(63 days)
nordicBrainEx (K133910)
No
The description focuses on traditional image processing algorithms (BOLD, DTI, DSC, DCE) and does not mention AI or ML.
No.
The device is a post-processing application for MRI data that provides analysis and visualization capabilities. It is intended for medical personnel, such as radiologists or medical technicians, to assist in interpreting MRI data. It does not exert any direct therapeutic action on the patient.
Yes
The device provides "analysis and visualization capabilities of dynamic MRI data of the brain, presenting the derived properties and parameters in a clinically useful context" and performs "functional analyses" such as BOLD, DTI, DSC, and DCE Perfusion analysis, which are used to derive parameters related to brain function and characteristics of blood vessel structure, all of which are indicative of a diagnostic purpose.
Yes
The device is described as a "post-processing application for dynamic MRI data" and "software provides comprehensive functionality for dynamic image analysis and visualization". It runs on a "standard Windows workstation" and its function is solely the analysis and presentation of data acquired from a separate hardware device (MRI scanner). There is no mention of any hardware component being part of the nordicBrainEx 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.
- Device Function: The nordicBrainEx is a post-processing application for dynamic MRI data. It analyzes and visualizes medical images (MRI scans) of the brain.
- Input Data: The input data is dynamic MRI data, which is image data acquired directly from the patient's body using an imaging modality (MRI). It does not process samples taken from the body.
The device falls under the category of medical image processing software or radiology software, which are distinct from IVDs. While it provides information that can be used in clinical decision-making, it does so by analyzing images, not biological samples.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The nordicBrainEx 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.
- DCE Perfusion analysis: Enables analysis of Dynamic Contrast Enhancement (DCE) MR data. In contrast to DSC Perfusion which uses T2* weighted sequence, DCE Perfusion uses T1-weighted sequence to measure bolus passage. Parameters are calculated to provide information about blood vessel structure and characteristics. The output maps from these calculations include interstitial volume (Ve), plasma volume (Vp), transfer constant map (Ktras), rate constant map (Kep), area under the curve (AUC), time to peak (TTP), peak, wash In and wash Out.
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
Anatomical Site
Brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The software is intended to be used by medical personnel, such as radiologists or medical technicians, trained in the methods provided by the application.
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 assure that the nordicBrainEx 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Nordic Image Control and Evaluation (nordicICE) Software (K090546)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
nordicBrainEx (K133910)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three heads, representing the department's focus on health, human services, and science. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is simple and monochromatic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 27, 2017
NordicNeuroLab AS % Chandana Gurung Bhandari VP Quality Møllendalsveien 65C N-5009 Bergen NORWAY
Re: K163324 Trade/Device Name: nordicBrainEx Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 1, 2016 Received: December 2, 2016
Dear Chandana 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 (21 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Industry and Consumer Education 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'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below. |
| ------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------- |
|---|
| 510(k) Number (if known) | K163324 |
|---|---|
| Device Name | nordicBrainEx |
| Indications for Use (Describe) | nordicBrainEx provides analysis and visualization capabilities of dynamic MRI data of the brain, presenting the derived properties and parameters in a clinically useful context. |
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
| FORM FDA 3881 (8/14) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 EF |
|---|---|---|
| ---------------------- | ------------- | ------------------------------------------- |
3
510(k) Summary NordicNeuroLab AS nordicBrainEx
Submitter: NordicNeuroLab AS Møllendalsveien 65C N-5009 Bergen Norway Phone: +47 55 70 70 95 +47 55 70 70 96 Fax:
Primary Contact: Chandana Gurung Bhandari (chandana@nordicneurolab.com)
Date of Preparation: 26 January 2017
| Proprietary Name: | nordicBrainEx |
|---|---|
| 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 (nordicICE) Software (K090546) |
| Reference Device name: | nordicBrainEx (K133910) |
Device Description
The nordicBrainEx 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.
4
- . 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.
- DCE Perfusion analysis: Enables analysis of Dynamic Contrast Enhancement (DCE) MR data. In contrast to DSC Perfusion which uses T2* weighted sequence, DCE Perfusion uses T1-weighted sequence to measure bolus passage. Parameters are calculated to provide information about blood vessel structure and characteristics. The output maps from these calculations include interstitial volume (Ve), plasma volume (Vp), transfer constant map (Ktras), rate constant map (Kep), area under the curve (AUC), time to peak (TTP), peak, wash In and wash Out.
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, nordicICE, 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 |
5
| 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 | ||
| Nifti | ||
| General | ||
| functionality | 2D MPR visualization | |
| 3D Visualization | ||
| Volumes of interest | ||
| Measurement tools | ||
| DICOM compliant node | ||
| Reporting tool | 2D MPR visualization | |
| 3D Visualization | ||
| Regions of interest | ||
| Measurement tools | ||
| DICOM compliant node | ||
| Dynamic analyses | BOLD | |
| DTI | ||
| DSC | ||
| DCE | 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 nordicICE 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 16). 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 assure that the nordicBrainEx meets design and performance specifications as well as user needs when operated according to the operating instructions.