(57 days)
Yes
The summary explicitly mentions "algorithm training" and describes the size and source of the training data, which is characteristic of AI/ML development. It also mentions "AI and deep learning" in the "Mentions AI, DNN, or ML" section.
No
The device is an image processing application intended to assist clinicians in medical imaging assessment by analyzing MR DWI and FLAIR images; it does not directly provide therapy. Its intended use explicitly states it is "not intended to be used as a standalone diagnostic device and shall not be used to take decisions with diagnosis or therapeutic purposes."
No
The device description explicitly states: "MR DWI/FLAIR Measurement 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."
Yes
The device is described as an "image processing application, Picture Archiving Communications System (PACS) software module" and an "executable application" that runs on a separate technical platform (Medical Image Communications Device). It is explicitly stated as a "docker totally independent from the OLEA platform in which it is integrated" and has dedicated input/output channels for integration with "any compatible configurable technical platform." This indicates it is a software component designed to be installed and run on existing hardware infrastructure, not a standalone hardware device or a device that includes its own dedicated hardware.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological specimens: IVDs are designed to examine samples taken from the human body, such as blood, urine, tissue, etc., to provide information about a person's health.
- This device analyzes medical images: The intended use and device description clearly state that this device processes and analyzes MR Diffusion-weighted imaging (DWI) and MR FLAIR images. These are medical images, not biological specimens.
- The device's function is image processing and analysis: The device computes maps, extracts metrics from images, and assists in the assessment of medical images. This falls under the category of medical image analysis software, not IVD.
Therefore, while this device is a medical device used in the healthcare setting, it does not meet the definition of an In Vitro Diagnostic.
No
The input document does not contain any explicit statement that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
MR DWI/FLAIR Measurement V1.0 is an image processing application indicated for use in the analysis of:
(1) MR Diffusion-weighted imaging (DWI)
(2) MR FLAIR images.
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:
. computation of the map relative to the water diffusion, i.e., ADC map; .
. extraction and communication of metrics derived from the above map, i.e., hypointense area on ADC, and FLAIR series as well as ratios with contralateral information on FLAIR images.
The results of MR DWI/FLAIR Measurement 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 medical image. MR DWI/FLAIR Measurement 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 MR DWI/FLAIR Measurement V1.0 results.
MR DWI/FLAIR Measurement V1.0 can be integrated and deployed through technical platforms responsible for transferring, storing, converting formats, notifying of detected image variations and display of DICOM imaging data.
Product codes
LLZ
Device Description
Olea Medical proposes MR DWI/FLAIR Measurement 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 as its technical platform.
MR DWI/FLAIR Measurement V1.0 is an executable application which can run on the OLEA Platform. The OLEA Platform is a Medical Image Communications Device and outside the scope of this submission. MR DWI/FLAIR Measurement V1.0 is a docker totally independent from the OLEA platform in which it is integrated and has a dedicated Input/Output channels to be able to be integrated and deployed through any compatible configurable technical platform. Input DICOM images are received via the dedicated file system in which the application is integrated. When launched, the MR DWI/FLAIR Measurement V1.0 will retrieve and automatically analyze the image series. The output images will be sent to the same dedicated file system and can be visualized from any DICOM viewer by loading these results from the allocated file system.
To be used, the MR DWI/FLAIR Measurement V1.0 docker needs an independent technical base, which is provided by a Medical Image Communications Device (MICD). The technical platform allows the docker to:
- receive the inputs
- provide the outputs
- . visualize the outputs through Olea Platform viewer and/or export to other third party DICOM viewers.
Among other algorithms, MR DWI/FLAIR Measurement V1.0 includes a diffusion brain extraction tool (BET) applied before outputation.
Mentions image processing
Yes
Mentions AI, DNN, or ML
This deep learning algorithm filters the surrounding noise and excludes background pixels on raw images for MR DWI series.
MR DWI/FLAIR Measurement V1.0 uses a Diffusion Brain Extraction Tool (BET) based on Al algorithms.
