(211 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.
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.
The user is asking for information about the acceptance criteria and the study proving the device meets them for "Syngo Carbon Space VA20A".
Based on the provided text, the device is software-only, intended for display, review, and analysis of medical images. It does not perform diagnostic interpretation (CAD functionalities) and instead supports trained medical professionals. The submission emphasizes non-clinical testing and comparison to a predicate device ("syngo.via VB40A").
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding reported device performance values in a quantitative manner. Instead, the performance is described in terms of verification and validation testing, and conformance to standards to demonstrate substantial equivalence to the predicate device.
The "Comparison" table in Section 9 highlights several differences and states that the "Impact to Safety & Effectiveness" for these differences is "NA" or that "the necessary measures have been taken." This implies that the acceptance criteria for these aspects are met by demonstrating that the changes do not negatively impact safety and effectiveness or that the subject device performs at least as well as the predicate for enhanced features.
For example, for "Measurement, Evaluation/Interpretation Tools," the subject device has "enhanced" functionalities like "Lesion Quantification." The impact is stated as "This differences between the predicate device and the subject device doesn't impact the safety and effectiveness of the subject device as the necessary measures taken." This suggests that the acceptance criteria for these enhanced tools were met by confirming their safe and effective operation, likely through internal validation.
Similarly, for "Cyber Security," the enhancement of "System Hardening" is noted, and the impact is "The improved security function doesn't impact the safety and effectiveness of the subject device as the necessary measures taken." This implies the security performance meets enhanced criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document 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, there is no information about sample size for a clinical test set or data provenance.
However, for the "Lesion Segmentation Algorithm," it mentions "phantom and reader studies." It does not specify the sample size, data provenance, or whether the study was retrospective or prospective.
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)
Since no clinical studies were performed and the device does not provide automated diagnostic interpretation, the document does not specify the number or qualifications of experts used to establish ground truth for a test set in the conventional sense of diagnostic accuracy studies. For the "Lesion Segmentation Algorithm" (which is not a diagnostic interpretation tool but a measurement tool), reader studies were conducted, implying expert involvement, but details are not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Given the absence of clinical studies and detailed information on the "phantom and reader studies" for the Lesion Segmentation Algorithm, no information is provided regarding an adjudication method for a test set.
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 MRMC comparative effectiveness study is mentioned. The device is not a CAD or AI assistance tool for diagnosis but an image management and processing system. The "Lesion Quantification" feature is stated to be "a non-Deep learning algorithm."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The "Lesion Segmentation Algorithm" was evaluated in "phantom and reader studies." The fact that reader studies were mentioned suggests that human reading was involved in evaluating the algorithm's performance, but the document does not definitively state that a standalone performance evaluation of the algorithm itself (without human-in-the-loop) was conducted, nor does it provide performance metrics for such a standalone evaluation. The device as a whole is intended to "support the review and analysis of medical images by trained medical professionals," indicating a human-in-the-loop design.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the "Lesion Segmentation Algorithm," it is implied that expert readers were involved in the "reader studies." For the overall device, which is an image display and processing system, the ground truth for validation would likely involve adherence to technical specifications, image quality standards (e.g., DICOM conformance), and verification that processing functions yield expected results, rather than a clinical ground truth for disease presence.
8. The sample size for the training set
No information is provided about a training set size. The "Lesion Quantification" is described as a "non-Deep learning algorithm," which generally doesn't require a large training set in the same way as deep learning models.
9. How the ground truth for the training set was established
No information is provided about a training set or how its ground truth would have been established. As mentioned, the Lesion Quantification tool is a non-deep learning algorithm, suggesting a different development and validation paradigm than AI tools that rely heavily on large, expertly annotated training datasets.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Siemens Healthcare GmbH % Vijay Ramadas Regulatory Affairs Manager Siemensstr. 1 Forchheim. Baveria 91301 GERMANY
June 21, 2022
Re: K213665
Trade/Device Name: Syngo Carbon Space VA20A Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: May 16, 2022 Received: May 19, 2022
Dear Vijay Ramadas:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica Lamb. Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213665
Device Name Syngo Carbon Space VA20A
Indications for Use (Describe)
Syngo Carbon Space is a software intended to display medical data and to support the review and analysis of medical images by trained medical professionals.
