(171 days)
Not Found
No
The summary describes standard image processing and analysis techniques (DWI, Fiber Tracking, Dynamic Analysis, Perfusion, Permeability) and explicitly states it's a PACS-compliant viewing, analysis, and processing software. There is no mention of AI, ML, or related concepts, nor are there descriptions of training or test sets typically associated with AI/ML development.
No
The device is described as image processing software used for viewing, processing, and analysis of medical images, and does not directly provide therapy.
Yes
The software provides capabilities for image viewing, processing, and analysis of medical images, including specialized modules for Diffusion Weighted MRI and Dynamic Analysis (Perfusion and Permeability). These analyses are used to visualize and quantify properties that can be clinically useful for diagnosis, such as water diffusion, white matter structure, tissue flow, and leakage of contrast material. The text explicitly states that these images, "when interpreted by a trained physician, may yield clinically useful information," which points to its role in informing medical diagnoses.
Yes
The device is described as a "software package" that runs on "standard 'off-the-shelf' workstation" and is used for "image viewing, processing and analysis of medical images." It explicitly states it is a "medical viewing, analysis and processing software package (PACS)" and does not mention any proprietary hardware components.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that Olea Sphere processes and analyzes medical images acquired from imaging devices like MRI and CT. It does not analyze biological samples like blood, urine, or tissue.
- The focus is on image processing and analysis. The software's functions revolve around viewing, processing, and analyzing image data to provide information about anatomical structures and physiological processes (like diffusion, perfusion, and permeability) within the body, as captured by the imaging modalities.
- The output is image-based information for interpretation by trained professionals. The software provides visualizations and calculated parameters derived from the images, which are then interpreted by physicians and medical technicians to aid in diagnosis or treatment planning. This is distinct from an IVD, which typically provides a result based on the analysis of a biological specimen.
In summary, Olea Sphere is a medical image processing and analysis software, not a device that performs tests on biological samples.
N/A
Intended Use / 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-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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI, CT
Anatomical Site
brain or more generally the central nervous system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained professionals including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" workstation.
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)
Non-Clinical Performance Data: 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: 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.
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.
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
510(k) Summary (in accordance with 21 CFR 807.92)
510(k) Number: K132095
Applicant Information l.
Applicant:
Olea Medical 93 avenue des Sorbiers, Zone Athelia IV La Ciotat 13600 France
Contact Person:
Caroline Lene Quality Manager Tel: (011) 33 4 42 71 24 20 Fax: (011) 33 4 42 71 24 27 e-mail: caroline.lene@olea-medical.com
Application Correspondent:
Same as Applicant
Date Prepared:
October 8, 2013
II. Device Name and Classification
Proprietary Name: Olea Sphere v2.3 Common/Usual Name: PACS Classification Name: Picture Archiving Communications System Regulation Number: 21 CFR 892.2050 Product Codes: LLZ Classification: Class II Classification Panel: Radiology Devices
III. Predicate Devices
The Olea Sphere v2.3 device is substantially equivalent to its cleared predicate models have the same fundamental scientific technology and intended use:
| 510(k) Number: | K120196 |
|---|---|
| Proprietary Name: | Olea Sphere |
| Common/Usual Name: | PACS |
| Classification Name: | Picture Archiving Communications System |
| Regulation Number: | 21 CFR 892.2050 |
| Product Codes: | LLZ |
| Classification: | Class II |
| Classification Panel: | Radiology Devices |
510(k) - Olea Sphere v2.3
Page 1
1
IV. Device Description
Olea Sphere is a medical viewing, analysis and processing software package (PACS) compliant with the DICOM standard and running on Windows, Macintosh or Linux operating systems.
Olea Sphere allows the display, analysis and post-processing of medical images.
These images, when interpreted by a trained physician, may vield clinically useful information.
V. Indications for Use
:
Olea Sphere is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" workstation and can be used to perform image viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities.
Olea Sphere provides both viewing and analysis capabilities of functional and dynamic imaging datasets acquired with MRI or other relevant modalities. including a Diffusion Weighted MRI (DWI) / Fiber Tracking Module and a Dynamic Analysis Module (dynamic contrast enhanced imaging data for MRI and CT).
The DWI Module is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data. The Fiber Tracking feature utilizes the directional dependency of the diffusion to display the white matter structure in the brain or more generally the central nervous system.
The Dynamic Analysis Module is used for visualization and analysis of dynamic imaging data, showing properties of changes in contrast over time where such techniques are useful or necessary. This functionality is referred to as:
Perfusion Module - the calculation of parameters related to tissue flow (perfusion) and tissue blood volume.
