Device(s):
Main Predicate Device:
| Device/Trade Name: | Syngo Carbon Space (VA20A) |
|---|---|
| K Number | K213665 |
| Classification Panel: | Radiology Devices |
| Classification Number: | 21 CFR 892.2050 |
| Classification Name: | Medical Image Management and Processing System |
| Device Class: | Class II |
| Product Code: | LLZ |
4
Reference Predicate Device 1:
| Device/Trade Name: | syngo.via (Version VB40A) |
|---|---|
| K Number | K191040 |
| Classification Panel: | Radiology Devices |
| Classification Number: | 21 CFR 892.2050 |
| Classification Name: | Picture archiving and communications system |
| Device Class: | Class II |
| Product Code: | LLZ |
Reference Predicate Device 2:
| Device/Trade Name: | syngo.plaza |
|---|---|
| K Number | K180563 |
| Classification Panel: | Radiology Devices |
| Classification Number: | 21 CFR 892.2050 |
| Classification Name: | Picture archiving and communications system |
| Device Class: | Class II |
| Product Code: | LLZ |
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
5
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 the 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 and the predicate device.
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 described in this premarket notification (Highlighted) and the following comparison table:
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &
Effectiveness |
|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name
and version | Syngo Carbon Space VA30A | Syngo Carbon Space VA20A
(K213665) | New version of the
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 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. | Same | NA |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &
Effectiveness |
| Contraindicatio
ns | 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. | 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. | Same | NA |
| Software
architecture | Syngo Carbon Space is based on a
client-server architecture | Syngo Carbon Space is based on a
client-server architecture | Same | NA |
| 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)
and non-DICOM objects. Supports
interfacing with HL7 (v2.5 / v2.3.1 /
v2.3 / FHIR R4) | Same | NA |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &
Effectiveness |
| 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 * available in in Diagnostic
Workspace only | Same | NA |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &
Effectiveness |
| Measurement,
Evaluation/Inte
rpretation
Tools | • Distance (Distance line, Distance
Polyline)
• Angle and Angle on stack*
• 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/Nearline study*
• Change Geometry*
• Snapshot
• CT Lung Change*
• MR General Reading*
• Alpha Blending*
- Available in in Diagnostic
Workspace only | • 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* - available in in Diagnostic
Workspace only | The tool set in the
subject device is
enhanced.
New basic reading tools
were added to the
subject device. | This differences
between the
predicate device and
the subject device
does not 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: | Same | NA |
| | • CR Image | • CR Image | | |
| | • CT Image | • CT Image | | |
| | • DX Image | • DX Image | | |
| | • ES Image | • ES Image | | |
| | • GM Image | • GM Image | | |
| | • MG Image | • MG Image | | |
| | • MR Image | • MR Image | | |
| | • NM Image | • NM Image | | |
| | • PET Image | • PET Image | | |
| | • OP/OPT Image | • OP/OPT Image | | |
| | • RF Image | • RF Image | | |
| | • RT IMAGE | • RT IMAGE | | |
| | • SM (WSI) | • SM (WSI) | | |
| | • XA Image | • XA Image | | |
| | • US Image | • US Image | | |
| | • Secondary capture objects | • Secondary capture objects | | |
| | DICOM non-image object display: | DICOM non-image object display: | | |
| | • ECG | • ECG | | |
| | • Encapsulated PDF | • Encapsulated PDF | | |
| | • PR | • PR | | |
| | Non-DICOM file display: | Non-DICOM file display: | | |
| | • Images: BMP, GIF, JPEG
(JFIF), JPEG 2000, JPEG-LE,
JPEG-LS, PCX, PNG, PNM,
TIFF, WBMP | • 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 | • Video: FLV, H.264, H.265,
INDEO2, INDEO3, INDEO4,
MPEG1, MPEG2, MPEG4, VP8,
VP9, WMV1, WMV2, WMV3 | | |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &
Effectiveness |
| | VP8, VP9, WMV1, WMV2,
WMV3
• Text Documents: CDA (XML),
PDF | • Text Documents: CDA (XML),
PDF | | |
| Operating
system | Diagnostic Workspace
Server | Diagnostic Workspace
Server | In the subject device
client supports | This Operating
System and browser |
| | • Microsoft Windows Server 2019 | • Microsoft Windows Server 2019 | Microsoft Windows 11
Operating system
compared to the
predicate device. | version difference
between the
predicate device and
the subject device |
| | • Windows 10 Enterprise | • Windows 10 Enterprise | | doesn't impact the |
| | • Red Hat Enterprise Linux 8.4 | • Red Hat Enterprise Linux 8.4 | Microsoft Internet
Explorer browser
support is removed and
the compatible browsers
for Physician Access is
upgraded to newer
version. | safety and
effectiveness of the
subject device as
necessary measures
have been taken |
| | Client | Client | | |
| | • Microsoft Windows 10
(Pro, Pro-Education, Enterprise) | • Microsoft Windows 10
(Pro, Pro-Education, Enterprise) | | |