Input Imaging Modality
MR Diffusion-weighted imaging (DWI), MR FLAIR images
Anatomical Site
Brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained professionals with medical imaging education including, but not limited to, physicians and medical technicians in the imaging assessment workflow.
Description of the training set, sample size, data source, and annotation protocol
218 cases from multiple institutions were used for algorithm training. The analysis was performed based on the information available in the DICOM metadata of the cases. DICOM data used were sourced from the following manufacturers: Siemens, General Electric, Philips and Canon. The reference standard was established by manual segmentation performed by expert clinicians.
Description of the test set, sample size, data source, and annotation protocol
another set of 28 cases from multiple institutions were respectively used for the algorithm testing. The test database was constructed with cases coming from different institutions than the training and validation set. The analysis was performed based on the information available in the DICOM metadata of the cases. DICOM data used were sourced from the following manufacturers: Siemens, General Electric, Philips and Canon. The reference standard was established by manual segmentation performed by expert clinicians.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Product risk assessment;
- Software modules verification tests;
- Software validation test;
- Comparative clinical image study.
Relative FLAIR: As shown in the relative FLAIR Bland-Altman analysis, the average estimated bias (average of differences) was close to zero (0.004). Furthermore, Bland-Altman analysis estimates that 95% of the measurement differences ranged between -0.013 and +0.021 (considered as the maximum of the 95% limits of agreement).
Normalized FLAIR: As shown in the normalized FLAIR Bland-Altman analysis, the average estimated bias (average of differences) was close to zero (0.05). Furthermore, Bland-Altman analysis estimates that 95% of the measurement differences ranged between -0.100 and +0.199 (considered as the maximum of the 95% limits of agreement).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
DICE indexes between ADC hypointense area segmentations on FLAIR images generated with both devices were excellent, ranging from 0.816 to 0.976.
DICE indexes between both devices were excellent and equal to those found in the relative FLAIR analysis, i.e., ranging from 0.816 to 0.976.
Predicate Device(s)
Reference Device(s)
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). 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.
April 26, 2023
Olea Medical % John J. Smith Partner Hogan Lovells US LLP Columbia Square, 555 Thirteenth Street, NW WASHINGTON DC 20004
Re: K230552
Trade/Device Name: MR DWI/FLAIR Measurement V1.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: February 28, 2023 Received: February 28, 2023
Dear John J. 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. 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
1
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 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 medical devices and radiation-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,
D.G.K.
Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
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510(k) Number (if known) K230552
Device Name
MR DWI/FLAIR Measurement V1.0
MR DWI/FLAIR Measurement V1.0 is an image processing application indicated for use in the analysis of:
(1) MR Diffusion-weighted imaging (DWI)
(2) MR FLAIR images.
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:
. computation of the map relative to the water diffusion, i.e., ADC map;
extraction and communication of metrics derived from the above map. i.e., hypointense area on ADC, and FLAIR series as well as ratios with contralateral information on FLAIR images.
The results of MR DW/FLAIR Measurement V1.0 are intended to be used in conjunction with other patient information and, based on professional judgment, to assist the clinical 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 medical image. MR DWI/FLAIR Measurement 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 MR DWI/FLAIR Measurement V1.0 results.
MR DW/FLAIR Measurement V1.0 can be integrated and deployed through technical platforms, responsible for transfering, storing, converting formats, notifying of detected image variations and display of DICOM 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)
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510(k) SUMMARY
Olea Medical's MR DWI/FLAIR Measurement 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: April 19, 2023
Name of Device: MR DWI/FLAIR Measurement 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)
| Product name | Olea Sphere V3.0 |
|---|---|
| 510(k) number | K152602 |
| Trend name | Olea Sphere V3.0 |
| Classification name | System, image processing, radiological |
| Classification panel | Radiology |
| CFR code | 21 CFR 892.2050 |
| Classification | Class II |
| Product code | LLZ |
Reference Device: MR Diffusion Perfusion Mismatch V1.0 (K223502)
| Product name | MR Diffusion Perfusion Mismatch V1.0 |
|---|---|
| 510(k) number | K223502 |
| Trend name | MR Diffusion Perfusion Mismatch V1.0 |
| Classification name | System, image processing, radiological |
| Classification panel | Radiology |
| CFR code | 21 CFR 892.2050 |
| Classification | Class II |
| Product code | LLZ |
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A. Indications for Use
MR DWI/FLAIR Measurement V1.0 is an image processing application indicated for use in the analysis of:
(1) MR Diffusion-weighted imaging (DWI)
(2) MR FLAIR images.