Syngo Carbon Space "Diagnostic Workspace" is indicated for display, rendering, post-processing of medical data (mostly medical images) within healthcare institutions, for example, in the field of Radiology, Nuclear Medicine and Cardiology.
Syngo Carbon Space "Physician Access" is indicated for display and rendering of medical data within healthcare institutions.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a graphic of orange dots.
Traditional 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
-
- Submitter: Siemens Healthcare GmbH Henkestrasse 127 91052 Erlangen Germany
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- Establishment Registration Number: 3004977335
3. Contact Person:
Mr. Vijay Ramadas Regulatory Affairs Manager Siemens Healthcare GmbH, Siemensstr. 1 91301 Forchheim Germany
E-mail: vijay.ramadas(@siemens-healthineers.com Telephone: +49 (172) 4324369 Fax: +49 (9191) 18-4404
4. Device Name and Classification
| Device/Trade Name: | Syngo Carbon Space (VA20A) |
|---|---|
| Classification Panel: | Radiology |
| Classification Number: | 21 CFR 892.2050 |
| Classification Name: | Medical Image Management and Processing System |
| Device Class: | Class II |
| Product Code: | LLZ |
5. Legally Marketed Predicate Device:
| Device/Trade Name: | syngo.via (VB40A) |
|---|---|
| 510(k) Clearance: | K191040 |
| Clearance Date: | May 16, 2019 |
| Classification Name: | Picture Archiving and Communications System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.2050 |
| Device Class: | Class II |
| Product Code: | LLZ |
| Recall Information: | This predicate device has not been the subject ofany design related recalls. |
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6. Device Description:
Syngo Carbon Space is a software only medical device which is intended to be installed on recommended common IT Hardware. The hardware is not seen as part of the medical device. Syngo Carbon Space is intended to support reviews and analysis of medical images by trained medical practitioners. The software is used in Radiology for reading images and throughout the healthcare institutions for image & result distribution.
Syngo Carbon Space is a medical device, provided in two variants/options.
- Diagnostic Workspace (Fat/Thick Client) -
- -Physician Access (Thin/Web Client)
In any scenario, both the options can be installed/run on the same machine and be used simultaneously.
Syngo Carbon Space Diagnostic Workspace provides a reading workspace for Radiology that supports display of medical image data & documents and connects intelligent work tools (diagnostic and non-diagnostic software elements) to enable easy access to the data needed, easy access to external tools and creation of actionable results.
Syngo Carbon Space Physician Access provides a zero-footprint web application for enterprise-wide viewing of DICOM, non-DICOM, multimedia data and clinical documents to facilitate image and result distribution in the healthcare institution.
Since Syngo Carbon Space is a software only product, shelf-life is not applicable because of low likelihood of time-dependent product degradation. Hence performance data is not needed to establish maintenance of device performance characteristics over the shelf-life period
Syngo Carbon Space is a software only medical device, which is delivered by download only option to be installed on common IT hardware. This hardware must fulfil the defined requirements. Any hardware platform that complies to the specified minimum hardware and software requirements and with successful installation verification and validation activities can be supported. The hardware itself is not seen as part of the medical device and therefore not in the scope of this 510(k) submission.
Syngo Carbon Space provides tools and features to cover the radiological tasks reading images and support reporting through third party tools. It supports DICOM and Non-DICOM objects. In a comprehensive imaging suite, Syngo Carbon Space interoperates with a Radiology Information System (RIS) to enable customer specific workflows.
Syngo Carbon Space is based on a client-server architecture. The server processes and renders the data from the connected modalities. The server provides central services including image processing and temporary storage. The client provides the user interface for interactive image viewing and processing and can be installed and started on each workplace that has a network connection to the server.
Syngo Carbon Space supports various monitor setups and can be adapted to a range of image types by connecting different monitor types.
The subject device and the predicate device share fundamental scientific technology. This device description holds true for the subject device, Syngo Carbon
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Space software version VA20A, as well as the predicate device, syngo.via, software version VB40A.
7. Intended Use:
Syngo Carbon Space is a software intended to display medical data and to support the review and analysis of medical images by trained medical professionals.
8. Indications for Use:
Syngo Carbon Space is a software intended to display medical data and to support the review and analysis of medical images by trained medical professionals.
