(87 days)
Not Found
No
The document describes standard image processing, analysis, and viewing software with specific modules for DWI, Fiber Tracking, Perfusion, and Permeability analysis. There is no mention of AI, ML, deep learning, or any related concepts in the intended use, device description, or performance studies. The analysis methods described are based on established techniques for analyzing diffusion-weighted and dynamic contrast-enhanced imaging data.
No
The device is described as an image processing software package for viewing, processing, and analyzing medical images. It provides information to be interpreted by trained physicians but does not directly treat or diagnose a disease or condition.
Yes
Explanation: The device is an image processing software that provides capabilities for viewing, analysis, and post-processing of medical images. It specifically mentions modules for Diffusion Weighted MRI (DWI), Fiber Tracking, Perfusion, and Permeability, which are used to derive quantitative information from medical images, aiding in the assessment of tissue properties and changes over time. This information is intended to be interpreted by trained physicians to yield clinically useful information, indicating its role in diagnosis. The predicate devices are also diagnostic image analysis software.
Yes
The device is explicitly described as a "software package" and "software only" throughout the document, running on standard "off-the-shelf" workstations and processing images from existing DICOM compliant imaging devices. There is no mention of proprietary hardware included with the device.
Based on the provided information, Olea Sphere is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVDs analyze biological samples: IVDs are designed to examine specimens taken from the human body, such as blood, urine, tissue, etc., to provide information about a person's health.
- Olea Sphere analyzes medical images: Olea Sphere's intended use and description clearly state that it processes and analyzes medical images acquired from imaging modalities like MRI and CT. It does not interact with or analyze biological samples.
- Focus on image processing and analysis: The software's features are centered around viewing, manipulating, processing, and analyzing image data, not laboratory testing of biological materials.
Therefore, Olea Sphere falls under the category of medical image processing and analysis software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Olea Sphere 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.
Olea Sphere 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) / Fiber Tracking Module and a Dynamic Analysis Module (dynamic contrast enhanced imaging data for MRI and CT).
The DWI Module is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data. The Fiber Tracking feature utilizes 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 functionality is 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 leakage of injected contrast material from intravascular to extracellular space.
Product codes
LLZ
Device Description
Olea Sphere is a medical viewing, analysis and processing software package (PACS) compliant with the DICOM standard and running on Windows, Macintosh or Linux operating systems.
Olea Sphere 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 wide 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 & Saving
- Image Viewing ●
- Image Manipulation
- Image Analysis
- Imaging Processing
- Perfusion Post-processing .
- Permeability Post-processing .
- Diffusion Weighted Image / Tensor Image Post-processing .
- Fiber Tracking Post-processing .
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI, CT
Anatomical Site
brain or more generally the central nervous system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospitals, imaging centers, radiologist reading practices by professional who requires and is granted access to patient image, demographic and report information.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
OLEA Medical has conducted extensive validation testing of the Olea Sphere system, as a PACS that is capable of providing reliable post-processing and display of images for instantaneous multi-parametric analysis. All of the different components of the Olea Sphere software have been stress tested to ensure that the system as a whole provides all the capabilities necessary to operate according to its intended use.
The tests performed included:
- Product Risk Assessment
- Software modules verification tests .
- t Software validation test
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
.K12019.6
Image /page/0/Picture/1 description: The image shows a logo or emblem that appears to be for an organization or company. The left side of the image contains a dark, abstract shape that could represent a building or structure. To the right of this shape, there is text, but it is difficult to read due to the image quality. The text seems to be stacked, with one word or phrase above another, suggesting it could be the name of the organization or a slogan.
APR 1 9 2012
510(k) Summary (in accordance with 21 CFR 807.92)
510(k) Number K
I. Applicant Information
Applicant:
OLEA MEDICAL 93 avenue des Sorbiers, Zone Athelia IV La Ciotat 13600 France
e-mail: caroline.lene@olea-medical.com
Contact Person:
Application Correspondent:
EMERGO GROUP INC. 611 West 5th Street, Third Floor Austin, TX 78701 U.S.A.
