(269 days)
Neurovascular Insight V1.0 is an optional user interface for use on a compatible technical integration environment and designed to be used by trained professionals with medical imaging education including, but not limited to, physicians. Neurovascular Insight V1.0 is intended to:
- Display and, if necessary, export neurological DICOM series and outputs provided by compatible processing docker applications, through the technical integration environment.
- Allow the user to edit and modify parameters that are optional inputs of aforementioned applications. These modified parameters are provided by the technical integration environment as inputs to the docker application to reprocess the outputs. When available, Neurovascular Insight V1.0 display can be updated with the reprocessed outputs.
- If requested by an application, allow the user to confirm information before displaying associated outputs and export them.
The device does not alter the original image information and is not intended to be used as a diagnostic device. The outputs of each compatible application must be interpreted by the predefined intended users, as specified in the application's own labeling. Moreover, 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. It is not intended to be used in lieu of the standard care imaging.
Trained professionals are responsible for viewing the full set of native images per the standard of care.
Neurovascular Insight V1.0 is an optional user interface for use on a compatible technical integration environment and designed to be used by trained professionals with medical imaging education including, but not limited to, physicians and medical technicians.
It is worth noting that Neurovascular Insight V1.0 is an evolution of the FDA cleared medical device Olea S.I.A. Neurovascular V1.0 (K223532).
Neurovascular Insight V1.0 does not contain any calculation feature or any algorithm (deterministic or AI).
The provided FDA 510(k) clearance letter for Neurovascular Insight V1.0 states that the device "does not contain any calculation feature or any algorithm (deterministic or AI)." Furthermore, it explicitly mentions, "Neurovascular Insight V1.0 provides no output. Therefore, the comparison to predicate was based on the comparison of features available within both devices. No performance feature requires a qualitative or quantitative comparison and validation."
Based on this, it's clear that the device is a user interface and does not include AI algorithms or generate outputs that would require a study involving acceptance criteria for AI performance (e.g., sensitivity, specificity, accuracy). Therefore, the questions related to AI-specific performance criteria, ground truth establishment, training sets, and MRMC studies are not applicable to this particular device.
The "study" conducted for this device was a series of software verification and validation tests to ensure its functionality as a user interface and its substantial equivalence to its predicate.
Here's a breakdown of the requested information based on the provided document, highlighting where the requested information is not applicable due to the device's nature:
1. A table of acceptance criteria and the reported device performance
Note: As the device is a user interface without AI or output generation, there are no quantitative performance metrics like sensitivity, specificity, or accuracy that would typically be associated with AI algorithms. The acceptance criteria relate to the successful execution of software functionalities.
| Acceptance Criteria (Based on information provided) | Reported Device Performance |
|---|---|
| Product risk assessment successfully completed | Confirmed |
| Software modules verification tests successfully completed | Confirmed |
| Software validation test successfully completed | Confirmed |
| System provides all capabilities necessary to operate according to its intended use | Confirmed |
| System operates in a manner substantially equivalent to the predicate device | Confirmed |
| All features tested during verification phases (Software Test Description) | Successfully performed as reported in Software Test Report (STR) |
| Specific features highlighted by risk analysis tested during usability process (human factor considered) | User Guide followed, no clinically blocking bugs, no incidents during processing |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated as a number of patient cases or images, as the testing was focused on software functionality rather than AI performance on a dataset. The testing refers to "software modules verification tests" and "software validation test."
- Data Provenance: Not applicable in the context of clinical data for AI development/validation, as the device doesn't use or produce clinical outputs requiring such data. The testing was internal software validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable: Given that the device is a user interface and does not utilize AI or produce diagnostic outputs, there was no need to establish clinical ground truth for a test set by medical experts in the traditional sense. The "ground truth" for its functionality would be the design specifications and successful execution of intended features. The document mentions "operators" who "reported no issue" during usability testing, but these are likely system testers/engineers, not clinical experts establishing diagnostic ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable: No clinical ground truth was established, so no adjudication method was required.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No: The document explicitly states, "Neurovascular Insight V1.0 does not contain any calculation feature or any algorithm (deterministic or AI)." Therefore, an MRMC study comparing human readers with and without AI assistance was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No: The device does not contain an algorithm, only a user interface. Standalone algorithm performance testing is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable: No clinical ground truth was established, as the device is a user interface without AI or diagnostic output generation. The "ground truth" for its validation was adherence to software specifications and intended functionalities.
8. The sample size for the training set
- Not Applicable: The device does not contain any AI algorithms, therefore, no training set was used.
9. How the ground truth for the training set was established
- Not Applicable: No training set was used.
FDA 510(k) Clearance Letter - Neurovascular Insight V1.0
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
Olea Medical S.A.S.
