(87 days)
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.
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
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.
The provided document describes the Olea Sphere PACS software, which is intended for viewing, processing, and analyzing medical images, including functional and dynamic imaging datasets from MRI and CT.
Please note: This document primarily focuses on establishing substantial equivalence to predicate devices and outlines the device's features and intended use. It does not contain a detailed study proving the device meets specific performance acceptance criteria through quantitative metrics. Instead, it relies on the established performance of its predicate devices and a general statement of internal validation.
Here's an breakdown based on the information available:
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics like sensitivity, specificity, or AUC for specific tasks. Instead, it asserts that the Olea Sphere performs "substantially equivalent" to its predicate devices in terms of intended use, environment of use, limitations of use, principles of operation, and performance characteristics.
The "performance characteristics" section in the comparison table (pages 11-12) lists the main software features expected and implies that the new device performs these features similarly to the predicates.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence: Ability to perform core PACS functions | Olea Sphere provides image loading & saving, viewing, manipulation, |
| (Image Loading/Saving, Viewing, Manipulation, Processing). | and processing, perfusion maps, and diffusion weighted imaging/tensor |
| imaging maps (per pages 11-12). | |
| Dynamic Image Analysis: Visualization and analysis of | Olea Sphere performs dynamic analysis, including dedicated analysis |
| dynamic imaging data, including perfusion and permeability | methods and visualization tools for dynamic contrast-enhanced imaging |
| modules. | data (MRI/CT), calculation of parameters related to tissue flow |
| (perfusion) and tissue blood volume, and leakage (permeability) (per | |
| pages 10-11). | |
| DWI/Fiber Tracking: Visualization of water diffusion | Olea Sphere's DWI Module visualizes local water diffusion properties |
| properties and display of white matter structure. | and the Fiber Tracking feature displays white matter structure in the |
| brain or central nervous system (per pages 9-10). | |
| Substantial Equivalence to Predicates: | Olea Sphere is substantially equivalent to Nordic Image Control and |
| Demonstrated equivalence in intended use, environment of use, | Evaluation (nordicICE) Software (K090546) and shares identical |
| limitations, principles of operation, and performance characteristics. | software architecture for many features with Perfscape V2.0 (K111161) |
| (per page 13). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on the sample size of a test set (e.g., number of images or cases) used for performance validation. It states that "OLEA Medical has conducted extensive validation testing of the Olea Sphere system," but does not specify the dataset used for these tests. Therefore, data provenance (country of origin, retrospective/prospective) is also not indicated.
3. Number of Experts and Qualifications for Ground Truth
The document does not mention the use of experts to establish a ground truth for a test set. This type of information is typically provided for studies assessing diagnostic accuracy, which is not the focus of this submission, as it mainly aims to demonstrate functional equivalence for a PACS viewing and analysis software.
4. Adjudication Method
No adjudication method is described, as there is no mention of a study involving expert readers and ground truth establishment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The document aims to demonstrate substantial equivalence to existing PACS systems, not to quantify improvement with AI assistance. The device description suggests a tool for analysis, but there is no mention of it being an "AI" device in the context of improving human reader performance.
6. Standalone (Algorithm Only) Performance Study
No standalone performance study is mentioned with quantitative metrics. The validation described is likely functional (e.g., software testing, verification) rather than a clinical performance study measuring accuracy against a reference standard.
7. Type of Ground Truth Used
No specific type of ground truth (e.g., expert consensus, pathology, outcomes data) is mentioned as being used for performance validation in the context of diagnostic accuracy. Given the nature of the device (PACS for viewing and analysis), the "validation" described likely refers to software functionality and accuracy of calculations, rather than diagnostic accuracy against a clinical ground truth.
8. Sample Size for the Training Set
The document does not refer to a training set or machine learning algorithms in a way that would require specifying a sample size for training. The Olea Sphere is described as a "software package" for image viewing, processing, and analysis, and its features are compared to predicate devices with similar functionalities, implying a traditional software development and validation approach rather than an AI/ML model.