Tel: (011) 33 4 42 71 24 20 Fax: (011) 33 4 42 71 24 27
Kristi Gusman Project Manager Tel: (512) 327-9997 Fax: (512) 327-9998 e-mail: kristi@emergogroup.com
Date Prepared:
Contact Person:
November 30, 2011
Caroline Lene Quality Manager
II. Device Name and Classification
Proprietary Name: Common/Usual Name: Classification Name: Regulation Number: Product Codes: Classification: Classification Panel:
Olea Sphere PACS Picture Archiving Communications System 21 CFR 892.2050 · LLZ Class II Radiology Devices
510(k) - Olea Sphere
1
Image /page/1/Picture/0 description: The image shows a logo with a geometric shape on the left and text on the right. The geometric shape appears to be a cube-like structure with multiple layers or sections. The text on the right is arranged in multiple lines, with the top line being larger and bolder than the lines below. The overall image has a high-contrast appearance, with dark elements against a light background.
III. Predicate Devices
The Olea Sphere device is substantially equivalent to the following FDA cleared predicate device with regard to indications for use, performance and technological characteristics:
| 510(k) Number: | K090546 |
|---|---|
| Trade Name: | Nordic Image Control and Evaluation |
| (nordicICE) Software | |
| Manufacturer: | NordicImagingLab AS |
| Classification Name: | Picture Archiving Communications System |
| Common/Usual Name: | PACS |
| Regulation Number: | 21 CFR 892.2050 |
| Product Codes: | LLZ |
| Classification: | Class II |
The software architecture of many of the features of the Olea Sphere is essentially identical to that used by the following FDA cleared predicate device:
| 510(k) Number: | K111161 |
|---|---|
| Trade Name: | Perfscape V2.0 |
| Manufacturer: | Olea Medical |
| Classification Name: | Picture Archiving Communications System |
| Common/Usual Name: | PACS |
| Regulation Number: | 21 CFR 892.2050 |
| Product Codes: | LLZ |
| Classification: | Class II |
For completeness, both predicate devices have been included for comparison purposes.
IV. Device Description
Olea Sphere is a medical viewing, analysis and processing software package (PACS) compliant with the DICOM standard and running on Windows, Macintosh or Linux operating systems.
Olea Sphere allows the display, analysis and post-processing of medical images.
2
Image /page/2/Picture/0 description: The image shows two logos side by side. The logo on the left is a circular design with a complex pattern inside. The logo on the right has text stacked on top of each other. The text is difficult to read due to the image quality.
These images, when interpreted by a trained physician, may yield clinically useful information.
The software provides a wide 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 & Saving
- Image Viewing ●
- . Image Manipulation
- . Image Analysis
- . Imaging Processing
- Perfusion Post-processing .
- Permeability Post-processing .
- Diffusion Weighted Image / Tensor Image Post-processing .
- Fiber Tracking Post-processing .
The main users of the program are medical imaging professionals who need to visualize and analyze images acquired primarily with MRI or CT systems. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations.
V. Intended Use
Olea Sphere 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.
Olea Sphere 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) / Fiber Tracking Module and a Dynamic Analysis Module (dynamic contrast enhanced imaging data for MRI and CT).
The DWI Module is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data. The Fiber Tracking feature utilizes
510(k) - Olea Sphere
3
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 functionality is 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 leakage of injected contrast material from intravascular to extracellular space.
VI. Summary of the Technical Characteristics
Olea Sphere is a PACS software designed to access series of MRI and CT perfusion and diffusion images in DICOM format. The system utilizes the information contained in each image meta-data to compare images and to perform zoom, pan and crop functions.
Olea Sphere offers a viewing and analysis module that allows to display simultaneously available DICOM image datasets and to save the results into the DICOM database.
Olea Sphere offers four types of display for a particular data set:
-
- The multi-slice view displays simultaneously all the images of selected series in tabular format where rows represent image series and columns represent cross-sectional levels;
-
- The mono-slice view displays simultaneously one image of selected series at a given slice location;
-
- The MPR/3D view displays selected series in a three dimensional projections:
-
- The follow-up view displays images of series acquired over time.
The system allows the calculation of surfaces and volumes over a set of unfiltered images by using "segmentation masks". This also allows the user to optimize selected images by customizing the segmentation masks based on
4
Image /page/4/Picture/0 description: The image shows a logo or emblem that appears to be for an organization or company. The left side of the logo features a geometric shape, possibly representing a building or structure. To the right, there is text, but the specific words are not clear due to the image quality. The overall design is simple and bold, with a focus on geometric shapes and text.
user defined areas and to save the results of this image optimization into PDF format files.
The following Predicate Device Comparison Table provides a summary of the comparison between the Olea Sphere and the predicate devices listed in Section III, with respect to intended use, environment of use, limitations of use, principles of operation and performance characteristics. More detailed information regarding the basis for the determination of substantial equivalence can be found at Section 12 of this 510(k) submission.