℅ John Smith
Partner
Hogan Lovells US LLP
Columbia Square 555 Thirteenth Street, NW
Washington, DC 20004
Re: K243680
Trade/Device Name: Neurovascular Insight V1.0
Regulation Number: 21 CFR 892.2050
Regulation Name: Medical Image Management And Processing System
Regulatory Class: Class II
Product Code: LLZ
Dated: July 21, 2025
Received: July 21, 2025
Dear John Smith:
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 (the 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 available 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.
August 25, 2025
Page 2
U.S. FOOD & DRUG ADMINISTRATION
Olea Medical S.A.S.
℅ John Smith
Partner
Hogan Lovells US LLP
Columbia Square 555 Thirteenth Street, NW
Washington, DC 20004
August 25, 2025
Re: K243680
Trade/Device Name: Neurovascular Insight V1.0
Regulation Number: 21 CFR 892.2050
Regulation Name: Medical Image Management And Processing System
Regulatory Class: Class II
Product Code: LLZ
Dated: July 21, 2025
Received: July 21, 2025
Dear John Smith:
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 (the 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 available 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.
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
K243680 - John Smith Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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
Page 3
K243680 - John Smith Page 3
the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/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, PhD
Assistant Director
Imaging Software Team
DHT8B: Division of Radiological Imaging
Devices and Electronic Products
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
| Submission Number (if known) | K243680 |
|---|---|
| Device Name | Neurovascular Insight V1.0 |
Indications for Use (Describe)
Neurovascular Insight V1.0 is an optional user interface for use on a compatible technical integration environment and designed to be used by trained professionals with medical imaging education including, but not limited to, physicians. Neurovascular Insight V1.0 is intended to:
- Display and, if necessary, export neurological DICOM series and outputs provided by compatible processing docker applications, through the technical integration environment.
- Allow the user to edit and modify parameters that are optional inputs of aforementioned applications. These modified parameters are provided by the technical integration environment as inputs to the docker application to reprocess the outputs. When available, Neurovascular Insight V1.0 display can be updated with the reprocessed outputs.
- If requested by an application, allow the user to confirm information before displaying associated outputs and export them.
The device does not alter the original image information and is not intended to be used as a diagnostic device. The outputs of each compatible application must be interpreted by the predefined intended users, as specified in the application's own labeling. Moreover, 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. It is not intended to be used in lieu of the standard care imaging.
Trained professionals are responsible for viewing the full set of native images per the standard of care.
Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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Page 5
510(k) Summary
510(k) #: K243680
Prepared on: 2025-07-18
Contact Details
21 CFR 807.92(a)(1)
| Field | Value |
|---|---|
| Applicant Name | Olea Medical S.A.S. |
| Applicant Address | 93 Avenue des Sorbiers ZI ATHELIA IV La Ciotat 13600 France |
| Applicant Contact Telephone | +33(0)442712420 |
| Applicant Contact | Mrs. Nathalie Palumbo |
| Applicant Contact Email | qa-ra@olea-medical.com |
| Correspondent Name | Hogan Lovells US LLP |
| Correspondent Address | Columbia Square 555 Thirteenth Street, NW Washington DC 20004 United States |
| Correspondent Contact Telephone | +12026373638 |
| Correspondent Contact | Mr. John J. Smith |
| Correspondent Contact Email | john.smith@hoganlovells.com |
Device Name
21 CFR 807.92(a)(2)
| Field | Value |
|---|---|
| Device Trade Name | Neurovascular Insight V1.0 |
| Common Name | Medical image management and processing system |
| Classification Name | System, Image Processing, Radiological |
| Regulation Number | 892.2050 |
| Product Code(s) | LLZ, N/A |
Legally Marketed Predicate Devices
21 CFR 807.92(a)(3)
| Predicate | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K223532 | Olea S.I.A. Neurovascular V1.0 | LLZ |
| K233342 | CINA-ASPECTS | POK |
Device Description Summary
21 CFR 807.92(a)(4)
Neurovascular Insight V1.0 is an optional user interface for use on a compatible technical integration environment and designed to be used by trained professionals with medical imaging education including, but not limited to, physicians and medical technicians.
It is worth noting that Neurovascular Insight V1.0 is an evolution of the FDA cleared medical device Olea S.I.A. Neurovascular V1.0 (K223532).
Neurovascular Insight V1.0 does not contain any calculation feature or any algorithm (deterministic or AI).
Page 6
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
Neurovascular Insight V1.0 is an optional user interface for use on a compatible technical integration environment and designed to be used by trained professionals with medical imaging education including, but not limited to, physicians. Neurovascular Insight V1.0 is intended to:
- Display and, if necessary, export neurological DICOM series and outputs provided by compatible processing docker applications, through the technical integration environment.
