(195 days)
Not Found
No
The device description explicitly states, "Olea S.I.A. Neurovascular V1.0 does not contain any calculation feature or any algorithm (deterministic or Al)."
No
The device explicitly states, "The device ... is not intended to be used as a diagnostic device and shall not be used to take decisions with diagnosis or therapeutic purposes." Its function is limited to displaying and allowing modification of parameters for reprocessing, not direct therapeutic action.
No
The "Intended Use / Indications for Use" section explicitly states: "The device... is not intended to be used as a diagnostic device and shall not be used to take decisions with diagnosis or therapeutic purposes."
Yes
The device description explicitly states that Olea S.I.A. Neurovascular V1.0 is an "interface embedded on Olea S.I.A. V1.0 platform" and "communicates with API that exists on Olea S.I.A. V1.0 platform only." It is launched via a web browser, indicating it is a software application that relies on an underlying platform but is itself software. The description focuses solely on its software functionalities (displaying outputs, modifying parameters) and does not mention any associated hardware components that are part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that Olea S.I.A. Neurovascular V1.0 is a user interface for displaying and interacting with outputs from applications that process MR and CT images. It does not perform any tests on biological samples.
- Intended Use: The intended use is to display and allow modification of parameters for image processing applications, assisting clinicians in medical imaging assessment. It explicitly states it is not intended to be used as a diagnostic device and shall not be used to take decisions with diagnosis or therapeutic purposes.
- Device Description: The device description focuses on its role as an interface for visualizing and interacting with image processing results. It does not mention any components or processes related to analyzing biological samples.
Therefore, Olea S.I.A. Neurovascular V1.0 falls under the category of medical image processing and management systems, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Olea S.I.A. Neurovascular V1.0 is an optional user interface for use on the Olea Medical technical integration platform Olea S.I.A. V1.0 and is designed to be used by trained radiologists and surgeons.
Olea S.I.A. Neurovascular V1.0 is intended to:
- display MR and CT series and outputs provided by compatible docker applications processing, through the technical integration platform,
- . allow the user to edit and modify parameters that are optional inputs of aforementioned applications. These modified parameters are provided through the technical integration platform as inputs to the docker application to reprocess outputs. When available, Olea S.I.A. Neurovascular V1.0 display can be updated with the reprocessed outputs.
The device does not alter the original image information and is not intended to be used as a diagnostic device and shall not be used to take decisions with diagnosis or therapeutic purposes. The information displayed is intended to be used in conjunction with other patient information and based on professional judgment, to assist the clinician in the medical imaging assessment.
Trained radiologists and surgeons are responsible for viewing the full set of native images per the standard of care.
Product codes
LLZ
Device Description
Olea S.I.A. Neurovascular V1.0 is a visualization of docker applications results. It is an interface embedded on Olea S.I.A. V1.0 platform and uses the components of Olea S.I.A. V1.0 platform to display the outputs of docker applications to which it is entirely dedicated.
Olea S.I.A. Neurovascular V1.0 allows the user to visualize native DICOM series and docker applications outputs and to modify parameters that are optional inputs of these applications.
To be used, Olea S.I.A. Neurovascular V1.0 needs:
- o a technical base, which is provided by Olea S.I.A. V1.0 platform; and
- 0 one or more applications installed on the Olea S.I.A. V1.0 platform that provide outputs that can be managed by Olea S.I.A. Neurovascular V1.0.
The technical platform:
- receives outputs from docker applications; ●
- o makes these outputs available to related DICOM viewers. If the docker applications are compatible with Olea S.I.A. Neurovascular V1.0, they are proposed as the default software to visualize the outputs;
- 0 retrieves the modified parameters in Olea S.I.A. Neurovascular V1.0 to be able to relaunch the concerned docker applications with these new input parameters.
Olea S.I.A. Neurovascular V1.0 does not contain any calculation feature or any algorithm (deterministic or Al).
Olea S.I.A. Neurovascular V1.0 is an interface embedded on Olea S.I.A. V1.0 platform. Olea S.I.A. Neurovascular V1.0 communicates with API that exists on Olea S.I.A. V1.0 platform only. Olea S.I.A. Neurovascular V1.0 is launched via a link to a web browser and a secure connection.
Olea S.I.A. Neurovascular V1.0 receives data coming from docker applications. These data can either be maps, VOIs, or metrics. Olea S.I.A. Neurovascular V1.0 is able to display these results on a dedicated user interface designed in accordance with the clinical need that provides tools to visualize and manipulate images. There is no Olea S.I.A. Neurovascular V1.0 functionality on top of the applications cleared functionalities: the subject device only serves for display of cleared outputs and/or information.
Olea S.I.A. Neurovascular V1.0 also gives the possibility to edit and modify parameters that are optional inputs of aforementioned applications. These modified parameters are provided through the technical integration platform as inputs to the docker application to reprocess outputs. When available, Olea S.I.A. Neurovascular V1.0 display is updated with the reprocessed outputs.
