(171 days)
Olea Sphere is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" workstation and can be used to perform image viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities.
Olea Sphere provides both viewing and analysis capabilities of functional and dynamic imaging datasets acquired with MRI or other relevant modalities. including a Diffusion Weighted MRI (DWI) / Fiber Tracking Module and a Dynamic Analysis Module (dynamic contrast enhanced imaging data for MRI and CT).
The DWI Module is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data. The Fiber Tracking feature utilizes the directional dependency of the diffusion to display the white matter structure in the brain or more generally the central nervous system.
The Dynamic Analysis Module is used for visualization and analysis of dynamic imaging data, showing properties of changes in contrast over time where such techniques are useful or necessary. This functionality is referred to as:
Perfusion Module - the calculation of parameters related to tissue flow (perfusion) and tissue blood volume.
Permeability Module - the calculation of parameters related to leakage of injected contrast material from intravascular to extracellular space.
Olea Sphere is a medical viewing, analysis and processing software package (PACS) compliant with the DICOM standard and running on Windows, Macintosh or Linux operating systems.
Olea Sphere allows the display, analysis and post-processing of medical images.
These images, when interpreted by a trained physician, may vield clinically useful information.
The provided text describes a submission for 510(k) clearance for the Olea Sphere v2.3, a Picture Archiving Communications System (PACS) with advanced imaging analysis capabilities. However, it explicitly states that no clinical testing was conducted in support of this version. Instead, the substantial equivalence to its predicate device (Olea Sphere) is based on non-clinical performance data and the proven safety and efficacy of similar devices already on the market.
Therefore, many of the requested details about acceptance criteria, study design, ground truth, experts, and sample sizes for clinical validation are not applicable to this submission as no such studies were performed for the Olea Sphere v2.3 itself.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
Since no clinical studies were performed for Olea Sphere v2.3 to establish new clinical acceptance criteria, the "performance" described is largely a comparison to its predicate device and adherence to general PACS standards. The submission highlights technological updates rather than new clinical outcome performance metrics.
| Feature / Criterion | Reported Device Performance (Olea Sphere v2.3 vs. Predicate) |
|---|---|
| Image Analysis: Volume of Interest (VOI) Segmentation | Enhanced automatic volume segmentation: The new version includes a "Region-based volume segmentation" method equivalent to region growing. However, the segmentation remains "always supervised by the user" who "can always adjust the segmentation with the existing manual delineation tools." |
| Image Analysis: Visualization & Comparison | Enhanced visualization and comparison: New features include "Histogram normalization" and "Image subtraction." |
| Perfusion Deconvolution Algorithm | New probabilistic, Bayesian method added: The fundamental scientific technology remains the same (perfusion model and deconvolution process). Bayesian probability is cited as a standard methodology known to outperform SVD in terms of accuracy. References [1, 2, 3] are provided for the SVD and Bayesian methods. |
| Permeability Modeling | T1-mapping for signal conversion & new output parameters: The fundamental scientific technology (kinetic modeling and compartmental models) is the same. The addition of T1-mapping allows loading additional MR sequences for converting transient signal response into concentration values, which are "more and more commonly acquired in clinical settings." New output maps include PEAK_ENHANCEMENT, CURVE_WASHOUT, SER, and T10. This also enables permeability parameter estimation "in case of acquisitions with a lower temporal resolution." |
| Diffusion Weighted Imaging/Tensor Imaging | Motion Correction: The existing motion correction algorithm (from perfusion and permeability modules) is now available in the DWI and DTI module. 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| Software Configuration and Module Execution | Enhanced configuration and workflow: The software now allows user-defined settings and workflow-driven use, where a workflow is a sequence of modules executed in a wizard mode. Factory pre-defined settings are now editable through the user interface, not just property files. |
| General Acceptance (Implicit for PACs Device) | Complies with applicable voluntary standards related to PACS systems. Passed all testing in accordance with national and international standards. Provides reliable post-processing and display of images for instantaneous multi-parametric analysis. Provides all capabilities necessary to operate safely and effectively through stress testing of all components. 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|
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable (N/A). No clinical testing was conducted for Olea Sphere v2.3. The submission focuses on non-clinical verification and validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- N/A. No clinical testing was conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. No clinical testing was conducted.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- N/A. No clinical testing was conducted. The device is a PACS with analysis tools, not specifically an AI-assisted diagnostic tool in the sense of an MRMC study with human readers improving with AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- While the document mentions "stress testing" and "verification and validation testing" of software components (non-clinical performance data), it does not detail any standalone performance studies in a clinical context. The device is explicitly stated to be "used by trained professionals" for image viewing, processing, and analysis, implying a human-in-the-loop use case.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A. For the non-clinical testing, the "ground truth" would likely refer to expected computational outputs or adherence to DICOM standards, rather than clinical ground truth derived from expert consensus or pathology. The document does not specify the ground truth methods for its non-clinical verification.
