OLEA SPHERE

K132095 · Olea Medical · LLZ · Dec 26, 2013 · Radiology

Device Facts

• Record ID: K132095
• Device Name: OLEA SPHERE
• Applicant: Olea Medical
• Product Code: LLZ · Radiology
• Decision Date: Dec 26, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

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 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.

Device Story

Olea Sphere v2.3 is a PACS software package for viewing, analyzing, and post-processing medical images (MRI/CT). It ingests DICOM-compliant datasets; performs functional/dynamic analysis; and outputs processed images, perfusion maps, and permeability parameters. Used in hospitals and imaging centers by radiologists and trained technicians. The software utilizes deconvolution algorithms (SVD variants and Bayesian methods) to calculate tissue flow, blood volume, and contrast leakage. It assists clinicians in visualizing white matter structures via fiber tracking and assessing hemodynamic properties. Benefits include enhanced diagnostic information through quantitative analysis of dynamic contrast-enhanced data.

Clinical Evidence

No clinical testing was conducted. Substantial equivalence is supported by non-clinical verification and validation testing, including stress testing of software components and compliance with applicable voluntary standards for PACS.

Technological Characteristics

Software-based PACS; runs on Windows, Macintosh, or Linux off-the-shelf workstations. Features include DICOM-compliant image processing, DWI/Fiber Tracking, and Dynamic Analysis (Perfusion/Permeability). Algorithms include SVD-based deconvolution (sSVD, cSVD, oSVD) and Bayesian probabilistic methods. Supports VOI segmentation (region growing/manual), histogram normalization, and image subtraction.

Indications for Use

Indicated for trained professionals, including physicians and medical technicians, to perform viewing, processing, and analysis of DICOM-compliant medical images (MRI/CT). Used for functional/dynamic imaging analysis, including DWI/fiber tracking for CNS white matter visualization and dynamic contrast-enhanced perfusion/permeability analysis.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• Olea Sphere (K120196)

Submission Summary (Full Text)

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# 510(k) Summary (in accordance with 21 CFR 807.92)

### 510(k) Number: K132095

### Applicant Information l.

Applicant:

Olea Medical 93 avenue des Sorbiers, Zone Athelia IV La Ciotat 13600 France

Contact Person:

Caroline Lene Quality Manager Tel: [phone] Fax: [phone] e-mail: [e-mail]

Application Correspondent:

Same as Applicant

Date Prepared:

October 8, 2013

#### II. Device Name and Classification

Proprietary Name: Olea Sphere v2.3 Common/Usual Name: PACS Classification Name: Picture Archiving Communications System Regulation Number: 21 CFR 892.2050 Product Codes: LLZ Classification: Class II Classification Panel: Radiology Devices

### III. Predicate Devices

The Olea Sphere v2.3 device is substantially equivalent to its cleared predicate models have the same fundamental scientific technology and intended use:

| 510(k) Number: | K120196 |
|-----------------------|-----------------------------------------|
| Proprietary Name: | Olea Sphere |
| Common/Usual Name: | PACS |
| Classification Name: | Picture Archiving Communications System |
| Regulation Number: | 21 CFR 892.2050 |
| Product Codes: | LLZ |
| Classification: | Class II |
| Classification Panel: | Radiology Devices |

510(k) - Olea Sphere v2.3

Page 1

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### 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.

These images, when interpreted by a trained physician, may vield clinically useful information.

### V. 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.

### VI. Substantial Equivalence Discussion

The following table compares the features of the Olea Sphere v2.3 to its predicate Olea Sphere, since the two devices have the same fundamental scientific technology and intended use.

