Who is the manufacturer of OLEA SPHERE?

Olea Medical filed the 510(k) submission for OLEA SPHERE (K120196).

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).

What are the predicate devices for OLEA SPHERE?

Nordic Image Control and Evaluation (nordicICE) Software (K090546); Perfscape V2.0 (K111161).

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

K120196 · Olea Medical · LLZ · Apr 19, 2012 · Radiology

Device Facts

Record ID	K120196
Device Name	OLEA SPHERE
Applicant	Olea Medical
Product Code	LLZ · Radiology
Decision Date	Apr 19, 2012
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 is a PACS software package for medical imaging professionals in hospitals and clinics. It ingests DICOM-compliant MRI and CT datasets. The software performs image viewing, manipulation, and post-processing, including perfusion and permeability analysis (calculating tissue flow, blood volume, and contrast leakage) and diffusion-weighted imaging/fiber tracking (visualizing white matter structure). Users operate the software on standard off-the-shelf workstations. The output consists of processed images, parametric maps, and quantitative data, which are interpreted by physicians to assist in clinical decision-making. The device benefits patients by providing advanced functional and dynamic imaging analysis to support diagnostic workflows.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including product risk assessment, software module verification, and software validation testing.

Technological Characteristics

PACS software running on Windows, Macintosh, or Linux. Compliant with DICOM standards. Features include image loading/saving, viewing, manipulation, and processing (perfusion, permeability, DWI, fiber tracking). Utilizes image metadata for zoom, pan, and crop functions. Employs segmentation masks for surface/volume calculations. Standalone software for off-the-shelf workstations.

Indications for Use

Indicated for use by trained medical professionals (physicians, technicians) for viewing, processing, and analyzing medical images (MRI, CT) acquired via DICOM-compliant modalities. Includes modules for Diffusion Weighted MRI (DWI), fiber tracking of the central nervous system, and dynamic analysis (perfusion/permeability) of contrast-enhanced imaging data. Not for primary interpretation of lossy compressed mammographic or digitized film screen images.

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

Nordic Image Control and Evaluation (nordicICE) Software (K090546)
Perfscape V2.0 (K111161)

Related Devices

K152602 — Olea Sphere V3.0 · Olea Medical · Mar 3, 2016
K132095 — OLEA SPHERE · Olea Medical · Dec 26, 2013
K192912 — AutoMIStar · Apollo Medical Imaging Technology Pty. , Ltd. · Dec 31, 2019
K161601 — Dynamika · Image Analysis Limited · May 17, 2017
K231656 — Brainomix 360 e-MRI · Brainomix Limited · Aug 30, 2023

Submission Summary (Full Text)

{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: - 1. 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; - 2. The mono-slice view displays simultaneously one image of selected series at a given slice location; - 3. The MPR/3D view displays selected series in a three dimensional projections: - 4. 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 1 | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | र्मी 1.4 2 | | ు : ప " 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 1. 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 {15}------------------------------------------------ ### 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 {16}------------------------------------------------ # 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) Page 1 of 1 of Aadiological Devices ostic Device Evaluation and Safety Di 510K K120196