(77 days)
Yes
The document explicitly states that a "deep learning algorithm for organ segmentation" is used, and deep learning is a subset of machine learning and artificial intelligence.
No
This device is for advanced visualization, evaluation, manipulation, and communication of clinical data from medical imaging. It is an image processing tool used by professionals for diagnosis and analysis, not for therapeutic intervention.
Yes
The Device Description explicitly states, "Syngo Carbon Clinicals is a software only Medical Device, which provides dedicated advanced imaging tools for diagnostic reading."
Yes
The device description explicitly states "Syngo Carbon Clinicals is a software only Medical Device".
Based on the provided information, Syngo Carbon Clinicals is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "advanced visualization tools to prepare and process the medical image for evaluation, manipulation and communication of clinical data that was acquired by the medical imaging modalities (for example, CT, MR, etc.)". This focuses on processing and analyzing medical images obtained from imaging modalities, not on analyzing samples taken from the human body (like blood, urine, tissue, etc.).
- Device Description: The description reinforces this by stating it's a "software only Medical Device, which provides dedicated advanced imaging tools for diagnostic reading."
- Input Data: The input data is explicitly listed as "CT, MR, CR Image, DX Image," which are all types of medical images, not biological samples.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. Syngo Carbon Clinicals operates on medical images, not biological specimens.
No
The provided text does not explicitly state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The 'Control Plan Authorized (PCCP) and relevant text' section is marked "Not Found".
Intended Use / Indications for Use
Syngo Carbon Clinicals is intended to provide advanced visualization tools to prepare and process the medical image for evaluation, manipulation and communication of clinical data that was acquired by the medical imaging modalities (for example, CT, MR, etc.)
The software package is designed to support technicians and physicians in qualitative and quantitative measurements and in the analysis of clinical data that was acquired by medical imaging modalities.
An interface shall enable the connection between the Syngo Carbon Clinicals software package and the interconnected software solution for viewing, manipulation, communication, and storage of medical images.
Product codes (comma separated list FDA assigned to the subject device)
QIH
Device Description
Syngo Carbon Clinicals is a software only Medical Device, which provides dedicated advanced imaging tools for diagnostic reading. These tools can be called up using standard interfaces any native/syngo based viewing applications (hosting applications) that is part of the SYNGO medical device portfolio. These tools help prepare and process the medical image for evaluation, manipulation and communication of clinical data that was acquired by medical imaging modalities (e.g., MR, CT etc.)
Deployment Scenario: Syngo Carbon Clinicals is a plug-in that can be added to any SYNGO based hosting applications (for example: Syngo Carbon Space, syngo.via etc...). The hosting application (native/syngo Platform-based software) is not described within this 510k submission. The hosting device decides which tools are used from Syngo Carbon Clinicals. The hosting device does not need to host all tools from the Syngo Carbon Clinicals, a desired subset of the provided tools can be used. The same can be enabled or disabled thru licenses.
When preparing the radiologist's reading workflow on a dedicated workplace or workstation, Syngo Carbon Clinicals can be called to generate additional results or renderings according to the user needs using the tools available.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
CT, MR, etc.
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
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No clinical studies were carried out for the product, all performance testing was conducted in a non-clinical fashion as part of verification and validation activities of the medical device.
Lesion Ouantification: 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 and 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.
Organ Segmentation: The results of phantom and reader studies conducted on the Organ Segmentation Algorithm, in the reference 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 without any modifications.
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 reference device is still applicable for the subject device.
Non-clinical tests were conducted for the subject device during product development. The modifications described in this Premarket Notification were supported with verification and validation testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Siemens Healthcare GmbH Vijay Ramadas Regulatory Affairs Manager Siemensstraße 3 Forchheim, Bayern 91301 Germany
Re: K232856
December 1, 2023
Trade/Device Name: Syngo Carbon Clinicals Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System
Regulatory Class: Class II Product Code: QIH Dated: November 14, 2023 Received: November 14, 2023
Dear Ramadas 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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica Lamb
Jessica Lamb Assistant Director DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
Submission Number (if known)
Device Name
Syngo Carbon Clinicals
Indications for Use (Describe)
Syngo Carbon Clinicals is intended to provide advanced visualization tools to prepare and process the medical image for evaluation, manipulation and communication of clinical data that was acquired by the medical imaging modalities (for example, CT, MR, etc.)
The software package is designed to support technicians and physicians in qualitative and quantitative measurements and in the analysis of clinical data that was acquired by medical imaging modalities.
An interface shall enable the connection between the Syngo Carbon Clinicals software package and the interconnected software solution for viewing, manipulation, and storage of medical images.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a design of orange dots.
September 15, 2023
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.