8. The sample size for the training set:
- N/A. No clinical testing or machine learning model training (in the modern AI sense requiring large labeled datasets) is described in the context of this 510(k) submission. The new features (like Bayesian deconvolution) are described as standard methodologies rather than novel machine learning models requiring extensive training data specific to this device.
9. How the ground truth for the training set was established:
- N/A. As no dedicated training set for a clinical machine learning model is mentioned, this is not applicable.
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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: (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
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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 processingsoftware package to be used bytrained professionals including butnot limited to physicians and medicaltechnicians. The software runs on astandard "off-the-shelf" workstationand can be used to perform imageviewing, processing and analysis ofmedical images. Data and imagesare acquired through DICOMcompliant imaging devices andmodalities.Olea Sphere provides both viewingand analysis capabilities offunctional and dynamic imagingdatasets acquired with MRI or otherrelevant modalities, including aDiffusion Weighted MRI (DWI) /Fiber Tracking Module and aDynamic Analysis Module (dynamiccontrast enhanced imaging data forMRI and CT).The DWI Module is used to visualizelocal water diffusion properties fromthe analysis of diffusion-weightedMRI data. The Fiber Tracking featureutilizes the directional dependency ofthe diffusion to display the white | Olea Sphere v2.3 is an imageprocessing software package to beused by trained professionalsincluding but not limited tophysicians and medical technicians.The software runs on a standard"off-the-shelf" workstation and canbe used to perform image viewing,processing and analysis of medicalimages. Data and images areacquired through DICOM compliantimaging devices and modalities.Olea Sphere v2.3 provides bothviewing and analysis capabilities offunctional and dynamic imagingdatasets acquired with MRI or otherrelevant modalities, including aDiffusion Weighted MRI (DWI) /Fiber Tracking Module and aDynamic Analysis Module (dynamiccontrast enhanced imaging data forMRI and CT).The DWI Module is used to visualizelocal water diffusion properties fromthe analysis of diffusion-weightedMRI data. The Fiber Tracking featureutilizes the directional dependency ofthe diffusion to display the white | None |
| Device Name | Olea Sphere - K120196 | Olea Sphere v2.3 - K132095 | Changes |
| matter structure in the brain or moregenerally the central nervoussystem. | matter structure in the brain or moregenerally the central nervoussystem. | ||
| The Dynamic Analysis Module isused for visualization and analysis ofdynamic imaging data, showingproperties of changes in contrastover time where such techniques areuseful or necessary. Thisfunctionality is referred to as: | The Dynamic Analysis Module isused for visualization and analysis ofdynamic imaging data, showingproperties of changes in contrastover time where such techniques areuseful or necessary. Thisfunctionality is referred to as: | ||
| Perfusion Module - the calculation ofparameters related to tissue flow(perfusion) and tissue blood volume. | Perfusion Module - the calculation ofparameters related to tissue flow(perfusion) and tissue blood volume. | ||
| Permeability Module - thecalculation of parameters related toleakage of injected contrast materialfrom intravascular to extracellularspace. | Permeability Module - thecalculation of parameters related toleakage of injected contrast materialfrom intravascular to extracellularspace. | ||
| Environment ofUse | Olea Sphere is for use in hospitals,imaging centers, radiologist readingpractices by professional whorequires and is granted access topatient image, demographic andreport information. | Olea Sphere v2.3 is for use inhospitals, imaging centers,radiologist reading practices byprofessional who requires and isgranted access to patient image,demographic and report information. | None |
| Limitations ofUse | Lossy compressed mammographicimages and digitized film screenimages must not be reviewed forprimary image interpretations. | Lossy compressed mammographicimages and digitized film screenimages must not be reviewed forprimary image interpretations. | None |
| Device Name | Olea Sphere - K120196 | Olea Sphere v2.3 - K132095 | Changes |
| Principles ofOperation | The Olea Sphere software offerscomprehensive functionality fordynamic image analysis andvisualization, where signal changesover time are analyzed to determinevarious modality dependentfunctional parameters. | The Olea Sphere v2.3 softwareoffers comprehensive functionalityfor dynamic image analysis andvisualization, where signal changesover time are analyzed to determinevarious modality dependentfunctional parameters. | None |