| | • Microsoft Windows 11
(Pro, Pro-Education,
Enterprise) | | | |
| | Physician Access
Server | Physician Access
Server | | |
| | • Red Hat Enterprise Linux 8.4 | • Red Hat Enterprise Linux 8.4 | | |
| | Client | Client | | |
| | All operating systems that with
support for the following HTML5-
and JavaScript enabled browsers: | All operating systems that with
support for the following HTML5-
and JavaScript enabled browsers: | | |
| | • Google Chrome ≥ 90
(tested and recommended
Chrome 100) | • Google Chrome ≥ 83
(tested and recommended) | | |
| | • Microsoft Edge ≥ 90
(tested and recommended:
Edge 100) | • Microsoft Internet Explorer ≥
11
(not recommended) | | |
| | • Mozilla Firefox ≥ 91 | • Microsoft Edge ≥ 83
(tested and recommended:
Edge 89) | | |
| | • Mozilla Firefox ESR ≥ 91 | • Mozilla Firefox ≥ 78 | | |
| | • Apple Safari ≥ 14 | • Mozilla Firefox ESR ≥ 78 | | |
| | | • Apple Safari ≥ 13 | | |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &
Effectiveness |
| Impact on
Image
Acquisition
Devices | Client – Mobile device
iPadOS ≥ 14, Safari web browser
None
Syngo Carbon Space is a pure
viewing and/or post-processing
software and it has no influence on
the image acquisition devices. | Client – Mobile device
iPadOS ≥ 14, Safari web browser
None
Syngo Carbon Space 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 |
| 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 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). | 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 Carbon Space is based on a
client-server architecture | Same | NA |
| Software self-
test / checks | 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. | 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. | Same | NA |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &
Effectiveness |
| 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 (OS level and Network level) | Same | NA |
| 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 Carbon Space. | Same | NA |
| 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 |
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| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &
Effectiveness |
|--------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 | 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 | Same | NA |
| 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 | 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 | Same | NA |
| 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 panel collects measurements,
annotations, and graphical objects.
Additionally, the user can create new
findings, edit findings. It also allows
creation of automatic findings. | Same | NA |
| 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)] | 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)] | Same | NA |
| 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 | 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 | Same | NA |
| 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 Along with
access to nearline studies and prior
RIS reports | 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 Patient Jacket is
enhanced with the
access to additional
studies and reports
compared to the
predicate device. | 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* Magnifier * available in in Diagnostic
Workspace only | Same | NA |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &
Effectiveness |
| Annotation
Tool | • Arrow*
• Marker*
• Text
- available in in Diagnostic
Workspace only | • Arrow*
• Marker*
• Text - available in in Diagnostic
Workspace only | Same | NA |
| Printing | Diagnostic workspace:
Provides printing functionality with
able to review, modify the images
along with selecting the print sheet
format exposing then the DICOM
printer.
Also, able to monitor the printing
status and retry a printing task, if
needed.
Note
• DICOM printer must be configured as DICOM
nodes
• Grayscale & color printing is supported
Physician Access:
Provides printing functionality on a
paper printer. | Diagnostic workspace:
Structured findings can be printed on a
paper printer.
Physician Access:
Provides printing functionality on a
paper printer. | DICOM Print is
supported in the subject
device, in addition to
paper print when
compared to the
predicate device | 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 and document
collections. | 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 Quantification Algorithm, in the predicate device, 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 were found acceptable.
There are no changes to the algorithm and its performance that requires a new bench testing for the subject device. The results/summary from the predicate device is still applicable for the subject device.
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 -
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 bv 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
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this submission are our cybersecurity considerations as they relate to the device Syngo Carbon Space.
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 VA30A, does not introduce any new significant potential safety risks and is substantially equivalent to and performs as well as the predicate device Syngo Carbon Space VA20A.