(174 days)
Not Found
No
The summary describes standard image processing and analysis techniques commonly used in medical imaging, without mentioning AI or ML.
No
This device is image processing software for viewing, processing, and analyzing medical images. It does not exert any direct therapeutic action on a patient.
Yes
Explanation: The device is image processing software that provides viewing and analysis capabilities for medical images acquired from diagnostic devices (MRI, CT). It calculates parameters related to tissue flow, permeability, relaxation times, and fat fraction, which are used to derive clinically useful information for diagnosis.
Yes
The device is described as a software package that runs on a standard "off-the-shelf" workstation and performs image viewing, processing, and analysis of medical images acquired from DICOM compliant imaging devices. The description focuses solely on the software's functionalities and does not mention any proprietary hardware components included with the device.
Based on the provided information, Olea Sphere V3.0 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of disease.
- Olea Sphere V3.0's Function: Olea Sphere V3.0 is an image processing software package that analyzes medical images acquired from imaging modalities like MRI and CT. It does not interact with or analyze biological specimens. Its function is to process and analyze existing medical images.
Therefore, while it is a medical device used for diagnostic purposes, it falls under the category of medical imaging software rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Olea Sphere V3.0 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, image collage and analysis of medical images are acquired through DICOM compliant imaging devices and modalities.
Olea Sphere V3.0 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 (e.g. dynamic exogenous or endogenous 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 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 while repeating acquisitions (e.g. over time without variable acquisition parameters) 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 contrass material from intravascular to extracellular space.
Arterial Spin Labeling (ASL) Module - the calculation of parameters related to tissue flow based on a MR technique using the water in arterial blood as endogenous tracer to evaluate the perfusion.
Relaxometry Module - the calculation of parameters related to the MR longitudinal and transversal relaxation time and rate.
Metabolic Module - the calculation of parameters related to the fat fraction based on a MR technique using opposedphase imaging.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
Olea Sphere V3.0 is a medical viewing, analysis and processing, Picture Archiving Communications System (PACS) software, compliant with the DICOM standard and running on Windows or Linux operating systems.
Olea Sphere V3.0 allows the display, analysis and post-processing of medical images. 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
- Arterial Spin Labeling (ASL) ●
- · Diffusion-Weighted Imaging (DWI) / Tensor Imaging post-processing (DTI) / Intra-Voxel Incoherent Motion (IVIM)
- · Fiber Tracking post-processing
- · Collage
- · Relaxometry post-processing
- · Metabolic post-processing
Depending on the purpose of the imaging, the following optional plug-in are used by the software:
- DWI (for MR imaging) .
- DTI (for MR imaging) .
- Perfusion (for MR and CT imaging) ●
- Permeability (for MR and CT imaging)
- Kinetics (for MR imaging) .
- ASL (for MR imaging) .
- Analysis (for MR and CT imaging) ●
- Olea Vision (for MR imaging) ●
- IVIM (for MR imaging) ●
- Collage (for MR imaging) .
- Metabolic (for MR imaging) .
- Relaxometry (for MR imaging) .
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI, CT
Anatomical Site
Central nervous system, brain, myocardial (for predicate device)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained professionals including but not limited to physicians and medical technicians. Use in hospitals, imaging centers, radiologist reading practices.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Olea Medical has conducted extensive validation testing of the Olea Sphere V3.0 system, as a PACS that is capable of providing reliable post-processing and display of images for instantaneous multi-parametric analysis. Internal verification and validation testing confirms that the product specifications are met, in support of the substantial equivalence of the intended use and technological characteristic as the predicate devices.
All of the different components of the Olea Sphere V3.0 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 and in a manner substantially equivalent to the predicate devices.
The main groups of tests nerformed include:
- . Product Risk Assessment
- Software modules verification tests
- Software validation test
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K132095, K121434, K130749, K141977
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the smallest and the bottom profile being the largest.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 3, 2016
Olea Medical % Ms. Caroline Lene Ouality and Regulatory Affairs Manager 93 avenue des Sorbiers, Zone Athelia IV La Ciotat, 13600 FRANCE
Re: K152602
Trade/Device Name: Olea Sphere V3.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 11, 2016 Received: February 11, 2016
Dear Ms. Lene:
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 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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,
Robert Oals
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Image /page/2/Picture/4 description: The image shows a sequence of alphanumeric characters. The sequence starts with the letter 'K', followed by the numbers '152602'. The characters are all in a simple, sans-serif font and are evenly spaced.