| Olea Sphere provides both viewingand analysis capabilities offunctional and dynamic imagingdatasets acquired with MRI or otherrelevant modalities, includingdiffusion weighted MRI (DWI) / fibertracking, and dynamic analysis(dynamic contrast enhanced imagingdata for MRI and CT). | Olea Sphere v2.3 provides bothviewing and analysis capabilities offunctional and dynamic imagingdatasets acquired with MRI or otherrelevant modalities, includingdiffusion weighted MRI (DWI) / fibertracking, and dynamic analysis(dynamic contrast enhanced imagingdata for MRI and CT). | ||
| DWI / Fiber Tracking Module:Diffusion analysis is used tovisualize local water diffusionproperties from the analysis ofdiffusion-weighted MRI data. Fibertracking utilizes the directionaldependency of the diffusion todisplay the white matter structure inthe brain or more generally thecentral nervous system. | DWI / Fiber Tracking Module:Diffusion analysis is used tovisualize local water diffusionproperties from the analysis ofdiffusion-weighted MRI data. Fibertracking utilizes the directionaldependency of the diffusion todisplay the white matter structure inthe brain or more generally thecentral nervous system. | ||
| Dynamic Analysis: Dynamic analysisis used for visualization and analysisof dynamic imaging, showingproperties of changes in contrastover time where such techniques areuseful or necessary. This | Dynamic Analysis: Dynamic analysisis used for visualization and analysisof dynamic imaging, showingproperties of changes in contrastover time where such techniques areuseful or necessary. This | ||
| Device Name | Olea Sphere - K120196 | Olea Sphere v2.3 - K132095 | Changes |
| functionality includes dedicatedanalysis methods and visualizationtools for dynamic contrast enhancedimaging data (from MRI or CT)where a bolus injection of a contrastagent material results in a temporalchange in the signal intensity. Thisdynamic change in signal intensity isused to calculate functionalparameters related to tissue flow(perfusion) and tissue blood volumeas well as leakage (due to capillarypermeability) of the injected contrastmaterial from the intravascular to theextracellular space. This functionalityis referred to as: | functionality includes dedicatedanalysis methods and visualizationtools for dynamic contrast enhancedimaging data (from MRI or CT)where a bolus injection of a contrastagent material results in a temporalchange in the signal intensity. Thisdynamic change in signal intensity isused to calculate functionalparameters related to tissue flow(perfusion) and tissue blood volumeas well as leakage (due to capillarypermeability) of the injected contrastmaterial from the intravascular to theextracellular space. This functionalityis referred to as: | ||
| Perfusion Module: Calculation ofparameters related to tissue flow(perfusion) and tissue blood volume.Permeability Module: Calculation ofparameters related to leakage ofinjected contrast material fromintravascular to extracellular space. | Perfusion Module: Calculation ofparameters related to tissue flow(perfusion) and tissue blood volume.Permeability Module: Calculation ofparameters related to leakage ofinjected contrast material fromintravascular to extracellular space. | ||
| Device Name | Olea Sphere - K120196 | Olea Sphere v2.3 - K132096 | Changes |
| PerformanceCharacteristics:Image Analysis | Qualitative or quantitative analysis ofcertain features in an image or animage set:• Volume of interest (VOI) analysis; | Qualitative or quantitative analysis ofcertain features in an image or animage set:• Volume of interest (VOI) analysis; | Enhanced Volume of Interestsegmentation with a moreautomatic volume segmentationmethod equivalent to the regiongrowing. |
| Segmentation of volumes of interestbased on:- A region growing method- Manual delineation | Segmentation of volumes of interestbased on:- A region growing method- Manual delineation- Region-based volumesegmentation• Histogram normalization• Image subtraction | The segmentation is alwayssupervised by the user that canalways adjust the segmentationwith the existing manualdelineation tools.Enhanced visualization andcomparison of images withhistogram normalization andimage subtraction. | |
| PerformanceCharacteristics:Perfusion | • State of the art deconvolutionalgorithm:o sSVD (standard);o cSVD (block circulant);o oSVD (adaptative). | • State of the art deconvolutionalgorithm:o sSVD (standard);o cSVD (block circulant);o oSVD (adaptative);o probabilistic, bayesianmethod. | The fundamental scientifictechnology is the same (beingbased on the same perfusionmodel and deconvolutionprocess). The Bayesianprobability is a standardmethodology that is known tooutperform the SVD in terms ofaccuracy. |
| (Deconvolution)The deconvolution process isimplemented by the Singular ValueDecomposition (SVD). Perfusionmaps and the singular valuedecomposition are defined inReferences [1, 2]. | (Deconvolution)The deconvolution process isimplemented either by the SingularValue Decomposition (SVD) orprobabilistically by a Bayesianalgorithm.Perfusion maps and the singularvalue decomposition and theprobabilistic Bayesian method aredefined in References [1, 2, 3]. | ||
