(102 days)
Not Found
No
The document describes standard image processing algorithms (BOLD, DTI, DSC) for analyzing functional MRI data. There is no mention of AI, ML, or related terms, nor is there any description of training or test sets typically associated with ML model development.
No
The device is described as advanced visualization and processing software for analyzing functional MR data of the brain, intended for medical personnel to aid in diagnosis, not to provide therapy.
Yes
The software "provides analysis and visualization capabilities of dynamic MRI data of the brain, presenting the derived properties and parameters in a clinically useful context," and is intended to be used by medical personnel like radiologists. This indicates its use in aiding the diagnosis of medical conditions. The mention of algorithms like BOLD, DTI, and DSC analysis, which highlight changes in the brain, visualize water diffusion properties, and calculate perfusion-related parameters, further supports its diagnostic purpose.
Yes
The device is described as "advanced visualization and processing software" and a "post-processing application for dynamic MRI data." It runs on a standard PC workstation and processes data from DICOM compliant imaging devices. There is no mention of any hardware component being part of the device itself.
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.
- nordicBrainEx Function: nordicBrainEx is a software that processes and analyzes imaging data (MRI) acquired from the human brain. It does not analyze biological samples taken from the body.
- Intended Use: The intended use clearly states it's for analyzing functional MR data of the brain, acquired through DICOM compliant imaging devices. This is image processing and analysis, not in vitro testing.
Therefore, nordicBrainEx falls under the category of medical image processing software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use statement is: "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 "off-the-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."
The indications for use statement is: "nordicBrainEx provides analysis and visualization capabilities of dynamic MRI data of the brain, presenting the derived properties and parameters in a clinically useful context."
Product codes
LLZ
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. 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
dynamic MRI data, DICOM compliant MR data
Anatomical Site
Brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical personnel, such as radiologists or medical technicians
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
"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."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
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
1
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 PC | |
| workstation | "Off-the-shelf" windows PC | |
| workstation | ||
| Input data | DICOM compliant MR data | DICOM compliant MR data |
| RAW | ||
| Analyze | ||
| Nift! | ||
| General functionality | 2D MPR visualization | |
| 3D Visualization | ||
| Volumes of interest | 2D MPR visualization | |
| 3D Visualization | ||
| Regions of interest |
NordicNeuroLab AS- Traditional 510(k) nordicBrainEx Software
510 (k) Summary Page 5-3
2
510(k)- K133910
K133910
Page 3 of 3
| | Measurement tools
DICOM compliant node
Reporting tool | Measurement tools
DICOM compliant node |
|------------------|-------------------------------------------------------------|-------------------------------------------|
| Dynamic analyses | BOLD
DTI
DSC | BOLD
DWI
DTI
DSC
DCE |
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
3
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.
4
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
5
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