Permeability Module - the calculation of parameters related to leakage of injected contrast material from intravascular to extracellular space.
VI. Substantial Equivalence Discussion
The following table compares the features of the Olea Sphere v2.3 to its predicate Olea Sphere, since the two devices have the same fundamental scientific technology and intended use.
2
Comparison Table
・・
| Device Name | Olea Sphere - K120196 | Olea Sphere v2.3 - K132095 | Changes |
|---|---|---|---|
| Product Code | LLZ | LLZ | None |
| Regulation # | 892.2050 | 892.2050 | None |
| Class | II | II | None |
| Intended Use | Olea Sphere is an image processing | ||
| software package to be used by | |||
| trained professionals including but | |||
| not limited to physicians and medical | |||
| technicians. The software runs on a | |||
| standard "off-the-shelf" workstation | |||
| and can be used to perform image | |||
| viewing, processing and analysis of | |||
| medical images. Data and images | |||
| are acquired through DICOM | |||
| compliant imaging devices and | |||
| modalities. |
Olea Sphere provides both viewing
and analysis capabilities of
functional and dynamic imaging
datasets acquired with MRI or other
relevant modalities, including a
Diffusion Weighted MRI (DWI) /
Fiber Tracking Module and a
Dynamic Analysis Module (dynamic
contrast enhanced imaging data for
MRI and CT).
The DWI Module is used to visualize
local water diffusion properties from
the analysis of diffusion-weighted
MRI data. The Fiber Tracking feature
utilizes the directional dependency of
the diffusion to display the white | Olea Sphere v2.3 is an image
processing software package to be
used by trained professionals
including but not limited to
physicians and medical technicians.
The software runs on a standard
"off-the-shelf" workstation and can
be used to perform image viewing,
processing and analysis of medical
images. Data and images are
acquired through DICOM compliant
imaging devices and modalities.
Olea Sphere v2.3 provides both
viewing and analysis capabilities of
functional and dynamic imaging
datasets acquired with MRI or other
relevant modalities, including a
Diffusion Weighted MRI (DWI) /
Fiber Tracking Module and a
Dynamic Analysis Module (dynamic
contrast enhanced imaging data for
MRI and CT).
The DWI Module is used to visualize
local water diffusion properties from
the analysis of diffusion-weighted
MRI data. The Fiber Tracking feature
utilizes the directional dependency of
the diffusion to display the white | None |
| Device Name | Olea Sphere - K120196 | Olea Sphere v2.3 - K132095 | Changes |
| | matter structure in the brain or more
generally the central nervous
system. | matter structure in the brain or more
generally the central nervous
system. | |
| | The Dynamic Analysis Module is
used for visualization and analysis of
dynamic imaging data, showing
properties of changes in contrast
over time where such techniques are
useful or necessary. This
functionality is referred to as: | The Dynamic Analysis Module is
used for visualization and analysis of
dynamic imaging data, showing
properties of changes in contrast
over time where such techniques are
useful or necessary. This
functionality is referred to as: | |
| | Perfusion Module - the calculation of
parameters related to tissue flow
(perfusion) and tissue blood volume. | Perfusion Module - the calculation of
parameters related to tissue flow
(perfusion) and tissue blood volume. | |
| | Permeability Module - the
calculation of parameters related to
leakage of injected contrast material
from intravascular to extracellular
space. | Permeability Module - the
calculation of parameters related to
leakage of injected contrast material
from intravascular to extracellular
space. | |
| Environment of
Use | Olea Sphere is for use in hospitals,
imaging centers, radiologist reading
practices by professional who
requires and is granted access to
patient image, demographic and
report information. | Olea Sphere v2.3 is for use in
hospitals, imaging centers,
radiologist reading practices by
professional who requires and is
granted access to patient image,
demographic and report information. | None |
| Limitations of
Use | Lossy compressed mammographic
images and digitized film screen
images must not be reviewed for
primary image interpretations. | Lossy compressed mammographic
images and digitized film screen
images must not be reviewed for
primary image interpretations. | None |
| Device Name | Olea Sphere - K120196 | Olea Sphere v2.3 - K132095 | Changes |
| Principles of
Operation | The Olea Sphere software offers
comprehensive functionality for
dynamic image analysis and
visualization, where signal changes
over time are analyzed to determine
various modality dependent
functional parameters. | The Olea Sphere v2.3 software
offers comprehensive functionality
for dynamic image analysis and
visualization, where signal changes
over time are analyzed to determine
various modality dependent
functional parameters. | None |
| | Olea Sphere provides both viewing
and analysis capabilities of
functional and dynamic imaging
