(102 days)
nordicBrainEx is an advanced visualization and processing software, with specific focus on providing algorithms designed to analyze functional MR data of the brain. The software runs on a standard "offthe-shelf" PC workstation and can be used with data and images acquired through DICOM compliant imaging devices and modalities.
The software is intended to be used by medical personnel, such as radiologists or medical technicians, trained in the methods provided by the application. In order to best accommodate this group of users, it is specifically designed to have an easy to use and streamlined workflow, as well as an intuitive graphical user interface.
nordicBrainEx provides analysis and visualization capabilities of dynamic MRI data of the brain, presenting the derived properties and parameters in a clinically useful context.
The nordicBrainEx Software is a post-processing application for dynamic MRI data developed with focus on ease of use and high performance on a standard Windows workstation. The software provides comprehensive functionality for dynamic image analysis and visualization of MRI data, where signal changes over time are analyzed to determine various modality dependent functional parameters. The following algorithms provide the main functional analyses of the application.
- BOLD: BOLD fMRI analysis is used to highlight small magnetic susceptibility changes in the human brain in areas with altered blood-flow resulting from neuronal activity.
- DTI: Diffusion analysis is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data. Fiber tracking utilizes the directional dependency of the diffusion to display the white matter structure in the brain.
- DSC: Calculations of perfusion related parameters that provide information about the blood vessel structure and characteristics. Examples of such maps are blood volume, blood flow, time to peak, mean transit time and leakage.
In addition to these specific functional analyses, the application also provides general visualization tools, a database for data handling, and a reporting feature. This is to ensure that the workflow of the application is optimized to ensure efficiency and high throughput in a clinical environment.
The nordicBrainEx Software is a post-processing application designed for dynamic MRI data, focusing on the analysis and visualization of functional MR data of the brain. The device's performance was assessed through extensive in-house testing to ensure it meets design and performance specifications and user needs.
Here's the breakdown of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text states that "Prospectively defined verification and validation activities for the nordicBrainEx Software assure that the nordicBrainEx Software meets design and performance specifications as well as user needs when operated according to the operating instructions." However, specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or detailed reported device performance metrics are NOT explicitly stated in the document. The document primarily focuses on demonstrating substantial equivalence to a predicate device (nordicICE Software K090546) based on technological and operational characteristics.
| Acceptance Criteria Category | Acceptance Criteria (Thresholds/Goals) | Reported Device Performance |
|---|---|---|
| Functional Analysis Accuracy | Not explicitly stated (e.g., BOLD, DTI, DSC map accuracy against a gold standard) | "Successful completion of said tests verifies the claimed characteristics of nordicBrainEx" |
| User Interface & Workflow | Not explicitly stated (e.g., ease of use, streamlined workflow, intuitive GUI) | "specifically designed to have an easy to use and streamlined workflow, as well as an intuitive graphical user interface." |
| Compatibility | DICOM compliant MR data input | "can be used with data and images acquired through DICOM compliant imaging devices and modalities." |
| Performance (Speed/Efficiency) | Not explicitly stated (e.g., processing time targets) | "developed with focus on ease of use and high performance on a standard Windows workstation." |
| Substantial Equivalence | Equivalence to nordicICE Software (K090546) in intended use, indications for use, and technical/operational characteristics | "The nordicBrainEx Software is substantially equivalent to the nordicICE Software (K090546) in technological characteristics and operational characteristics." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified. The document mentions "extensive in-house testing" but does not provide details on the number of cases or datasets used for verification and validation.
- Data Provenance: Not specified. The document does not mention the country of origin of the data or whether it was retrospective or prospective. It only states that the software "can be used with data and images acquired through DICOM compliant imaging devices and modalities."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not specified. The document does not mention the use of experts to establish a ground truth for testing, nor their number or qualifications.
4. Adjudication Method for the Test Set
Not specified. No information is provided regarding any adjudication method (e.g., 2+1, 3+1, none) used for the test set.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No. The document does not mention any Multi Reader Multi Case (MRMC) comparative effectiveness study. The evaluation focused on the device's technical performance and substantial equivalence to a predicate device, not on assessing human reader improvement with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The performance testing described as "extensive in-house testing" for "design and performance specifications" and "user needs" suggests an evaluation of the algorithm's functionality and output. While not explicitly termed "standalone performance," the context implies that the algorithms for BOLD, DTI, and DSC analyses were tested for their ability to produce the described parameters. However, no specific standalone metrics (e.g., accuracy, precision) are provided. The device is intended to be used by medical personnel, indicating a human-in-the-loop context for clinical application, but the verification tests would inherently assess the algorithm's output quality.
7. The Type of Ground Truth Used
Not specified explicitly. Given the nature of the device (post-processing for functional MRI data), ground truth would typically come from established physiological models, other validated imaging techniques, or potentially comparison with manually segmented/analyzed images by experts. However, the document does not specify how ground truth was established for its internal testing.
8. The Sample Size for the Training Set
Not applicable/Not specified. The nordicBrainEx Software is described as a post-processing application with defined algorithms (BOLD, DTI, DSC). The text implies algorithm-based analysis rather than a machine learning model that would require a separate training set. Therefore, a "training set" in the context of machine learning is not mentioned or implied.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not specified. As there is no mention of a training set, the establishment of its ground truth is also not mentioned.