9. How Ground Truth for the Training Set Was Established
As no training set is mentioned in the context of machine learning, there is no information on how its ground truth would have been established.
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.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
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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.
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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
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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
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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
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场 申乐
Predicate Device Comparison Table
| Product Code | LLZ | LLZ | LLZ | None. | acquired with MRI or otherrelevant modalities, includinga Diffusion Weighted MRI(DWI) / Fiber TrackingModule and a DynamicAnalysis Module (dynamiccontrast enhanced imagingdata for MRI and CT). | acquired with MRI or otherrelevant modalities, includingblood oxygen level dependent(BOLD) fMRI, diffusionweighted MRI (DWI) / fibertracking and dynamicanalysis. | Response Time to Peak,permeability and leakagebetween intravascular andextracellular space (MRIonly), and temporalMaximum IntensityProjection (CT only).PerfScape V2.0 alsogenerates Diffusion WeightedImages and/or DiffusionTensor Images (MRI only).These images, wheninterpreted by a trainedphysician, may yieldclinically useful information. |
|---|---|---|---|---|---|---|---|
| Regulation # | 892.2050 | 892.2050 | 892.2050 | None. | The DWI Module is used tovisualize local water diffusionproperties from the analysisof diffusion-weighted MRIdata. The Fiber Trackingfeature utilizes the directionaldependency of the diffusionto display the white matterstructure in the brain or moregenerally the central nervoussystem. | DWI/Fiber Tracking:Diffusion analysis is used tovisualize local water diffusionproperties from the analysisof diffusion-weighted MRIdata. Fiber tracking utilize thedirectional dependency of thediffusion to display the whitematter structure in the brain. | PerfScape V2.0 is compliantwith the DICOM standardallowing the system tovisualize medical images.The system is a multiplatformsoftware running onWindows, Mac and Linuxoperating systems. |
| Class | II | II | II | None. | |||
| Intended Use | Olea Sphere is an imageprocessing software packageto be used by trainedprofessionals including butnot limited to physicians andmedical technicians. Thesoftware runs on a standard"off-the-shelf" workstationand can be used to performimage viewing, processingand analysis of medicalimages. Data and images areacquired through DICOMcompliant imaging devicesand modalities.Olea Sphere provides bothviewing and analysiscapabilities of functional anddynamic imaging datasets | Nordic Image Control andEvaluation (nordicICE)Software is an imageprocessing software packageto be used by trainedprofessionals including butnot limited to physician andmedical technicians. Thesoftware runs on a standard"off-the-shelf" PCworkstation and can be usedto perform image viewing,processing and analysis ofmedical images. Data areimages acquired throughDICOM compliant imagingdevices and modalities.nordicICE provides bothviewing and analysiscapabilities of functional anddynamic imaging datasets | PerfScape V2.0 is a PACSsystem that allows thedisplay, analysis and post-processing of dynamicallyacquired Magnetic Resonance(MRI) and ComputedTomography (CT) datasets toevaluate image intensityvariations over time.PerfScape V2.0 retrieves andaccepts data from existingMRI and CT systems. Basedon these data, PerfScape V2.0performs quality controlchecks, displays DiffusionWeighted Images (MRI only)and generates parametricmaps such as Relative BloodVolume, Relative BloodFlow, Relative Mean TransitTime, Time to Peak, Impulse | Olea Sphere andnordicICE haveessentially an identicalIntended Use, with theexception that OleaSphere does not includethe BOLD fMRIanalysis feature (seepart in yellow).Olea Sphere andPerfScape V2.0 havesubstantially equivalentIntended Use, with theexception thatPerfScape V2.0 is onlylimited to the postprocessing of perfusiondatasets (CT or MRI),diffusion datasets anddiffusion tensorimaging. |
510(k) – Olea Sphere
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510(k) – Olea Sphere