Device Name Olea Sphere V3.0
Indications for Use (Describe)
Olea Sphere V3.0 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, image collage and analysis of medical images are acquired through DICOM compliant imaging devices and modalities.
Olea Sphere V3.0 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 (e.g. dynamic exogenous or endogenous 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 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 while repeating acquisitions (e.g. over time without variable acquisition parameters) 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 contrass material from intravascular to extracellular space.
Arterial Spin Labeling (ASL) Module - the calculation of parameters related to tissue flow based on a MR technique using the water in arterial blood as endogenous tracer to evaluate the perfusion.
Relaxometry Module - the calculation of parameters related to the MR longitudinal and transversal relaxation time and rate.
Metabolic Module - the calculation of parameters related to the fat fraction based on a MR technique using opposedphase imaging.
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)
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Image /page/4/Picture/0 description: The image contains the logo for Olea Medical. The logo consists of a purple and orange cube with a white figure on each side. To the right of the cube is the text "Olea" in purple and "MEDICAL" in orange.
Section 7 – 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 |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Caroline Léné
Quality and Regulatory Affairs 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: | Olea Medical
93 avenue des Sorbiers, Zone Athelia IV
La Ciotat 13600
France |
| Contact Person: | Caroline Léné
Quality and Regulatory Affairs Manager
Tel: (011) 33 4 42 71 24 20
Fax: (011) 33 4 42 71 24 27
e-mail: caroline.lene@olea-medical.com |
| Date Prepared: | September 9, 2015 |
Device Identification
| Proprietary Name: | Olea Sphere V3.0 |
|---|---|
| ------------------- | ------------------ |
| Proprietary Name: | Olea Sphere V3.0 |
|---|---|
| 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 |
II.
5
Image /page/5/Picture/0 description: The image is a logo for Olea Medical. The logo consists of a purple and orange hexagon with a white silhouette of a person on the orange side and a white cluster of dots on the purple side. To the right of the hexagon is the word "Olea" in purple, with the word "MEDICAL" in orange underneath.
III. Predicate Devices
The Olea Sphere V3.0 device is substantially equivalent to the following FDA cleared predicate device with regard to indications for use, performance and technological characteristics:
1)
| 510(k) Number: | K132095 |
|---|---|
| Trade Name: | Olea Sphere V2.3 |
| Manufacturer: | Olea Medical |
| Classification Name: | Picture Archiving Communications System |
| Common/Usual Name: | PACS |
| Regulation Number: | 21 CFR 892.2050 |
| Product Code: | LLZ |
| Classification: | Class II |
Additionally, the software architecture of some of the new features introduced in the Olea Sphere V3.0 is essentially identical to the architecture used by the following FDA cleared predicate devices:
2)
| 510(k) Number: | K121434 |
|---|---|
| Trade Name: | Software Syngo MR D13A for the Magnetom |
| Systems Aera/Skyra/Avanto/Verio | |
| Manufacturer: | Siemens Medical Solutions, Inc. |
| Classification Name: | System, Nuclear Magnetic Resonance Imaging |
| Common/Usual Name: Magnetic Resonance Diagnostic Device | |
| Regulation Number: | 21 CFR 892.1000 |
| Product Code: | LNH |
| Classification: | Class II |
| 510(k) Number: | K130749 |
|---|---|
| Trade Name: | Syngo.MR General; Syngo.MR Cardiology; |
| Syngo.MR Vascular | |
| Manufacturer: | Siemens Medical Solutions USA, Inc. |
| Classification Name: | Picture Archiving Communications System |
| Common/Usual Name: | PACS |
| Regulation Number: | 21 CFR 892.2050 |
| Product Code: | LLZ |
| Classification: | Class II |
6
Image /page/6/Picture/0 description: The image shows the logo for Olea Medical. The logo consists of a purple and orange cube with a white figure inside. To the right of the cube is the text "Olea" in purple and "medical" in orange.
- 510(k) Number: K141977 Magnetom Aera with Software Syngo MR E11A, Trade Name: Magnetom Skyra with Software Syngo MR E11A, Magnetom Skyra with 24 RF Channel Manufacturer: Siemens Medical Solutions USA, Inc. Classification Name: Class II: Magnetic Resonance Imaging System Common/Usual Name: Magnetic Resonance Diagnostic Device Regulation Number: 21 CFR 892.1000 Product Code: LNH Classification: Class II
IV. Device Description
Olea Sphere V3.0 is a medical viewing, analysis and processing, Picture Archiving Communications System (PACS) software, compliant with the DICOM standard and running on Windows or Linux operating systems.