| Device Name - | Olea Sphere - K120196 | Olea Sphere v2.3 - K132095 | Changes |
| PerformanceCharacteristics: | 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: | ||
| AUC, TTP, Washin, Washout, Peak,Ktrans, Kep, Ve, Vp. | AUC, TTP, Washin, Washout, Peak,PEAK_ENHANCEMENT,CURVE_WASHOUT, SER, Ktrans,Kep, Ve, Vp. T10.Permeability Algorithms: | ||
| (T1 mapping)Estimation of pre-contrast T1 mapfrom additional MR sequences | |||
| PerformanceCharacteristics:DiffusionWeightedImaging /Tensor Imaging | Diffusion Algorithms: | Diffusion Algorithms:(Motion Correction) | Availability of the existing motioncorrection algorithm (perfusionand permeability modules) in theDWI and DTI module. |
| PerformanceCharacteristics:Softwareconfigurationand moduleexecution | Software configuration:● Factory pre-defined settings(editable through propertiesfiles) | Software configuration:● Factory pre-defined settings(editable through userinterface)● User-defined settings● Workflow-driven use | Enhanced configuration of thesoftware.A workflow is made of a list ofmodules that are executedsuccessively in a sort of wizardmode with user-defined settings. |
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510(k) - Olea Sphare v2.3
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References
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| # | Document Identifier | Document Title |
|---|---|---|
| [1] | Magnetic Resonance inMedicine 36:715-725 (1996) | High resolution measurement of cerebral blood flowusing intravascular tracer bolus passages. Part I:Mathematical approach and statistical analysis. LeifØstergaard, Robert M. Weisskoff, David A. Chesler,Carsten Gyldensted, Bruce R. Rosen |
| [2] | Magnetic Resonance inMedicine 50:164-174 (2003) | Tracer arrival timing-insensitive technique forestimating flow in MR perfusion-weighted imagingusing singular value decomposition with a block-circulant deconvolution matrix. Wu O, Østergaard L,Weisskoff RM, Benner T, Rosen BR, Sorensen AG. |
| [3] | IEEE Trans Med Imaging2012 Jul; 31(7):1381-95 | Bayesian hemodynamic parameter estimation bybolus tracking perfusion weighted imaging. T.Boutelier, K. Kudo, F. Pautot, and M. Sasaki |
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Non-Clinical Performance Data VII.
Olea Medical has conducted extensive verification and validation testing of the Olea Sphere v2.3, as a PACS that is capable of providing reliable postprocessing 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 safely and effectively.
The Olea Sphere v2.3 complies with the applicable voluntary standards related to PACS systems. The device passed all the testing in accordance with national and international standards.
Clinical Performance Data VIII.
No clinical testing was conducted in support of the Olea Sphere v2.3, as the indications for use are equivalent to those of its predicate model, the Olea Sphere. These types of devices have been on the market for many years with proven safety and efficacy of use. The non-clinical testing detailed in this submission supports the substantial equivalence of this device.
Statement of Substantial Equivalence IX.
Based on identical intended use and technological characteristics, the Olea Sphere v2.3 is substantially equivalent to its predicate model, the Olea Sphere.
The Olea Sphere v2.3, as designed and manufactured, does not raise new questions regarding its safety and effectiveness as compared to the predicate model and is determined to be substantially equivalent to the predicate model, the Olea Sphere.
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Image /page/11/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 8, 2014
Olea Medical % Ms. Caroline Lene Quality Manager 93 avenue des Sorbiers, Zone Athelia IV La Ciotat 13600 FRANCE
Re: K132095
Trade/Device Name: Olea Sphere v2.3 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 8, 2013 Received: October 15, 2013
Dear Ms. Lene:
This letter corrects our substantially equivalent letter of December 26, 2013.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2-Ms. Caroline Lene
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also. please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dcfault.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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D. O'Hara
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K132095
Device Name Olea Sphere v2.3
Indications for Use (Describe)
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-shell" workstation and can be used to perform image viewing, processing and analysis of medical 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 MRL or other relevant modalties, 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 contrast material from intravascular to extracellular space.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | Michael D. O'Hara |
|---|---|
| ------------------------------------------------------------------------------ | ------------------- |
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§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).