(71 days)
syngo.MR Applications is a syngo based post-acquisition image processing software for viewing, manipulating, evaluating, and analyzing MR, MR-PET, CT, PET, CT-PET images and MR spectra.
Applications are syngo svnao.MR based post-processing The software/applications to be used for viewing and evaluating MR images provided by a magnetic resonance diagnostic device and enabling structured evaluation of MR images.
The syngo.MR Applications is a combination of eight (8) former separately cleared medical devices which are now handled as features / functionalities within syngo.MR Applications.
These functionalities are combined unchanged compared to their former cleared descriptions; of course some minor enhancements and improvements are made. The syngo.MR Applications are syngo.via based MR data viewing, processing and reading software allowing MR image evaluation in a structured way and supporting convenient reading and / or evaluation of MR images and data.
The provided text describes the regulatory clearance of a medical device called "syngo.MR Applications" and discusses its safety and effectiveness in comparison to predicate devices. However, it does not contain a detailed study report with specific acceptance criteria, reported device performance metrics, sample sizes, or ground truth establishment methods for a specific algorithm's performance.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to already cleared devices rather than providing a detailed performance study for a novel algorithm.
Therefore, many of the requested details about acceptance criteria and a study proving those criteria are not present in the provided text.
Based on the available information, here's what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated for specific algorithmic performance. The document focuses on showing that the combined functionalities of syngo.MR Applications maintain an "equivalent safety and performance profile" to predicate devices.
- Reported Device Performance: No quantitative performance metrics (e.g., accuracy, sensitivity, specificity, AUC) are provided for any specific functionality of the syngo.MR Applications software. The document mentions "minor improvements and enhancements of the existing functionalities," such as improved functional analysis in MR Cardiac Analysis workflow, a pen tool for editing LV and RV contours, and other UI/UX improvements, but no objective performance data is given for these.
2. Sample size used for the test set and the data provenance
- Not provided. The document does not describe any specific test set used to evaluate the performance of an algorithm within syngo.MR Applications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not provided. Since no specific performance study on a test set is detailed, information about ground truth establishment or experts is absent.
4. Adjudication method for the test set
- Not provided.
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 is not mentioned. The document focuses on the software's capabilities for viewing, manipulating, evaluating, and analyzing images, and its substantial equivalence to predicate devices, not on a human-in-the-loop performance study or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No standalone algorithmic performance study is explicitly described with quantitative results. The document describes "post-acquisition image processing software for viewing, manipulating, evaluating, and analyzing MR, MR-PET, CT, PET, CT-PET images and MR spectra." While this implies algorithmic processing, no specific, isolated algorithm performance metrics are reported.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not provided.
8. The sample size for the training set
- Not provided.
9. How the ground truth for the training set was established
- Not provided.
In summary: The provided document is a regulatory submission affirming substantial equivalence of a software suite for image processing to existing cleared devices. It describes the functionalities of the software and references compliance with various standards (ISO 14971, IEC 62304, DICOM), but it does not contain the detailed performance study data (acceptance criteria, specific metrics, sample sizes, ground truth methods) that would be expected for a novel AI/ML algorithm's validation. The "device" in this context is a comprehensive software platform with various post-processing functionalities, not a single, measurable AI algorithm with specific performance claims in the way requested by the prompt.
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Siemens Medical Solutions USA, Inc. % Cordell L. Fields, Esq. Regulatory Affairs Technical Specialist 40 Liberty Boulevard, Mailcode 65-1A MALVERN PA 19355
April 19, 2018
Re: K180336
Trade/Device Name: syngo.MR Applications Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ LNH Dated: February 6, 2018 Received: February 7, 2018
Dear Mr. Fields:
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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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(1-800-638-2041 or 301-796-7100).
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone
Sincerely,
Michael D. O'Hara For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
| 510(k) Number (if known) | K180336 |
|---|---|
| Device Name | syngo.MR Applications |
| Indications for Use (Describe) | syngo.MR Applications is a syngo based post-acquisition image processing software for viewing, manipulating, evaluating, and analyzing MR, MR-PET, CT, PET, CT-PET images and MR spectra. |
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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Traditional 510(k) Premarket Notification for: syngo.MR Applications VB30
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Section 5 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act 1990 and 21 CFR § 807.92.