Olea Sphere V3.0 allows the display, analysis and post-processing of medical images. 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
- Arterial Spin Labeling (ASL) ●
- · Diffusion-Weighted Imaging (DWI) / Tensor Imaging post-processing (DTI) / Intra-Voxel Incoherent Motion (IVIM)
- · Fiber Tracking post-processing
- · Collage
- · Relaxometry post-processing
- · Metabolic post-processing
7
Image /page/7/Picture/0 description: The image is a logo for Olea Medical. The logo consists of a cube with two visible faces. The left face is purple and has a white, abstract image of a person made of circles. The right face is orange and has a white silhouette of a person. To the right of the cube is the text "Olea" in purple and "Medical" in orange.
Depending on the purpose of the imaging, the following optional plug-in are used by the software:
- DWI (for MR imaging) .
- DTI (for MR imaging) .
- Perfusion (for MR and CT imaging) ●
- Permeability (for MR and CT imaging)
- Kinetics (for MR imaging) .
- ASL (for MR imaging) .
- Analysis (for MR and CT imaging) ●
- Olea Vision (for MR imaging) ●
- IVIM (for MR imaging) ●
- Collage (for MR imaging) .
- Metabolic (for MR imaging) .
- Relaxometry (for MR imaging) .
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. Indications for Use Statement
Olea Sphere V3.0 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, image collage and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities.
Olea SphereV3.0 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 (e.g., dynamic exogenous or endogenous 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.
8
Image /page/8/Picture/0 description: The image is a logo for Olea Medical. The logo consists of a purple and orange hexagon with a white figure inside. To the right of the hexagon is the text "Olea" in purple and "Medical" in orange.
The Dynamic Analysis Module is used for visualization and analysis of dynamic imaging data, showing properties of changes in contrast while repeating acquisitions (e.g., over time with or without variable acquisition parameters) 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.
Arterial Spin Labeling (ASL) Module - the calculation of parameters related to tissue flow based on a MR technique using the water in arterial blood as endogenous tracer to evaluate the perfusion.
Relaxometry Module - the calculation of parameters related to the MR longitudinal and transversal relaxation time and rate.
Metabolic Module - the calculation of parameters related to the fat signal fraction based on a MR technique using opposed-phase imaging.
VI. Summary of the Technical Characteristics
Olea Sphere V3.0 is a PACS software designed to access series of MRI and CT images in DICOM format, which can be used to perform image viewing, processing, image collage and analysis of medical images. The system utilizes the information contained in each image meta-data to compare images and to perform zoom, pan and crop functions.
Olea Sphere V3.0 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 V3.0 offers four types of display for a particular data set:
-
- 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;
-
- The mono-slice view displays simultaneously one image of selected series at a given slice location;
9
Image /page/9/Picture/0 description: The image contains the logo for Olea Medical. The logo consists of a purple and orange cube with a white figure on the orange side and a white molecular structure on the purple side. To the right of the cube is the text "Olea" in purple and "Medical" in orange.
-
- The MPR/3D view displays selected series in a 3-dimensional projections; and
-
- The follow-up view displays images of series acquired over time.
The system allows the calculation of surfaces and volumes over a set of images by using "segmentation masks". This also allows the user to optimize selected images by customizing the segmentation masks based on user defined areas and to save the results of this image optimization into PDF format files.
The following Predicate Devices Comparison Table provides a summary of the comparison between the Olea Sphere V3.0 and the predicate devices listed in Section III, with respect to indications for use, environment of use, intended use and limitations of use, principles of operation and performance characteristics.
10
Image /page/10/Picture/0 description: The image is a logo for Olea Medical. The logo consists of a purple and orange hexagon with a stylized human figure inside. The word "Olea" is written in purple, and the word "Medical" is written in orange below it. The hexagon is divided into two sections, with the left side being purple and the right side being orange. The purple side contains a series of white circles, and the orange side contains a white human figure.