Syngo Carbon Space "Diagnostic Workspace" is indicated for display, rendering, postprocessing of medical data (mostly medical images) within healthcare institutions, for example, in the field of Radiology, Nuclear Medicine and Cardiology.
Syngo Carbon Space "Physician Access" is indicated for display and rendering of medical data within healthcare institutions.
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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 nameand version (Knumber) | Syngo Carbon Space VA20A | syngo.via VB40A (K191040) | New product | 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.via is a software solutionintended to be used for viewing,manipulation, communication, andstorage of medical images.It can be used as a stand-alonedevice or together with a variety ofcleared and unmodified syngo basedsoftware options.syngo.via supports interpretation andevaluation of examinations withinhealthcare institutions, for example,in Radiology, Nuclear Medicine andCardiology environments. | Syngo Carbon Space is adevice available in twooptions,Diagnostic-Workspace(Thick Client)Physician Access(Web Client)with same intended useand Indications to use.Additionally, SyngoCarbon Space displaysNon-DICOM Artifacts | Display of Non-DICOM artifacts inthe subject devicedoesn't impact thesafety andeffectiveness of thedevice, as necessarymeasures have beentaken |
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| 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 beused as a sole basis for clinicaldecisions.Syngo Carbon Space "PhysicianAccess" is not intended for diagnosisof digital mammography images.Syngo Carbon Space "PhysicianAccess" is not intended to be usedfor diagnostic purpose on mobiledevices in the United States ofAmerica (USA).Syngo Carbon Space "PhysicianAccess" is not intended to be used asa sole basis for clinical decisions. | The system is not intended for thedisplaying of digital mammographyimages for diagnosis in the U.S. | The subject deviceincludes additionalcontraindicationstatements which acts asa caution to the userabout the usage of thedevice while making aclinical decision frommedical images orclinical documents. | The difference in'contra-Indications'between thepredicate device andthe subject devicedoesn't impact thesafety andeffectiveness of thesubject device asnecessary measureshave been taken |
| Softwarearchitecture | Syngo Carbon Space is based on aclient-server architecture | syngo.via is based on a client-serverarchitecture | Same | NA |
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| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &Effectiveness |
|---|---|---|---|---|
| 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)objects. Allows interfacing withHL7 (v2.5 / v2.3.1 / v2.3). | Syngo Carbon Spaceadditionally allowscommunication withnon-DICOM artefactsand FHIR interface | The difference inimagecommunicationbetween thepredicate device andthe subject devicedoesn't impact thesafety andeffectiveness of thesubject device asnecessary measureshave been taken |
| 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 | Same | NA |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &Effectiveness |
| Measurement,Evaluation/InterpretationTools | • 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• Time Curve, Time ROI** available in in DiagnosticWorkspace only | • Distance (Distance Line,Distance Polyline)• Angle• 2D ROI (Circle, Freehand,Polygonal)• 3D VOI (Sphere, Freehand)• Pixel Lens• Ranges (Parallel, Radial, RadialSliced, Curved, Spine, Vascular)• Assisted Perpendicular Tool• Automatic Organ Segmentation• Interactive Tissue Segmentation• Time Curve, Time ROI• Define Vessel• SUV Measurement• Automatic Anatomy Labeling(rib, spine)• Basic Onco Tool (AssistedPerpendicular Tool)• Change Visualization• Next Study/ Previous Study | Theevaluation/interpretationfunctionalities in thesubject device areenhanced.Lesion QuantificationEnables the user toperform diametermeasurements and tocreate segmentationobjects of suspect lesionsin lung parenchyma. Thisis a non-Deep learningalgorithm | This differencesbetween thepredicate device andthe subject devicedoesn't impact thesafety andeffectiveness of thesubject device as thenecessary measurestaken |
| Supportedobjectsfor display | DICOM image object display: | DICOM image object display: | The subject devicesupports additionalimage object types fordisplay: | This difference insupported DICOMmodality and Non-DICOM object typesbetween thepredicate device andthe subject devicedoesn't impact thesafety andeffectiveness of thesubject device asnecessary measureshave been taken |