510(k) - Olea Sphere
IO(K) - Olea Sphere
5
场 申乐
Predicate Device Comparison Table
| Product Code | LLZ | LLZ | LLZ | None. | acquired with MRI or other
relevant modalities, including
a Diffusion Weighted MRI
(DWI) / Fiber Tracking
Module and a Dynamic
Analysis Module (dynamic
contrast enhanced imaging
data for MRI and CT). | acquired with MRI or other
relevant modalities, including
blood oxygen level dependent
(BOLD) fMRI, diffusion
weighted MRI (DWI) / fiber
tracking and dynamic
analysis. | Response Time to Peak,
permeability and leakage
between intravascular and
extracellular space (MRI
only), and temporal
Maximum Intensity
Projection (CT only).
PerfScape V2.0 also
generates Diffusion Weighted
Images and/or Diffusion
Tensor Images (MRI only).
These images, when
interpreted by a trained
physician, may yield
clinically useful information. |
|--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation # | 892.2050 | 892.2050 | 892.2050 | None. | The DWI Module is used to
visualize local water diffusion
properties from the analysis
of diffusion-weighted MRI
data. The Fiber Tracking
feature utilizes the directional
dependency of the diffusion
to display the white matter
structure in the brain or more
generally the central nervous
system. | DWI/Fiber Tracking:
Diffusion analysis is used to
visualize local water diffusion
properties from the analysis
of diffusion-weighted MRI
data. Fiber tracking utilize the
directional dependency of the
diffusion to display the white
matter structure in the brain. | PerfScape V2.0 is compliant
with the DICOM standard
allowing the system to
visualize medical images.
The system is a multiplatform
software running on
Windows, Mac and Linux
operating systems. |
| Class | II | II | II | None. | | | |
| Intended Use | Olea Sphere 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.
Olea Sphere provides both
viewing and analysis
capabilities of functional and
dynamic imaging datasets | Nordic Image Control and
Evaluation (nordicICE)
Software is an image
processing software package
to be used by trained
professionals including but
not limited to physician and
medical technicians. The
software runs on a standard
"off-the-shelf" PC
workstation and can be used
to perform image viewing,
processing and analysis of
medical images. Data are
images acquired through
DICOM compliant imaging
devices and modalities.
nordicICE provides both
viewing and analysis
capabilities of functional and
dynamic imaging datasets | PerfScape V2.0 is a PACS
system that allows the
display, analysis and post-
processing of dynamically
acquired Magnetic Resonance
(MRI) and Computed
Tomography (CT) datasets to
evaluate image intensity
variations over time.
PerfScape V2.0 retrieves and
accepts data from existing
MRI and CT systems. Based
on these data, PerfScape V2.0
performs quality control
checks, displays Diffusion
Weighted Images (MRI only)
and generates parametric
maps such as Relative Blood
Volume, Relative Blood
Flow, Relative Mean Transit
Time, Time to Peak, Impulse | Olea Sphere and
nordicICE have
essentially an identical
Intended Use, with the
exception that Olea
Sphere does not include
the BOLD fMRI
analysis feature (see
part in yellow).
Olea Sphere and
PerfScape V2.0 have
substantially equivalent
Intended Use, with the
exception that
PerfScape V2.0 is only
limited to the post
processing of perfusion
datasets (CT or MRI),
diffusion datasets and
diffusion tensor
imaging. | | | |
510(k) – Olea Sphere
6
Image /page/6/Picture/0 description: The image shows a black and white graphic with some text. The text appears to be a stylized letter 'd' on top of a solid black rectangle. The letter 'd' is not fully formed, and the rectangle is not perfectly shaped.
510(k) – Olea Sphere
7
| 4995
::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::
14 11 12 12 11 12 11
- 19 - 12 - 12 - 12 - 14 - 14 - 1
DACK
CALLEM
6
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|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
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12 |
| | 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
functionality is referred to as: | Dynamic Analysis: Dynamic
analysis is used for
visualization and analysis of
dynamic imaging data of the
brain, showing properties of
changes in contrast over time
where such techniques are
useful or necessary. This
functionality is referred to as: | | |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-------|
| | Perfusion Module - the
calculation of parameters
related to tissue flow
(perfusion) and tissue blood
volume. | nordicICE Perfusion Module
- Calculation of parameters
related to tissue flow
(perfusion) and tissue blood
volume. | | |
| | Permeability Module – the
calculation of parameters
related to leakage of injected
contrast material from
intravascular to extracellular
space. | nordicICE DCE Module -
Calculation of parameters
related to leakage of injected
contrast material from
intravascular to extracellular
space. | | |
| Environment
of Use | Olea Sphere is for use in
hospitals, imaging centers,
radiologist reading practices | Nordic Image Control and
Evaluation (nordicICE)
Software is for use in | PerfScape V2.0 is for use in
hospitals, imaging centers,
radiologist reading practices | None. |
510(k) – Olea Sphere
. . . .
