(28 days)
Yes
The device description explicitly states that it uses "machine learning models trained on a proprietary clinical database" for localizing regions of the brain.
No
The device is a software application that aids in processing, visualizing, and interpreting medical images for neurosurgical planning, but it does not directly treat or prevent medical conditions.
Yes
The software aids qualified medical professionals in processing, visualizing, and interpreting anatomical structures from medical images as an aid in localizing specific brain regions, which is a diagnostic function.
Yes
The device description explicitly states "OptimMRI (v2) is a software application". There is no mention of accompanying hardware components that are part of the regulated device itself. While it processes images from commercially available imaging devices and its output is compatible with other neurosurgical planning software, the device being cleared is solely the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: 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. They are used to provide information for diagnosis, monitoring, or screening.
- OptimMRI's Function: OptimMRI is a software application that processes and analyzes medical images (MR images) of the brain. It aids in visualizing anatomical structures and planning neurosurgical procedures. It does not perform tests on biological samples.
Therefore, OptimMRI falls under the category of medical imaging software or surgical planning software, not In Vitro Diagnostics.
No
The provided text does not contain any explicit statement that the FDA has reviewed, approved, or cleared a PCCP for this specific device.
Intended Use / Indications for Use
OptimMRI is a software application intended to aid qualified medical professionals in processing, visualizing, and interpreting anatomical structures from medical images. The software can be used to process pre-operative DICOM compatible MR images to generate 3D annotated models of the brain that aid the user in neurosurgical functional planning. The annotated MR images can further be used in conjunction with other clinical methods as an aid in localization of the Subthalamic Nuclei (STN) and Ventral Intermediate Nucleus (VIM) regions of interest.
Product codes
QIH, LLZ
Device Description
OptimMRI (v2) is a software application for processing medical images of the brain that enables 3D visualization and analysis of anatomical structures. Specifically, the software can be used to read DICOM compatible pre-operative MR images acquired by commercially available imaging devices. These images can be processed to generate 3D markers in specific regions of the brain to allow qualified medical professionals to display, review, analyze, annotate, interpret, export, and plan neurosurgical functional procedures. OptimMRI (v2) is used as an aid to localize regions of the brain such as Subthalamic Nuclei (STN) and Ventral Intermediate Nucleus (VIM) using advanced image processing techniques and machine learning models trained on a proprietary clinical database. The software supports workflow for creating pre-operative plans prior to carrying out the intraoperative procedure.
OptimMRI (v2) is configured as web-based software and its output is compatible with neurosurgical planning software supporting 3D DICOM format. Three models have been implemented within OptimMRI (v2) to segment the following regions of interest of the brain:
- -STN region of interest (STN itself)
- -Inferior part of the Ventral Intermediate Nucleus (VIM) and Zona Incerta
- -Inferior-lateral part of the Ventral Intermediate Nucleus (VIM)
Mentions image processing
Yes
Mentions AI, DNN, or ML
Mentions: "machine learning models"
Input Imaging Modality
MR images (DICOM compatible)
Anatomical Site
Brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified medical professionals / in neurosurgical functional planning
Description of the training set, sample size, data source, and annotation protocol
...machine learning models trained on a proprietary clinical database. (No further details available)
Description of the test set, sample size, data source, and annotation protocol
STN and VIM region of interest (ROI) annotation accuracy for the subject device was validated using the same performance test protocol and acceptance criteria as the predicate OptimMRI (K230150).
Summary of Performance Studies
Study Type: Verification and validation testing
Sample Size: Not specified
AUC: Not specified
MRMC: Not specified
Standalone Performance: Not specified
Key Results: Results from the performance evaluation studies demonstrated that at least 90% of surface distances of inferior-lateral regions of VIM structure were not greater than 2.0mm compared to reference devices Guide XT (K213930) and SureTune4 (DEN210003).
Key Metrics
Not greater than 2.0mm surface distance for at least 90% of observations.
Predicate Device(s)
K230150 - OptimMRI, REBRAIN SAS
Reference Device(s)
K213930 - Brainlab Elements Guide XT, Guide 3.0, Brainlab AG, DEN210003 - SureTune4 Software, Medtronic
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
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August 12, 2024
Rebrain, SAS Thomas Queuche Quality and Regulatory Affairs Manager Plateforme Technologique d'Innovation Biomédicale (PTIB) Hôpital Xavier Arnozan Avenue du Haut Lévêque Pessac. 33600 France
Re: K242054
Trade/Device Name: OptimMRI (v2) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH, LLZ Dated: July 12, 2024 Received: July 15, 2024
Dear Thomas Queuche:
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.
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).
1
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 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-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 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.
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-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,
FDA
Daniel M. Krainak, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Submission Number (if known)
Device Name
OptimMRI (v2)
Indications for Use (Describe)
OptimMRI is a software application intended to aid qualified medical professionals in processing, visualizing, and interpreting anatomical structures from medical images. The software can be used to process pre-operative DICOM compatible MR images to generate 3D annotated models of the brain that aid the user in neurosurgical functional planning. The annotated MR images can further be used in conjunction with other clinical methods as an aid in localization of the Subthalamic Nuclei (STN) and Ventral Intermediate Nucleus (VIM) regions of interest.
