(183 days)
Yes
The device description explicitly states that it permits specialized annotation of anatomic structures using machine learning models.
No
The device is a software application for processing and visualizing medical images. It aids in surgical planning and localization but does not directly treat a condition or provide therapy itself.
Yes
Explanation: The device aids in the localization of specific brain regions (STN and VIM) and helps in interpreting anatomical structures for neurosurgical functional planning, which constitutes diagnostic functions. While it supports planning, the core function involves processing and interpreting images to understand anatomical structures and localize specific regions, which is a diagnostic activity.
Yes
The device description explicitly states "OptimMRI is a software application" and describes its function as processing and visualizing medical images. There is no mention of accompanying hardware components.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring, or compatibility purposes.
- OptimMRI's Function: OptimMRI processes and analyzes medical images (MR images) of the brain. It does not examine biological specimens derived from the human body.
- Intended Use: The intended use is to aid medical professionals in processing, visualizing, and interpreting anatomical structures from medical images for neurosurgical functional planning and localization of specific brain regions. This is a function related to image analysis and surgical planning, not in vitro testing of biological samples.
Therefore, OptimMRI falls under the category of medical image processing and analysis software, not an In Vitro Diagnostic device.
No
The input explicitly states "Control Plan Authorized (PCCP) and relevant text: Not Found", indicating no mention of PCCP authorization in the letter.
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 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 anatomy to allow qualified medical professionals to display, review, analyze, annotate, interpret, export, and plan neurosurgical functional procedures. OptimMRI is used as an aid to localize regions of the brain such as Subthalamic Nuclei (STN) and Ventral Intermediate Nucleus (VIM).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Permit specialized annotation of anatomic structures using machine learning models
Input Imaging Modality
MR images (DICOM compatible)
Anatomical Site
brain, Subthalamic Nuclei (STN), Ventral Intermediate Nucleus (VIM)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified medical professionals, neurosurgical functional planning
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
A total of 44 cerebral MRIs (88 hemispheres) were retrospectively annotated for the STN performance study, and 31 cerebral MRIs (62 hemispheres) were used for the VIM study. Qualified and experienced medical professionals performed the segmentation, and all validation criteria were met.
Summary of Performance Studies
The performance evaluation studies against reference devices Guide XT (K213930) and SureTune4 (DEN210003) demonstrated that at least 90% of surface distances of STN or VIM were not greater than 2.0mm when using segmentation tools for OptimMRI. The STN result is identical to the predicate SIS Software that used high-resolution 7T MRIs of the brain.
Key Metrics
Not Found
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).
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July 21, 2023
RebrAIn, SAS % Ram Bedi Consultant Plateforme Technologique d'Innovation Biomédicale (PTIB) Hôpital Xavier Arnozan Avenue du Haut Lévêque 33600 Pessac. France
Re: K230150
Trade/Device Name: OptimMRI Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH, LLZ Dated: June 21, 2023 Received: June 21, 2023
Dear Ram Bedi:
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.
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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 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.
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
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Indications for Use
510(k) Number (if known) K230150
Device Name OptimMRI
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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Image /page/3/Picture/0 description: The image shows the logo for RebrAIn. The word "RebrAIn" is written in a sans-serif font, with the "Rebr" portion in teal and the "AIn" portion in dark purple. Above the "AIn" portion of the logo is a stylized flower-like design with teal leaves and dark purple berries.
Chapter 6. 510(k) Summary
| Submitter's Name: | RebrAln, SAS |
|---|---|
| Address: | Plateforme Technologique d'Innovation Biomédicale (PTIB) Hôpital Xavier Arnozan Avenue du Haut Lévêque 33600 Pessac, France |
| Contact: Telephone: | Ram Bedi, PhD, MBA (425) 985 86780 |
| Date: | January 17, 2023 |
| Device/Trade Name: | OptimMRI |
| Common Name: | Medical Image Processing Software |
| Classification Name: | System, Image Processing, Radiological Picture Archiving and Communications System |
| Classification Panel: | Radiology |
| CFR Code: | 21 CFR 892.2050 |
| Classification: | II |
| Product Code: | Primary: QIH |
| Secondary: LLZ | |
| Predicate Device: | K162830 – SIS Software, Surgical Information Sciences, Inc. |
| Device Description: | OptimMRI 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 anatomy to allow qualified medical |
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professionals to display, review, analyze, annotate, interpret, export, and plan neurosurgical functional procedures. OptimMRI is used as an aid to localize regions of the brain such as Subthalamic Nuclei (STN) and Ventral Intermediate Nucleus (VIM).
OptimMRI complies with the following standards:
ISO, 14971 Third Edition 2019-12, Medical devices -Application of Risk Management to medical devices
IEC, 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION, Medical device software - Software life cycle processes
IEC, 82304-1 Edition 1.0 2016-10, Health software - Part 1 : General requirements for product safety
ISO 15223-1:2021, Medical devices - Symbols to be used with information to be supplied by the manufacturer — Part 1
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
IEC 62366-1:2015+AMD1:2020 Medical devices - Part 1: Application of usability engineering to medical devices + Amend. 1
ANSI UL 2900-1 Ed.1 2017 Standard for Software Cybersecurity Network-Connectable Products, Part I: 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.
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Image /page/5/Picture/1 description: The image shows the logo for RebrAIn. The word "Rebr" is in a teal color, and the "AIn" is in a dark red color. Above the "AIn" is a teal and dark red design that looks like leaves.
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.
Comparison to Predicate Device
The OptimMRI software is substantially equivalent to the predicate that has already been cleared for USA distribution with 510(k) premarket notification number K162830. Briefly, the subject and predicate devices are based on the following same technological elements:
- . Software tools for the visualization of DICOM compliant medical images
- . Permit specialized annotation of anatomic structures using machine learning models
- . Output data compatible with multiple surgical planning systems
- Support for 2D and 3D visualization tools ●
- Export of images and reports in DICOM format ●
The following technological differences exist between the subject and predicate device:
- . Subject device is indicated for only pre-operative usaqe
- Segmentation process is semi-automatic for subject . device compared to fully automatic for the predicate device
- . Fusion imaging capability is not available in the subject device
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- Region of interest is annotated with 3D crosses on the ● subject device compared to 3D segmented anatomical volumes on the predicate
- Localization of VIM region of interest is not available on . the predicate device
Accuracy of segmentations for OptimMRI was compared to previously cleared commercially available comparable software tools. A total of 44 cerebral MRIs (88 hemispheres) were retrospectively annotated for the STN performance study, and 31 cerebral MRIs (62 hemispheres) were used for the VIM study. Qualified and experienced medical professionals performed the segmentation, and all validation criteria were met. The performance evaluation studies against reference devices Guide XT (K213930) and SureTune4 (DEN210003) demonstrated that at least 90% of surface distances of STN or VIM were not greater than 2.0mm when using segmentation tools for OptimMRI. The STN result is identical to the predicate SIS Software that used highresolution 7T MRIs of the brain.
No new safety or efficacy issues were introduced by OptimMRI compared to the predicate device. There are no differences in indications for use between OptimMRI and the Software (K162830). predicate ટાટ Furthermore, performance data demonstrate that the functionality, output and clinical usage of OptimMRI is substantially equivalent to the predicate device.