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APR 0 4 2014
510(k) Summary NordicNeuroLab AS nordicBrainEx Software
| Submitter: | NordicNeuroLab AS |
|---|---|
| Møllendalsveien 65C | |
| N-5009 Bergen | |
| Norway | |
| Phone: +47 55 70 70 95 | |
| Fax: | +47 55 70 70 96 |
Primary Contact: Chandana Gurung Bhandari (chandana@nordicneurolab.com)
| Proprietary Name: | nordicBrainEx Software |
|---|---|
| Device Common Name: | PACS |
| Device: | System, image processing, radiological |
| Classification Name: | Picture archiving and communication system |
| Classification Regulation: | 892.2050 |
| Class: | II |
| Panel: | Radiology |
| Product Code: | LLZ |
Predicate device name:
Nordic Image Control and Evaluation (nordiclCE) Software K090546
Device Description
The nordicBrainEx Software is a post-processing application for dynamic MRI data developed with focus on ease of use and high performance on a standard Windows workstation. The software provides comprehensive functionality for dynamic image analysis and visualization of MRI data, where signal changes over time are analyzed to determine various modality dependent functional parameters. The following algorithms provide the main functional analyses of the application.
- BOLD: BOLD fMRI analysis is used to highlight small magnetic susceptibility changes in the ● human brain in areas with altered blood-flow resulting from neuronal activity.
- DTI: Diffusion analysis is used to visualize local water diffusion properties from the analysis of � diffusion-weighted MRI data. Fiber tracking utilizes the directional dependency of the diffusion to display the white matter structure in the brain.
- DSC: Calculations of perfusion related parameters that provide information about the blood . vessel structure and characteristics. Examples of such maps are blood volume, blood flow, time to peak, mean transit time and leakage.
NordicNeuroLab AS- Traditional 510(k) nordicBrainEx Software
510 (k) Summary Page 5-2
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510(k)- K133910
In addition to these specific functional analyses, the application also provides general visualization tools, a database for data handling, and a reporting feature. This is to ensure that the workflow of the application is optimized to ensure efficiency and high throughput in a clinical environment.
Intended Use
nordicBrainEx is an advanced visualization and processing software, with specific focus on providing algorithms designed to analyze functional MR data of the brain. The software runs on a standard "offthe-shelf" PC workstation and can be used with data and images acquired through DICOM compliant imaging devices and modalities.
The software is intended to be used by medical personnel, such as radiologists or medical technicians, trained in the methods provided by the application. In order to best accommodate this group of users, it is specifically designed to have an easy to use and streamlined workflow, as well as an intuitive graphical user interface.
Indications For Use
nordicBrainEx provides analysis and visualization capabilities of dynamic MRI data of the brain, presenting the derived properties and parameters in a clinically useful context.
The indications for use of the predicate device, nordic!CE, is formulated in a more general way with focus on delivering specific functionality to a clinical environment. However, since those functionalities are the same as those in nordicBrainEx the more specific indications of nordicBrainEx are considered to be substantially equivalent to those of nordicICE. See SE discussion for more details.
Technological Characteristics and Substantial Equivalence
The nordicBrainEx Software is substantially equivalent to the nordicICE Software (K090546) in technological characteristics and operational characteristics.
| nordicBrainEx | nordicICE | |
|---|---|---|
| Development framework | Embarcadero C++ Builder XE2 | Embarcadero C++ Builder 2010 |
| Programming language | C++ | C++ |
| Operating environment | "Off-the-shelf" windows PCworkstation | "Off-the-shelf" windows PCworkstation |
| Input data | DICOM compliant MR data | DICOM compliant MR dataRAWAnalyzeNift! |
| General functionality | 2D MPR visualization3D VisualizationVolumes of interest | 2D MPR visualization3D VisualizationRegions of interest |
NordicNeuroLab AS- Traditional 510(k) nordicBrainEx Software
510 (k) Summary Page 5-3
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510(k)- K133910
K133910
Page 3 of 3
| Measurement toolsDICOM compliant nodeReporting tool | Measurement toolsDICOM compliant node | |
|---|---|---|
| Dynamic analyses | BOLDDTIDSC | BOLDDWIDTIDSCDCE |
More details can be found in the substantial equivalence discussion.
The rationale for determining the substantial equivalence between nordicBrainEx and nordiclCE is based on the defined intended use, indications for use, and the technical and operational characteristics of the two applications. To verify that nordicBrainEx fulfils the defined characteristics and requirements, it has been subject to extensive in-house testing (see section below). The successful completion of said tests verifies the claimed characteristics of nordicBrainEx, and thus supports the determination of substantial equivalence.
Performance Testing
Prospectively defined verification and validation activities for the nordicBrainEx Software assure that the nordicBrainEx Software meets design and performance specifications as well as user needs when operated according to the operating instructions.
NordicNeuroLab AS- Traditional 510(k) nordicBrainEx Software
510 (k) Summary Page 5-4
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with outstretched wings, rendered in a simple, bold line drawing. Encircling the bird figure is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and appears to be in a sans-serif font.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 4, 2014
NordicNeuroLab AS % Ms. Chandana Gurung Bhandari VP Quality Mollendalsveien 65C N-5009 Bergen NORWAY
Re: K133910
Trade/Device Name: nordicBrainEx v 2.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 21, 2014 Received: March 26, 2014
Dear Ms. Bhandari:
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. 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 (2) CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Bhandari
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael D. O'Hara
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): K133910
Device Name: nordicBrainEx Software
Indications for Use:
nordicBrainEx provides analysis and visualization capabilities of dynamic MRI data of the brain, presenting the derived properties and parameters in a clinically useful context.
Prescription Use _ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Michael D. O'Hara
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health K133910 510(k) _______________________________________________________________________________________________________________________________________________________________________
NordicNeuroLab AS - Traditional 510(k) nordicBrainEx Software
Indication for Use Statement Page 4-2
§ 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).