Mentions image processing
Olea S.I.A. Neurovascular V1.0 is intended to:
- . display MR and CT series and outputs provided by compatible docker applications processing, through the gration platform.
Mentions AI, DNN, or ML
Olea S.I.A. Neurovascular V1.0 does not contain any calculation feature or any algorithm (deterministic or Al).
Input Imaging Modality
MR and CT
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained radiologists and surgeons.
Hospitals, imaging centers and 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 validation testing of the Olea S.I.A. Neurovascular V1.0. Internal verification and validation testing confirms that the product specifications are met, and support of the substantial equivalence of the intended use and technological characteristics to the predicate device.
Olea S.I.A. Neurovascular V1.0 has been validated 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 device.
The following performance evaluations were conducted:
- Product risk assessment; ●
- Software modules verification tests;
- . Software validation test.
Based on the performance testing, the Olea S.I.A. Neurovascular V1.0 has a safety and effectiveness profile that is similar to the predicate device.
Olea S.I.A. Neurovascular V1.0 provides no output. Therefore, the comparison to predicate was based on the comparison of features available within both devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Olea Sphere V3.0 (K152602)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
Olea Medical % John Smith, M.D., J.D. Partner Hogan Lovells US LLP Columbia Square 555 Thirteenth Street, NW WASHINGTON DC 20004
June 6, 2023
Re: K223532
Trade/Device Name: Olea S.I.A. Neurovascular V1.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: May 9, 2023 Received: May 9, 2023
Dear John Smith, M.D., J.D.:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Jessica Lamb
Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
| 510(k) Number (if known) | K223532 |
|---|---|
| -------------------------- | --------- |
Device Name
Olea S.I.A. Neurovascular V1.0
Olea S.I.A. Neurovascular V1.0 is an optional user interface for use on the Olea Medical integration platform Olea S.I.A. V1.0 and is designed to be used by trained radiologists and surgeons.
Olea S.I.A. Neurovascular V1.0 is intended to:
- . display MR and CT series and outputs provided by compatible docker applications processing, through the gration platform.
- . allow the user to edit and modify parameters that are optional inputs of aforementioned applications. These modified parameters are provided through the technical integration platform as inputs to reprocess outputs. When available. Olea S.I.A. Neurovascular V1.0 display can be updated with the reprocessed outputs.
The device does not alter the original image information and is not intended to be used as a diagnostic device and shall not be used to take decisions with diagnosis or therapeutic purposes. The intended to be used in conjunction with other patient information and based on professional judgment, to assist the clinician in the medical imaging assessment.
Trained radiologists and surgeons are responsible for viewing the full set of native images per the standard of care.
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY
Olea Medical's Olea S.I.A. Neurovascular V1.0
Submitter
Olea Medical 93 avenue des Sorbiers, ZI ATHELIA IV 13600, La Ciotat France
Phone: +33 4 42 71 24 20 Facsimile: +33 4 42 71 24 27 Contact Person: Nathalie Palumbo
Date Prepared: November 23, 2022
Name of Device: Olea S.I.A. Neurovascular V1.0
Common or Usual Name: PACS
Regulation Name: Medical Image Management and Processing System
Regulatory Class: 21 CFR 892.2050
Product Code: LLZ
Predicate Device: Olea Sphere V3.0 (K152602)
Intended Use / Indications for Use
Olea S.I.A. Neurovascular V1.0 is an optional user interface for use on the Olea Medical technical integration platform Olea S.I.A. V1.0 and is designed to be used by trained radiologists and surgeons.
Olea S.I.A. Neurovascular V1.0 is intended to:
- display MR and CT series and outputs provided by compatible docker applications processing, through the technical integration platform,
- . allow the user to edit and modify parameters that are optional inputs of aforementioned applications. These modified parameters are provided through the technical integration platform as inputs to the docker application to reprocess outputs. When available, Olea S.I.A. Neurovascular V1.0 display can be updated with the reprocessed outputs.
The device does not alter the original image information and is not intended to be used as a diagnostic device and shall not be used to take decisions with diagnosis or therapeutic purposes. The information displayed is intended to be used in conjunction with other patient information and based on professional judgment, to assist the clinician in the medical imaging assessment.
4
Trained radiologists and surgeons are responsible for viewing the full set of native images per the standard of care.
Device Description
Introduction
Olea S.I.A. Neurovascular V1.0 is a visualization of docker applications results. It is an interface embedded on Olea S.I.A. V1.0 platform and uses the components of Olea S.I.A. V1.0 platform to display the outputs of docker applications to which it is entirely dedicated.
Olea S.I.A. Neurovascular V1.0 allows the user to visualize native DICOM series and docker applications outputs and to modify parameters that are optional inputs of these applications.
Olea S.I.A. Neurovascular V1.0 interaction with the Olea S.I.A. technical platform and docker applications
To be used, Olea S.I.A. Neurovascular V1.0 needs:
- o a technical base, which is provided by Olea S.I.A. V1.0 platform; and
- 0 one or more applications installed on the Olea S.I.A. V1.0 platform that provide outputs that can be managed by Olea S.I.A. Neurovascular V1.0.
