s ay APR 1,9 2012

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

5 10(k) Number K____

1. Applicant Information

Applicant:OLEA MEDICAL93 avenue des Sorbiers, Zone Athelia IVLa Ciotat 13600France

Contact Person: Caroline LeneQuality Manager,Tel: (011) 33 442 71 24 20Fax: (011) 334.42 71 24 27e-mail: carol ine. lene@olea-medical.com

App lication Correspondent:EMERGO GROUP INC.611 West 5th Street, Third FloorAustin, TX 78701U.S.A.

Contact Person: Kristi GusmanProject ManagerTel: (512) 327-9997Fax: (512) 327-9998e-mail: kristiemergogroup.com

Date Prepared: November 30, 2011

11. Device Name and Classification

Proprietary Name: Olea SphereCommon/Usual Name: PACSClassification Name: Picture Archiving Communications SystemRegulation Number: 21 CFR 892.2050Product Codes: LLZClassification: Class I1Classification Panel: Radiology Devices

510(k) -Olea Sphere Page 5-1

111. Predicate Devices

The Olea Sphere device is substantially equivalent to the following FDAcleared predicate device with regard to indications for use, performance andtechnological characteristics:

5 10(k) Number: K090546Trade Name: Nordic Image Control and Evaluation

(nordiclCE) SoftwareManufacturer: NordiclmagingLab ASClassification Name: Picture Archiving Communications SystemCommon/Usual Name: PACSRegulation Number: 21 CFR 892.2050Product Codes: LLZClassification: Class 11

The software architecture of many of the features of the Olca Sphere isessentially identical to that used by the following FDA cleared predicatedevice:

5 10(k) Number: K111161Trade Name: Perfscape V2.OManufacturer: Olea MedicalClassification Name: Picture Archiving Communications SystemCommon/Usual Name: PACSRegulation Number: 21 CFR 892.2050Product Codes: LLZClassification: 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 medicalimages.

5 1 (k) -Olea Sphere Page 5-2

These images, when interpreted by a trained physician, may yield clinicallyuseful information.

The software provides a wide range of basic image processing andmanipulation functions, in addition to comprehensive dynamic imageprocessing 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 tovisualize and analyze images acquired primarily with MRI or CT systems.Lossy compressed mamnmographic images and digitized film Screen imagesmust not be reviewed for primary image interpretations.

V. Intended Use

Olea Sphere is an image processing software package to be used by trainedprofessionals including but not limited to physicians and medical technicians.The software runs on a standard 'off-the-shelfP workstation and can be used toperform image viewing, processing and analysis of medical images. Data andimages are acquired through DICOM compliant imaging devices andmodalities.

Olea Sphere provides both viewing and analysis capabilities of functional anddynamic imaging datasets acquired with MRI or other relevant modalities,including a Diffusion Weighted MRI (DWl) / Fiber Tracking Module and aDynamic Analysis Module (dynamic contrast enhanced imaging data for MRIand CT).

The DWI Module is used to visualize local water diffusion properties from theanalysis of diffusion-weighted MRI data. The Fiber Tracking feature utilizes

510(k) - Olea Sphere Page 5-3

the directional dependency of the diffusion to display the white matterstructure in the brain or more generally the central nervous system.

The Dynamic Analysis Module is used for visualization and analysis ofdynamic imaging data, showing properties of changes in contrast over timewhere such techniques, are useful or necessary. This functionality is referred toas:

Perfusion Module - the calculation of parameters related to tissue flow(perfusion) and tissue blood volume.

Permeability Module - the calculation of parameters related to leakage ofinjected 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 CTperfusion and diffusion images in DICOM format. The system utilizes theinformation contained in each image meta-data to compare images and toperform zoom, pan and crop functions.

Olea Sphere offers a viewing and analysis module that allows to displaysimultaneously available DICOM image datasets and to save the results intothe DICOM database.

Olea Sphere offers four types of display for a particular data set:

I. The multi-slice view displays simultaneously all the images of selectedseries in tabular format where rows represent image series andcolumns represent cross-sectional levels;

2. The mono-slice view displays simultaneously one image of selectedseries 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 ofunfiltered images by using "segmentation masks". This also allows the user tooptimize selected images by customizing the segmentation masks based on

510(k) - Olea Sphere Page 5-4

user defined areas and to save the results of this image optimization into PDFformat files.

The following Predicate Device Comparison Table provides a summary ofthe comparison between the Olea Sphere and the predicate devices listed inSection III, with respect to intended use, environment of use, limitations ofuse, principles of operation and performance characteristics. More detailedinformation regarding the basis for the determination of substantialequivalence can be found at Section 12 of this 5 10(k) submission.