Predicate Device Comparison Table
| Device Name | Subject Device:
Olea Sphere V3.0 | Predicate #1:
(K132095)
Olea Sphere (V2.3) | Predicate #2:
(K121434)
Software Syngo
MR D13A for the
Magnetom Systems
Aera/Skyra/Avanto
/Verio | Predicate #3:
(K130749)
Syngo.MR
General;
Syngo.MR
Cardiology;
Syngo.MR
Vascular | Predicate #4:
(K141977)
Magnetom Aera
with Software
Syngo MR E11A,
Magnetom Skyra
with Software
Syngo MR E11A,
Magnetom Skyra
with 24 RF
Channel | Significant
Differences |
|------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | LLZ | LLZ | LNH | LLZ | LNH | The subject device |
| Regulation # | 892.2050 | 892.2050 | 892.1000 | 892.2050 | 892.1000 | and predicates #1
and #3 are classified
as Product Code
LLZ under
regulation 892.1000
whereas predicates
#2 and #4 are
classified as Product
Code LNH, under
regulation 892.1000. |
| Class | II | II | II | II | II | No difference. |
| Indications | Olea Sphere V3.0 is | Olea Sphere is an | The Magnetom | The software | The Magnetom | Olea Sphere V3.0 |
| for Use | an image processing
software package to | image processing
software package to | systems
Aera/Skyra/Avanto/ | comprising the
syngo.MR post- | systems [Magnetom
Aera and Magnetom | and Olea Sphere
V2.3 (predicate #1) |
| | | | | | | |
| be used by trained
professionals | be used by trained
professionals | Verio with software
syngo MR D13A are | processing
applications are | Skyra] are indicated | have essentially an | |
| including but not | including but not | indicated for use as | post-processing | for use as a magnetic | identical Indication | |
| limited to physicians | limited to physicians | magnetic resonance | software/applicati | resonance diagnostic | for Use, with the | |
| and medical | and medical | diagnostic devices | ons to be used for | device (MRDD) that | exception that Olea | |
| technicians. The | technicians. The | (MRDD) that | viewing and | produces transverse, | Sphere V2.3 does | |
| software runs on a | software runs on a | produce transverse, | evaluating the | sagittal, coronal and | not include ASL,
Collage, | |
| standard "off-the- | standard "off-the- | sagittal, coronal and | designated images | oblique cross | Relaxometry and | |
| shelf" workstation | shelf" workstation | oblique cross- | provided by a | sectional images, | Metabolic analysis | |
| and can be used to | and can be used to | sectional images, | magnetic | spectroscopic images | capabilities (see | |
| perform image | perform image | spectroscopic images | resonance | and/or spectra, and | parts in yellow ). | |
| viewing, processing, | viewing, processing | and/or spectra, and | diagnostic device. | that displays the | | |
| image collage and | and analysis of | that display the | All of the | internal structure | With respect to ASL | |
| analysis of medical | medical images. | internal structure | software | and/or function of | analysis, Olea | |
| images. Data and | Data and images are | and/or function of | applications | the head, body, or | Sphere V3.0 and th | |
| images are acquired | acquired through | the head, body, or | comprising the | extremities. | Software Syngo M | |
| through DICOM | DICOM compliant | extremities. Other | syngc.MR post- | Other physical | D13A predicate #2 | |
| compliant imaging | imaging devices and | physical parameters | processing | parameters derived | have substantially | |
| devices and | modalities. | derived from the | applications have | from the images | equivalent | |
| modalities. | | images and/or | their own | and/or spectra may | indications for use. | |
| Olea SphereV3.0 | Olea Sphere | spectra may also be | indications for | also be produced. | | |
| provides both | provides both | produced. | use. | Depending on the | With respect to the | |
| viewing and analysis | viewing and analysis | Depending on the | | region of interest, | Collage feature | |
| capabilities of | capabilities of | region of interest, | Syngo.MR | contrast agents may | Olea Sphere V3.0 | |
| functional and | functional and | contrast agents may | General: is a | be used. These | and the Syngo.MR | |
| dynamic imaging | dynamic imaging | be used. | syngo based post- | images and/or | General predicate # | |
| datasets acquired | datasets acquired | These images and/or | processing | spectra and the | have substantially | |
| with MRI or other | with MRI or other | spectra and the | software for | physical parameters | equivalent | |
| relevant modalities, | relevant modalities, | physical parameters | viewing, | derived from the | indications for use. | |
| including a | including a | derived from the | manipulating, and | images and/or | | |
| | Diffusion Weighted
MRI (DWI) / Fiber
Tracking Module
and a Dynamic
Analysis Module
(e.g. dynamic
exogenous or
endogenous 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 | 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 | images and/or
spectra, when
interpreted by a
trained physician,
yield information
that may assist in
diagnosis.