| DICOM image object display:• CR Image• CT Image• DX Image• ES Image• GM Image• MG Image• MR Image• NM Image• PET Image• OP/OPT Image• RF Image• RT IMAGE• SM (WSI)• XA Image• US Image• Secondary capture objects | DICOM image object display:• CR Image• CT Image• DX Image• MG Image• MR Image• NM Image• PET Image• XA Image• US Image• Secondary capture objects | DICOM image objectdisplay:• ES Image• GM Image• OP/OPT Image• SM (WSI)DICOM non-imageobject display:• ECG• Encapsulated PDF• PRNon-DICOM filedisplay:• Images: BMP, GIF,JPEG (JFIF), JPEG2000, JPEG-LE,JPEG-LS, PCX,PNG, PNM, TIFF,WBMP• Video: FLV, H.264,H.265, INDEO2,INDEO3, INDEO4,MPEG1, MPEG2,MPEG4, VP8, VP9, | ||
| DICOM non-image object display:• ECG• Encapsulated PDF• PRNon-DICOM file display:• Images: BMP, GIF, JPEG(JFIF), JPEG 2000, JPEG-LE,JPEG-LS, PCX, PNG, PNM,TIFF, WBMP• Video: FLV, H.264, H.265,INDEO2, INDEO3, INDEO4,MPEG1, MPEG2, MPEG4 | ||||
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety & Effectiveness |
| VP8, VP9, WMV1, WMV2, WMV3• Text Documents: CDA (XML), PDF | WMV1, WMV2, WMV3• Text Documents: CDA (XML), PDF | |||
| Operatingsystem | Diagnostic Workspace | Windows client | In the subject device | This Operating |
| Server | client supports Microsoft | System difference | ||
| Microsoft Windows Server 2019 Windows 10 IoT Red Hat Enterprise Linux 8.4 | Microsoft Windows 7 SP1 Microsoft Windows 8 (8.1 Pro, 8.1 Enterprise) Microsoft Windows 10 (Home, Pro, Education, Enterprise) | Windows 10 Operatingsystem and Serversupports MicrosoftWindows Server 2019,Windows 10 IoT, andRed Hat EnterpriseLinux 8.4 compared tothe predicate device. | between the | |
| Client | predicate device and | |||
| Microsoft Windows 10(Pro, Pro-Education, Enterprise) | Windows Server | the subject device | ||
| Microsoft Windows Server2008 R2 Microsoft Windows Server2012 R2 Microsoft Windows Server2016 | doesn't impact the | |||
| Physician Access | safety and | |||
| Server | effectiveness of the | |||
| Red Hat Enterprise Linux 8.4 | subject device as | |||
| Client - WorkplaceAll operating systems that withsupport for the following HTML5-and JavaScript enabled browsers: | necessary measureshave been taken | |||
| Google Chrome ≥ 83(tested and recommended) Microsoft Internet Explorer ≥11(not recommended) Microsoft Edge ≥ 83(tested and recommended:Edge 89) Mozilla Firefox ≥ 78 Mozilla Firefox ESR ≥ 78 Apple Safari ≥ 13 | ||||
| Client - Mobile deviceiPadOS > 14, Safari web browser | ||||
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety & Effectiveness |
| Impact onImageAcquisitionDevices | NoneSyngo Carbon Space is a pure viewing and/or post-processing software and it has no influence on the image acquisition devices. | Nonesyngo.via is a pure viewing and/or post-processing software and it has no influence on the image acquisition devices. | Same | NA |
| CADFunctionalities | NoneNo automated diagnostic interpretation capabilities like CAD are included. All image data are to be interpreted by trained personnel. | NoneNo automated diagnostic interpretation capabilities like CAD are included. All image data are to be interpreted by trained personnel. | Same | NA |
| Clinicalcondition thedevice isintended todiagnose, treat,or manage | No limitation on the clinical condition of the patient. | No limitation on the clinical condition of the patient. | Same | NA |
| Intendedpatientpopulation | No limitation concerning the patient population (e.g., age, weight, health, condition) | No limitation concerning the patient population (e.g., age, weight, health, condition) | Same | NA |
| Site of the bodythe device isintended to beused | No limitation concerning region of body or tissue type | No limitation concerning region of body or tissue type | Same | NA |
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| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &Effectiveness |
|---|---|---|---|---|
| Intended 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.via is used in Radiology,Nuclear Medicine, and Cardiologyenvironments (e.g., darkened/shaded rooms).For reading images certifiedmonitors are required (e.g. medicaldiagnostic displays). | 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.via is based on a client-serverarchitecture | Same | NA |
| Software self-test / checks | Same | NA | ||
| 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. | Indicates the user in case that datacoming from an interface cannot beassigned to a task flow to assign itmanually.In case of a data mismatch due toincorrect or inconsistent use ofDICOM rules the administrator canchange the data transfer protocol andpatient identification rules (DICOMParser Tool). | |||
| When the audit trail folder exceedsthe configured level of storage, awarning message is sent to theadministrator by e-mail, ifconfigured. | ||||
| 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. | ||||
| Database recovery tool restores thedata if the integrity checks betweenthe Short term Storage and syngo.viadatabase fails. | ||||
| A new instance of DICOM object iscreated in case of any non-reversible | ||||
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &Effectiveness |
| modification is performed on theDICOM Object (e.g. Lossycompression, reduction of colordepth, resampling of image matrix,etc.) | ||||