datasets acquired with MRI or other
relevant modalities, including
diffusion weighted MRI (DWI) / fiber
tracking, and dynamic analysis
(dynamic contrast enhanced imaging
data for MRI and CT). | Olea Sphere v2.3 provides both
viewing and analysis capabilities of
functional and dynamic imaging
datasets acquired with MRI or other
relevant modalities, including
diffusion weighted MRI (DWI) / fiber
tracking, and dynamic analysis
(dynamic contrast enhanced imaging
data for MRI and CT). | |
| | DWI / Fiber Tracking Module:
Diffusion analysis is used to
visualize local water diffusion
properties from the analysis of
diffusion-weighted MRI data. Fiber
tracking utilizes the directional
dependency of the diffusion to
display the white matter structure in
the brain or more generally the
central nervous system. | DWI / Fiber Tracking Module:
Diffusion analysis is used to
visualize local water diffusion
properties from the analysis of
diffusion-weighted MRI data. Fiber
tracking utilizes the directional
dependency of the diffusion to
display the white matter structure in
the brain or more generally the
central nervous system. | |
| | Dynamic Analysis: Dynamic analysis
is used for visualization and analysis
of dynamic imaging, showing
properties of changes in contrast
over time where such techniques are
useful or necessary. This | Dynamic Analysis: Dynamic analysis
is used for visualization and analysis
of dynamic imaging, showing
properties of changes in contrast
over time where such techniques are
useful or necessary. This | |
| Device Name | Olea Sphere - K120196 | Olea Sphere v2.3 - K132095 | Changes |
| | functionality includes dedicated
analysis methods and visualization
tools for dynamic contrast enhanced
imaging data (from MRI or CT)
where a bolus injection of a contrast
agent material results in a temporal
change in the signal intensity. This
dynamic change in signal intensity is
used to calculate functional
parameters related to tissue flow
(perfusion) and tissue blood volume
as well as leakage (due to capillary
permeability) of the injected contrast
material from the intravascular to the
extracellular space. This functionality
is referred to as: | functionality includes dedicated
analysis methods and visualization
tools for dynamic contrast enhanced
imaging data (from MRI or CT)
where a bolus injection of a contrast
agent material results in a temporal
change in the signal intensity. This
dynamic change in signal intensity is
used to calculate functional
parameters related to tissue flow
(perfusion) and tissue blood volume
as well as leakage (due to capillary
permeability) of the injected contrast
material from the intravascular to the
extracellular space. This functionality
is referred to as: | |
| | Perfusion Module: Calculation of
parameters related to tissue flow
(perfusion) and tissue blood volume.
Permeability Module: Calculation of
parameters related to leakage of
injected contrast material from
intravascular to extracellular space. | Perfusion Module: Calculation of
parameters related to tissue flow
(perfusion) and tissue blood volume.
Permeability Module: Calculation of
parameters related to leakage of
injected contrast material from
intravascular to extracellular space. | |
| Device Name | Olea Sphere - K120196 | Olea Sphere v2.3 - K132096 | Changes |
| Performance
Characteristics:
Image Analysis | Qualitative or quantitative analysis of
certain features in an image or an
image set:
• Volume of interest (VOI) analysis; | Qualitative or quantitative analysis of
certain features in an image or an
image set:
• Volume of interest (VOI) analysis; | Enhanced Volume of Interest
segmentation with a more
automatic volume segmentation
method equivalent to the region
growing. |
| | Segmentation of volumes of interest
based on:
- A region growing method
- Manual delineation | Segmentation of volumes of interest
based on: - A region growing method
- Manual delineation
- Region-based volume
segmentation
• Histogram normalization
• Image subtraction | The segmentation is always
supervised by the user that can
always adjust the segmentation
with the existing manual
delineation tools.
Enhanced visualization and
comparison of images with
histogram normalization and
image subtraction. |
| Performance
Characteristics:
Perfusion | • State of the art deconvolution
algorithm:
o sSVD (standard);
o cSVD (block circulant);
o oSVD (adaptative). | • State of the art deconvolution
algorithm:
o sSVD (standard);
o cSVD (block circulant);
o oSVD (adaptative);
o probabilistic, bayesian
method. | The fundamental scientific
technology is the same (being
based on the same perfusion
model and deconvolution
process). The Bayesian
probability is a standard
methodology that is known to
outperform the SVD in terms of
accuracy. |
| | (Deconvolution)
The deconvolution process is
implemented by the Singular Value
Decomposition (SVD). Perfusion
maps and the singular value
decomposition are defined in
References [1, 2]. | (Deconvolution)
The deconvolution process is
implemented either by the Singular
Value Decomposition (SVD) or
probabilistically by a Bayesian
algorithm.