The Magnetom
systems may also be
used for imaging
during interventional
procedures when
performed with MR
compatible devices
such as in-room
display and MR-safe
biopsy needles. | evaluating MR
images.
Syngo.MR
Cardiology: is a
syngo based post-
processing
software for
viewing,
manipulating, and
evaluating MR
cardiac images.
Syngo.MR
Vascular: is a
syngo based post-
processing
software for
viewing,
manipulating, and
evaluating MR
vascular images. | interpreted by a
trained physician,
yield information
that may assist in
diagnosis.
The Magnetom
systems may also be
used for imaging
during interventional
procedures when
performed with MR
compatible devices
such as in-room
display and MR-Safe
biopsy needles. | With respect to the
Relaxometry and
Metabolic analysis,
Olea Sphere V3.0
and Magnetom Aera
with Software
Syngo MR E11A
predicate #4 have
substantially
equivalent
indications for use. |
11
Image /page/11/Picture/0 description: The image is a logo for Olea Medical. The logo consists of a purple and orange cube with a white figure inside. The word "Olea" is written in purple, and the word "Medical" is written in orange below it.
12
Image /page/12/Picture/0 description: The image is a logo for Olea Medical. The logo consists of a purple and orange cube with a white silhouette of a person on the orange side and a white cluster of circles on the purple side. To the right of the cube is the text "Olea" in purple and "medical" in orange.
13
Image /page/13/Picture/0 description: The image contains the logo for Olea Medical. The logo consists of a purple and orange hexagon with a white figure inside. To the right of the hexagon is the text "Olea" in purple and "medical" in orange.
| visualization and
analysis of dynamic
imaging data,
showing properties
of changes in
contrast while
repeating
acquisitions (e.g.
over time with or
without variable
acquisition
parameters) 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 | 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. | extracellular space. | | | |
| Arterial Spin
Labeling (ASL)
Module - the
calculation of
parameters related to
tissue flow based on
a MR technique
using the water in
arterial blood as
endogenous tracer to
evaluate the
perfusion. | | | | |
| Relaxometry Module
- the calculation of
parameters related to
the MR longitudinal
and transversal
relaxation time and
rate. | | | | |
| Metabolic Module -
the calculation of
parameters related to
the fat signal fraction
based on a MR
technique using
opposed-phase | | | | |
14
Image /page/14/Picture/0 description: The image shows the logo for Olea Medical. The logo consists of a purple and orange hexagon with a white figure inside. To the right of the hexagon is the text "Olea" in purple and "medical" in orange.
15
Image /page/15/Picture/0 description: The image is a logo for Olea Medical. The logo consists of a purple and orange cube with a white figure inside. The text "Olea" is in purple and the text "medical" is in orange.
| imaging. | ||||||
|---|---|---|---|---|---|---|
| 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 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. | Clinical/Hospital | |||||
| Environment | Clinical/Hospital | |||||
| Environment | Clinical/Hospital | |||||
| Environment | No difference. | |||||
| Limitations of | ||||||
| Use/Intended | ||||||
| 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. | Indicated for use as a | |||||
| magnetic resonance | ||||||
| diagnostic device | ||||||
| (MRDD). | Intended for MR | |||||
| volume data sets. | Indicated for use as a | |||||
| magnetic resonance | ||||||
| diagnostic device | ||||||
| (MRDD). | No difference. Olea | |||||
| Sphere V3.0 and | ||||||
| Olea Sphere V2.3 | ||||||
| (predicate #1) have | ||||||
| the same limitations | ||||||
| of use. |
The Olea Sphere
V3.0 ASL, Collage,
Relaxometry and
Metabolic analysis
features have the
same limitation of
use (i.e. magnetic
resonance
imaging) as
predicates #2, #3
and #4 respectively |
| Principles of
Operation | The Olea Sphere | The Olea Sphere | It provides both the | Syngo.MR | Software Syngo MR | Olea Sphere V3.0
and Olea Sphere
V2.3 (predicate #1) |
| | 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
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
(e.g. dynamic | 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
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 | MR technique
acquisition and the
map generation post-
processing software.
