(21 days)
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 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.
The provided text is a 510(k) summary for the Syngo Carbon Space (VA30A) device, a medical image management and processing system. The core of this submission is to demonstrate substantial equivalence to a predicate device (Syngo Carbon Space VA20A).
However, the provided text does not contain the detailed clinical or non-clinical performance test results with acceptance criteria and reported performance values that would typically be presented in a table. It states that "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." and "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."
Therefore, I cannot populate the table of acceptance criteria and reported device performance from the provided text directly. The document focuses on demonstrating that the new version of the software (VA30A) maintains the same safety and effectiveness as the previous version (VA20A) by highlighting identical intended use, indications for use, contraindications, and core functionalities. It also details minor enhancements to existing features (like measurement tools and patient jacket functionality) and updates to supported operating systems and browsers, which were validated through non-clinical performance testing.
Here's a breakdown of the requested information based on the provided text, with explicit notes on what is NOT available:
1. A table of acceptance criteria and the reported device performance
This information is NOT explicitly detailed in the provided document. The document states that "all performance testing was conducted in a non-clinical fashion as part of verification and validation activities" and "The testing results support that all the software specifications have met the acceptance criteria." However, it does not enumerate specific acceptance criteria or the quantitative results of these non-clinical tests for the VA30A or its predicate beyond a high-level statement of conformance.
The document emphasizes that 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." This implies that the performance demonstrated by the predicate device (VA20A) is considered valid for the subject device (VA30A), but the specific performance metrics and their acceptance criteria are not provided in this summary.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: NOT specified. The document mentions "non-clinical performance testing" and "verification and validation activities" but does not provide details on the sample size of data or tests used for these validations.
- Data Provenance: NOT specified. Given that no clinical studies were performed, the data would have been synthetic or from internal testing environments. The origin (country) or nature (retrospective/prospective) of any test data is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- NOT applicable/specified. Since no clinical studies were performed and the testing was non-clinical and focused on software verification and validation, there is no mention of experts establishing ground truth for a clinical test set. The validation would have been against pre-defined software requirements or simulated scenarios.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- NOT applicable/specified. As no clinical studies or reader studies are reported, there's no mention of an adjudication method for ground truth.
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
- No, an MRMC comparative effectiveness study was NOT done. The document explicitly states: "No clinical studies were carried out for the product". The device is a "Medical Image Management and Processing System" and doesn't appear to include AI-assisted diagnostic capabilities (the text mentions "No automated diagnostic interpretation capabilities like CAD are included. All image data are to be interpreted by trained personnel.").
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, in spirit, standalone non-clinical testing was performed for software verification. While not described as an "algorithm only" performance study in the context of diagnostic accuracy, the entire submission is based on "non-clinical performance testing" and "verification and validation activities" to ensure the software functions as intended and meets specifications. The document states: "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."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- NOT applicable/specified in the context of clinical ground truth. For non-clinical software testing, ground truth would be established by specified software requirements, functional correctness, performance benchmarks (e.g., speed, data integrity, display accuracy against known inputs), and adherence to standards (DICOM, HL7). The document doesn't detail how specific "ground truths" were established for these technical tests.
8. The sample size for the training set
- NOT applicable/specified. As this is not a submission for an AI/ML algorithm that requires a training set for model development, there is no mention of a training set size. The device is a software system for image management and processing.
9. How the ground truth for the training set was established
- NOT applicable/specified. (See point 8)
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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
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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
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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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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 |
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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
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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.
