(342 days)
Dynamika Version 5.0 is an image processing software package to be used by trained medical professionals with a level of medical expertise (including physicians, radiology technicians). The software runs on a standard offthe-shelf workstation and can be used to perform image viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities.
Dynamika Version 5.0 provides both viewing and analysis capabilities of dynamic imaging datasets acquired with MRI.
Dynamika Version 5.0 is used for the visualization, analysis and reporting of dynamic MRI data, showing the properties of changes in contrast over time.
The package may be used to calculate permeability parameters related to the leakage of injected contrast material from intravascular to extracellular space. Parametric maps may be overlaid onto the original image for interpretation.
Dynamika Version 5.0 is intended to be used within hospitals and medical clinics. It is licensed and not intended for general public use.
Dynamika Version 5.0 is a software package for viewing, analysis and processing of medical images from MRI. The software is compliant with the DICOM standard and is suitable for running on Windows, Macintosh or Linux operating systems.
Dynamika Version 5.0 allows the display, analysis and post-processing of medical images.
These images, when interpreted by a trained physician, may yield clinically useful information.
The software provides a range of basic image processing and manipulation functions, in addition to comprehensive dynamic image processing and display.
The main features of the software are:
-
- Image Loading and Saving.
-
- Image Viewing.
-
- Image Manipulation.
-
- Image Analysis.
-
- Imaging Processing and Generation of Parametric Maps.
- Permeability Post-processing. 6.
-
- Reporting of User-Selected Findings and Assessment.
- Communication and Storage of Results (DICOM import/export, 8. query/retrieve and study storage).
Dynamika Version 5.0 is designed for medical imaging professionals with expertise in interpreting medical MRI images. Dynamika Version 5.0 can also be used to view multi-modality, digital images including ultrasound and mammography images. However, the software package is not intended for primary interpretation of digital mammography images.
The document provides a comparison table between the Dynamika Version 5.0 device and its predicate device, Olea Sphere Version 2.3, to demonstrate substantial equivalence, rather than detailing specific acceptance criteria and a study to prove they are met. The information provided is more aligned with demonstrating that the new device has similar characteristics and performs comparably to a legally marketed device.
Based on the provided text, a direct table of acceptance criteria and reported device performance of Dynamika Version 5.0 against defined metrics is not explicitly stated. Instead, the document focuses on comparison to a predicate device for regulatory clearance.
However, I can extract the closest information to what you've requested from the "Summary Table of Key Areas of Demonstration of Substantial Equivalence between the New Device and Legally Marketed Predicate Devices."
Here's an interpretation based on the document's content:
1. A table of acceptance criteria and the reported device performance
The document does not present "acceptance criteria" in the traditional sense of metrics like sensitivity, specificity, or quantitative thresholds for the device's performance. Instead, it demonstrates that the device's features and performance characteristics are substantially equivalent to a predicate device.
Table: Comparison of Dynamika Version 5.0 to Predicate Device (Olea Sphere Version 2.3)
| Feature or Specification of the Device | Dynamika Version 5.0 (Target Device) | Predicate Device (Olea Sphere Version 2.3) |
|---|---|---|
| Intended Use – General Purpose | Image processing software package to be used by trained medical professionals (physicians, radiographers, radiology technicians) for viewing, processing, and analysis of medical images acquired through DICOM compliant devices. Provides viewing and analysis capabilities of dynamic imaging datasets acquired with MRI. Used for visualization, analysis, and reporting of dynamic MRI data, showing changes in contrast over time. May calculate permeability parameters related to contrast leakage (intravascular to extracellular space) with parametric maps overlaid for interpretation. Intended for use in hospitals and medical clinics, not for general public use. | Image processing software package to be used by trained professionals (physicians, medical technicians) for viewing, processing, and analysis of medical images acquired through DICOM compliant devices. Provides viewing and analysis capabilities of functional and dynamic imaging datasets acquired with MRI or other relevant