Who is the manufacturer of Dynamika?

Image Analysis Limited filed the 510(k) submission for Dynamika (K161601).

What is the FDA product code for Dynamika?

LLZ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Dynamika?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Dynamika?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Dynamika

K161601 · Image Analysis Limited · LLZ · May 17, 2017 · Radiology

Device Facts

Record ID	K161601
Device Name	Dynamika
Applicant	Image Analysis Limited
Product Code	LLZ · Radiology
Decision Date	May 17, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device

Intended 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. 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.

Device Story

Software package for viewing, processing, and analyzing DICOM-compliant MRI images; operates on standard off-the-shelf workstations (Windows, Macintosh, Linux). Inputs include dynamic MRI datasets; processes data to visualize contrast changes over time and calculate permeability parameters (e.g., Ktrans, Ve, Vp, iAUGC60). Features include image loading/viewing, manipulation, motion correction, and generation of parametric maps overlaid on original images. Used in hospitals and clinics by trained medical professionals (physicians, technicians). Output is displayed on-screen for clinical interpretation; assists in assessing tissue perfusion and permeability. Benefits include standardized analysis of dynamic contrast-enhanced MRI data to support clinical decision-making.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via non-clinical testing, including product risk assessment, software verification/validation (algorithm, integration, and system functional testing), and compliance with NEMA DICOM standards.

Technological Characteristics

PACS software for DICOM MRI images. Supports 2D, 3D, and 4D display modes. Features include region growing, manual segmentation, image subtraction, and patient motion correction. Kinetic modeling uses vascular deconvolution algorithms. Connectivity via DICOM import/export, query/retrieve, and study storage. Runs on standard off-the-shelf hardware (Windows, Mac, Linux).

Indications for Use

Indicated for trained medical professionals (physicians, radiographers, radiology technicians) for viewing, processing, and analysis of DICOM-compliant medical images, specifically dynamic MRI datasets. Used for visualization, analysis, and reporting of contrast changes over time and calculation of permeability parameters related to contrast leakage from intravascular to extracellular space. Not intended for primary interpretation of digital mammography.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

Olea Sphere v2.3 (K132095)

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K123306 — NORDIC TUMOREX · Nordicneurolab · May 20, 2013
K090546 — MODIFICATION TO NORDICICE SOFTWARE · Nordicimaginglab AS · Jun 8, 2009
K113337 — VISIA DYNAMIC REVIEW · MeVis Medical Solutions AG · Dec 30, 2011

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them. 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ ## 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) | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *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: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 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. {4}------------------------------------------------ ### 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. {5}------------------------------------------------ #### 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: - 1. Image Loading and Saving. - 2. Image Viewing. - 3. Image Manipulation. - 4. Image Analysis. - 5. Imaging Processing and Generation of Parametric Maps. - Permeability Post-processing. 6. - 7. 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. {6}------------------------------------------------ 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. {7}------------------------------------------------ # 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 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 | | | Manufacturer and TradeName | Dynamika Version 5.0, Image Analysis | Olea Sphere Version 2.3, Olea Medical | | | Intended Use – General purpose or function of the device. | 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 | Olea Sphere v2.3 is an image processing software package to be used by trained professionals including but not limited to physicians and medical 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. | Dynamika Version 5.0 and Olea Sphere Version 2.3 have the same general Intended Use with the following exceptions: Dynamika Version 5.0 does not include features included within the Olea Sphere v2.3 Perfusion or DWI/Fibre Tracking 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 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 | | | | | functionality is normally referred to as: Perfusion Module: the calculation of parameters related to tissue flow (perfusion) and tissue blood volume. Permeability Module: the calculation of parameters related to the leakage of injected contrast material from intravascular to extracellular space. Olea Sphere Version 2.3 is an image processing software package to be used by trained professionals but not limited to physicians and medical technicians. When interpreted by a skilled physician, this device provides information that may be used for screening, diagnosis and interventional planning. Patient management decisions should not be based solely on the results of Olea Sphere v2.3. The DWI/Fiber Tracking Module is designed to track white matter within the brain 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 allow the user to view and analyse dynamic MRI scans contained in sets of DICOM files, providing measurements and statistics associated with the use of a contrast agent in MRI scans and analysing signal intensity changes over time in different tissues within the patient's body. Dynamika also corrects for patient motion and creates subtractions and multiplanar formats. | package offers comprehensive functionality for dynamic image analysis and visualization, where signal changes over time are analysed to determine various modality dependent functional parameters. Olea Sphere Version 2.3 software provides both viewing and analysis capabilities of functional and dynamic imaging datasets acquired with MRI or other relevant modalities, including diffusion weighted MRI (DWI)/ fiber tracking and dynamic analysis (dynamic contrast enhanced imaging data from MRI and CT). Modules include the DWI/Fibre Tracking Module and the Dynamic Analysis. | operation are technologically similar. The main difference is that Dynamika Version 5.0 is designed as an integrated package in comparison with Olea Sphere v2.3 modular architecture. Olea Sphere v2.3 comprises of plug-in modules for Image Viewing, visualization and analysis of dynamic analysis (Dynamic Analysis module), Perfusion, Permeability and DWI/Fiber Tracking. | | | Dynamika has a dynamic analysis functionality as part of the software package. Dynamic analysis is used for the visualization and analysis of dynamic imaging, showing properties of changes in contrast over time where such techniques are useful or necessary (in clinical research or practice). Dynamika includes dedicated analysis methods and visualisation tools for dynamic contrast enhanced imaging data (from MRI) where an injection of a contrast agent material results in a temporal | DWI/Fibre Tracking Module Diffusion analysis is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data. Fiber tracking utilizes the directional dependency on the diffusion to display the white matter structure in the brain or more generally the central nervous | Dynamika Version 5.0 contains similar image visualisation and analysis operation to the predicate device, but is limited in operation to the Dynamic Analysis and Permeability Modules of Olea Sphere v2.3. Dynamika Version<br…