Date of Summary Preparation: February 06, 2018
I. General Information
| Importer / Distributor: | Siemens Medical Solutions USA, Inc.40 Liberty BoulevardMailcode: 65-1AMalvern, PA 19355 |
|---|---|
| Registration Number: | 2240869 |
| Manufacturer: | Siemens Healthcare GmbHHenkestr. 127D-91052 Erlangen, Germany |
| Registration Number: | 3002808157 |
| Contact Person: | Cordell L. Fields, Esq.Regulatory Affairs Technical SpecialistSiemens Medical Solutions USA, Inc.65 Valley Stream PkwyMail Code 65-1AMalvern, PA 19355, USAPhone: (610) 448-6469Fax: (610) 427-3465Email: cordell.fields@siemens-healthineers.com |
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Device Name and Classification
| Data | Details |
|---|---|
| Trade name /DeviceProprietaryName: | syngo.MR ApplicationsIt covers single and engine applications:• syngo.MR General○ syngo.MR Reading○ syngo.MR General Routine○ syngo.MR Cardiac Reader○ syngo.MR Composing○ syngo.MR General Engine2• syngo.MR Cardiology○ syngo.MR Cardiac 4D VentricularFunction○ syngo.MR Cardiac Flow○ syngo.MR Cardio Engine• syngo.MR Neurology○ syngo.MR Neuro Perfusion○ syngo.MR Neuro Perfusion Mismatch○ syngo.MR Neuro fMRI○ syngo.MR Tractography○ syngo.MR Neuro Perfusion Engine○ syngo.MR Neuro 3D Engine• syngo.MR Oncology○ syngo.MR Onco○ syngo.MR 3D Lesion Segmentation○ syngo.MR Tissue4D○ syngo.MR Onco Engine○ syngo.MR Onco Engine Pro○ syngo.MR OncoCare• syngo.BreVis• syngo.mMR General• syngo.MR Spectroscopy○ syngo.MR Spectro SVS○ syngo.MR Spectro CSI○ syngo.MR Spectro Extension• syngo.MR Vascular○ syngo.MR Vascular Analysis |
| ClassificationName: | Regulation Description:Picture Archiving and Communication System (PACS) |
2 syngo.MR General Engine is the precondition for all other, advanced MR post-processing applications and engines
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| Data | Details |
|---|---|
| ClassificationPanel: | Radiology |
| DeviceClassification: | Class II devices |
| Regulationnumber: | 21 CFR § 892.2050 |
| Product Code: | Primary: LLZ, Secondary: LNH |
| Data | Details |
|---|---|
| Trade name /DeviceProprietaryName: | syngo.MR ApplicationsIt covers single and engine applications:syngo.MR General syngo.MR Reading syngo.MR General Routine syngo.MR Cardiac Reader syngo.MR Composing syngo.MR General Engine syngo.MR Cardiology syngo.MR Cardiac 4D Ventricular Function syngo.MR Cardiac Flow syngo.MR Cardio Engine syngo.MR Neurology syngo.MR Neuro Perfusion syngo.MR Neuro Perfusion Mismatch syngo.MR Neuro fMRI syngo.MR Tractography syngo.MR Neuro Perfusion Engine syngo.MR Neuro 3D Engine syngo.MR Oncology syngo.MR Onco syngo.MR 3D Lesion Segmentation syngo.MR Tissue4D syngo.MR Onco Engine syngo.MR Onco Engine Pro syngo.MR OncoCare syngo.BreVis syngo.mMR General syngo.MR Spectroscopy |
Traditional 510(k) Premarket Notification for: syngo.MR Applications VB30
February 06, 2018
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| Data | Details |
|---|---|
| syngo.MR Spectro SVS syngo.MR Spectro CSI syngo.MR Spectro Extension syngo.MR Vascular syngo.MR Vascular Analysis | |
| Single functionalitiesand engines | Description |
| syngo.MR General | |
| syngo.MR Reading | Enables reading of 2D, 3D, and 4D MR data.Includes:• Basic workflow• Workflow customization• Follow-up support• Rescan handlingContext-specific reporting |
| syngo.MR GeneralRoutine | It extends syngo.via by adding dedicated worflows and tools for routineand advanced reading of MR examinations. Several workflows areprovided like MR Neurology, MR Prostate Reading, MR BreastReading, and MR Cardio-Vascular Reading workflows.syngo.MR General Routine provides several MR Evaluation tools:Subtraction, MeanCurve, Image Filter, 2D/3D Distortion Correction.ADC and b-value tool (for extrapolated b-values), Multiplication,Division, Addition, Elastic Motion Correction.Workflow optimized reporttemplates. |