modalities, including a Diffusion Weighted MRI (DWI)/Fibre Tracking Module and a Dynamic Analysis Module (dynamic contrast imaging data for MRI and CT). Visualization and analysis of dynamic imaging data, showing changes in contrast over time. Includes modules for Perfusion and Permeability (calculation of parameters related to tissue flow/perfusion and tissue blood volume; calculation of parameters related to leakage of injected contrast material from intravascular to extracellular space). Intended for use in hospitals and medical clinics, not for general public use. When interpreted by a skilled physician, provides information that may be used for screening, diagnosis, and interventional planning. Patient management decisions should not be based solely on results. The DWI/Fiber Tracking Module is designed to track white matter within the brain and the nervous system. |
| Principles of Operation | Image processing software package to allow viewing and analysis of dynamic MRI scans (DICOM files), providing measurements and statistics associated with contrast agent use in MRI, and analyzing signal intensity changes over time in different tissues. Corrects for patient motion and creates subtractions and multiplanar formats. Dynamic analysis functionality for visualization and analysis of dynamic imaging (contrast changes over time), including dedicated analysis methods and visualization tools for dynamic contrast-enhanced imaging data (DCE-MRI) to calculate functional parameters related to tissue perfusion and tissue blood volume (permeability) of injected contrast material. | Comprehensive functionality for dynamic image analysis and visualization where signal changes over time are analyzed to determine various modality-dependent functional parameters. Provides viewing and analysis capabilities of functional and dynamic imaging datasets acquired with MRI or other relevant modalities, including DWI/Fiber Tracking and Dynamic Analysis. Modules include DWI/Fibre Tracking (visualizing local water diffusion properties, fiber tracking for white matter structure) and Dynamic Analysis (visualization and analysis of dynamic imaging for contrast changes over time, including Perfusion and Permeability modules). |
| Environment of Use | Within hospitals and medical clinics. Licensed, not for general public use. | Within hospitals and medical clinics. Licensed, not for general public use. |
| Limitations of Use | Not intended for primary interpretation of mammography images. | Not intended for primary interpretation of mammography images. |
| Performance Characteristics: Image Analysis | Supports qualitative and quantitative analysis of certain features in an image or set: Region of interest (ROI) analysis; Segmentation of volumes of interest via region growing method and manual delineation; Image subtraction; Patient Motion Correction. | Supports qualitative and quantitative analysis of certain features in an image or set: Volume of interest (VOI) analysis; Segmentation of volumes of interest via region growing method, manual delineation, and region-based volume segmentation; Histogram normalization; Image subtraction; Patient Motion Correction. |
| Performance Characteristics: Permeability | State-of-the-art kinetic modeling with vascular deconvolution algorithm. Parametric Map Generation: Maximum Enhancement (ME), Time of Onset of Enhancement (Tonset), Initial Rate of Enhancement (IRE), Time to Peak Enhancement (TTP), Time of Washout (Twashout), Initial Rate of Washout (IRW), Area under the curve (AUC). Kinetic modeling with quantitative pixel-by-pixel analysis. Generation of permeability maps using signal conversion based on relative signal enhancement: Initial area under the Gd concentration curve (iAUGC60), Ktrans, Ve, Vp. T1-mapping allows loading additional MRI sequences for signal conversion into concentration values. | State-of-the-art kinetic modeling with vascular deconvolution algorithm. Generation of permeability maps using signal conversion based on relative signal enhancement or T1 mapping: AUC, Peak enhancement (PEAK), Initial up-slope (Washin), Down slope (Washout), Time to Peak enhancement (TTP), Peak Percentage Enhancement (PEAK_ENHANCEMENT), Relative washout (CURVE_WASHOUT), Signal Enhancement Ratio (SER). Ktrans, Kep, Ve, Vp, T10. T1-mapping allows loading additional MRI sequences for signal conversion into concentration values. Permeability Algorithms: (T1 mapping) Estimation of pre-contrast T1 map from additional MR sequences. |
| Voluntary Standards | Yes, DICOM Compliant. | Yes, DICOM Compliant. |
| Reporting | User customized reporting. DEMRIQ parameters. | User customized reporting. |
Study to prove device meets acceptance criteria:
The document describes "extensive verification and validation testing" conducted for the Dynamika Version 5.0 system. This included:
- Product Risk Assessment.