5 10(k) - Olea Sphere Page 5-5

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VII. Summary of Testing

OLEA Medical has conducted extensive validation testing of the Olca Spheresystem, as a PACS that is capable of providing reliable post-processing anddisplay of images for instantaneous multi-parametric analysis. All of thedifferent components of the Olea Sphere software have been stress tested toensure that the system as a whole provides all the capabilities necessary tooperate according to its intended use.

The tests performed included:

* Product Risk Assessment* Software modules verification tests* Software validation test

V11I1. Conclusions

Based on the comparison of intended use and technological characteristics, theOlea Sphere system is substantially equivalent to the Nordic Image Controland Evaluation (nordicICE) Software manufactured by Nord ici magingLab AS(K090546).

Additionally the software architecture of many of thefeatures of the OleaSphere is essentially identical to that one of the Perfscape V2.0 softwaremanufactured by Olea Medical (K I 1116 1).

5 10(k) - Olca Sphere Page 5-14

t D EPARTMENT OFHEALTH &HUMAN SERVICES Public Health Service

Food and Drug Administration10903 New Hampshire AvenueDocument Control Room - W066-G609Silver Spring, MD 20993-0002

OLBA Medical% Ms. Kristi Gusman APR) 192012Project ManagerEmergo Group Inc.611 West 5t1h Street, Third FloorAUSTIN TX 78701

Re: K120196Trade/Device Name: Olca SphereRegulation Number: 21 CFR 892.2050Regulation Name: Picture archiving and communications systemRegulatory Class: 11Product Code: LLZDated: November 30, 2011Received: January 23, 2012

Dear Ms. Gusman:

We have reviewed your Section 5 10(k) premarket notification of intent to market the devicereferenced above and have determined the device is substantially equivalent (for the indicationsfor use stated in the enclosure) to legally marketed predicate devices marketed in interstatecommerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or todevices 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. Thegeneral controls provisions of the Act include requirements for annual registration, listing ofdevices, good manufacturing practice, labeling, and prohibitions against miisbranding andadulteration.

If your device is classified (see above) into class 11 (Special Controls), it may be subject to suchadditional 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 flitherannouncements 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 (21CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of

Page 2

medical device-related adverse events) (21 CFR 803); and good manufacturing practicerequirements as set forth in the quality systems (QS) regulation (21 CFR. Part 820). This letterwill allow you to begin marketing your device as described in your Section 5 10(k) premarketnotification. The FDA finding of substantial equivalence of your device to a legally marketedpredicate device results in a classification for your device and thus, petmits your device toproceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and809), 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 premarketnotification" (21 CFR Part 807.97). For questions regarding the reporting of adverse eventsunder the MDR regulation (21 CFR Part 803), please go tohttp://wA-ww.fda.sgov/MedicalDevices/SafetyReportaProblem/default.htm for the CDRH's Officeof Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from theDivision of Small Manufacturers, International and Consumer Assistance at its toll-free number(800) 638-2041 or (301) 796-7100 or at its Internet addresshttp://www.fda.raov /cdrhlindustry/sup~port/index.html.

c ing DirectorDivision of Radiological DevicesOffice of In Vitro Diagnostic Device

Evaluation and SafetyCenter for Devices and Radiological Health

Enclosure

4. Indication for Use Statement

510(k) Number (if known): _______

Device Name: Olca Sphere

Indications for Use:

Olea Sphere is an image processing software package to be used by trained professionalsincluding but not limited to physicians and medical technicians. The software runs on astandard "off-the-shelfr' workstation and can be used to perform image viewing,processing and analysis of medical images. Data and images are acquired throughDICOM compliant imaging devices and modalities.

Olea Sphere provides both viewing and analysis capabilities of functional and dynamicimaging datasets acquired with MRJ or other relevant modalities, including a DiffusionWeighted MRT (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 ofdiffusion-weighted MRI data. The Fiber Tracking feature utilizes the directionaldependency of the diffusion to display the white matter Structure in the brain or moregenerally the central nervous system..

The Dynamic Analysis Module is used for visualization and analysis of dynamic imagingdata, showing properties of changes in contrast over time where such techniques areuseful or necessary. This functionality is referred to as:

Perfusion Module - the calculation of parameters related to tissue flow (perfusion) andtissue blood volume.

Permeability Module - the calculation of parameters related to leakage of injectedcontrast material from intravascular to extracellular space.

Prescription Use X AND/OR Over-The-Counter Use ____

(Part 21 CFR 801 Subpart 0) (21 CFR 801 Subpat C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHERPAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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o in vitro Die sIic Device Evaluation and Safety

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