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| The Dynamic AnalysisModule is used forvisualization and analysis ofdynamic imaging data,showing properties ofchanges in contrast over timewhere such techniques areuseful or necessary. Thisfunctionality is referred to as: | Dynamic Analysis: Dynamicanalysis is used forvisualization and analysis ofdynamic imaging data of thebrain, showing properties ofchanges in contrast over timewhere such techniques areuseful or necessary. Thisfunctionality is referred to as: | |||
|---|---|---|---|---|
| Perfusion Module - thecalculation of parametersrelated to tissue flow(perfusion) and tissue bloodvolume. | nordicICE Perfusion Module- Calculation of parametersrelated to tissue flow(perfusion) and tissue bloodvolume. | |||
| Permeability Module – thecalculation of parametersrelated to leakage of injectedcontrast material fromintravascular to extracellularspace. | nordicICE DCE Module -Calculation of parametersrelated to leakage of injectedcontrast material fromintravascular to extracellularspace. | |||
| Environmentof Use | Olea Sphere is for use inhospitals, imaging centers,radiologist reading practices | Nordic Image Control andEvaluation (nordicICE)Software is for use in | PerfScape V2.0 is for use inhospitals, imaging centers,radiologist reading practices | None. |
510(k) – Olea Sphere
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| 4THE LA1. 2017 11 11:20 1andSTATES13 |
|---|
| gﺘﻘﺪﻣﺔ ﺍ2 |
| ::Property |
| by professional who requiresand is granted access topatient image, demographicand report information. | hospitals, imaging centers,nursing homes and radiologistreading practices by any userwho requires and is grantedaccess to patient image,demographic, and reportinformation. | by professional who requiresand is granted access topatient image, demographicand report information. | ||
|---|---|---|---|---|
| Limitations ofUse | Lossy compressedmammographic images anddigitized film screen imagesmust not be reviewed forprimary imageinterpretations. | Lossy compressedmammographic images anddigitized film screen imagesmust not be reviewed forprimary imageinterpretations. | Lossy compressedmammographic images anddigitized film screen imagesmust not be reviewed forprimary imageinterpretations. | None. |
| Principles ofOperation | The Olea Sphere softwareoffers comprehensivefunctionality for dynamicimage analysis andvisualization, where signalchanges over time areanalyzed to determine variousmodality dependentfunctional parameters. | The nordicICE softwareoffers comprehensivefunctionality for dynamicimage analysis andvisualization, where signalchanges over time areanalyzed to determine variousmodality dependentfunctional parameters. | The PerfScape V2.0 softwareoffers comprehensivefunctionality for dynamicimage analysis andvisualization, where signalchanges over time areanalyzed to determine variousmodality dependentfunctional parameters. | Olea Sphere andnordicICE haveessentially identicalPrinciples of Operation,with the exception thatOlea Sphere does notinclude the BOLDfMRI analysis feature(see part in yellow). |
| Olea Sphere provides bothviewing and analysis | nordicICE provides bothviewing and analysis | PerfScape V2.0 provides bothviewing and analysis | Olea Sphere andPerfScape V2.0 have |
510(k) -- Olea Sphere
Page 5-9
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| capabilities of functional anddynamic imaging datasetsacquired with MRI or otherrelevant modalities, includingdiffusion weighted MRI(DWI) / fiber tracking, anddynamic analysis (dynamiccontrast enhanced imagingdata for MRI and CT). | capabilities of functional anddynamic imaging datasetsacquired with MRI or otherrelevant modalities, includingdiffusionweighted MRI (DWI) / fibertracking, and dynamicanalysis. | capabilities of functional anddynamic imaging datasetsacquired with MRI or otherrelevant modalities, includingdiffusion weighted MRI(DWI), and dynamic analysis(contrast enhanced imagingdata for MRI and CT). | essentially identicalPrinciples of Operation,with the exception thatPerfScape V2.0 doesnot include the FiberTracking and theDCE/Permeabilityprocessing and analysistools. |
|---|---|---|---|
| DWI / Fiber TrackingModule: Diffusion analysis isused to visualize local waterdiffusion properties from theanalysis of diffusion-weighted MRI data. Fibertracking utilizes thedirectional dependency of thediffusion to display the white | Image: A black bar graph | DWI / DTI Module:Diffusion analysis is used tovisualize local water diffusionproperties from the analysisof diffusion-weighted MRIdata. |
.