- Software verification and validation testing, covering algorithm (unit) level testing, integration, and system functional testing.
The document states that the testing ensured the system "provides the capabilities to operate safely and effectively according to its intended use." It also notes compliance with the FDA recommended voluntary NEMA DICOM safety standard for PACS.
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 does not provide details on the sample size used for any test set or the provenance of data. It only broadly mentions "extensive verification and validation testing."
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)
The document does not provide any information about experts used to establish ground truth or their qualifications. Since no clinical testing was performed (see point 5), it's unlikely that expert-adjudicated ground truth for clinical performance was established.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not specify any adjudication method.
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 clinical testing or MRMC study was done. The document explicitly states: "No clinical testing was used to demonstrate substantial equivalence between Dynamika Version 5.0 and the predicate device (Olea Sphere Version 2.3) as these types of devices have been on the market for many years with proven safety and efficacy of use. Therefore, the non-clinical testing detailed within the submission supports the substantial equivalence of this device." This implies no human-in-the-loop performance studies or effect size measurements were conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document mentions "algorithm (unit) level testing" as part of software verification and validation. While this implies standalone testing of the algorithm components, it does not provide specific performance metrics or a detailed study description for such testing. The focus of the submission is substantial equivalence to a predicate PACS device, rather than a novel AI algorithm requiring standalone diagnostic performance validation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical testing, the "ground truth" would likely be based on engineering specifications and expected software behavior, verified through unit, integration, and system functional testing. Given the context of PACS and image processing, it would involve confirming that calculations are correct, images are displayed accurately, and features function as designed against known inputs, rather than clinical ground truth from pathology or expert consensus.
8. The sample size for the training set
The document does not mention any training set or its sample size. This is consistent with the device being an image processing software (PACS) rather than a machine learning or AI diagnostic aid that typically requires a training set.
9. How the ground truth for the training set was established
As no training set is mentioned, this question is not applicable.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 17, 2017
Image Analysis Limited % Jens Kaftan Application Correspondent OABC Minister House 272-274 Vauxhall Bridge Road London, SW1V 1BA UNITED KINGDOM
Re: K161601
Trade/Device Name: Dynamika Version 5.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 1, 2017 Received: May 1, 2017
Dear Jens Kaftan:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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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Indications for Use
510(k) Number (if known) K161601
Device Name Dynamika Version 5.0
Indications for Use (Describe)
Dynamika Version 5.0 is an image processing software package to be used by trained medical professionals with a level of medical expertise (including physicians, radiology technicians). The software runs on a standard offthe-shelf workstation and can be used to perform image viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities.
Dynamika Version 5.0 provides both viewing and analysis capabilities of dynamic imaging datasets acquired with MRI.
Dynamika Version 5.0 is used for the visualization, analysis and reporting of dynamic MRI data, showing the properties of changes in contrast over time.
The package may be used to calculate permeability parameters related to the leakage of injected contrast material from intravascular to extracellular space. Parametric maps may be overlaid onto the original image for interpretation.
Dynamika Version 5.0 is intended to be used within hospitals and medical clinics. It is licensed and not intended for general public use.
| 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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Premarket Notification 510(k)
Section 5.
510(k) Summary - 21 CFR 807.92.
510(k) Number K161601
I. Applicant Information.
Applicant:
Image Analysis Limited, QABC Minster House 272-274 Vauxhall Bridge Road London SW1V 1BA UK
Contact Person:
Jens Kaftan, Head of Product
Tel: +44 741 302 2053 E-mail: jens.kaftan@ia-grp.com
Date Prepared: Apr 25, 2017
II. Device Name and Classification.
Proprietary Name: Dynamika Version 5.0. Common/Usual Name: Dynamika, Dynamika Enterprise, PACS. Classification Name: Picture Archiving and Communications System Regulation Number: 21 CFR 892.2050 Product Code: LLZ Classification Panel: Radiology Devices.
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III. Predicate Device.
The Dynamika Version 5.0 device is substantially equivalent to the following FDA cleared predicate device with regard to intended use and technological characteristics.