Perfusion maps and the singular
value decomposition and the
probabilistic Bayesian method are
defined in References [1, 2, 3]. | |
| Device Name - | Olea Sphere - K120196 | Olea Sphere v2.3 - K132095 | Changes |
| Performance
Characteristics: | State of the art kinetic modeling with vascular deconvolution algorithm. Generation of permeability maps using signal conversion based on relative signal enhancement: Area under the curve (AUC); Peak enhancement (PEAK); initial up-slope of the curve (Washin); Down-slope of the curve (Washout); Time To Peak enhancement(TTP); Rate constant for transfer of contrast agent from plasma to extravascular, extracellular space (EES) (Ktrans) Rate constant for transfer of contrast agent from EES to plasma (Kep) Fractional volume of EES (Ve) Plasma volume (Vp) | State of the art kinetic modeling with vascular deconvolution algorithm. Generation of permeability maps using signal conversion based on relative signal enhancement or T1 mapping: Area under the curve (AUC); Peak enhancement (PEAK); initial up-slope of the curve (Washin); Down-slope of the curve (Washout); Time To Peak enhancement (TTP); Peak percentage enhancement (PEAK_ENHANCEMENT); Relative washout (CURVE_WASHOUT); Signal Enhancement Ratio (SER); Rate constant for transfer of contrast agent from plasma to extravascular, extracellular space (EES) (Ktrans) Rate constant for transfer of contrast agent from EES to plasma (Kep) Fractional volume of EES (Ve) Plasma volume (Vp) Pre-contrast T1 (T10) | The fundamental scientific technology is the same (being based on the same kinetic modeling and compartmental models). |
| Permeability | | | The T1-mapping allows loading additional image series (MRI sequences) that are more and more commonly acquired in clinical settings. These additional image series make it possible to convert the transient signal response into concentration values following rapid administration of a contrast agent. |
| | | | The kinetic curve type assessment allows permeability parameter estimation in case of acquisitions with a lower temporal resolution. |
| Device Name : | 'Olea Sphere'- K120196 | 'Olea Sphere v2.3 - K132096 | Changes |
| | Permeability Output Maps: | Permeability Output Maps: | |
| | 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 map
from additional MR sequences | |
| Performance
Characteristics:
Diffusion
Weighted
Imaging /
Tensor Imaging | Diffusion Algorithms: | Diffusion Algorithms:
(Motion Correction) | Availability of the existing motion
correction algorithm (perfusion
and permeability modules) in the
DWI and DTI module. |
| Performance
Characteristics:
Software
configuration
and module
execution | Software configuration:
● Factory pre-defined settings
(editable through properties
files) | Software configuration:
● Factory pre-defined settings
(editable through user
interface)
● User-defined settings
● Workflow-driven use | Enhanced configuration of the
software.
A workflow is made of a list of
modules that are executed
successively in a sort of wizard
mode with user-defined settings. |
.
3
4
510(k) - Olea Sphare v2.3
.
・
:
Page 5
5
6
7
・
.
8
9
References
・
| # | Document Identifier | Document Title |
|---|---|---|
| [1] | Magnetic Resonance in | |
| Medicine 36:715-725 (1996) | High resolution measurement of cerebral blood flow | |
| using intravascular tracer bolus passages. Part I: | ||
| Mathematical approach and statistical analysis. Leif | ||
| Østergaard, Robert M. Weisskoff, David A. Chesler, | ||
| Carsten Gyldensted, Bruce R. Rosen | ||
| [2] | Magnetic Resonance in | |
| Medicine 50:164-174 (2003) | Tracer arrival timing-insensitive technique for | |
| estimating flow in MR perfusion-weighted imaging | ||
| using 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 Imaging | |
| 2012 Jul; 31(7):1381-95 | Bayesian hemodynamic parameter estimation by | |
| bolus tracking perfusion weighted imaging. T. | ||
| Boutelier, K. Kudo, F. Pautot, and M. Sasaki |
1
10
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.
11
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
12
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
13
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 |
|---|---|
| ------------------------------------------------------------------------------ | ------------------- |
14
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."