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 +49 (9191) 18-4404 Fax:
4. Device Name and Classification
| Device/Trade Name: | Syngo Carbon Clinicals |
|---|---|
| Classification Panel: | Radiology Devices |
| Classification Number: | 21 CFR 892.2050 |
| Classification Name: | Medical Image Management and Processing System |
| Device Class: | Class II |
| Product Code: | QIH |
5. Predicate Device(s):
Main Predicate Device
| Device/Trade Name: | Syngo Carbon Space |
|---|---|
| 510(k) Clearance: | K230561 |
| 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 Device 1
| Device/Trade Name: | syngo.via RT Image Suite |
|---|---|
| 510(k) Clearance: | K220783 |
| Classification Panel: | Radiology Devices |
| Classification Number: | 21 CFR 892.5050 |
| Classification Name: | Medical Charged-Particle Radiation Therapy System |
| Device Class: | Class II |
| Product Code: | MUJ |
Reference Device 2
Device/Trade Name: 510(k) Clearance: Classification Panel: Classification Number: Classification Name: Device Class: Product Code:
syngo.via K191040 Radiology Devices 21 CFR 892.2050 Medical Image Management and Processing System Class II LLZ
Reference Device 3
Device/Trade Name: 510(k) Clearance: Classification Panel: Classification Number: Classification Name: Device Class: Product Code:
syngo.CT Lung CAD K231157 Radiology Devices 21 CFR 892.2050 Medical Image Management and Processing System Class II OEB
6. Device Description:
Syngo Carbon Clinicals is a software only Medical Device, which provides dedicated advanced imaging tools for diagnostic reading. These tools can be called up using standard interfaces any native/syngo based viewing applications (hosting applications) that is part of the SYNGO medical device portfolio. These tools help prepare and process the medical image for evaluation, manipulation and communication of clinical data that was acquired by medical imaging modalities (e.g., MR, CT etc.)
Deployment Scenario: Syngo Carbon Clinicals is a plug-in that can be added to any SYNGO based hosting applications (for example: Syngo Carbon Space, syngo.via etc...). The hosting application (native/syngo Platform-based software) is not described within this 510k submission. The hosting device decides which tools are used from Syngo Carbon Clinicals. The hosting device does not need to host all tools from the Syngo Carbon Clinicals, a desired subset of the provided tools can be used. The same can be enabled or disabled thru licenses.
5
When preparing the radiologist's reading workflow on a dedicated workplace or workstation, Syngo Carbon Clinicals can be called to generate additional results or renderings according to the user needs using the tools available.
7. Intended/Indications for use:
Syngo Carbon Clinicals is intended to provide advanced visualization tools to prepare and process the medical image for evaluation, manipulation and communication of clinical data that was acquired by the medical imaging modalities (for example, CT, MR, etc.)
The software package is designed to support technicians and physicians in qualitative and quantitative measurements and in the analysis of clinical data that was acquired by medical imaging modalities.
An interface shall enable the connection between the Syngo Carbon Clinicals software package and the interconnected software solution for viewing, manipulation, communication, and storage of medical images.
8. Technological Characteristics:
The Syngo Carbon Clinicals plug-in provides the below listed tools.
- Cinematic insight – An advanced visualization tool for cinematic rendering of anatomical structures using presets
- Manual Calibration The Calibration tool is used manually calibrate non-● calibrated images to enable measurement on such images
- Basic Onco Tools
- Assisted Perpendicular Tool to draw perpendicular distance lines to O perform diameter measurements and thus to evaluate lesions
- Lesion Quantification Tool to perform diameter measurements O (longest diameter, perpendicular diameter) and to create segmentation objects of suspect lesions in lung parenchyma with one click (semi automatically)
- Lung Nodule Marker Tool used to evaluate lung parenchyma for o suspect lesions. This tool can also be used to evaluate lesions across different time points
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 | Syngo Carbon Clinicals (VA30A) | Syngo Carbon Space (VA30A)
K230561 | New Product | NA |
| Manufacturer | Siemens Healthcare GmbH | Siemens Healthcare GmbH | Same | NA |
| Indications for use | Syngo Carbon Clinicals is intended to provide
advanced visualization tools to prepare and
process the medical image for evaluation,
manipulation and communication of clinical
data that was acquired by the medical imaging
modalities (for example, CT, MR, etc.)
The software package is designed to support
technicians and physicians in qualitative and
quantitative measurements and in the analysis
of clinical data that was acquired by medical
imaging modalities.
An interface shall enable the connection
between the Syngo Carbon Clinicals software
package and the interconnected software
solution for viewing, manipulation,
communication, and storage of medical
images. | 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. | The indications for use of
Syngo Carbon Clinicals is a
subset of the predicate.