Predicate Device 510(k) Number: K132095 Proprietary Name: Olea Sphere v2.3. Manufacturer: Olea Medical Common/Usual Name: PACS. Classification Name: Picture Archiving and Communications System Regulation Number: 21 CFR 892.2050 Product Code: LLZ Classification: Class II Classification Panel: Radiology Devices.
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IV. Device Description.
Dynamika Version 5.0 is a software package for viewing, analysis and processing of medical images from MRI. The software is compliant with the DICOM standard and is suitable for running on Windows, Macintosh or Linux operating systems.
Dynamika Version 5.0 allows the display, analysis and post-processing of medical images.
These images, when interpreted by a trained physician, may yield clinically useful information.
The software provides a range of basic image processing and manipulation functions, in addition to comprehensive dynamic image processing and display.
The main features of the software are:
-
- Image Loading and Saving.
-
- Image Viewing.
-
- Image Manipulation.
-
- Image Analysis.
-
- Imaging Processing and Generation of Parametric Maps.
- Permeability Post-processing. 6.
-
- Reporting of User-Selected Findings and Assessment.
- Communication and Storage of Results (DICOM import/export, 8. query/retrieve and study storage).
Dynamika Version 5.0 is designed for medical imaging professionals with expertise in interpreting medical MRI images. Dynamika Version 5.0 can also be used to view multi-modality, digital images including ultrasound and mammography images. However, the software package is not intended for primary interpretation of digital mammography images.
V. Intended Use/ Indications For Use.
Dynamika Version 5.0 is an image processing software package to be used by trained medical professionals with a level of medical expertise (including physicians, radiographers and radiology technicians). The software runs on a standard off-the-shelf workstation and can be used to perform image viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities.
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Dynamika Version 5.0 provides both viewing and analysis capabilities of dynamic imaging datasets acquired with MRI.
Dynamika Version 5.0 is used for the visualization, analysis and reporting of dynamic MRI data, showing the properties of changes in contrast over time.
The package may be used to calculate permeability parameters related to the leakage of injected contrast material from intravascular to extracellular space. Parametric maps may be overlaid onto the original image for interpretation.
Dynamika Version 5.0 is intended to be used within hospitals and medical clinics. It is licensed and not intended for general public use.
Dynamika Version 5.0 has the same general intended use as the predicate device. The indications for use are more limited for Dynamika Version 5.0 due to the additional Perfusion and DWI modules available for use with Olea Sphere Version 2.3. The indications for use for Dynamika Version 5.0 are however, within the scope of the predicate device when using the Permeability Module and do not raise any new safety or effectiveness concerns. There are no new indications for use for Dynamika Version 5.0 and therefore, the general Intended Use is unchanged. Reference 510(k) Summary Table below for details.
VI. Summary of Technological Characteristics.
Dynamika is a PACS software designed to access series of MRI images in DICOM format.
Dynamika Version 5.0 offers multiple display modes to view uploaded images including temporal slice view (2-D), volume view (3-D) and volume view over multiple time frames (4-D). This is identical to the predicate device.
The following table compares the main features, principles of operation, fundamental scientific technology and intended use of Dynamika Version 5.0 when compared to the predicate device. Olea Sphere Version 2.3.
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VII. Summary Table of Key Areas of Demonstration of Substantial Equivalence between the New Device and Legally Marketed Predicate Devices.
Image Analysis (IA): Comparison to Legally Marketed (Predicate) Devices.
FDA Guidance Document for the Submission of Premarket Notifications for Medical Image Management Devices.