| Cyber Security | • User access control• Audit Trail• Documentation of systemsecurity information, Networktraffic & Firewall control• Support of virus / malwareprotection• System Hardening (OS level andNetwork level) | • User access control• Audit Trail• Documentation of systemsecurity information, Networktraffic & Firewall control• Support of virus / malwareprotection.• System Hardening• Device guard (Whitelisting) | The security of thesubject device wasimproved by enhancingthe System Hardening atOS level as well asNetwork Level.OS level: Thetechnologies (operatingsystem, browser, webserver etc.) used in ITsystems attached to thenetwork are hardened(configured securely)according to the IASEDISA standard.Network level: Providesprotection to the systemfrom malicious networktraffic. | The improvedsecurity functiondoesn't impact thesafety andeffectiveness of thesubject device as thenecessary measurestaken |
| Hardware | Hardware is not understood as part ofthe medical device but needs tocomply with the minimumrequirements as specified by SyngoCarbon Space. | Hardware is not understood as partof the medical device but needs tocomply with the minimumrequirements as specified bysyngo.via. | Same | NA |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety &Effectiveness |
| Graphical userinterface | 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. | Yes, with reduced color palette,clearer structure, and text labels onicons. Floating panels increases theuser friendliness as the user canmove the panels wherever they areconvenient with. | Same | NA |
| PatientBrowser | 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 | Simplified search functionality,clearer structure of search results,unlimited search results, periodicupdates of search results, imagepreview, Correct & re-arrange andflexible floating patient browserwindow. | Syngo Carbon Space hasan additional feature"Inbox" | The Inbox feature inthe subject devicedoesn't impact thesafety andeffectiveness of thedevice as necessarymeasures have beentaken |
| 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 | The Series Navigator lists allcurrently loaded data within aworkflow.Series Navigator supports theThumbnail view and switchingbetween Preview, List andThumbnail views for both series andinstances level. | The functionality isenhanced in the subjectdevice. | This series navigatordifference betweenthe predicate deviceand the subjectdevice doesn'timpact the safety andeffectiveness of thesubject device asnecessary measureshave been taken |
| Findings panel | Findings panel collectsmeasurements, annotations, andgraphical objects. Additionally, theuser can create new findings, editfindings. It also allows creation ofautomatic findings. | Findings Navigator collectsmeasurements, annotations, andgraphical objects. Additionally, theuser can create new findings, editfindings, trend findings over time,cluster findings based on bodyregion. | The functionality isenhanced in the subjectdevice.The Findings panel in thesubject deviceadditionally providesautomatic findingscreation option to createstructured findings. | This difference infindings assistantbetween thepredicate device andthe subject devicedoesn't impact thesafety andeffectiveness of thesubject device asnecessary measureshave been taken |
| 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)] | Findings and measurements areautomatically sent to the syngo.viashort Term Storage (STS) trackedand listed by the syngo.via. Theradiologist can save or print a report,or send it to a connected informationsystem, such as a HIS or RIS. | The reportingfunctionality in thesubject device ismodified and connectedto third-party reportingsolutions when comparedto the predicate device. | This difference inreportingfunctionalitybetween thepredicate device andthe subject devicedoesn't impact thesafety andeffectiveness of thesubject device asnecessary measureshave been taken |
| 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 | Data can be sent to an archive ifsyngo.via is connected to a PACS orcorresponding DICOM node. | New option in thefunctionality of thesubject device.The image archiving inthe subject device takesplace via syngo.sharecore option. | This difference ofimage archivingbetween thepredicate device andthe subject devicedoesn't impact thesafety andeffectiveness of thesubject device asnecessary measureshave been taken |
| 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. | The Add study dialog allows toquery and retrieve studies fromremote DICOM nodes for samepatient | The Patient Jacket isenhanced with thefeature, study contentpreview (thumbnailimage for image series) | 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 | There are enhancementsto the interaction toolalgorithm in the subjectdevice compared to thepredicate device.MagnifierThe Magnifier toolallows the user tomagnify a section of theimage in order to get acloser view of thesection. | This difference ininteraction toolbetween thepredicate device andthe subject devicedoesn't impact thesafety andeffectiveness of thesubject device asnecessary measureshave been taken |