Subject device is used in
qualitative and quantitative
measurements and in the
analysis of clinical data
which is the same as the
predicate device.
Note: For our equivalency
comparison, the Syngo
Carbon Space "Diagnostic
Workspace" shall be
considered since the
functionalities of Syngo
Carbon Space "Physician
Access" is not relevant to our
subject device scope.
The Predicate device
additionally also is used for
display and rendering of
medical data. | None |
7
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &
Effectiveness |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| Contraindications | Syngo Carbon Clinicals is not indicated for
mammography images for diagnosis in the
U.S.
Syngo Carbon Clinicals is not 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. | Same | None |
| Software
architecture | Syngo Carbon Clinicals has architecture that
is based on a layered pattern where the
various clinical tools/functionality are
decomposed into modules/common tools
which provide their individual functionalities. | Syngo Carbon Space is based on a
client-server architecture | A client server architecture is
not used in the subject device
due to the nature of the use
of the subject device with the
interfacing/hosting
applications. | None |
| Image
communication | Syngo Carbon Clinicals relies on the
interfacing application for 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) | Syngo Carbon Clinicals does
not have its own
communication, it relies on
the interfacing/hosting
application for Image
communication. | None |
8
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &
Effectiveness |
|-----------------------------|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Image display
algorithms | • Rendering Tools: Cinematic Insight | • MPR: MPR, MPR Thick,
• MPR/MPR*
• MIP: MIP, MIP Thin
• MinIP View
• VRT*: Plain VRT, Adapt VRT,
• VRT Thin, Cinematic VRT (cVRT)
• Fused View *
• Invert Image
- available in in Diagnostic
Workspace only | Syngo Carbon Clinicals
provides the rendering tool:
Cinematic Insight which is
a combination of the
Automatic Organ
segmentation and the cVRT
technique of image display
which is available in the
predicate device.
This feature uses a deep
learning algorithm for organ
segmentation (algorithm that
was cleared as part of the
reference device syngo.via
RT Image suite (K220783).
No changes have been made
to this algorithm compared
to the reference device
The segmented organ is then
rendered using the cVRT
technique available in the
predicate device. | This feature does not
impact the safety and
effectiveness of the
subject device as the
necessary measures are
taken |
9
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &
Effectiveness |
|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Measurement,
Evaluation/Interpr
etation
Tools | • Oncological evaluation:
• Lesion Quantification
• Assisted Perpendicular Tool
• Lung Nodule Marker
• Orthopaedic measurements:
• Manual calibration | • Lesion Quantification*
• Assisted Perpendicular Tool*
• Automatic Organ Segmentation*
• 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) *
• Interactive Tissue Segmentation*
• Time Curve, Time ROI*
• SUV Measurement*
• Automatic Anatomy Labeling (rib, spine) *
• Next Study/ Previous Study*
- available in in Diagnostic Workspace only | Lung Nodule Marker tool is
used to evaluate the lung for
suspected lesions across time
points.
Manual calibration tool is a
simple linear tool, where the
user input of measurement is
required for calibration of the
image using a known size
display image/an object of
known size is available in the
image | This feature does not
impact the safety and
effectiveness of the
subject device as the
necessary measures are
taken |
10
| Supported objects
for display | DICOM image object display | DICOM image object display: | The supported objects for
display in the subject device
is a subset of the predicate
device. | None |
|----------------------------------|----------------------------|-----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|------|
| | • CT Image | • CR Image | | |
| | • DX Image | • CT Image | | |
| | • CR 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 | | |
11
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &
Effectiveness |
|---------------|----------------|--------------------------------------------------------------------------------------------------------------------|------------|-------------------------------------|
| | | INDEO2, INDEO3, INDEO4,
MPEG1, MPEG2, MPEG4, VP8,
VP9, WMV1, WMV2, WMV3
Text Documents: CDA (XML),
PDF | | |
12
©Siemens Healthcare GmbH, 2023
| Operating
system | None | Diagnostic Workspace | The interfacing/hosting
application to Syngo Carbon
Clinicals provides the
operating system which the
plug-in can use | None |
|---------------------|------|---------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|------|
| | | Server | | |
| | | • Microsoft Windows Server 2019 | | |
| | | • Windows 10 Enterprise | | |
| | | • Red Hat Enterprise Linux 8.4
Client | | |
| | | • Microsoft Windows 10
(Pro, Pro-Education, Enterprise) | | |
| | | Physician Access
Server | | |
| | | • Red Hat Enterprise Linux 8.4
Client | | |
| | | All operating systems that with
support for the following HTML5-
and JavaScript enabled browsers: | | |
| | | • 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 | | |
13
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &
Effectiveness |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| | | Client – Mobile device
iPadOS ≥ 14, Safari web browser | | |
| Impact on
Image | None
Syngo Carbon Clinicals provides advanced
visualization tools to prepare and process the
medical images and it has no influence on the
image acquisition devices | None
Syngo Carbon Space is a pure viewing | Same | None |
| Acquisition
Devices | | and/or post-processing software and it
has no influence on the image