| Feature or Specification ofthe Device | Target Device – IA Dynamika | Predicate Device. | Differences |
|---|---|---|---|
| Cleared 510k ControlNumber | K132095 | ||
| Product Code | LLZ | LLZ | |
| Regulation | 892.2050 | 892.2050 | |
| Class | II | II | |
| Manufacturer andTradeName | Dynamika Version 5.0, ImageAnalysis | Olea Sphere Version 2.3, Olea Medical | |
| Intended Use – Generalpurpose or function of thedevice. | Dynamika Version 5.0 is an imageprocessing software package to beused by trained medical professionalswith a level of medical expertise(including physicians, radiographersand radiology technicians). Thesoftware runs on a standard off-the-shelf workstation and can be used toperform image viewing, processingand analysis of medical images. Dataand images are acquired through | Olea Sphere v2.3 is an image processingsoftware package to be used by trainedprofessionals including but not limited tophysicians and medical technicians. Thesoftware runs on a standard "off-the-shelf" workstation and can be used toperform image viewing, processing andanalysis of medical images. Data andimages are acquired through DICOMcompliant imaging devices andmodalities. | Dynamika Version 5.0 and OleaSphere Version 2.3 have the samegeneral Intended Use with thefollowing exceptions:Dynamika Version 5.0 does not includefeatures included within the OleaSphere v2.3 Perfusion or DWI/FibreTracking modules.Dynamika Version 5.0 is limited to the |
| Feature or Specification of the Device | Target Device – IA Dynamika | Predicate Device. | Differences |
| Cleared 510k Control Number | K132095 | ||
| Product Code | LLZ | LLZ | |
| Regulation | 892.2050 | 892.2050 | |
| Class | II | II | |
| DICOM compliant imaging devices and modalities. | Olea Sphere Version 2.3 provides both viewing and analysis capabilities of functional and dynamic imaging datasets acquired with MRI or other relevant modalities, including a Diffusion Weighted MRI (DWI)/Fibre Tracking Module and a Dynamic Analysis Module (dynamic contrast imaging data for MRI and CT). The package acquires data and images through DICOM compliant imaging devices and modalities. | processing of dynamic images from MRI. | |
| Dynamika Version 5.0 provides both viewing and analysis capabilities of dynamic imaging datasets acquired with MRI. | The general Intended Use (tool-use) of Dynamika Version 5.0 is identical to Olea Sphere v2.3 as both devices are used to view, analyse and process medical images as expected from a PACS. | ||
| Dynamika Version 5.0 is used for the visualization, analysis and reporting of dynamic MRI data, showing the properties of changes in contrast over time. | The Indications For Use is a sub-set of the predicate device as Olea Sphere v2.3 has additional modules. As there are no new indications for use for Dynamika Version 5.0 outside of the scope of the predicate device, the overall or general Intended Use (tool use) remains unchanged. Therefore, the Intended Use is substantially equivalent to Olea Sphere v2.3. In addition, the predicate device can be operated with only the Image View, Permeability and Dynamic Analysis modules) and no further safety and performance issues have been raised with the same Indications for Use. | ||
| The package may be used to calculate permeability parameters related to the leakage of injected contrast material from intravascular to extracellular space. Parametric maps may be overlaid onto the original image for interpretation. | The DWI Module is used to visualise local water diffusion properties from the analysis of diffusion weighted MRI data. The Fibre Tracking feature utilizers the directional dependency of the diffusion to display the white matter structure in the brain or more generally the central nervous system. | ||
| Dynamika Version 5.0 is intended to be used within hospitals and medical clinics. It is licensed and not intended for general public use. | The Dynamic Analysis Module is used for visualization and analysis of dynamic imaging data, showing properties of changes in contrast over time where such techniques are useful or necessary. This | ||
| Feature or Specification ofthe Device | Target Device – IA Dynamika | Predicate Device. | Differences |
| Cleared 510k ControlNumber | K132095 | ||
| Product Code | LLZ | LLZ | |
| Regulation | 892.2050 | 892.2050 | |
| Class | II | II | |