| syngo.MR CardiacReader | With syngo.MR Cardiac Reader the Cardiac Reading step within theCardiac Analysis Workflow is provided. The Cardiac Reading enablesviewing and evaluating different kinds of cardiac images using thecommon tools. |
| syngo.MR Composing | syngo.MR Composing is a dedicated offline application for creation offull-format images from overlapping MR volume data sets acquired atmultiple stages. It can be used to compose images in any of the otherworkflows. |
| syngo.MR GeneralEngine4 | syngo.MR General Engine contains:• syngo.MR General Routine• syngo.MR Cardiac Readersyngo.MR General Engine is the precondition for all other, advancedMR post-processing applications and Engines. |
| syngo.MR Cardiology | |
| syngo.MR Cardiac 4DVentricular Function | syngo.MR Cardiac 4D Ventricular Function processes MR cine imagesof the heart which enables users to generates quantitative results forphysicians in the diagnostic process. The MR cardiac interactivereporting template is included. |
| Single functionalitiesand engines | Description |
| syngo.MR CardiacFlow | Processes velocity-encoded MR images to evaluate blood flowdynamics e.g. in the heart and the great vessels. The applicationgenerates quantitative results for physicians in the diagnostic process.The MR cardiac interactive reporting template is included. |
| syngo.MR CardioEngine | syngo.MR Cardio Engine contains:syngo.MR Cardiac 4D Ventricular Function syngo.MR Cardiac Flow |
| syngo.MR Neurology | |
| syngo.MR NeuroPerfusion5 | Extends the MR Neurology workflow with advanced processing toolsfor the analysis of brain perfusion datasets and allows theassessment and evaluation of various spots of cerebral lesions. |
| syngo.MR NeuroPerfusion Mismatch | Extends the assessment of brain perfusion datasets with calculation ofmismatch area and mismatch ratio between two different contrasts (forexample diffusion and perfusion) to support therapy decisions. |
| syngo.MR Neuro fMRI | A workflow oriented visualization package for BOLD fMRI. It enablesthe visualization of task-related areas of activation overlayed onto 2Dor 3D anatomical datasets, providing the spatial correspondence ofBOLD results with cortical landmarks or brain lesions. Image-basedregistration and multi-contrast evaluation are also available. Functionaland anatomical image data can be exported for surgical planning asDICOM datasets. |
| syngo.MRTractography | Enables the representation of diffusion paths of the human brainbased on diffusion tensor imaging. syngo.MR Tractography supportssurgery planning and is suitable for neurophysiological research inrelation to cortical networking and pathologies of the white matter. |
| syngo.MR NeuroPerfusion Engine | syngo.MR Neuro Perfusion Engine contains:syngo.MR Neuro Perfusion syngo.MR Neuro Perfusion Mismatch |
| syngo.MR Neuro 3DEngine | syngo.MR Neuro 3D Engine contains:syngo.MR Neuro fMRI syngo.MR Tractography |
| syngo.MR Oncology | |
| syngo.MR Onco | An image viewing, processing and reading software that allows foroncological MR image evaluation in a structured way. |
| Single functionalitiesand engines | Description |
| syngo.MR 3D LesionSegmentation | Provides convenient volumetric evaluation of lesions and/or otherstructure of interest as well as particularly useful tools for oncologyapplications. |
| syngo.MR Tissue4D | A post-processing workflow which supports the physician in reading ofdynamic contrast-enhanced MR data sets. |
| syngo.MR OncoCare | Enables the physician to evaluate signal intensities in segmentedregions of interest with the help of histograms and color maps as wellas evaluation the change of time in typical lesion parameters likediameter or volume (trending). |
