Who is the manufacturer of OLEA SPHERE?

Olea Medical filed the 510(k) submission for OLEA SPHERE (K132095).

What is the FDA product code for OLEA SPHERE?

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

What is the regulatory pathway for OLEA SPHERE?

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

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

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

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

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.

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)

{0}------------------------------------------------ # 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: (011) 33 4 42 71 24 20 Fax: (011) 33 4 42 71 24 27 e-mail: caroline.lene@olea-medical.com 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 {1}------------------------------------------------ ### 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. {2}------------------------------------------------ # Comparison Table ・・ | 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 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 | Olea Sphere v2.3 is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" workstation and can be used to perform image viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities. Olea Sphere v2.3 provides both viewing and analysis capabilities of functional and dynamic imaging datasets acquired with MRI or other relevant modalities, including a Diffusion Weighted MRI (DWI) / 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 | None | | Device Name | Olea Sphere - K120196 | Olea Sphere v2.3 - K132095 | Changes | | | matter structure in the brain or more generally the central nervous system. | 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: | 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. | 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. | Permeability Module - the 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 by professional who requires and is granted access to patient image, demographic and report information. | Olea Sphere v2.3 is for use in hospitals, imaging centers, radiologist reading practices by professional who requires and is granted access to patient image, demographic and report information. | None | | 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. | None | | Device Name | Olea Sphere - K120196 | Olea Sphere v2.3 - K132095 | Changes | | 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 Olea Sphere v2.3 software offers comprehensive functionality for dynamic image analysis and visualization, where signal changes over time are analyzed to determine various modality dependent functional parameters. | None | | | Olea Sphere provides both viewing and analysis capabilities of functional and dynamic imaging datasets acquired with MRI or other relevant modalities, including diffusion weighted MRI (DWI) / fiber tracking, and dynamic analysis (dynamic contrast enhanced imaging data for MRI and CT). | Olea Sphere v2.3 provides both viewing and analysis capabilities of functional and dynamic imaging datasets acquired with MRI or other relevant modalities, including diffusion weighted MRI (DWI) / fiber tracking, and dynamic analysis (dynamic contrast enhanced imaging data for MRI and CT). | | | | 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 matter structure in the brain or more generally the central nervous system. | 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 matter structure in the brain or more generally the central nervous system. | | | | Dynamic Analysis: Dynamic analysis is used for visualization and analysis of dynamic imaging, showing properties of changes in contrast over time where such techniques are useful or necessary. This | Dynamic Analysis: Dynamic analysis is used for visualization and analysis of dynamic imaging, showing properties of changes in contrast over time where such techniques are useful or necessary. This | | | Device Name | Olea Sphere - K120196 | Olea Sphere v2.3 - K132095 | Changes | | | 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 permeability) of the injected contrast material from the intravascular to the extracellular space. This functionality is referred to as: | 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 permeability) of the injected contrast material from the intravascular to the extracellular space. This functionality is referred to as: | | | | Perfusion Module: Calculation of parameters related to tissue flow (perfusion) and tissue blood volume. Permeability Module: Calculation of parameters related to leakage of injected contrast material from intravascular to extracellular space. | 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. | | | Device Name | Olea Sphere - K120196 | Olea Sphere v2.3 - K132096 | Changes | | Performance Characteristics: Image Analysis | Qualitative or quantitative analysis of certain features in an image or an image set: • Volume of interest (VOI) analysis; | Qualitative or quantitative analysis of certain features in an image or an image set: • Volume of interest (VOI) analysis; | Enhanced Volume of Interest segmentation with a more automatic volume segmentation method equivalent to the region growing. | | | Segmentation of volumes of interest based on: - A region growing method - Manual delineation | Segmentation of volumes of interest based on: - A region growing method - Manual delineation - Region-based volume segmentation • Histogram normalization • Image subtraction | The segmentation is always supervised by the user that can always adjust the segmentation with the existing manual delineation tools. Enhanced visualization and comparison of images with histogram normalization and image subtraction. | | Performance Characteristics: Perfusion | • State of the art deconvolution algorithm: o sSVD (standard); o cSVD (block circulant); o oSVD (adaptative). | • State of the art deconvolution algorithm: o sSVD (standard); o cSVD (block circulant); o oSVD (adaptative); o probabilistic, bayesian method. | The fundamental scientific technology is the same (being based on the same perfusion model and deconvolution process). The Bayesian probability is a standard methodology that is known to outperform the SVD in terms of accuracy. | | | (Deconvolution) The deconvolution process is implemented by the Singular Value Decomposition (SVD). Perfusion maps and the singular value decomposition are defined in References [1, 2]. | (Deconvolution) The deconvolution process is implemented either by the Singular Value Decomposition (SVD) or probabilistically by a Bayesian algorithm. Perfusion maps and the singular value decomposition and the probabilistic Bayesian method are defined in References [1, 2, 3]. | | | Device Name - | Olea Sphere - K120196 | Olea Sphere v2.3 - K132095 | Changes | | Performance 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:…

OLEA SPHERE

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Submission Summary (Full Text)

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Indications for Use

Device Story

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Technological Characteristics

Indications for Use

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Predicate Devices

Submission Summary (Full Text)

Panel 1

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