| functionality is normally referred to as:Perfusion Module: the calculation ofparameters related to tissue flow(perfusion) and tissue blood volume.Permeability Module: the calculation ofparameters related to the leakage ofinjected contrast material fromintravascular to extracellular space.Olea Sphere Version 2.3 is an imageprocessing software package to be usedby trained professionals but not limitedto physicians and medical technicians.When interpreted by a skilled physician,this device provides information thatmay be used for screening, diagnosis andinterventional planning. Patientmanagement decisions should not bebased solely on the results of OleaSphere v2.3.The DWI/Fiber Tracking Module isdesigned to track white matter within thebrain and the nervous system. | |||
| Principles of Operation. | Dynamika is an image processing | The Olea Sphere Version 2.3 software | The fundamental principles of |
| Feature or Specification of the Device | Target Device – IA Dynamika | Predicate Device. | Differences |
| Cleared 510k Control Number | K132095 | ||
| Product Code | LLZ | LLZ | |
| Regulation | 892.2050 | 892.2050 | |
| Class | II | II | |
| software package designed to allowthe user to view and analyse dynamicMRI scans contained in sets ofDICOM files, providingmeasurements and statisticsassociated with the use of a contrastagent in MRI scans and analysingsignal intensity changes over time indifferent tissues within the patient'sbody. Dynamika also corrects forpatient motion and createssubtractions and multiplanar formats. | package offers comprehensivefunctionality for dynamic image analysisand visualization, where signal changesover time are analysed to determinevarious modality dependent functionalparameters.Olea Sphere Version 2.3 softwareprovides both viewing and analysiscapabilities of functional and dynamicimaging datasets acquired with MRI orother relevant modalities, includingdiffusion weighted MRI (DWI)/ fibertracking and dynamic analysis (dynamiccontrast enhanced imaging data fromMRI and CT). Modules include theDWI/Fibre Tracking Module and theDynamic Analysis. | operation are technologically similar.The main difference is that DynamikaVersion 5.0 is designed as an integratedpackage in comparison with OleaSphere v2.3 modular architecture. OleaSphere v2.3 comprises of plug-inmodules for Image Viewing,visualization and analysis of dynamicanalysis (Dynamic Analysis module),Perfusion, Permeability and DWI/FiberTracking. | |
| Dynamika has a dynamic analysisfunctionality as part of the softwarepackage. Dynamic analysis is usedfor the visualization and analysis ofdynamic imaging, showing propertiesof changes in contrast over timewhere such techniques are useful ornecessary (in clinical research orpractice). Dynamika includesdedicated analysis methods andvisualisation tools for dynamiccontrast enhanced imaging data (fromMRI) where an injection of a contrastagent material results in a temporal | DWI/Fibre Tracking Module Diffusionanalysis is used to visualize local waterdiffusion properties from the analysis ofdiffusion-weighted MRI data. Fibertracking utilizes the directionaldependency on the diffusion to displaythe white matter structure in the brain ormore generally the central nervous | Dynamika Version 5.0 contains similarimage visualisation and analysisoperation to the predicate device, but islimited in operation to the DynamicAnalysis and Permeability Modules ofOlea Sphere v2.3. Dynamika Version5.0 does not include additional featurescontained within the Olea Sphere v2.3Perfusion and DWI/Fiber TrackingModules.As it is possible to operate Olea Spherev2.3 independently with the Image | |
| Feature or Specification ofthe Device | Target Device – IA Dynamika | Predicate Device. | Differences |
| Cleared 510k ControlNumber | K132095 | ||
| Product Code | LLZ | LLZ | |
| Regulation | 892.2050 | 892.2050 | |
| Class | II | II | |
| change in the signal intensity. Thisdynamic change in signal intensity isused to calculate functionalparameters related to tissue perfusionand tissue blood volume(permeability) of the injected contrastmaterial from the intravascular to theextracellular space (as observed byDCE-MRI). | system.Dynamic analysis is used for thevisualization and analysis of dynamicimaging, showing properties of changesin contrast over time where suchtechniques are useful or necessary (inclinical research or practice). Dynamikaincludes dedicated analysis methods andvisualisation tools for dynamic contrastenhanced imaging data from MRI)where an injection of a contrast agentmaterial results in a temporal change inthe signal intensity. This dynamicchange in signal intensity is used tocalculate functional parameters related totissue flow (perfusion) and tissue bloodvolume (permeability) of the injectedcontrast material from the intravascularto the extracellular space. Thisfunctionality is referred to as:Perfusion module. Calculation ofparameters related to tissue flow(perfusion) and tissue blood volume.Permeability module: Calculation of | Viewing, Dynamic Analysis andPermeability Modules without anyadditional technological changes to thesoftware. This would not present anyadditional safety or performanceconcerns. | |