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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| | Special 510(k) Premarket Notification
OptimMRI (v2) - K242054
510(k) Summary | Page 1 of 3 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Submitter's Name: | RebrAln, SAS | |
| Address: | Plateforme Technologique d'Innovation Biomédicale (PTIB)
Hôpital Xavier Arnozan
Avenue du Haut Lévêque
33600 Pessac, France | |
| Contact: | Thomas QUEUCHE, Quality and Regulatory Affairs Manager | |
| Telephone: | +33 5 57 10 28 58 | |
| Date: | July 12, 2024 | |
| Trade Name: | OptimMRI (v2) | |
| Model No: | N/A | |
| Regulation description: | Medical Image Management and Processing System | |
| Regulation number: | 21 CFR 892.2050 | |
| Classification Number(s): | Primary product code : QIH
Secondary product code : LLZ | |
| Regulatory Class: | Class II | |
| Predicate Device: | K230150 - OptimMRI, REBRAIN SAS | |
| Reference Devices: | K213930 - Brainlab Elements Guide XT, Guide 3.0, Brainlab AG
DEN210003 - SureTune4 Software, Medtronic | |
Device Description:
OptimMRI (v2) is a software application for processing medical images of the brain that enables 3D visualization and analysis of anatomical structures. Specifically, the software can be used to read DICOM compatible pre-operative MR images acquired by commercially available imaging devices. These images can be processed to generate 3D markers in specific regions of the brain to allow qualified medical professionals to display, review, analyze, annotate, interpret, export, and plan neurosurgical functional procedures. OptimMRI (v2) is used as an aid to localize regions of the brain such as Subthalamic Nuclei (STN) and Ventral Intermediate Nucleus (VIM) using advanced image processing techniques and machine learning models trained on a proprietary clinical database. The software supports workflow for creating pre-operative plans prior to carrying out the intraoperative procedure.
OptimMRI (v2) is configured as web-based software and its output is compatible with neurosurgical planning software supporting 3D DICOM format. Three models have been implemented within OptimMRI (v2) to segment the following regions of interest of the brain:
- -STN region of interest (STN itself)
- -Inferior part of the Ventral Intermediate Nucleus (VIM) and Zona Incerta
- -Inferior-lateral part of the Ventral Intermediate Nucleus (VIM)
OptimMRI (v2) complies with the following standards:
- IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION, Medical device software --Software life cycle processes
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Image /page/4/Picture/1 description: The image shows the word "RebrAIn" in a stylized font. The first part of the word, "Rebr", is in a teal color, while the "AIn" part is in a dark purple color. Above the "AIn" part of the word, there is a stylized image of leaves and berries in teal and purple colors.
- IEC 82304-1 Edition 1.0 2016-10, Health software Part 1 : General requirements for product safety
- -ISO 14971 Third Edition 2019-12, Medical devices - Application of Risk Management to medical devices
- -IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION, Medical devices - Part 1: Application of usability engineering to medical devices
- -AAMI CR34971:2022, Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning
- -IEC/TR 80002-1 Edition 1.0 2009-09, Medical device software - Part 1 : Guidance of the application of ISO 14971 to medical device
- -ISO 20417 First edition 2021-04 Corrected version 2021-12, Medical devices -Information to be supplied by the manufacturer
- -ISO 15223-1 Fourth edition 2021-07, Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
- -ANSI UL 2900-1 First Edition 2017, Standard for Safety, Standard for Software Cybersecurity Network-Connectable Products, Part 1: General Requirements.
- -IEC 80001-1 Edition 1.0 2010-10 Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities.
- -AAMI TIR57:2016, Principles for medical device security - Risk management
- -ANSI AAMI SW96:2023, Standard for medical device security - Security risk management for device manufacturers
Indications for Use:
OptimMRI (v2) is a software application intended to aid qualified medical professionals in processing, visualizing, and interpreting anatomical structures from medical images. The software can be used to process pre-operative DICOM compatible MR images to generate 3D annotated models of the brain that aid the user in neurosurgical functional planning. The annotated MR images can further be used in conjunction with other clinical methods as an aid in localization of the Subthalamic Nuclei (STN) and Ventral Intermediate Nucleus (VIM) regions of interest.
Comparison to Predicate Device
The OptimMRI (v2) software is substantially equivalent to the previously cleared predicate OptimMRI (K230150). Briefly, the subject and predicate devices are based on the following same technological elements:
- Import, reading and storage of MR images in 3D DICOM format; -
- -Rotation, scaling, magnification (zoom) of the image
- -Navigation through MRI slices;
- -Selecting AC, PC and MP landmarks
- -Semi-automatic segmentation process
- Implementation of models to generate STN or VIM regions of interest and convert them into 3D crosses where the center of the cross is the position calculated by the model;
- Output annotated MR images with 3D crosses in DICOM format -
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The only technical difference consists of the addition of a new model in the subject device to help localize the inferior-lateral-region of the VIM. Verification and validation testing for OptimMRI (v2) software demonstrates that the identified minor technical differences do not raise any new safety or efficacy concerns during the controlled software development process.
Testing to Support the Software Modifications (Non-Clinical Testing) :
Following the modifications, extensive verification testing was conducted to validate that the software functions as specified and performs similarly to the predicate device using the same acceptance criteria and the same test methods as used for the previously cleared predicate device.
STN and VIM region of interest (ROI) annotation accuracy for the subject device was validated using the same performance test protocol and acceptance criteria as the predicate OptimMRI (K230150). Results from the performance evaluation studies demonstrated that at least 90% of surface distances of inferior-lateral regions of VIM structure were not greater than 2.0mm compared to reference devices Guide XT (K213930) and SureTune4 (DEN210003).
Conclusions:
OptimMRI (v2) has the same indications for use and principles of operation as its predicate device. Design controls ensure that the minor differences between the subject and predicate device with the addition of the model for the VIM do not raise any new issues of safety and effectiveness when the device is used as labeled. Furthermore, performance data demonstrate that the functionality, output and clinical usage of OptimMRI (v2) is substantially equivalent to the predicate device. Therefore, it can be concluded that the OptimMRI (v2) is substantially equivalent to the previously cleared OptimMRI predicate device (K230150).