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# Comparison Table

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| Device Name | Olea Sphere - K120196 | Olea Sphere v2.3 - K132095 | Changes |
|-----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | LLZ | LLZ | None |
| Regulation # | 892.2050 | 892.2050 | None |
| Class | II | II | None |
| Intended Use | Olea Sphere is an image processing<br>software package to be used by<br>trained professionals including but<br>not limited to physicians and medical<br>technicians. The software runs on a<br>standard "off-the-shelf" workstation<br>and can be used to perform image<br>viewing, processing and analysis of<br>medical images. Data and images<br>are acquired through DICOM<br>compliant imaging devices and<br>modalities.<br><br>Olea Sphere provides both viewing<br>and analysis capabilities of<br>functional and dynamic imaging<br>datasets acquired with MRI or other<br>relevant modalities, including a<br>Diffusion Weighted MRI (DWI) /<br>Fiber Tracking Module and a<br>Dynamic Analysis Module (dynamic<br>contrast enhanced imaging data for<br>MRI and CT).<br><br>The DWI Module is used to visualize<br>local water diffusion properties from<br>the analysis of diffusion-weighted<br>MRI data. The Fiber Tracking feature<br>utilizes the directional dependency of<br>the diffusion to display the white | Olea Sphere v2.3 is an image<br>processing software package to be<br>used by trained professionals<br>including but not limited to<br>physicians and medical technicians.<br>The software runs on a standard<br>"off-the-shelf" workstation and can<br>be used to perform image viewing,<br>processing and analysis of medical<br>images. Data and images are<br>acquired through DICOM compliant<br>imaging devices and modalities.<br><br>Olea Sphere v2.3 provides both<br>viewing and analysis capabilities of<br>functional and dynamic imaging<br>datasets acquired with MRI or other<br>relevant modalities, including a<br>Diffusion Weighted MRI (DWI) /<br>Fiber Tracking Module and a<br>Dynamic Analysis Module (dynamic<br>contrast enhanced imaging data for<br>MRI and CT).<br><br>The DWI Module is used to visualize<br>local water diffusion properties from<br>the analysis of diffusion-weighted<br>MRI data. The Fiber Tracking feature<br>utilizes the directional dependency of<br>the diffusion to display the white | None |
| Device Name | Olea Sphere - K120196 | Olea Sphere v2.3 - K132095 | Changes |
| | matter structure in the brain or more<br>generally the central nervous<br>system. | matter structure in the brain or more<br>generally the central nervous<br>system. | |
| | The Dynamic Analysis Module is<br>used for visualization and analysis of<br>dynamic imaging data, showing<br>properties of changes in contrast<br>over time where such techniques are<br>useful or necessary. This<br>functionality is referred to as: | The Dynamic Analysis Module is<br>used for visualization and analysis of<br>dynamic imaging data, showing<br>properties of changes in contrast<br>over time where such techniques are<br>useful or necessary. This<br>functionality is referred to as: | |
| | Perfusion Module - the calculation of<br>parameters related to tissue flow<br>(perfusion) and tissue blood volume. | Perfusion Module - the calculation of<br>parameters related to tissue flow<br>(perfusion) and tissue blood volume. | |
| | Permeability Module - the<br>calculation of parameters related to<br>leakage of injected contrast material<br>from intravascular to extracellular<br>space. | Permeability Module - the<br>calculation of parameters related to<br>leakage of injected contrast material<br>from intravascular to extracellular<br>space. | |
| Environment of<br>Use | Olea Sphere is for use in hospitals,<br>imaging centers, radiologist reading<br>practices by professional who<br>requires and is granted access to<br>patient image, demographic and<br>report information. | Olea Sphere v2.3 is for use in<br>hospitals, imaging centers,<br>radiologist reading practices by<br>professional who requires and is<br>granted access to patient image,<br>demographic and report information. | None |
| Limitations of<br>Use | Lossy compressed mammographic<br>images and digitized film screen<br>images must not be reviewed for<br>primary image interpretations. | Lossy compressed mammographic<br>images and digitized film screen<br>images must not be reviewed for<br>primary image interpretations. | None |
| Device Name | Olea Sphere - K120196 | Olea Sphere v2.3 - K132095 | Changes |
| Principles of<br>Operation | The Olea Sphere software offers<br>comprehensive functionality for<br>dynamic image analysis and<br>visualization, where signal changes<br>over time are analyzed to determine<br>various modality dependent<br>functional parameters. | The Olea Sphere v2.3 software<br>offers comprehensive functionality<br>for dynamic image analysis and<br>visualization, where signal changes<br>over time are analyzed to determine<br>various modality dependent<br>functional parameters. | None |
| | Olea Sphere provides both viewing<br>and analysis capabilities of<br>functional and dynamic imaging<br>datasets acquired with MRI or other<br>relevant modalities, including<br>diffusion weighted MRI (DWI) / fiber<br>tracking, and dynamic analysis<br>(dynamic contrast enhanced imaging<br>data for MRI and CT). | Olea Sphere v2.3 provides both<br>viewing and analysis capabilities of<br>functional and dynamic imaging<br>datasets acquired with MRI or other<br>relevant modalities, including<br>diffusion weighted MRI (DWI) / fiber<br>tracking, and dynamic analysis<br>(dynamic contrast enhanced imaging<br>data for MRI and CT). | |
