(77 days)
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 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.
The provided text is a 510(k) summary for Syngo Carbon Clinicals (K232856). It focuses on demonstrating substantial equivalence to a predicate device through comparison of technological characteristics and non-clinical performance testing. The document does not describe acceptance criteria for specific device performance metrics or a study that definitively proves the device meets those criteria through clinical trials or quantitative bench testing with specific reported performance values.
Instead, it relies heavily on evaluating the fit-for-use of algorithms (Lesion Quantification and Organ Segmentation) that were previously studied and cleared as part of predicate or reference devices, and ensuring their integration into the new device without modification to the core algorithms. The non-clinical performance testing for Syngo Carbon Clinicals focuses on verification and validation of changes/integrations, and conformance to relevant standards.
Therefore, many of the requested details about acceptance criteria and reported device performance cannot be extracted directly from this document. However, I can provide information based on what is available.
Acceptance Criteria and Study for Syngo Carbon Clinicals
Based on the provided 510(k) summary, formal acceptance criteria with specific reported performance metrics for the Syngo Carbon Clinicals device itself are not explicitly detailed in a comparative table against a clinical study's results. The submission primarily relies on the equivalency of its components to previously cleared devices and non-clinical verification and validation.
The "study" proving the device meets acceptance criteria is fundamentally a non-clinical performance testing, verification, and validation process, along with an evaluation of previously cleared algorithms from predicate/reference devices for "fit for use" in the subject device.
Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, a direct table of specific numerical acceptance criteria and a corresponding reported device performance from a clinical study is not present. The document describes acceptance in terms of:
| Feature/Algorithm | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Lesion Quantification Algorithm | "Fit for use" in the subject device, with design mitigations for drawbacks/limitations identified in previous studies of the predicate 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 and were found acceptable." (No new specific performance metrics are reported for Syngo Carbon Clinicals, but rather acceptance of the mitigations). |
| Organ Segmentation Algorithm | "Fit for use" in the subject device without any modifications, based on previous studies of the reference device. | "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." (No new specific performance metrics are reported for Syngo Carbon Clinicals). |
| Overall Device Functionality | Conformance to specifications, safety, and effectiveness comparably to the predicate device. | "Results of all conducted testing were found acceptable in supporting the claim of substantial equivalence." (General statement, no specific performance metrics). Consistent with "Moderate Level of Concern" software. |
| Software Verification & Validation | All software specifications met the acceptance criteria. | "The testing results support that all the software specifications have met the acceptance criteria." (General statement). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated for specific test sets in this document for Syngo Carbon Clinicals. The evaluations of the Lesion Quantification and Organ Segmentation algorithms refer to "phantom and reader studies" from their respective predicate/reference devices, but details on the sample sizes of those original studies are not provided here.
- Data Provenance: Not specified. The original "phantom and reader studies" for the algorithms were likely internal to the manufacturers or collaborators, but this document does not detail their origin (e.g., country, specific institutions). The text indicates these were retrospective studies (referring to prior evaluations).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not specified. The document mentions "reader studies" were conducted for the predicate/reference devices' algorithms, implying involvement of human readers/experts, but the number is not stated.
- Qualifications of Experts: Not specified. It can be inferred that these would be "trained medical professionals" as per the intended user for the device, but specific qualifications (e.g., radiologist with X years of experience) are not provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified for the historical "reader studies" referenced. This document does not detail the methodology for establishing ground truth or resolving discrepancies among readers if multiple readers were involved.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Comparative Effectiveness Study: The document itself states, "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." Therefore, no MRMC comparative effectiveness study for human readers with and without AI assistance for Syngo Carbon Clinicals was performed or reported in this submission. The device is a set of advanced visualization tools, not an AI-assisted diagnostic aid that directly impacts reader performance in a comparative study mentioned here.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: The core algorithms (Lesion Quantification and Organ Segmentation) were evaluated in "phantom and reader studies" as part of their previous clearances (predicate/reference devices). While specific standalone numerical performance metrics for these algorithms (e.g., sensitivity, specificity, accuracy) are not reported in this document, the mention of "phantom" studies suggests a standalone evaluation component. The current submission, however, evaluates these previously cleared algorithms for "fit for use" within the new Syngo Carbon Clinicals device, implying their standalone performance was considered acceptable from their original clearances.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not explicitly detailed. The referenced "phantom and reader studies" imply that for phantoms, the ground truth would be known (e.g., physical measurements), and for reader studies, it would likely involve expert consensus or established clinical benchmarks. However, the exact method for establishing ground truth in those original studies is not provided here.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not specified in this 510(k) summary. The document mentions that the deep learning algorithm for organ segmentation was "cleared as part of the reference device syngo.via RT Image suite (K220783)." This implies that any training data for this algorithm would have been part of the K220783 submission, not detailed here for Syngo Carbon Clinicals.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not specified in this 510(k) summary. As with the training set size, this information would have been part of the original K220783 submission for the organ segmentation algorithm and is not detailed in this document.
