CT Perfusion V1.0

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Olea Medical % John J. Smith Partner Hogan Lovells US LLP Columbia Square 555 Thirteenth Street. NW WASHINGTON DC 20004 Re: K223091 June 9, 2023 Trade/Device Name: CT Perfusion 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 16, 2023 Received: May 16, 2023 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 (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. 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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) | K223091 | |--------------------------|---------| | Device Name | | #### CT Perfusion V1.0 CT Perfusion V1.0 is an automatic calculation tool in radiology. The device is an image processing software allowing computation of parametric maps from CT Perfusion of volumes of interest based on numerical thresholds applied to the aforementioned maps. Computation of mismatch between extracted volumes is automatically provided. The device is intended to be used by trained with medical imaging education including but not limited to, physicians and medical technicians in the imaging assessment workflow by extraction and communication of metrics from CT Perfusion dataset. The results of CT Perfusion V1.0 are intended to be used in conjunction and, based on professional judgment, to assist the clinician in the medical imaging assessment. Trained professionals are responsible for viewing the full set of native images per the standard of care. The device does not alter the original image. CT Perfusion V1.0 is not intended to be used as a standalone diagnostic device and shall not be used to take decisions with diagnosis or therapeutic purposes. Patient management decisions should not solely be based on CT Perfusion V1.0 results. CT Perfusion V1.0 can be integrated and deployed through technical platforms, responsible for transfering formats, notifying of detected image variations and display DICOM of imaging data. | 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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. 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The Company's 510(k) Summary is provided on the following pages. {4}------------------------------------------------ # 510(k) SUMMARY ### Olea Medical's CT Perfusion V1.0 #### Submitter K223091 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: September 30, 2022 Name of Device: CT Perfusion V1.0 Common or Usual Name: Picture archiving and communication system (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) - Manufacturer: Olea Medical . - Regulation Number: 21 CFR 892.2050 - Product Code: LLZ {5}------------------------------------------------ #### Intended Use / Indications for Use CT Perfusion V1.0 is an automatic calculation tool indicated for use in radiology. The device is an image processing software allowing computation of parametric maps from CT Perfusion data and extraction of volumes of interest based on numerical thresholds applied to the aforementioned maps. Computation of mismatch between extracted volumes is automatically provided. The device is intended to be used by trained professionals with medical imaging education including but not limited to, physicians and medical technicians in the imaging assessment workflow by extraction and communication of metrics from CT Perfusion dataset. The results of CT Perfusion V1.0 are 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 professionals are responsible for viewing the full set of native images per the standard of care. The device does not alter the original image. CT Perfusion V1.0 is not intended to be used as a standalone diagnostic device and shall not be used to take decisions with diagnosis or therapeutic purposes. Patient management decisions should not solely be based on CT Perfusion V1.0 results. CT Perfusion V1.0 can be integrated and deployed through technical platforms, responsible for transferring, storing, converting formats, notifying of detected image variations and display DICOM of imaqing data. #### Device Description #### Introduction The CT perfusion V1.0 application can be used to automatically compute qualitative as well as quantitative perfusion maps based on the dynamic (first-pass) effect of a contrast agent (CA). The perfusion application assumes that the input data describes a well-defined and transient signal response following rapid administration of a contrast agent. Olea Medical proposes CT Perfusion V1.0 as an image processing application, Picture Archiving Communications System (PACS) software module that is intended for use in a technical environment, which incorporates a Medical Image Communications Device (MICD) (21 CFR 892.2020) as its technical platform. ## CT Perfusion V1.0 interaction with the technical platform For optimal performance, the docker needs a technical base (MICD). The technical platform allows the docker to: - . receive the inputs; - provide the outputs; . - visualize the outputs as the docker has no interface. . The technical base can support several applications encapsuled in a docker such as CT Perfusion V1.0. {6}------------------------------------------------ ## Principles of operation and technological characteristics of CT Perfusion V1.0 CT Perfusion V1.0 image processing application is designed as a docker installed on a technical platform, a Medical Image Communications Device. Image /page/6/Figure/2 description: The image shows a diagram of the CT Perfusion V1.0 application. The input to the application is