| Specification | Subject Device | Predicate Device | Comparison | Impact to Safety & Effectiveness |
| Annotation Tool | Arrow* Marker* Text * available in in Diagnostic Workspace only | Arrow Marker Text | Same | NA |
| Printing | Diagnostic workspace:Structured findings can be printed on a paper printer.Physician Access:Provides printing functionality on a paper printer. | Provides printing functionality at a DICOM printer or on paper printer.User may preview and re-arrange the images on the print sheet printing. The print sheet supports basic manipulations like zoom/pan and windowing. | Both the subject and predicate devices have the option for paper printing. | This difference in printing between the predicate device and the subject device doesn't impact the safety and effectiveness of the subject device as necessary measures have been taken |
| Online help system | Yes, with search, indexing, filtering, library function and document collections. | Yes, with search, indexing, filtering, library function, document collections, and user-generated content. | Same | NA |
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10. Clinical Testing
No clinical studies were carried out for the product, all performance testing was conducted in a non-clinical fashion as part of verification and validation activities of the medical device
11. Bench Testing Evaluation Summary
The results of phantom and reader studies conducted on the Lesion Segmentation Algorithm were evaluated for fit for use in the subject device and it was concluded that the Algorithm can be integrated in the subject device with few design mitigations to overcome the drawbacks/limitations specified in these studies. These design mitigations were validated by Non-Clinical performance testing of the subject device and were found acceptable.
12. Non-clinical Performance Testing:
Non-clinical tests were conducted for the device Syngo Carbon Space during product development. The modifications described in this Premarket Notification were supported with verification and validation testing.
Siemens Healthcare GmbH claims conformance to the following standards:
- NEMA PS 3.1 3.20 (2016) Digital Imaging and Communications in Medicine -(DICOM) Set
- ISO/IEC 10918-1 First edition 1994-02-15 + Technical Corrigendum 1 (2005) -(JPEG)
- ISO 14971 Third Edition 2019-12 -
- -IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION
- IEC 82304-1 Edition 1.0 2016-10 -
- IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION -
- -IEEE Std 3333.2.1-2015
13. Software Verification and Validation:
Software documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" is also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software. Non-clinical tests were conducted on the device Syngo Carbon Space during product development.
The Risk Analysis was completed, and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence.
Siemens Healthcare GmbH conforms to the Cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient. Contained in Section B of this submission are our cybersecurity considerations as they relate to the device Syngo Carbon Space.
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14. Summary:
Performance tests were conducted to test the functionality of the device Syngo Carbon Space. These tests have been performed to assess the functionality of the subject device. Results of all conducted testing were found acceptable in supporting the claim of substantial equivalence.
15. Safety and Effectiveness Information:
Software specifications, descriptions, hazard analysis, and labeling information are submitted in support of this premarket notification. The device labeling contains instructions for use with cautions to provide for safe and effective use of the device.
The results of the hazard analysis combined with the appropriate preventive measures taken indicate the device is of moderate level of concern, as per the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
16. Conclusion as to Substantial Equivalence:
The predicate device was cleared based on non-clinical supportive information. The comparison of technological characteristics, device hazards, non-clinical performance data, and software validation data demonstrates that the subject device performs comparably to and is as safe and effective as the predicate device that is currently marketed for the same intended use.
In summary, we are of the opinion that the subject device Syngo Carbon Space, software version VA20A, does not introduce any new significant potential safety risks and is substantially equivalent to and performs as well as the predicate device syngo.via VB40A.
§ 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).