| syngo.MR OncoEngine | syngo.MR Onco Engine contains:• syngo.MR Onco• syngo.MR 3D Lesion Segmentation |
| syngo.MR OncoEngine Pro | syngo.MR Onco Engine Pro contains:• syngo.MR Onco Engine• syngo.MR OncoCare |
| syngo.MR BreVis | A software package intended for use in viewing and analyzingmagnetic resonance imaging (MRI) studies. |
| syngo.mMR General | A syngo based post-processing software for viewing, manipulating andevaluating MR, PET and MR-PET images. |
| syngo.MR Spectroscopy | |
| syngo.MR SpectroSVS | Provides evaluation of MR Single Voxel Spectroscopy (SVS) data withcomprehensive workflow guidance. |
| syngo.MR Spectro CSI | Provides evaluation of MR Chemical Shift Imaging (CSI) data withcomprehensive workflow guidance. syngo.MR Spectro CSI includesthe possibility of an integrated reading of MR images and CSIspectroscopy data for prostate exams. |
| syngo.MR SpectroExtension | Provides access to advanced parameters, which allow the advanceduser to configure the post processing and display of spectro resultsaccording to his / her personal needs. Both Single Voxel Spectroscopy(SVS) and Chemical Shift Imaging (CSI) data are supported. |
| syngo.MR Vascular | |
| syngo.MR VascularAnalysis | Enables assessment / quantification of general vascular pathologies. |
II. Safety and Effectiveness Information Supporting Substantial Equivalence
Intended Use
"syngo.MR Applications is a syngo based post-acquisition image processing software for viewing, manipulating, evaluating, and analyzing MR, MR-PET, CT, PET, CT-PET images and MR spectra."
Device Description
Applications are syngo svnao.MR based post-processing The software/applications to be used for viewing and evaluating MR images provided by a magnetic resonance diagnostic device and enabling structured evaluation of MR images.
The syngo.MR Applications is a combination of eight (8) former separately cleared medical devices which are now handled as features / functionalities within syngo.MR Applications.
These functionalities are combined unchanged compared to their former cleared descriptions; of course some minor enhancements and improvements are made. The syngo.MR Applications are syngo.via based MR data viewing, processing and reading software allowing MR image evaluation in a structured way and supporting convenient reading and / or evaluation of MR images and data.
3 While viewing (i.e. assessing) of images from other vendors is always possible; for advanced post-processing applications, some of the post-processing steps may depend on information contained in private DICOM tags ,therefore evaluation and processing of images can't be guaranteed for other vendors.
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The table below shows the functionalities of the syngo.MR Applications:
4 syngo.MR General Engine is the precondition for all other, advanced MR post-processing applications and engines
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§ The application syngo.MR Neuro Dynamics described in K151353 (and cleared August 07, 2015) is only available within syngo.MR Neuro Perfusion (neurospecific Mean Curve Tool), but no longer as single application. The syngo.MR Neuro Perfusion Engine Pro, described in K151353 (and cleared August 07, 2015), is therefore obsolete within SMRVB20, as all applications are already part of syngo.MR Neuro Perfusion Engine.
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Traditional 510(k) Premarket Notification for: syngo.MR Applications VB30
February 06, 2018
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Except for the new product composition, there are some minor improvements and enhancements of the existing functionalities within the syngo.MR Applications.