510(k) – Olea Sphere
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| matter structure in the brainor more generally the centralnervous system. | matter structure in the brain. | matter structure in the brain. |
|---|---|---|
| Dynamic Analysis: Dynamicanalysis is used forvisualization and analysis ofdynamic imaging data,showing properties ofchanges in contrast over timewhere such techniques areuseful or necessary. Thisfunctionality includesdedicated analysis methodsand visualization tools fordynamic contrast enhancedimaging data (from MRI orCT) where a bolus injectionof a contrast agent materialresults in a temporal changein the signal intensity. Thisdynamic change in signalintensity is used to calculatefunctional parameters relatedto tissue flow (perfusion) andtissue blood volume as wellas leakage (due to capillary | Dynamic Analysis: Dynamicanalysis is used forvisualization and analysis ofdynamic imaging data of thebrain, showing properties ofchanges in contrast over timewhere such techniques areuseful or necessary. Thisfunctionality includesdedicated analysis methodsand visualization tools fordynamic contrast enhancedimaging data (from MRI orCT) where a bolus injectionof a contrast agent materialresults in a temporal changein the signal intensity. Thisdynamic change in signalintensity is used to calculatefunctional parameters relatedto tissue flow (perfusion) andtissue blood volume as wellas leakage (due to capillary | Dynamic Analysis: Dynamicanalysis is used forvisualization and analysis ofdynamic imaging data of thebrain, showing properties ofchanges in contrast over timewhere such techniques areuseful or necessary. Thisfunctionality includesdedicated analysis methodsand visualization tools fordynamic contrast enhancedimaging data (from MRI orCT) where a bolus injectionof a contrast agent materialresults in a temporal changein the signal intensity. Thisdynamic change in signalintensity is used to calculatefunctional parameters relatedto tissue flow (perfusion) andtissue blood volume as wellas leakage (due to capillary |
Page 5-11
510(k) – Olea Sphere
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| permeability) of the injectedcontrast material from theintravascular to theextracellular space. Thisfunctionality is referred to as: | permeability) of the injectedcontrast material from theintravascular to theextracellular space. Thisfunctionality is referred to as: | permeability) of the injectedcontrast material from theintravascular to theextracellular space. Thisfunctionality is referred to as: | ||
|---|---|---|---|---|
| Perfusion Module:Calculation of parametersrelated to tissue flow(perfusion) and tissue bloodvolume. | Perfusion Module:Calculation of parametersrelated to tissue flow(perfusion) and tissue bloodvolume. | Perfusion Module:Calculation of parametersrelated to tissue flow(perfusion) and tissue bloodvolume. | ||
| Permeability Module:Calculation of parametersrelated to leakage of injectedcontrast material fromintravascular to extracellularspace. | Permeability Module:Calculation of parametersrelated to leakage of injectedcontrast material fromintravascular to extracellularspace | Permeability Module:Calculation of parametersrelated to leakage of injectedcontrast material fromintravascular to extracellularspace. | ||
| PerformanceCharacteristics | 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 devicesperform in asubstantially equivalentmanner, with theexception that inPerfscape V2.0 no |
| • Image Processing;• Perfusion Maps; | • Image Processing;• Perfusion Maps; | • Image Processing;• Perfusion Maps; | Image Analysis, FiberTracking and |
510(k) — Olea Sphere
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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 WeightedImaging/Tensor ImagingMaps; | Diffusion WeightedImaging/Tensor ImagingMaps; | Diffusion WeightedImaging/Tensor ImagingMaps. |
|---|---|---|
| Permeability Mapsfeatures are available(see part in yellow). |
510(k) – Olea Sphere
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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).
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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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Page 2
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.
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Over-The-Counter Use (21 CFR 801 Subpart C)
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of Aadiological Devices ostic Device Evaluation and Safety Di
510K K120196
§ 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).