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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).
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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
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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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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 |
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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.
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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
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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 andversion | 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 provideadvanced visualization tools to prepare andprocess the medical image for evaluation,manipulation and communication of clinicaldata that was acquired by the medical imagingmodalities (for example, CT, MR, etc.)The software package is designed to supporttechnicians and physicians in qualitative andquantitative measurements and in the analysisof clinical data that was acquired by medicalimaging modalities.An interface shall enable the connectionbetween the Syngo Carbon Clinicals softwarepackage and the interconnected softwaresolution for viewing, manipulation,communication, and storage of medicalimages. | Syngo Carbon Space is a software intended todisplay medical data and to support the reviewand analysis of medical images by trainedmedical professionals.Syngo Carbon Space "Diagnostic Workspace"is indicated for display, rendering, post-processing of medical data (mostly medicalimages) within healthcare institutions, forexample, in the field of Radiology, NuclearMedicine and Cardiology. | The indications for use ofSyngo Carbon Clinicals is asubset of the predicate.Subject device is used inqualitative and quantitativemeasurements and in theanalysis of clinical datawhich is the same as thepredicate device.Note: For our equivalencycomparison, the SyngoCarbon Space "DiagnosticWorkspace" shall beconsidered since thefunctionalities of SyngoCarbon Space "PhysicianAccess" is not relevant to oursubject device scope.The Predicate deviceadditionally also is used fordisplay and rendering ofmedical data. | None |
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| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &Effectiveness |
|---|---|---|---|---|
| Contraindications | Syngo Carbon Clinicals is not indicated formammography images for diagnosis in theU.S.Syngo Carbon Clinicals is not to be used as asole basis for clinical decisions | Syngo Carbon Space "Diagnostic Workspace"is not intended for diagnosis of digitalmammography images.Syngo Carbon Space "Diagnostic Workspace"is not intended to be used as a sole basis forclinical decisions. | Same | None |
| Softwarearchitecture | Syngo Carbon Clinicals has architecture thatis based on a layered pattern where thevarious clinical tools/functionality aredecomposed into modules/common toolswhich provide their individual functionalities. | Syngo Carbon Space is based on aclient-server architecture | A client server architecture isnot used in the subject devicedue to the nature of the useof the subject device with theinterfacing/hostingapplications. | None |
| Imagecommunication | Syngo Carbon Clinicals relies on theinterfacing application for Imagecommunication. | Standard network protocols likeTCP/IP and standard communicationprotocol including DICOM (2016a)and non-DICOM objects. Supportsinterfacing with HL7 (v2.5 / v2.3.1 /v2.3 /FHIR R4) | Syngo Carbon Clinicals doesnot have its owncommunication, it relies onthe interfacing/hostingapplication for Imagecommunication. | None |
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| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &Effectiveness |
|---|---|---|---|---|
| Image displayalgorithms | • 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 DiagnosticWorkspace only | Syngo Carbon Clinicalsprovides the rendering tool:Cinematic Insight which isa combination of theAutomatic Organsegmentation and the cVRTtechnique of image displaywhich is available in thepredicate device.This feature uses a deeplearning algorithm for organsegmentation (algorithm thatwas cleared as part of thereference device syngo.viaRT Image suite (K220783).No changes have been madeto this algorithm comparedto the reference deviceThe segmented organ is thenrendered using the cVRTtechnique available in thepredicate device. | This feature does notimpact the safety andeffectiveness of thesubject device as thenecessary measures aretaken |
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| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &Effectiveness |
|---|---|---|---|---|
| Measurement,Evaluation/InterpretationTools | • 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, AutoContour) • 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 isused to evaluate the lung forsuspected lesions across timepoints.Manual calibration tool is asimple linear tool, where theuser input of measurement isrequired for calibration of theimage using a known sizedisplay image/an object ofknown size is available in theimage | This feature does notimpact the safety andeffectiveness of thesubject device as thenecessary measures aretaken |
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| Supported objectsfor display | DICOM image object display | DICOM image object display: | The supported objects fordisplay in the subject deviceis a subset of the predicatedevice. | 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 |
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| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &Effectiveness |
|---|---|---|---|---|