| Feature or Specification of the Device | Target Device – IA Dynamika | Predicate Device. | Differences |
| Cleared 510k Control Number | K132095 | ||
| Product Code | LLZ | LLZ | |
| Regulation | 892.2050 | 892.2050 | |
| Class | II | II | |
| parameters related to leakage of injectedcontrast material from intravascular toextracellular space. | |||
| Environment of Use | Dynamika is intended to be usedwithin hospitals and medical clinics.It is licensed and not intended forgeneral public use. | Olea Sphere v2.3 is intended to be usedwithin hospitals and medical clinics. It islicensed and not intended for generalpublic use. | No differences. Both devices are usedin the same environment. |
| Limitations of Use. | Dynamika is not intended for primaryinterpretation of mammographyimages. | Olea Sphere v2.3 is not intended forprimary interpretation of mammographyimages. | No differences. Both devices cannot beused as primary interpretation ofmammography. |
| Performance Characteristics:Image Analysis | The Dynamika package supportsqualitative and quantitative analysisof certain features in an image or animage set.Region of interest (ROI) analysis;Segmentation of volumes of interestbased upon:• A region growing method.• Manual delineation.Image subtraction.Patient Motion Correction. | Olea Sphere v2.3 supports qualitativeand quantitative analysis of certainfeatures in an image or an image set.Volume of interest (VOI) analysis;Segmentation of volumes of interestbased upon:• A region growing method.• Manual delineation.• Region-based volumesegmentation.Histogram normalization.Image subtraction | Dynamika Version 5.0 has regiongrowing method feature which iscontrolled by the user with manualdelineation tools. The predicate devicealso contains a region growing method.Dynamika Version 5.0 and thepredicate device both have pre-processing algorithms for patientmotion correction during theacquisition and upload of image data.Dynamika Version 5.0 does not haveautomatic volume segmentationmethods, enhanced visualization orcomparison of images with histogram |
| Feature or Specification ofthe Device | Target Device – IA Dynamika | Predicate Device. | Differences |
| Cleared 510k ControlNumber | K132095 | ||
| Product Code | LLZ | LLZ | |
| Regulation | 892.2050 | 892.2050 | |
| Class | II | II | |
| Patient Motion Correction. | normalization as additionaltechnological features. Additionalfeatures do not raise any safety andeffectiveness concerns. (ReferenceSection 12). | ||
| Performance Characteristics:Permeability. | State of the art kinetic modelling withvascular deconvolution algorithm. | State of the art kinetic modelling withvascular deconvolution algorithm. | Fundamental scientific principles andkinetic modelling are both the same.Permeability performancecharacteristics can be determined byboth devices. Perfusion and DWI Add-on Modules are not available inDynamika Version 5.0. These arediscussed in the SE discussion. |
| Parametric Map Generation.Maximum Enhancement (ΜΕ).Time of Onset of Enhancement(Tonset).Initial Rate of Enhancement (IRE).Time to Peak Enhancement (TTP).The Time of Washout (Twashout).The Initial Rate of Washout (IRW).Area under the curve (AUC).Kinetic modelling with quantitativepixel by pixel analysis.Generation of permeability mapsusing signal conversion based uponrelative signal enhancement.• Initial area under the Gdconcentration curve | Generation of permeability maps usingsignal conversion based on relativesignal enhancement or T1 mapping:• Area under the curve (AUC)• Peak enhancement (PEAK).• Initial up-slope of the curve(Washin).• Down slope of the curve(Washout).• Time to Peak enhancement(TTP).• Peak Percentage Enhancement(PEAK_ENHANCEMENT).• Relative washout(CURVE_WASHOUT)• Signal Enhancement Ratio(SER). | ||
| Feature or Specification ofthe Device | Target Device – IA Dynamika | Predicate Device. | Differences |
| Cleared 510k ControlNumber | K132095 | ||
| Product Code | LLZ | LLZ | |
| Regulation | 892.2050 | 892.2050 | |
| Class | II | II | |