acquisition devices | | |
| CAD | None | None | Same | None |
| Functionalities | No automated diagnostic | No automated diagnostic | | |
| | interpretation capabilities like CAD | interpretation capabilities like CAD | | |
| | are included. All image data are to be
interpreted by trained personnel. | are included. All image data are to be
interpreted by trained personnel. | | |
| Clinical | No limitation on the clinical condition | No limitation on the clinical condition | Same | None |
| condition the | of the patient | of the patient | | |
| device is | | | | |
| intended to | | | | |
| diagnose, treat,
or manage | | | | |
| Intended | No limitation concerning the patient | No limitation concerning the patient | Same | None |
| patient
population | population (e.g., age, weight, health,
condition) | population (e.g., age, weight, health,
condition) | | |
| Site of the body
the device is | No limitation concerning region of
body or tissue type | No limitation concerning region of
body or tissue type | Same | None |
| intended to be
used | | | | |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety & Effectiveness |
| Intended use environment | Syngo Carbon Clinicals offers a wide range of tools from the major clinical fields, i.e. general radiology, oncology environments. | Syngo Carbon Space "Diagnostic Workspace" is used in Radiology, Nuclear Medicine and Cardiology environments (e.g., darkened/ shaded rooms). | Same | None |
| Intended user(s) | Trained healthcare professionals | Trained healthcare professionals | Same | None |
| Device Type | Software application | Software application | Same | None |
| Cyber Security | The cybersecurity aspects for Syngo Carbon Clinicals is handled by the interfacing/hosting system. | 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) | Syngo Carbon Clinicals applications are running as a part of the interfacing device. The aspects for cybersecurity are assessed and provided to the interfacing application. | None |
| Hardware | Hardware is not understood as part of the medical device but needs to comply with the minimum requirements as specified by Syngo | Hardware is not understood as part of the medical device but needs to comply with the minimum requirements as specified by Syngo | Same | None |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &
Effectiveness |
| Graphical user
interface | Not offered by Syngo Carbon Clinicals | 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 | The subject device utilizes
the GUI provided by the
interfacing application | None |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety & Effectiveness |
| Patient
Browser | Not offered by Syngo Carbon Clinicals | 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 | NA | NA |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &
Effectiveness |
| Series
navigator /
Document
Preview | Not offered by Syngo Carbon Clinicals | 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 | NA | NA |
| Findings panel | Not offered by Syngo Carbon Clinicals | Findings panel collects measurements,
annotations, and graphical objects.
Additionally, the user can create new
findings, edit findings. It also allows
creation of automatic findings | The subject device utilizes
the findings panel provided
by the interfacing application | None |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &
Effectiveness |
| Reporting | Not offered by Syngo Carbon Clinicals | 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)] | The subject device utilizes
the Reporting functionality
provided by the interfacing
application | None |
| Image
Archiving | Not offered by Syngo Carbon Clinicals | 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 | The subject device utilizes
the archival functionality
provided by the interfacing
application | None |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &
Effectiveness |
| Annotation
Tool | Not offered by Syngo Carbon Clinicals | • Arrow*
• Marker*
• Text - available in Diagnostic
Workspace only | The subject device utilizes
the annotation functionality
provided by the interfacing
application | None |
| Printing | Not offered by Syngo Carbon Clinicals | Diagnostic workspace:
Structured findings can be printed on a
paper printer.
Physician Access:
Provides printing functionality on a
paper printer | The subject device utilizes
the Printing functionality
provided by the interfacing
application | None |
| Online help
system | Yes, with search, indexing, filtering,
library function and document
collections | Yes, with search, indexing, filtering,
library function and document
collections. | Same | None |
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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
Lesion Ouantification: 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 and 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.
Organ Segmentation: The results of phantom and reader studies conducted on the Organ Segmentation Algorithm, in the reference 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 without any modifications.
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 reference device is still applicable for the subject device.
12. Non-clinical Performance Testing:
Non-clinical tests were conducted for the subject device 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:
- -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 Clinicals 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.
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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 this submission are our cybersecurity considerations as they relate to the device Syngo Carbon Clinicals.
14. Summary:
Performance tests were conducted to test the functionality of the device Syngo Carbon Clinicals. 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 Clinicals, 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 VA30A.