DEPARTMENT OF HEALTH & HUMAN SERVICES · Dynamika Version 5.0 is an image processing software...
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DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service __________________________________________________________________________________________________________________________ Food and Drug Administration 10903 New Hampshire Avenue Document Control Center – WO66-G609 Silver Spring, MD 20993-0002 Image Analysis Limited Ə-HQV.DIWDQ Application Correspondent QABC 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.
Transcript of DEPARTMENT OF HEALTH & HUMAN SERVICES · Dynamika Version 5.0 is an image processing software...
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service__________________________________________________________________________________________________________________________
Food and Drug Administration10903 New Hampshire AvenueDocument Control Center – WO66-G609Silver Spring, MD 20993-0002
Image Analysis Limited
Application Correspondent QABC Minister House272-274 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 systemRegulatory Class: IIProduct 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.
Page 2— Jens Kaftan
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/ResourcesforYou/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,
Robert Ochs, Ph.D. DirectorDivision of Radiological HealthOffice of In Vitro Diagnostics
and Radiological HealthCenter for Devices and Radiological Health
Enclosure
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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: [email protected]
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:
1. Image Loading and Saving.
2. Image Viewing.
3. Image Manipulation.
4. Image Analysis.
5. Imaging Processing and Generation of Parametric Maps.
6. Permeability Post-processing.
7. Reporting of User-Selected Findings and Assessment.
8. Communication and Storage of Results (DICOM import/export,
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.
Image Analysis (IA): Comparison to Legally Marketed (Predicate) 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
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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.
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.
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.
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.
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
processing of dynamic images from
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.
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.
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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
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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.
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
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.
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
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 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
5.0 does not include additional features
contained within the Olea Sphere v2.3
Perfusion and DWI/Fiber Tracking
Modules.
As it is possible to operate Olea Sphere
v2.3 independently with the Image
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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
change in the signal intensity. This
dynamic change in signal intensity is
used to calculate functional
parameters related to tissue perfusion
and tissue blood volume
(permeability) of the injected contrast
material from the intravascular to the
extracellular space (as observed by
DCE-MRI).
system.
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 change in
the signal intensity. This dynamic
change in signal intensity is used to
calculate functional parameters related to
tissue flow (perfusion) and tissue blood
volume (permeability) of the injected
contrast material from the intravascular
to the extracellular space. This
functionality is referred to as:
Perfusion module. Calculation of
parameters related to tissue flow
(perfusion) and tissue blood volume.
Permeability module: Calculation of
Viewing, Dynamic Analysis and
Permeability Modules without any
additional technological changes to the
software. This would not present any
additional safety or performance
concerns.
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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 injected
contrast material from intravascular to
extracellular space.
Environment of Use Dynamika is intended to be used
within hospitals and medical clinics.
It is licensed and not intended for
general public use.
Olea Sphere v2.3 is intended to be used
within hospitals and medical clinics. It is
licensed and not intended for general
public use.
No differences. Both devices are used
in the same environment.
Limitations of Use. Dynamika is not intended for primary
interpretation of mammography
images.
Olea Sphere v2.3 is not intended for
primary interpretation of mammography
images.
No differences. Both devices cannot be
used as primary interpretation of
mammography.
Performance Characteristics:
Image Analysis
The Dynamika package supports
qualitative and quantitative analysis
of certain features in an image or an
image set.
Region of interest (ROI) analysis;
Segmentation of volumes of interest
based upon:
• A region growing method.
• Manual delineation.
Image subtraction.
Patient Motion Correction.
Olea Sphere v2.3 supports qualitative
and quantitative analysis of certain
features in an image or an image set.
Volume of interest (VOI) analysis;
Segmentation of volumes of interest
based upon:
• A region growing method.
• Manual delineation.
• Region-based volume
segmentation.
Histogram normalization.
Image subtraction.
Dynamika Version 5.0 has region
growing method feature which is
controlled by the user with manual
delineation tools. The predicate device
also contains a region growing method.
Dynamika Version 5.0 and the
predicate device both have pre-
processing algorithms for patient
motion correction during the
acquisition and upload of image data.
Dynamika Version 5.0 does not have
automatic volume segmentation
methods, enhanced visualization or
comparison of images with histogram
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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
Patient Motion Correction.
normalization as additional
technological features. Additional
features do not raise any safety and
effectiveness concerns. (Reference
Section 12).
Performance Characteristics:
Permeability.
State of the art kinetic modelling 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).
The Time of Washout (Twashout).
The Initial Rate of Washout (IRW).
Area under the curve (AUC).
Kinetic modelling with quantitative
pixel by pixel analysis.
Generation of permeability maps
using signal conversion based upon
relative signal enhancement.
• Initial area under the Gd
concentration curve
State of the art kinetic modelling with
vascular deconvolution algorithm.
Generation of permeability maps using
signal conversion based on relative
signal 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).
Fundamental scientific principles and
kinetic modelling are both the same.
Permeability performance
characteristics can be determined by
both devices. Perfusion and DWI Add-
on Modules are not available in
Dynamika Version 5.0. These are
discussed in the SE discussion.
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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
(iAUGC60).
• Rate constant for transfer of
contrast agent from plasma to
extravascular, extracellular
space (EES) (Ktrans).
• Fractional volume of EES
(Ve).
• Fractional volume of plasma
in tissue (Vp)
T1-mapping allows loading
additional image series (MRI
sequences) that are more and more
commonly acquired in clinical
settings. These additional image
series make it possible to convert the
transient signal response into
concentration values following rapid
administration of a contrast agent.
• Rate constant for transfer of
contrast agent from plasma to
extravascular, extracellular
space (EES) (Ktrans).
• Rate constant for transfer of
contrast agent from EES to
plasma (Kep).
• Fractional volume of EES (Ve).
• Plasma volume (Vp)
• Pre-contrast T1 (T10).
T1-mapping allows loading additional
image series (MRI sequences) that are
more and more commonly acquired in
clinical settings. These additional image
series make it possible to convert the
transient signal response into
concentration values following rapid
administration of a contrast agent.
Permeability Output Maps:
AUC, TTP, WashIn, Washout, Peak,
PEAK_ENHANCEMENT,
CURVE_WASHOUT, SER, Ktrans,
Kep. Ve, Vp, T10.
Permeability Algorithms:
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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
(T1 mapping)
Estimation of pre-contrast T1 map from
additional MR sequences.
Voluntary Standards Yes. DICOM Compliant. Yes. DICOM Compliant. Both devices maintain DICOM
compliance and technology is
equivalent. Dynamika Version 5.0 does
not support data from MRI scanners
but this has no impact on safety and
performance.
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 and
displays DEMRIQ parameters within
the Report. DEMRIQ parameters
provide additional composite variables
reflecting both the volume and degree
of enhancement for user information
only. Olea Sphere Version 2.3 does not
report DEMRIQ parameters.
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 post-
processing 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).
End of Section 5.