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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 nameand version | Syngo Carbon Space VA30A | Syngo Carbon Space VA20A(K213665) | New version of theproduct | NA |
| Manufacturer | Siemens Healthcare GmbH | Siemens Healthcare GmbH | Same | NA |
| Indications foruse | Syngo Carbon Space is a softwareintended to display medical data and tosupport the review and analysis ofmedical images by trained medicalprofessionals.Syngo Carbon Space "DiagnosticWorkspace" is indicated for display,rendering, post-processing of medicaldata (mostly medical images) withinhealthcare institutions, for example, inthe field of Radiology, NuclearMedicine and Cardiology.Syngo Carbon Space "PhysicianAccess" is indicated for display andrendering of medical data withinhealthcare institutions. | Syngo Carbon Space is a softwareintended to display medical data and tosupport the review and analysis ofmedical images by trained medicalprofessionals.Syngo Carbon Space "DiagnosticWorkspace" is indicated for display,rendering, post-processing of medicaldata (mostly medical images) withinhealthcare institutions, for example, inthe field of Radiology, NuclearMedicine and Cardiology.Syngo Carbon Space "PhysicianAccess" is indicated for display andrendering of medical data withinhealthcare institutions. | Same | NA |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &Effectiveness |
| Contraindications | Syngo Carbon Space "DiagnosticWorkspace" is not intended fordiagnosis of digital mammographyimages.Syngo Carbon Space "DiagnosticWorkspace" is not intended to be usedas a sole basis for clinical decisions.Syngo Carbon Space "PhysicianAccess" is not intended for diagnosisof digital mammography images.Syngo Carbon Space "PhysicianAccess" is not intended to be used fordiagnostic purpose on mobile devicesin the United States of America(USA).Syngo Carbon Space "PhysicianAccess" is not intended to be used asa sole basis for clinical decisions. | Syngo Carbon Space "DiagnosticWorkspace" is not intended fordiagnosis of digital mammographyimages.Syngo Carbon Space "DiagnosticWorkspace" is not intended to be usedas a sole basis for clinical decisions.Syngo Carbon Space "PhysicianAccess" is not intended for diagnosisof digital mammography images.Syngo Carbon Space "PhysicianAccess" is not intended to be used fordiagnostic purpose on mobile devicesin the United States of America(USA).Syngo Carbon Space "PhysicianAccess" is not intended to be used as asole basis for clinical decisions. | Same | NA |
| Softwarearchitecture | Syngo Carbon Space is based on aclient-server architecture | Syngo Carbon Space is based on aclient-server architecture | Same | NA |
| 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) | 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) | Same | NA |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &Effectiveness |
| Image displayalgorithms | 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 DiagnosticWorkspace 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 DiagnosticWorkspace only | Same | NA |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &Effectiveness |
| Measurement,Evaluation/InterpretationTools | • Distance (Distance line, DistancePolyline)• Angle and Angle on stack*• 2D ROI (Circle, Freehand,Polygonal, Auto Contour) • 3D VOI (Sphere, Freehand) • Pixel Lens• Ranges (Parallel, Radial, RadialSliced, 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/PreviousStudy/Nearline study• Change Geometry*• Snapshot• CT Lung Change*• MR General Reading*• Alpha Blending** Available in in DiagnosticWorkspace only | • Distance (Distance line, DistancePolyline)• Angle• 2D ROI (Circle, Freehand,Polygonal, Auto Contour) • 3D VOI (Sphere, Freehand) • Pixel Lens• Ranges (Parallel, Radial, RadialSliced, 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 DiagnosticWorkspace only | The tool set in thesubject device isenhanced.New basic reading toolswere added to thesubject device. | This differencesbetween thepredicate device andthe subject devicedoes not impact thesafety andeffectiveness of thesubject device as thenecessary measurestaken |
| Supportedobjectsfor 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 | |||
| Operatingsystem | Diagnostic WorkspaceServer | Diagnostic WorkspaceServer | In the subject deviceclient supports | This OperatingSystem and browser |
| • Microsoft Windows Server 2019 | • Microsoft Windows Server 2019 | Microsoft Windows 11Operating systemcompared to thepredicate device. | version differencebetween thepredicate device andthe 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 InternetExplorer browsersupport is removed andthe compatible browsersfor Physician Access isupgraded to newerversion. | safety andeffectiveness of thesubject device asnecessary measureshave 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 AccessServer | Physician AccessServer | |||
| • Red Hat Enterprise Linux 8.4 | • Red Hat Enterprise Linux 8.4 | |||
| Client | Client | |||
| All operating systems that withsupport for the following HTML5-and JavaScript enabled browsers: | All operating systems that withsupport for the following HTML5-and JavaScript enabled browsers: | |||
| • Google Chrome ≥ 90(tested and recommendedChrome 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 onImageAcquisitionDevices | Client – Mobile deviceiPadOS ≥ 14, Safari web browserNoneSyngo Carbon Space is a pureviewing and/or post-processingsoftware and it has no influence onthe image acquisition devices. | Client – Mobile deviceiPadOS ≥ 14, Safari web browserNoneSyngo Carbon Space is a pure viewingand/or post-processing software and ithas no influence on the imageacquisition devices. | Same | NA |
| CADFunctionalities | NoneNo automated diagnosticinterpretation capabilities like CADare included. All image data are to beinterpreted by trained personnel. | NoneNo automated diagnosticinterpretation capabilities like CADare included. All image data are to beinterpreted by trained personnel. | Same | NA |