| INDEO2, INDEO3, INDEO4,MPEG1, MPEG2, MPEG4, VP8,VP9, WMV1, WMV2, WMV3Text Documents: CDA (XML),PDF |
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©Siemens Healthcare GmbH, 2023
| Operatingsystem | None | Diagnostic Workspace | The interfacing/hostingapplication to Syngo CarbonClinicals provides theoperating system which theplug-in can use | None |
|---|---|---|---|---|
| Server | ||||
| • Microsoft Windows Server 2019 | ||||
| • Windows 10 Enterprise | ||||
| • Red Hat Enterprise Linux 8.4Client | ||||
| • Microsoft Windows 10(Pro, Pro-Education, Enterprise) | ||||
| Physician AccessServer | ||||
| • Red Hat Enterprise Linux 8.4Client | ||||
| All operating systems that withsupport 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 |
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| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &Effectiveness |
|---|---|---|---|---|
| Client – Mobile deviceiPadOS ≥ 14, Safari web browser | ||||
| Impact onImage | NoneSyngo Carbon Clinicals provides advancedvisualization tools to prepare and process themedical images and it has no influence on theimage acquisition devices | NoneSyngo Carbon Space is a pure viewing | Same | None |
| AcquisitionDevices | and/or post-processing software and ithas no influence on the imageacquisition 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 beinterpreted by trained personnel. | are included. All image data are to beinterpreted 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 |
| patientpopulation | population (e.g., age, weight, health,condition) | population (e.g., age, weight, health,condition) | ||
| Site of the bodythe device is | No limitation concerning region ofbody or tissue type | No limitation concerning region ofbody or tissue type | Same | None |
| intended to beused | ||||
| 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 userinterface | Not offered by Syngo Carbon Clinicals | Yes, with reduced color palette,clearer structure, and text labels onicons. Floating panels increases theuser friendliness as the user can movethe panels wherever they areconvenient with | The subject device utilizesthe GUI provided by theinterfacing application | None |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety & Effectiveness |
| PatientBrowser | Not offered by Syngo Carbon Clinicals | Search, browse & open data fordisplay from syngo.share core &remote DICOM nodes• Search, browse & open data fordisplay from external XDS(-I)repository) **• Archive functionality (uploadmedical data to syngo.share corefor archive)• Document properties functions(metadata modification andtagging)• Correct & re-arrange functions• Restore (trigger fetch fromarchive) functions• Distribution, export & sharingfunctions• Inbox - access to medical datashared by other users ****available in Physician Access only | NA | NA |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &Effectiveness |
| Seriesnavigator /DocumentPreview | Not offered by Syngo Carbon Clinicals | Yes, with a fast overview of thedisplayed and not displayed data(series, images) of the loaded studies,identify not yet seen series/images*,quickly identify the relevantseries/images for reading, and bringdata (timepoints/series/images) intodisplay in an efficient manner(Drag&Drop).Study / Timepoints are marked withindividual colors for betteridentification.The Series Navigator is calledDocument Preview for PhysicianAccess.* available in in DiagnosticWorkspace only | NA | NA |
| Findings panel | Not offered by Syngo Carbon Clinicals | Findings panel collects measurements,annotations, and graphical objects.Additionally, the user can create newfindings, edit findings. It also allowscreation of automatic findings | The subject device utilizesthe findings panel providedby the interfacing application | None |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &Effectiveness |
| Reporting | Not offered by Syngo Carbon Clinicals | No dedicated report creationfunctionality supported in SyngoCarbon Space.Structured findings can beautomatically transferred to externalthird-party reporting system via FHIRinterface for creation of structuredreport content [e.g. (Powerscribe [byNuance], SmartReports [by SmartReporting)] | The subject device utilizesthe Reporting functionalityprovided by the interfacingapplication | None |
| ImageArchiving | Not offered by Syngo Carbon Clinicals | Diagnostic Workspace:Syngo Carbon Space DiagnosticWorkspace does not store data orimages.Created results for a study (e.g.DICOM PR, SR objects) are stored insyngo.share core in context of theoriginal study. syngo.share core isresponsible for long term archiving ofthe original study and created results.Physician Access:Not applicable since Syngo CarbonSpace Physician Access does notcreate data or images that istransferred/stored | The subject device utilizesthe archival functionalityprovided by the interfacingapplication | None |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &Effectiveness |
| AnnotationTool | Not offered by Syngo Carbon Clinicals | • Arrow*• Marker*• Text* available in DiagnosticWorkspace only | The subject device utilizesthe annotation functionalityprovided by the interfacingapplication | None |
| Printing | Not offered by Syngo Carbon Clinicals | Diagnostic workspace:Structured findings can be printed on apaper printer.Physician Access:Provides printing functionality on apaper printer | The subject device utilizesthe Printing functionalityprovided by the interfacingapplication | None |
| Online helpsystem | Yes, with search, indexing, filtering,library function and documentcollections | Yes, with search, indexing, filtering,library function and documentcollections. | 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.
§ 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).