- Allow the user to edit and modify parameters that are optional inputs of aforementioned applications. These modified parameters are provided by the technical integration environment as inputs to the docker application to reprocess the outputs. When available, Neurovascular Insight V1.0 display can be updated with the reprocessed outputs.
- If requested by an application, allow the user to confirm information before displaying associated outputs and export them.
The device does not alter the original image information and is not intended to be used as a diagnostic device. The outputs of each compatible application must be interpreted by the predefined intended users, as specified in the application's own labeling. Moreover, 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. It is not intended to be used in lieu of the standard care imaging.
Trained professionals are responsible for viewing the full set of native images per the standard of care.
Indications for Use Comparison
21 CFR 807.92(a)(5)
Both the subject Neurovascular Insight V1.0 and predicate Olea S.I.A Neurovascular V1.0 are used for the visualization of MR and CT studies and the edition of parameters. Both systems are for use in clinical/hospital environments by any trained professionals.
The minor differences in the indications for use between the two devices are that:
- Neurovascular Insight V1.0 is for use on a compatible technical integration environment, whereas Olea S.I.A Neurovascular V1.0 is solely to be used on the Olea Medical technical integration platform Olea S.I.A. V1.0, which is a specific compatible technical integration environment.
- Neurovascular Insight V1.0 allows the user to confirm information before displaying associated outputs and export them if requested by an application, while Olea S.I.A Neurovascular V1.0 does not. However, this difference in indications for use is largely a reflection of a difference in technological characteristics, which is addressed in the section below.
- Neurovascular Insight V1.0 is intended to be used by trained professionals while Olea S.I.A Neurovascular V1.0 by trained radiologists and surgeons, which are a subset of trained professionals.
Therefore, both devices have substantially equivalent indications for use regarding visualization of MR and CT studies and edition of parameters.
Technological Comparison
21 CFR 807.92(a)(6)
Page 7
Both the subject Neurovascular Insight V1.0 and predicate Olea S.I.A. Neurovascular V1.0 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.
Neurovascular Insight V1.0 and Olea S.I.A. Neurovascular V1.0 have essentially equivalent features. Both are used to view MR and CT images and edit parameters. Note that the modification of both parameters, side selection and AIF/VOF selection, is identically managed in the subject device and in the predicate device.
The minor difference in the technological characteristics between the two devices is that Neurovascular Insight V1.0 allows the user to manually select ASPECTS region and confirm information before displaying associated outputs and export them if requested by an application, while Olea S.I.A Neurovascular V1.0 does not. However, this user feature to confirm outputs is supported by CINA-ASPECTS UI Agent, included in the reference CINA-ASPECTS device which was cleared for the same intended use with this same confirmation feature.
Therefore, this minor difference in the technological characteristics between both devices does not raise different questions of safety and effectiveness.
Non-Clinical and/or Clinical Tests Summary & Conclusions
21 CFR 807.92(b)
Page 8
Olea Medical has conducted validation testing of the Neurovascular Insight 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.
Neurovascular Insight 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 Neurovascular Insight V1.0 has a safety and effectiveness profile that is similar to the predicate device.
Neurovascular Insight V1.0 provides no output. Therefore, the comparison to predicate was based on the comparison of features available within both devices.
No performance feature requires a qualitative or quantitative comparison and validation. Each feature has been tested during the verification phases of Neurovascular Insight V1.0 as described in the software test description (STD) and successfully performed as reported in the software test report (STR). Specific features highlighted by the risk analysis have been additionally tested during the usability process of Neurovascular Insight V1.0 to consider human factor as mentioned in the use specification (see Appendix 'OM-DP-STK_HMI_MM-10-021-Use specification-V02_AINN'). All tests were executed in accordance with the User Guide and the operators reported no issue, without occurrence of any clinically blocking bug and no incident during processing.
For more details, please refer to Appendix 'OM-DP-STK_HMI_MM-10-018-Comparison and Validation-V02_AINN'.
Neurovascular Insight V1.0 subject device has substantially equivalent indications for use, technological characteristics, and principles of operation as Olea S.I.A Neurovascular V1.0 predicate device. The minor technological difference between Neurovascular Insight V1.0 and its predicate device raise no new questions of safety or effectiveness, as the user confirmation feature is included in the reference device which was cleared for the same intended use. The methods for verification and validation testing of the subject device are well-supported in this regulation and by the predicate and reference devices' clearances, and data from such testing demonstrates the device's safety and performance.
Thus, Neurovascular Insight V1.0 is substantially equivalent to predicate Olea S.I.A. Neurovascular V1.0.
§ 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).