The technical platform:
- receives outputs from docker applications; ●
- o makes these outputs available to related DICOM viewers. If the docker applications are compatible with Olea S.I.A. Neurovascular V1.0, they are proposed as the default software to visualize the outputs;
- 0 retrieves the modified parameters in Olea S.I.A. Neurovascular V1.0 to be able to relaunch the concerned docker applications with these new input parameters.
Olea S.I.A. Neurovascular V1.0 does not contain any calculation feature or any algorithm (deterministic or Al).
Olea S.I.A. Neurovascular V1.0 operating principles and technological characteristics
Olea S.I.A. Neurovascular V1.0 is an interface embedded on Olea S.I.A. V1.0 platform. Olea S.I.A. Neurovascular V1.0 communicates with API that exists on Olea S.I.A. V1.0 platform only. Olea S.I.A. Neurovascular V1.0 is launched via a link to a web browser and a secure connection.
Image /page/4/Figure/16 description: The image shows a diagram of a system with inputs, a central processing unit, and outputs. The inputs are Docker applications results, including maps, VOIs, and metrics. The central processing unit is labeled "Olea S.I.A. Neurovascular V1.0." The outputs include the display of Docker applications results and parameter modifications.
Figure 5: Olea S.I.A. Neurovascular V1.0 inputs/outputs
5
Olea S.I.A. Neurovascular V1.0 receives data coming from docker applications. These data can either be maps, VOIs, or metrics. Olea S.I.A. Neurovascular V1.0 is able to display these results on a dedicated user interface designed in accordance with the clinical need that provides tools to visualize and manipulate images. There is no Olea S.I.A. Neurovascular V1.0 functionality on top of the applications cleared functionalities: the subject device only serves for display of cleared outputs and/or information.
Olea S.I.A. Neurovascular V1.0 also gives the possibility to edit and modify parameters that are optional inputs of aforementioned applications. These modified parameters are provided through the technical integration platform as inputs to the docker application to reprocess outputs. When available, Olea S.I.A. Neurovascular V1.0 display is updated with the reprocessed outputs.
Substantial Equivalence
Table 1: Substantial Equivalence Comparison Table
| Olea S.I.A Neurovascular V1.0 | Olea Sphere® V3.0 (K152602) |
|---|---|
| MR and CT images visualization including | |
| standard viewing tools | YES |
| Manual selection | YES |
| Dedicated Report | YES |
To explain that the subject device and the predicate device are comparable, it is important to point out that Olea S.I.A. Neurovascular V1.0 features represent only a part of the features available in the predicate device Olea Sphere V3.0.
Both systems are used for the visualization and analysis of MR and CT studies. Both systems are for use in hospitals, imaging centers and radiologist reading practices by any trained radiologist or surgeon (part of trained professionals) who may require and is granted access to patient imaging, demographic, and report information.
Both the Olea S.I.A. Neurovascular V1.0 and Olea Sphere V3.0 have similar technological characteristics as they both provide the same tools:
- MR and CT images loading and visualization ●
- Standard viewing tools ●
- 3D MIP visualization ●
- Reset layout
- Manual side selection
- Manual AIF/VOF selection
- Dedicated report.
Olea S.I.A. Neurovascular V1.0 and Olea Sphere V3.0 have essentially equivalent features. The two minor differences are:
- Olea Sphere® V3.0 provides both viewing and processing capabilities while Olea S.J.A. o Neurovascular V1.0 is only for visualization, and
- Olea S.I.A. Neurovascular V1.0 is displayed in a web-browser whereas Olea Sphere's viewer is directly embedded in the software itself.
These minor differences do not impact the intended use of the device or raise different questions of safety and efficacy.
6
Performance Data
Olea Medical has conducted validation testing of the Olea S.I.A. Neurovascular V1.0. Internal verification and validation testing confirms that the product specifications are met, and support of the substantial equivalence of the intended use and technological characteristics to the predicate device.
Olea S.I.A. Neurovascular V1.0 has been validated 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 device.
The following performance evaluations were conducted:
- Product risk assessment; ●
- Software modules verification tests;
- . Software validation test.
Based on the performance testing, the Olea S.I.A. Neurovascular V1.0 has a safety and effectiveness profile that is similar to the predicate device.
Olea S.I.A. Neurovascular V1.0 provides no output. Therefore, the comparison to predicate was based on the comparison of features available within both devices.
Conclusions
Olea S.I.A. Neurovascular V1.0 is substantially equivalent to the predicate device, Olea Sphere® V3.0. The Olea S.I.A. Neurovascular V1.0 has the same intended use and similar indications for use, technological characteristics, and principles of operation as its predicate device.
In addition, the minor technological differences between the Olea S.I.A. Neurovascular V1.0 and its predicate devices raise no new questions of safety or effectiveness. Performance data demonstrate that the Olea S.I.A. Neurovascular V1.0 is as safe and effective as the Olea Sphere® V3.0. Thus, the Olea S.I.A. Neurovascular V1.0 is substantially equivalent.