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:
- computation of the map relative to the water diffusion, i.e., ADC map; .
- . extraction and communication of metrics derived from the above map, i.e., hypointense area on ADC, and FLAIR series as well as ratios with contralateral information on FLAIR images.
The results of MR DWI/FLAIR Measurement 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 medical image. MR DWI/FLAIR Measurement 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 MR DWI/FLAIR Measurement V1.0 results.
MR DWI/FLAIR Measurement V1.0 can be integrated and deployed through technical platforms responsible for transferring, storing, converting formats, notifying of detected image variations and display of DICOM imaging data.
B. Technological Characteristics
The MR FLAIR/DWI Measurement V1.0 pipeline takes a Fluid-Attenuated Inversion Recovery (FLAIR) sequence and a diffusion weighted imaging (DWI) sequence as input and provides automatically-generated relative and normalized FLAIR images.
Olea Medical proposes MR DWI/FLAIR Measurement 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 as its technical platform.
MR DWI/FLAIR Measurement V1.0 is an executable application which can run on the OLEA Platform. The OLEA Platform is a Medical Image Communications Device and outside the scope of this submission. MR DWI/FLAIR Measurement V1.0 is a docker totally independent from the OLEA platform in which it is integrated and has a dedicated Input/Output channels to be able to be integrated and deployed through any compatible configurable technical platform. Input DICOM images are received via the dedicated file system in which the application is integrated. When launched, the MR DWI/FLAIR Measurement V1.0 will retrieve and automatically analyze the image series. The output images will be sent to the same dedicated file system and can be visualized from any DICOM viewer by loading these results from the allocated file system.
To be used, the MR DWI/FLAIR Measurement V1.0 docker needs an independent technical base, which is provided by a Medical Image Communications Device (MICD). The technical platform allows the docker to:
5
- receive the inputs
- provide the outputs
- . visualize the outputs through Olea Platform viewer and/or export to other third party DICOM viewers.
Among other algorithms, MR DWI/FLAIR Measurement V1.0 includes a diffusion brain extraction tool (BET) applied before outputation. This deep learning algorithm filters the surrounding noise and excludes background pixels on raw images for MR DWI series. 218 cases, and another set of 28 cases from multiple institutions were respectively used for the algorithm training, validation and testing, with a good representation of the intended use population in terms of gender and age. Furthermore, the test database was constructed with cases coming from different institutions than the training and validation set.
The analysis was performed based on the information available in the DICOM metadata of the cases. DICOM data used were sourced from the following manufacturers: Siemens, General Electric, Philips and Canon.
The reference standard was established by manual segmentation performed by expert clinicians. The final model complies with the acceptance criteria based on the Dice on test dataset for brain tissue class.
C. Substantial Equivalence
The subject device MR DWI/FLAIR Measurement V1.0 is a subset of the predicate device, Olea Sphere V3.0 (Diffusion and Analysis modules). Both MR DWI/FLAIR Measurement V1.0 and Olea Sphere® V3.0 are user-defined software analysis tools used for the analysis of MR DWI and FLAIR studies. Both the MR DWIFLAIR Measurement V1.0 and the Olea Sphere V3.0 are intended for use in healthcare facilities and by the same users; both subject and predicate devices are intended for use by trained professionals. Patient management decisions should not be based solely on the results of either software. Therefore, the intended use of the software is the same.