Cardiac / Angio improvements:
- Improved functional analysis in the MR Cardiac Analysis workflow: ●
- o Mode for manual segmentation of the LV and RV
- o Pen tool for improved editing of LV and RV contours
- o Result values can be exported as text file
- o LV and RV contours can be saved and restored
- The workflows MR Angio SingleStation, MultiStation, TWIST and . TimCT are consolidated into the new workflow MR Angiography
Additional minor improvements:
- 4D Navigation Toolbar ●
- o Mini-Toolbar for 4D navigation
- o Display of clinical phase labels
- o Easy navigation in mulit-phase data
- Freehand ROI for seed selection in Tractography ●
- Series Navigator: series numbers now displayed ●
- ADC / computed b-values: now as pre-processing ●
- Tissue4D Maps: color-bar added to image segment ●
- Median added to histogram statistics ●
- Relative frequency added to histogram ●
- Color-bar added to image segment (LUT) .
- Wild card for series description ●
- Organ specific workflow .
General Safety and Effectiveness Concerns
The device labeling contains instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the device.
Risk Management is ensured via a Risk Analysis in compliance with ISO 14971:2007 to identify and provide mitigation to potential hazards in a Risk Analysis beginning early in the design phase and continuing throughout the development of the product. These risks are controlled via measures realized in software development. SW testing and product labeling. To minimize risks, Siemens adheres to recognized and established industry practices and standards. Furthermore, the operators are healthcare professionals familiar with and responsible for the evaluating and post-processing of MR images.
syngo.MR Applications conform to the applicable FDA recognized and international IEC, ISO and NEMA standards with regards to performance and safety as recommended by the respective MR FDA Guidance Document.
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| Rec.- No. | Product Area | Title of Standard | Ref.- No. & Date | Standards Development Organization |
|---|---|---|---|---|
| 5-96 | General | Medical devices -Application of usabilityengineering to medicaldevices | 62366-1:2015 | AAMI ANSIIEC |
| 5-40 | General | Medical devices - application ofrisk management to medicaldevices | 14971:2007 | ISO |
| 13-32 | Software | Medical device software -Software life cycleprocesses | 62304:2006 | AAMI ANSIIEC |
| 12-300 | Radiology | Digital Imaging andCommunications inMedicine (DICOM) Set PS3.1-3.20 (2011) | PS 3.1 -3.20 (2016) | NEMA |
The standards conformed to are the following:
Substantial Equivalence
The syngo.MR Applications VB30 has a different Intended Use as compared to the predicate devices. This is the result of the new product setup of combining the former eight (8) medical devices into one (1) device. However, the main functionalities of the former separate medical devices are used unchanged for syngo.MR Applications VB30, except for the aforementioned minor enhancements and improvements. The conclusions from the non-clinical data suggest that the additional features bear an equivalent safety and performance profile as that of the predicate devices and also does not affect the Indications for use of it. Therefore syngo.MR Applications are considered to be substantially equivalent to their primary predicate devices, which are current legally marketed devices.
| Table 1: Predicate devices for syngo.MR Applications | |
|---|---|
| ------------------------------------------------------ | -- |
| Predicate Device | FDA Clearance | Product Code |
|---|---|---|
| syngo.MR Post-ProcessingSoftware Version SMRVB20A | K163294cleared February 6, 2017 | LLZ, LNH |
| syngo.MR Post-ProcessingSoftware Version SMRVB10A | K151353cleared August 1, 2015 | LLZ,LNH |
| syngo.MR Spectroscopy | K120315cleared April 13, 2012 | LLZ |
| syngo.MR Post-ProcessingSoftware Version SMRVA16A | K130749cleared August 20, 2013 | LLZ,LNH |
| syngo.MR Post-ProcessingSoftware Version SMRVA16B | K133401cleared March 11, 2014 | LLZ,LNH |
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Conclusion as to Substantial Equivalence
The syngo.MR Applications are intended for similar indications as cleared in their according primary predicate devices.
In summary, Siemens is of the opinion that the syngo.MR Applications do not raise new questions of safety or effectiveness and are substantially equivalent to the currently marketed primary predicate devices as shown in Table 1.
Resulting from the new product setup of combining the eight (8) formerly cleared separate medical devices to one (1) medical device, the Intended Use changed. However, the main functionalities of the former devices will remain unchanged except for minor improvements and enhancements to give the device greater capabilities.
Therefore, Siemens believes that the subject device, the syngo.MR Applications is substantially equivalent to their primary predicate devices listed above in Table 1.
§ 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).