.
8
| 4
THE LA
- 2017 11 11:20 1
and
STATES
13 |
|--------------------------------------------------------------|
| g
ﺘﻘﺪﻣﺔ ﺍ
2 |
| :
:
Property |
| | by professional who requires
and is granted access to
patient image, demographic
and report information. | hospitals, imaging centers,
nursing homes and radiologist
reading practices by any user
who requires and is granted
access to patient image,
demographic, and report
information. | by professional who requires
and is granted access to
patient image, demographic
and report information. | |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Limitations of
Use | Lossy compressed
mammographic images and
digitized film screen images
must not be reviewed for
primary image
interpretations. | Lossy compressed
mammographic images and
digitized film screen images
must not be reviewed for
primary image
interpretations. | Lossy compressed
mammographic images and
digitized film screen images
must not be reviewed for
primary image
interpretations. | None. |
| Principles of
Operation | The Olea Sphere software
offers comprehensive
functionality for dynamic
image analysis and
visualization, where signal
changes over time are
analyzed to determine various
modality dependent
functional parameters. | The nordicICE software
offers comprehensive
functionality for dynamic
image analysis and
visualization, where signal
changes over time are
analyzed to determine various
modality dependent
functional parameters. | The PerfScape V2.0 software
offers comprehensive
functionality for dynamic
image analysis and
visualization, where signal
changes over time are
analyzed to determine various
modality dependent
functional parameters. | Olea Sphere and
nordicICE have
essentially identical
Principles of Operation,
with the exception that
Olea Sphere does not
include the BOLD
fMRI analysis feature
(see part in yellow). |
| | Olea Sphere provides both
viewing and analysis | nordicICE provides both
viewing and analysis | PerfScape V2.0 provides both
viewing and analysis | Olea Sphere and
PerfScape V2.0 have |
510(k) -- Olea Sphere
Page 5-9
.
9
| 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 for MRI and CT). | capabilities of functional and
dynamic imaging datasets
acquired with MRI or other
relevant modalities, including
diffusion
weighted MRI (DWI) / fiber
tracking, and dynamic
analysis. | capabilities of functional and
dynamic imaging datasets
acquired with MRI or other
relevant modalities, including
diffusion weighted MRI
(DWI), and dynamic analysis
(contrast enhanced imaging
data for MRI and CT). | essentially identical
Principles of Operation,
with the exception that
PerfScape V2.0 does
not include the Fiber
Tracking and the
DCE/Permeability
processing and analysis
tools. |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DWI / Fiber 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 of the
diffusion to display the white | Image: A black bar graph | DWI / DTI Module:
Diffusion analysis is used to
visualize local water diffusion
properties from the analysis
of diffusion-weighted MRI
data. | |
.
