Olea S.I.A. Neurovascular V1.0

K223532 · Olea Medical · LLZ · Jun 6, 2023 · Radiology

Device Facts

• Record ID: K223532
• Device Name: Olea S.I.A. Neurovascular V1.0
• Applicant: Olea Medical
• Product Code: LLZ · Radiology
• Decision Date: Jun 6, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

Olea S.I.A. Neurovascular V1.0 is a web-based visualization interface embedded on the Olea S.I.A. V1.0 platform. It receives MR and CT image data, maps, VOIs, and metrics from compatible docker applications. The device displays these results and allows users to modify optional input parameters, which are then sent back to the docker applications to reprocess outputs. Used in clinical settings (hospitals, imaging centers) by radiologists and surgeons. It does not perform independent calculations or analysis; it serves solely as a display and interaction layer for cleared application outputs. Clinicians use the displayed information alongside other patient data to assist in medical imaging assessment, while remaining responsible for reviewing native images per standard of care.

Clinical Evidence

Bench testing only. Validation included product risk assessment, software module verification, and software validation testing to confirm system capabilities and performance specifications are met.

Technological Characteristics

Web-based user interface embedded on Olea S.I.A. V1.0 platform. Communicates via API. Supports MR/CT image visualization, 3D MIP, manual side selection, and manual AIF/VOF selection. No internal calculation or algorithm features. Connectivity via secure web browser connection.

Indications for Use

Indicated for trained radiologists and surgeons to display and interact with MR and CT series and outputs from compatible docker applications on the Olea S.I.A. V1.0 platform. Not for diagnostic use; not for therapeutic decision-making.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Olea Sphere V3.0 (K152602)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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| 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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### 510(k) SUMMARY

## Olea Medical's Olea S.I.A. Neurovascular V1.0

## Submitter

K223532

Olea Medical 93 avenue des Sorbiers, ZI ATHELIA IV 13600, La Ciotat France

Phone: [phone] Facsimile: [phone] 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.

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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

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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<br>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.

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# 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.