Syngo ASL (Arterial
Spin Labeling) is an
MR technique using
the water in arterial
blood as an
endogenous contrast
agent to evaluate
perfusion non-
invasively. Syngo
ASL provides a
robust Pulsed
Arterial Spin
Labeling sequence
which provides in-
line calculation of
CBF maps from the
acquired data. | Syngo.MR
Composing
(optional) is an
offline application
for creation of
full-format
images from
overlapping MR
volume data sets
acquired at
multiple stages. | Software Syngo MR
E11A for the
Magnetom Systems
Aera/Skyra offers
two new
applications,
LiverLab (an
application of non-
invasive liver
evaluation) and
MyoMaps (an
application designed
to provide a means
to generate pixel
maps for myocardial
MR relaxation
times). | have essentially
identical principles
of operation, with
the exception that
Olea Sphere V2.3
does not include the
ASL, Collage,
Relaxometry and
Metabolic analysis
(see parts in
yellow).
With respect to the
ASL analysis, Olea
Sphere V3.0 and
Software Syngo MR
D13A (predicate #2)
have substantially
equivalent principles
of operation, with
the minor exception
that Olea Sphere
V3.0 does not
provide the MR
acquisition
technique, but only |
16
Image /page/16/Picture/0 description: The image is a logo for Olea Medical. The logo consists of a purple and orange hexagon with a white figure inside. The word "Olea" is written in purple, and the word "Medical" is written in orange below it. The logo is simple and modern, and it is likely used to represent a medical company or organization.
17
Image /page/17/Picture/0 description: The image is a logo for Olea Medical. The logo consists of a hexagon split into two colors, purple and orange. The purple side has a graphic of a person made of circles, and the orange side has a graphic of a person. To the right of the hexagon is the text "Olea" in purple and "Medical" in orange.
| exogenous or
endogenous contrast
enhanced imaging
data for MRI and
CT). | enhanced imaging
data for MRI and
CT). | | the map generation
post-processing
software. |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | | With respect to the
Collage feature
Olea Sphere V3.0
and Syngo.MR
General (predicate
#3) have
substantially
equivalent principles
of operation, with
the minor exception
that the Olea Sphere
V3.0 image
composing is not
necessarily offline. |
| Dynamic Analysis:
Dynamic analysis is
used for
visualization and
analysis of dynamic | Dynamic Analysis:
Dynamic analysis is
used for
visualization and
analysis of dynamic | | With respect to the
Relaxometry and
Metabolic analysis,
Olea Sphere V3.0
and Magnetom Aera
with Software
Syngo MR E11A
(predicate #4) have
substantially
equivalent principles
of operation. |
18
Image /page/18/Picture/0 description: The image is a logo for Olea Medical. The logo consists of a hexagon split into two colors, purple and orange. On the purple side, there is a cluster of white dots, and on the orange side, there is a white silhouette of a person. To the right of the hexagon is the text "Olea" in purple and "medical" in orange.
| imaging, showing
properties of
changes in contrast
while repeating
acquisitions (e.g.
over time with or
without variable
acquisition
parameters) 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 | imaging, 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
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.
This functionality
also includes | (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. | | | |
19
Image /page/19/Picture/0 description: The image is a logo for Olea Medical. The logo consists of a hexagon split into two colors, purple and orange. On the purple side, there is a cluster of white dots, and on the orange side, there is a white silhouette of a person. To the right of the hexagon, the word "Olea" is written in purple, and below it, the word "Medical" is written in orange.
20
Image /page/20/Picture/0 description: The image contains the logo for Olea Medical. The logo consists of a purple and orange hexagon with a human figure inside. To the right of the hexagon is the text "Olea" in purple and "medical" in orange.
| dedicated analysis
methods and
visualization tools
for MR technique
using the water in
arterial blood as
endogeneous tracer
to visualize tissue
perfusion and
evaluate blood flow
non-invasively. This
functionality is
referred to as:
Arterial Spin
Labeling (ASL)
Module - the
calculation of
parameters related to
tissue flow based on
a MR technique
using the water in
arterial blood as
endogenous tracer to
evaluate the
perfusion.
This functionality
also includes
| dedicated analysis | |||||
|---|---|---|---|---|---|
| methods and | |||||
| visualization tools | |||||
| for MR technique | |||||
| using intrinsic tissue | |||||
| properties to | |||||
| visualize and | |||||
| evaluate tissue | |||||
| relaxation times and | |||||
| fat signal fraction. | |||||
| This functionality is | |||||
| referred to as: |
Relaxometry Module
– the calculation of
parameters related to
the MR longitudinal
and transversal
relaxation time and
rate.