510(k) – Olea Sphere
10
| matter structure in the brain
or more generally the central
| nervous system. | matter structure in the brain. | matter structure in the brain. |
|---|---|---|
| Dynamic Analysis: Dynamic | ||
| analysis 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 | ||
| functionality includes | ||
| dedicated analysis methods | ||
| and visualization tools for | ||
| dynamic contrast enhanced | ||
| imaging data (from MRI or | ||
| CT) where a bolus 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 as well | ||
| as leakage (due to capillary | Dynamic Analysis: Dynamic | |
| analysis is used for | ||
| visualization and analysis of | ||
| dynamic imaging data of the | ||
| brain, showing properties of | ||
| changes in contrast over time | ||
| where such techniques are | ||
| useful or necessary. This | ||
| functionality includes | ||
| dedicated analysis methods | ||
| and visualization tools for | ||
| dynamic contrast enhanced | ||
| imaging data (from MRI or | ||
| CT) where a bolus 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 as well | ||
| as leakage (due to capillary | Dynamic Analysis: Dynamic | |
| analysis is used for | ||
| visualization and analysis of | ||
| dynamic imaging data of the | ||
| brain, showing properties of | ||
| changes in contrast over time | ||
| where such techniques are | ||
| useful or necessary. This | ||
| functionality includes | ||
| dedicated analysis methods | ||
| and visualization tools for | ||
| dynamic contrast enhanced | ||
| imaging data (from MRI or | ||
| CT) where a bolus 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 as well | ||
| as leakage (due to capillary |
Page 5-11
510(k) – Olea Sphere
11
| | permeability) of the injected
contrast material from the
intravascular to the
extracellular space. This
functionality is referred to as: | permeability) of the injected
contrast material from the
intravascular to the
extracellular space. This
functionality is referred to as: | 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. | Perfusion Module:
Calculation of parameters
related to tissue flow
(perfusion) and tissue blood
volume. | Perfusion Module:
Calculation of parameters
related to tissue flow
(perfusion) and tissue blood
volume. | |
| | Permeability Module:
Calculation of parameters
related to leakage of injected
contrast material from
intravascular to extracellular
space. | Permeability Module:
Calculation of parameters
related to leakage of injected
contrast material from
intravascular to extracellular
space | Permeability Module:
Calculation of parameters
related to leakage of injected
contrast material from
intravascular to extracellular
space. | |
| Performance
Characteristi
cs | Main software features:
• Image Loading & Saving;
• Image Viewing;
• Image Manipulation; | Main software features:
• Image Loading & Saving;
• Image Viewing;
• Image Manipulation; | Main software features:
• Image Loading & Saving;
• Image Viewing;
• Image Manipulation; | All three devices
perform in a
substantially equivalent
manner, with the
exception that in
Perfscape V2.0 no |
| | • Image Processing;
• Perfusion Maps; | • Image Processing;
• Perfusion Maps; | • Image Processing;
• Perfusion Maps; | Image Analysis, Fiber
Tracking and |
510(k) — Olea Sphere
12
Image /page/12/Picture/0 description: The image shows a black and white picture of what appears to be a letter. The letter is in a bold, sans-serif font. The letter is partially obscured by noise and artifacts.
| Diffusion Weighted
Imaging/Tensor Imaging
Maps; | Diffusion Weighted
Imaging/Tensor Imaging
Maps; | Diffusion Weighted
Imaging/Tensor Imaging
Maps. |
|-------------------------------------------------------|-------------------------------------------------------|----------------------------------------------------------------------|
| | | Permeability Maps
features are available
(see part in yellow). |
510(k) – Olea Sphere
.
.
:
:
.
:
. .
—
.
13
Image /page/13/Picture/0 description: The image is a black and white graphic that appears to be a logo or emblem. On the left side, there is a circular shape with a dark, solid fill. To the right of the circle, there is a rectangular shape with text inside. The text is difficult to read due to the low resolution and heavy contrast, but it seems to be arranged in multiple lines.
VII. Summary of Testing
OLEA Medical has conducted extensive validation testing of the Olea Sphere system, as a PACS that is capable of providing reliable post-processing and display of images for instantaneous multi-parametric analysis. All of the different components of the Olea Sphere software have been stress tested to ensure that the system as a whole provides all the capabilities necessary to operate according to its intended use.
The tests performed included:
- . Product Risk Assessment
- Software modules verification tests .
- t Software validation test
VIII. Conclusions
Based on the comparison of intended use and technological characteristics, the Olea Sphere system is substantially equivalent to the Nordic Image Control and Evaluation (nordicICE) Software manufactured by NordicImagingLab AS (K090546).
Additionally the software architecture of many of the features of the Olea Sphere is essentially identical to that one of the Perfscape V2.0 software manufactured by Olea Medical (K111161).
14
Image /page/14/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem resembling an abstract human figure or a bird-like shape, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
APR 1 9 2012
OLEA Medical % Ms. Kristi Gusman Project Manager Emergo Group Inc. 611 West 5th Street. Third Floor AUSTIN TX 78701
Re: K120196
Trade/Device Name: Olea Sphere Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 30, 2011 Received: January 23, 2012
Dear Ms. Gusman:
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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4. Indication for Use Statement
510(k) Number (if known):
Device Name:
Olea Sphere
Indications for Use:
Olea Sphere 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.
Olea Sphere 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) / Fiber Tracking Module and a Dynamic Analysis Module (dynamic contrast enhanced imaging data for MRI and CT).
The DWI Module is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data. The Fiber Tracking feature utilizes 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 functionality is 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 leakage of injected contrast material from intravascular to extracellular space.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
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of Aadiological Devices ostic Device Evaluation and Safety Di
510K K120196