| | DWI / Fiber Tracking Module:<br>Diffusion analysis is used to<br>visualize local water diffusion<br>properties from the analysis of<br>diffusion-weighted MRI data. Fiber<br>tracking utilizes the directional<br>dependency of the diffusion to<br>display the white matter structure in<br>the brain or more generally the<br>central nervous system. | DWI / Fiber Tracking Module:<br>Diffusion analysis is used to<br>visualize local water diffusion<br>properties from the analysis of<br>diffusion-weighted MRI data. Fiber<br>tracking utilizes the directional<br>dependency of the diffusion to<br>display the white matter structure in<br>the brain or more generally the<br>central nervous system. | |
| | Dynamic Analysis: Dynamic analysis<br>is used for visualization and analysis<br>of dynamic imaging, showing<br>properties of changes in contrast<br>over time where such techniques are<br>useful or necessary. This | Dynamic Analysis: Dynamic analysis<br>is used for visualization and analysis<br>of dynamic imaging, showing<br>properties of changes in contrast<br>over time where such techniques are<br>useful or necessary. This | |
| Device Name | Olea Sphere - K120196 | Olea Sphere v2.3 - K132095 | Changes |
| | functionality includes dedicated<br>analysis methods and visualization<br>tools for dynamic contrast enhanced<br>imaging data (from MRI or CT)<br>where a bolus injection of a contrast<br>agent material results in a temporal<br>change in the signal intensity. This<br>dynamic change in signal intensity is<br>used to calculate functional<br>parameters related to tissue flow<br>(perfusion) and tissue blood volume<br>as well as leakage (due to capillary<br>permeability) of the injected contrast<br>material from the intravascular to the<br>extracellular space. This functionality<br>is referred to as: | functionality includes dedicated<br>analysis methods and visualization<br>tools for dynamic contrast enhanced<br>imaging data (from MRI or CT)<br>where a bolus injection of a contrast<br>agent material results in a temporal<br>change in the signal intensity. This<br>dynamic change in signal intensity is<br>used to calculate functional<br>parameters related to tissue flow<br>(perfusion) and tissue blood volume<br>as well as leakage (due to capillary<br>permeability) of the injected contrast<br>material from the intravascular to the<br>extracellular space. This functionality<br>is referred to as: | |
| | Perfusion Module: Calculation of<br>parameters related to tissue flow<br>(perfusion) and tissue blood volume.<br>Permeability Module: Calculation of<br>parameters related to leakage of<br>injected contrast material from<br>intravascular to extracellular space. | Perfusion Module: Calculation of<br>parameters related to tissue flow<br>(perfusion) and tissue blood volume.<br>Permeability Module: Calculation of<br>parameters related to leakage of<br>injected contrast material from<br>intravascular to extracellular space. | |
| Device Name | Olea Sphere - K120196 | Olea Sphere v2.3 - K132096 | Changes |
| Performance<br>Characteristics:<br>Image Analysis | Qualitative or quantitative analysis of<br>certain features in an image or an<br>image set:<br>• Volume of interest (VOI) analysis; | Qualitative or quantitative analysis of<br>certain features in an image or an<br>image set:<br>• Volume of interest (VOI) analysis; | Enhanced Volume of Interest<br>segmentation with a more<br>automatic volume segmentation<br>method equivalent to the region<br>growing. |
| | Segmentation of volumes of interest<br>based on:<br>- A region growing method<br>- Manual delineation | Segmentation of volumes of interest<br>based on:<br>- A region growing method<br>- Manual delineation<br>- Region-based volume<br>segmentation<br>• Histogram normalization<br>• Image subtraction | The segmentation is always<br>supervised by the user that can<br>always adjust the segmentation<br>with the existing manual<br>delineation tools.<br>Enhanced visualization and<br>comparison of images with<br>histogram normalization and<br>image subtraction. |
| Performance<br>Characteristics:<br>Perfusion | • State of the art deconvolution<br>algorithm:<br>o sSVD (standard);<br>o cSVD (block circulant);<br>o oSVD (adaptative). | • State of the art deconvolution<br>algorithm:<br>o sSVD (standard);<br>o cSVD (block circulant);<br>o oSVD (adaptative);<br>o probabilistic, bayesian<br>method. | The fundamental scientific<br>technology is the same (being<br>based on the same perfusion<br>model and deconvolution<br>process). The Bayesian<br>probability is a standard<br>methodology that is known to<br>outperform the SVD in terms of<br>accuracy. |
| | (Deconvolution)<br>The deconvolution process is<br>implemented by the Singular Value<br>Decomposition (SVD). Perfusion<br>maps and the singular value<br>decomposition are defined in<br>References [1, 2]. | (Deconvolution)<br>The deconvolution process is<br>implemented either by the Singular<br>Value Decomposition (SVD) or<br>probabilistically by a Bayesian<br>algorithm.<br>Perfusion maps and the singular<br>value decomposition and the<br>probabilistic Bayesian method are<br>defined in References [1, 2, 3]. | |
| Device Name - | Olea Sphere - K120196 | Olea Sphere v2.3 - K132095 | Changes |
| Performance<br>Characteristics: | State of the art kinetic modeling with vascular deconvolution algorithm. Generation of permeability maps using signal conversion based on relative signal enhancement: 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); 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) | State of the art kinetic modeling with vascular deconvolution algorithm. Generation of permeability maps using signal conversion based on relative signal enhancement or T1 mapping: 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); 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) | The fundamental scientific technology is the same (being based on the same kinetic modeling and compartmental models). |
| Permeability | | | The 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. |
| | | | The kinetic curve type assessment allows permeability parameter estimation in case of acquisitions with a lower temporal resolution. |
| Device Name : | 'Olea Sphere'- K120196 | 'Olea Sphere v2.3 - K132096 | Changes |
| | Permeability Output Maps: | Permeability Output Maps:…