The MR DWI/FLAIR Measurement V1.0 and Olea Sphere V3.0 have substantially equivalent features as they both:
- . provide processing capabilities for the analysis of MR series;
- . are designed to be able to process MR DWI and FLAIR series;
- are able to provide same outputs;
- . are able to extract voxel values from relative and normalized FLAIR maps.
The four minor differences between the two devices are:
- In the intended use / indications for use: The MR DWI/FLAIR Measurement V1.0 represents । a subset of the Olea Sphere V3.0. Accordingly, the indication for use of the subject MR DWI/FLAIR Measurement V1.0 is considered substantially equivalent to that of the Diffusion and Analysis modules, subset of that of the Olea Sphere V3.0;
- -In the technical characteristics, the three differences are:
- Olea Sphere V3.0 is equipped with a visualization interface whereas MR O DWI/FLAIR Measurement V1.0 needs to communicate with the technical platform to visualize the outputs.
6
-
The second difference is related to an algorithm applied before maps computation: o
MR DWI/FLAIR Measurement V1.0 uses a Diffusion Brain Extraction Tool (BET) based on Al algorithms. It must be noted that this algorithm is identical to the recently FDA cleared MR Diffusion Perfusion Mismatch V1.0's one (K223502). This difference does not impact the calculation method of the outputs. -
O The third difference is that relative and normalized FLAIR values are automatically calculated into the subject device whereas, in the predicate, voxels values are exported to an Excel file and then relative and normalized FLAIR values are manually calculated.
However, these minor differences do not impact the safety or effectiveness of the subject device. Comparative testing has been performed to demonstrate substantial equivalence in safety and effectiveness between the MR DWI/FLAIR Measurement V1.0 and the relative subset within the Olea Sphere V3.0.
| MR DWI/FLAIR Measurement V1.0 | Olea Sphere® V3.0 (K152602) |
|---|---|
| ADC map computation | YES |
| Hypointense area segmentation on ADC map | YES |
| ADC hypointense area and symmetric contralateral | |
| volume segmentations on FLAIR series | YES |
| Relative and normalized FLAIR maps computation | YES |
| Table 1: Substantial equivalence comparison table | ||
|---|---|---|
D. Summary of Performance Testing
MR DWI/FLAIR Measurement V1.0 has been validated to ensure that the system meets all performance specifications 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;
- Comparative clinical image study. .
Based on the clinical performance as documented in the comparative clinical image study, the MR DWI/FLAIR Measurement V1.0 has a safety and effectiveness profile that is substantially equivalent to the predicate device. Below summarizes the testing results:
Relative FLAIR: As shown in the relative FLAIR Bland-Altman analysis, the average estimated bias (average of differences) was close to zero (0.004). Furthermore, Bland-Altman analysis estimates that 95% of the measurement differences ranged between -0.013 and +0.021 (considered as the maximum of the 95% limits of agreement).
DICE indexes between ADC hypointense area segmentations on FLAIR images generated with both devices were excellent, ranging from 0.816 to 0.976.
Normalized FLAIR: As shown in the normalized FLAIR Bland-Altman analysis, the average estimated bias (average of differences) was close to zero (0.05). Furthermore, Bland-Altman
7
analysis estimates that 95% of the measurement differences ranged between -0.100 and +0.199 (considered as the maximum of the 95% limits of agreement).
DICE indexes between both devices were excellent and equal to those found in the relative FLAIR analysis, i.e., ranging from 0.816 to 0.976.
E. Conclusions
MR DWI/FLAIR Measurement V1.0 is substantially equivalent to the predicate device, Olea Sphere® V3.0. The MR DWI/FLAIR Measurement 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 MR DWI/FLAIR Measurement V1.0 and its predicate devices raise no new questions of safety or effectiveness. Performance data demonstrate that the MR DWI/FLAIR Measurement V1.0 is as safe and effective as the Olea Sphere® V3.0. Thus, the MR DWI/FLAIR Measurement V1.0 is substantially equivalent.