| (iAUGC60). Rate constant for transfer ofcontrast agent from plasma toextravascular, extracellularspace (EES) (Ktrans). Fractional volume of EES(Ve). Fractional volume of plasmain tissue (Vp) T1-mapping allows loadingadditional image series (MRIsequences) that are more and morecommonly acquired in clinicalsettings. These additional imageseries make it possible to convert thetransient signal response intoconcentration values following rapidadministration of a contrast agent. | Rate constant for transfer ofcontrast agent from plasma toextravascular, extracellularspace (EES) (Ktrans). Rate constant for transfer ofcontrast agent from EES toplasma (Kep). Fractional volume of EES (Ve). Plasma volume (Vp) Pre-contrast T1 (T10). T1-mapping allows loading additionalimage series (MRI sequences) that aremore and more commonly acquired inclinical settings. These additional imageseries make it possible to convert thetransient signal response intoconcentration values following rapidadministration of a contrast agent.Permeability Output Maps:AUC, TTP, WashIn, Washout, Peak,PEAK_ENHANCEMENT,CURVE_WASHOUT, SER, Ktrans,Kep. Ve, Vp, T10.Permeability Algorithms: | ||
| Feature or Specification ofthe Device | Target Device – IA Dynamika | Predicate Device. | Differences |
| Cleared 510k ControlNumber | K132095 | ||
| Product Code | LLZ | LLZ | |
| Regulation | 892.2050 | 892.2050 | |
| Class | II | II | |
| (T1 mapping)Estimation of pre-contrast T1 map fromadditional MR sequences. | |||
| Voluntary Standards | Yes. DICOM Compliant. | Yes. DICOM Compliant. | Both devices maintain DICOMcompliance and technology isequivalent. Dynamika Version 5.0 doesnot support data from MRI scannersbut this has no impact on safety andperformance. |
| Reporting. | User customized reporting.DEMRIQ parameters. | User customized reporting. | Both devices have reporting functions.The output may be user-configured.Dynamika Version 5.0 calculates anddisplays DEMRIQ parameters withinthe Report. DEMRIQ parametersprovide additional composite variablesreflecting both the volume and degreeof enhancement for user informationonly. Olea Sphere Version 2.3 does notreport DEMRIQ parameters. |
Image Analysis (IA): Comparison to Legally Marketed (Predicate) Devices.
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The summary table shows that Dynamika Version 5.0 and the predicate device, Olea Sphere Version 2.3 have the same basic technological characteristics.
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VIII. Laboratory or Non-clinical testing.
Image Analysis Limited has conducted extensive verification and validation testing of the Dynamika Version 5.0 system, as a PACS that has the capability to provide reliable postprocessing and display of dynamic MRI images for multi-parametric analysis. All of the different components have been stress tested to ensure that the system as a whole provides the capabilities to operate safely and effectively according to its intended use.
The tests performed included:
- Product Risk Assessment.
- Software verification and validation testing. This includes algorithm (unit) level testing, integration and system functional testing.
This is identical to the predicate device.
The Dynamika Version 5.0 system also complies with the requirements of the FDA recommended voluntary NEMA DICOM safety standard for PACS, which is identical to the predicate device.
IX. Clinical testing.
No clinical testing was used to demonstrate substantial equivalence between Dynamika Version 5.0 and the predicate device (Olea Sphere Version 2.3) as these types of devices have been on the market for many years with proven safety and efficacy of use. Therefore, the non-clinical testing detailed within the submission supports the substantial equivalence of this device.
X. Conclusions.
Based upon the comparison of the intended use and technological characteristics with those of the predicate device, the Dynamika Version 5.0 software system has the same general intended use (with differences in indications for use due to additional modules available for use with the predicate device) and similar technological characteristics. The differences in indications for use do not result in a new intended use or raise any additional safety and effectiveness concerns. Non-clinical performance and validation testing at algorithm, integration and system level demonstrates that this device does not raise any new safety and effectiveness concerns. Therefore, Dynamika Version 5.0 is substantially equivalent to the predicate device, Olea Sphere Version 2.3 system manufactured by Olea Medical (K132095).
§ 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).