Metabolic Module –
the calculation of
parameters related to
the fat signal fraction
based on a MR
technique using
opposed-phase
imaging. | | | | | |
21
Image /page/21/Picture/0 description: The image shows the logo for Olea Medical. The logo consists of a purple and orange cube with a white figure on each side. To the right of the cube is the word "Olea" in purple and the word "medical" in orange.
22
Image /page/22/Picture/0 description: The image is a logo for Olea Medical. The logo consists of a purple and orange hexagon with a white figure inside. To the right of the hexagon is the text "Olea" in purple and "medical" in orange.
| Performance
Features | Main software
features: | Main software
features: | Main software
features: | Main software
features: | Main software
features: | Olea Sphere V3.0 performs in a substantially equivalent manner to the Olea Sphere V2.3 (predicate #1), with the exception that Olea Sphere V2.3 does not include the ASL, Collage, Relaxometry and Metabolic features (see parts in yellow).
Additionally, Olea Sphere V3.0 enhances the Diffusion Weighted Imaging with the addition of the Intra-Voxel Incoherent Motion analysis.
Additionally, Olea Sphere V3.0 includes the Kinetics analysis. |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|----------------------------|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Image Loading & Saving Image Viewing Image Manipulation Image Analysis Imaging Processing Perfusion post-processing Permeability post-processing Kinetics post-processing Arterial spin labeling Diffusion-Weighted Imaging / Tensor Imaging post-processing / Intra-Voxel Incoherent Motion Fiber Tracking post-processing | Image Loading & Saving; Image Viewing; Image Manipulation; Image Analysis; Imaging Processing; Perfusion Maps; Permeability Maps; Diffusion Weighted Imaging/Tensor Imaging Maps; Fiber Tracking. | Arterial spin labeling | Collage (composing) | Relaxometry post-processing Metabolic post-processing | |
23
Image /page/23/Picture/0 description: The image contains the logo for Olea Medical. The logo consists of a cube-like shape with two visible faces. The left face is purple and contains a pattern of white circles. The right face is orange and contains a white silhouette of a person. To the right of the cube is the text "Olea" in purple and "MEDICAL" in orange.
| Collage
(composing) Relaxometry
post-processing Metabolic post-
processing | | | which is a subset of
features already
included in the
Permeability
analysis of Olea
Sphere V2.3.
With respect to the
Olea Sphere V3.0
ASL, Collage,
Relaxometry and
Metabolic features,
they perform in a
substantially
equivalent manner
to their respective
predicates (predicate
#2, #3 and #4). |
| ------------------------------------------------------------------------------------- | -- | -- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
24
Image /page/24/Picture/0 description: The image contains the logo for Olea Medical. The logo consists of a purple and orange cube with a white figure on the orange side and white circles on the purple side. To the right of the cube is the text "Olea" in purple and "Medical" in orange.
VII. Summary of Performance Data
Olea Medical has conducted extensive validation testing of the Olea Sphere V3.0 system, as a PACS that is capable of providing reliable post-processing and display of images for instantaneous multi-parametric analysis. Internal verification and validation testing confirms that the product specifications are met, in support of the substantial equivalence of the intended use and technological characteristic as the predicate devices.
All of the different components of the Olea Sphere V3.0 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 and in a manner substantially equivalent to the predicate devices.
The main groups of tests nerformed include:
- . Product Risk Assessment
- Software modules verification tests
- Software validation test
Substantial Equivalence Conclusions VIII.
Based on the comparison of intended use, principles of operation and technological characteristics, the Olea Sphere V3.0 system is substantially equivalent to the Olea Sphere V2.3 software manufactured by Olea Medical (K132095).
Additionally the software architecture of many of the features of the Olea Sphere V3.0 is essentially identical to the architecture used by other predicates: Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/ Verio manufactured by Siemens Medical Solutions, Inc. (K121434), Syngo.MR General; Syngo.MR Cardiology; Syngo.MR Vascular manufactured by Siemens Medical Solutions USA, Inc. (K130749), and Magnetom Aera with Software Syngo MR E11A. Magnetom Skyra with Software Syngo MR E11A, Magnetom Skyra with 24 RF Channel manufactured by Siemens Medical Solutions USA, Inc. (K141977).
The minor technological differences between the Olea Sphere V3.0 and its predicate devices raise no new issues of safety or effectiveness. The performance and validation data demonstrate that the Olea Sphere V3.0 is as safe and effective as the predicate devices.