| Clinicalcondition thedevice isintended todiagnose, treat,or manage | No limitation on the clinical conditionof the patient. | No limitation on the clinical conditionof the patient. | Same | NA |
| Intendedpatientpopulation | No limitation concerning the patientpopulation (e.g., age, weight, health,condition) | No limitation concerning the patientpopulation (e.g., age, weight, health,condition) | Same | NA |
| Site of the bodythe device isintended to beused | No limitation concerning region ofbody or tissue type | No limitation concerning region ofbody or tissue type | Same | NA |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &Effectiveness |
| Intended useenvironment | Syngo Carbon Space "DiagnosticWorkspace" is used in Radiology,Nuclear Medicine and Cardiologyenvironments (e.g., darkened/ shadedrooms).Syngo Carbon Space "PhysicianAccess" is used in departmentalenvironments within healthcareinstitutions.For reading images certified monitorsare required (e.g., medical diagnosticdisplays). | Syngo Carbon Space "DiagnosticWorkspace" is used in Radiology,Nuclear Medicine and Cardiologyenvironments (e.g., darkened/ shadedrooms).Syngo Carbon Space "PhysicianAccess" is used in departmentalenvironments within healthcareinstitutions.For reading images certified monitorsare required (e.g., medical diagnosticdisplays). | Same | NA |
| Intendeduser(s) | Trained healthcare professionals | Trained healthcare professionals | Same | NA |
| Device Type | Software application | Software application | Same | NA |
| Softwarearchitecture | Syngo Carbon Space is based on aclient-server architecture | Syngo Carbon Space is based on aclient-server architecture | Same | NA |
| Software self-test / checks | Client installation is preventedautomatically in case if the systemdoesn't have the recommendedoperating system. Also during thelaunch of the client every time, thecompatibility to the server version ischecked and request toupdate/upgrade to client in case ofmismatch. | Client installation is preventedautomatically in case if the systemdoesn't have the recommendedoperating system. Also during thelaunch of the client every time, thecompatibility to the server version ischecked and request to update/upgradeto 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 userinterface | 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 |
|---|---|---|---|---|
| PatientBrowser | 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 |
| Seriesnavigator /DocumentPreview | 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 | 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 | Same | NA |
| Findings panel | Findings panel collectsmeasurements, annotations, andgraphical objects. Additionally, theuser can create new findings, editfindings. It also allows creation ofautomatic findings | Findings panel collects measurements,annotations, and graphical objects.Additionally, the user can create newfindings, edit findings. It also allowscreation of automatic findings. | Same | NA |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &Effectiveness |
| Reporting | 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)] | 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)] | Same | NA |
| ImageArchiving | 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 | 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 | Same | NA |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &Effectiveness |
| Patient Jacket | Provides access to patient history –other studies of patient stored insyngo.share core orremote DICOM nodes. Also providesa study content preview Along withaccess to nearline studies and priorRIS reports | Provides access to patient history –other studies of patient stored insyngo.share core orremote DICOM nodes. Also providesa study content preview. | The Patient Jacket isenhanced with theaccess to additionalstudies and reportscompared to thepredicate device. | This difference ofpatient jacketbetween thepredicate device andthe subject devicedoesn't impact thesafety andeffectiveness of thesubject device asnecessary measureshave been taken |
| Optimization &preparation/SpatialOperation tools | Image Preview Zoom/Pan Fit to Segment*, Fit toAcquisition Size* Synch, Align Windowing Rotate (2D image or 3DVolume*) Flip (Horizontal, Vertical) Shutters On/Off* Blow-up Scroll Movie Clipping* Punching and Masking* Magnifier * available in in DiagnosticWorkspace only | Image Preview Zoom/Pan Fit to Segment*, Fit toAcquisition Size* Synch, Align Windowing Rotate (2D image or 3DVolume*) Flip (Horizontal, Vertical) Shutters On/Off* Blow-up Scroll Movie Clipping* Punching and Masking* Magnifier * available in in DiagnosticWorkspace only | Same | NA |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &Effectiveness |
| AnnotationTool | • Arrow*• Marker*• Text* available in in DiagnosticWorkspace only | • Arrow*• Marker*• Text* available in in DiagnosticWorkspace only | Same | NA |
| Printing | Diagnostic workspace:Provides printing functionality withable to review, modify the imagesalong with selecting the print sheetformat exposing then the DICOMprinter.Also, able to monitor the printingstatus and retry a printing task, ifneeded.Note• DICOM printer must be configured as DICOMnodes• Grayscale & color printing is supportedPhysician Access:Provides printing functionality on apaper printer. | Diagnostic workspace:Structured findings can be printed on apaper printer.Physician Access:Provides printing functionality on apaper printer. | DICOM Print issupported in the subjectdevice, in addition topaper print whencompared to thepredicate device | This difference inprinting between thepredicate device andthe subject devicedoesn't impact thesafety andeffectiveness of thesubject device asnecessary measureshave been taken |
| Online helpsystem | Yes, with search, indexing, filtering,library function and documentcollections. | Yes, with search, indexing, filtering,library function and documentcollections. | 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.
§ 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).