CT Perfusion data. The application processes the data and generates parametric maps, volume 1 and volume 2 segmentation, and mismatch computation. The output of the application is the processed data. Figure 1: CT Perfusion V1.0 inputs/outputs CT Perfusion V1.0 is a docker totally independent from the technical platform in which it is integrated: - Input DICOM images are received by the technical platform; ● - Relevant series are automatically identified among the images received in the platform by ● reading the relevant DICOM tags and are provided to the application; - . The arrival of identified series will launch CT Perfusion V1.0; - The CT Perfusion V1.0 processes the identified series; - . The generated results are automatically pushed to the technical platform; - . The results can be visualized with any DICOM viewer comprising but not limited to the technical platform or exported to a dedicated file location. The CT Perfusion V1.0 application takes as input a full CT perfusion (CTP) sequence acquired following the injection of an iodine contrast agent. By processing these input image series, the application provides the following outputs: - . Parametric maps. - Volume 1 and volume 2 segmentation in DICOM format. Fusion of segmented Volume 1 and 2 and CTP map could be provided in PNG and DICOM secondary captures. - . Mismatch computation: - Mismatch volume = Volume 2-Volume 1 - Mismatch ratio = Volume 2/Volume 1 O - Relative Mismatch = (Volume 2-Volume 1)/Volume 2*100. O CT Perfusion V1.0 does not contain any Al-based algorithms. All calculations are based on deterministic algorithms. The CT Perfusion V1.0 offers automatic volume seqmentations based on a set of maps and thresholds. The user is able to tune/adjust these thresholds and the maps associated to thresholds in the configuration files. {7}------------------------------------------------ ### Substantial Equivalence The following Predicate Device Comparison Table provides a summary of the comparison between the CT Perfusion V1.0 and its predicate device. | CT Perfusion V1.0 | Olea Sphere® V3.0 (K152602) | |-----------------------------------------------------------------|-----------------------------| | Parametric maps computation | YES | | Hypoperfused areas segmentations on maps<br>(e.g : CBF and TTP) | YES | | Mismatch computation | YES | To explain that the subject device and the predicate device are comparable, it is important to point out that CT Perfusion V1.0 represents a subset of functionality of Olea Sphere V3.0. Comparative performance testing was conducted using the comparable Perfusion module in Olea Sphere V3.0. Both CT Perfusion V1.0 and Olea Sphere® V3.0 are user-defined software analysis tools used for the analysis of CT studies. Both devices are intended for use in hospitals and imaging centers. Importantly, neither software product is used for diagnosis. Patient management decisions should not be based solely on the results of either software. Therefore, the intended use of the software is the same. Both the CT Perfusion V1.0 and Olea Sphere V3.0 have similar technological characteristics as they both: - . provide processing capabilities for the analysis of CT series; - are designed to be able to process CT series; . - . are able to provide same outputs; - are able to automatically compute the mismatch between extracted volumes. CT Perfusion V1.0 and Olea Sphere V3.0 have essentially equivalent features. The only difference is that Olea Sphere V3.0 is equipped with a visualization interface whereas CT Perfusion V1.0 needs to communicate with a technical platform to visualize the outputs. This minor difference does not impact the intended use of the device or raise different questions of safety and efficacy. #### Performance Data Olea Medical has conducted extensive validation testing of the CT Perfusion V1.0. Internal verification and validation testing confirm that the product specifications are met and supports substantial equivalence of the intended use and technological characteristics to the predicate device. CT Perfusion 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; ● - Clinical image comparison study. ● {8}------------------------------------------------ Based on the performance as documented in the clinical image comparison study, the CT Perfusion V1.0 has a safety and effectiveness profile that is similar to the predicate device. Indeed: - . Parametric maps result comparison: All parametric maps (CBF, CBV, MTT, TTP, Delay, tMIP) computed with CT Perfusion V1.0 and Olea Sphere® V3.0 predicate device were identical: value differences voxel-by-voxel were equal to zero; Pearson and Spearman correlation coefficients were equal to 1. - . Volumes result comparison: Mean DICE index (similarity coefficient) was equal to 1 between CT Perfusion V1.0 and Olea Sphere® V3.0 predicate device segmentations. It could be concluded that volume shape and position were identical. For all cases, no difference was found as the volumes derived from both thresholds were similar between CT Perfusion V1.0 and Olea Sphere® V3.0 predicate device. #### Conclusions CT Perfusion V1.0 is substantially equivalent to the predicate device, Olea Sphere® V3.0. The CT Perfusion 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 CT Perfusion V1.0 and its predicate devices raise no new questions of safety or effectiveness. Performance data demonstrate that the CT Perfusion V1.0 is as safe and effective as the Olea Sphere® V3.0. Thus, the CT Perfusion V1.0 is substantially equivalent.