nordicBrainEx

K163324 · Nordicneurolab AS · LLZ · Jan 27, 2017 · Radiology

Device Facts

• Record ID: K163324
• Device Name: nordicBrainEx
• Applicant: Nordicneurolab AS
• Product Code: LLZ · Radiology
• Decision Date: Jan 27, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

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.

Device Story

Post-processing software for dynamic MRI brain data; runs on standard Windows PC workstations. Inputs: DICOM-compliant MRI data. Processing: algorithms analyze signal changes over time to derive functional parameters. Outputs: visualization maps, measurements, and reports. Used in clinical environments by radiologists or medical technicians. BOLD analysis highlights magnetic susceptibility changes related to neuronal activity; DTI visualizes water diffusion and white matter structure; DSC and DCE perfusion analyses calculate blood vessel characteristics (e.g., blood volume, flow, transit time, permeability). Output assists clinicians in evaluating brain function and structure, supporting clinical decision-making.

Clinical Evidence

Bench testing only. Verification and validation activities were prospectively defined and performed to ensure the software meets design and performance specifications and user needs. No clinical study data provided.

Technological Characteristics

Software-based post-processing application. Operates on standard off-the-shelf Windows PC workstations. Connectivity via DICOM-compliant nodes. Algorithms include BOLD, DTI, DSC, and DCE perfusion analysis. Development framework: Embarcadero C++ Builder XE2. Programming language: C++. Features 2D/3D visualization, measurement tools, and reporting.

Indications for Use

Indicated for analysis and visualization of dynamic MRI data of the brain to derive properties and parameters in a clinically useful context for medical personnel.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Nordic Image Control and Evaluation (nordicICE) Software (K090546)

Reference Devices

• nordicBrainEx (K133910)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>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) | |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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## 510(k) Summary NordicNeuroLab AS nordicBrainEx

Submitter: NordicNeuroLab AS Møllendalsveien 65C N-5009 Bergen Norway Phone: [phone] [phone] Fax:

Primary Contact: Chandana Gurung Bhandari ([e-mail])

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.

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- . 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<br>framework | Embarcadero C++ Builder XE2 | Embarcadero C++ Builder 2010 |

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| Programming<br>language | C++ | C++ |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Operating<br>environment | "Off-the-shelf" windows PC<br>workstation | "Off-the-shelf" windows PC<br>workstation |
| Input data | DICOM compliant MR data | DICOM compliant MR data<br>RAW<br>Analyze<br>Nifti |
| General<br>functionality | 2D MPR visualization<br>3D Visualization<br>Volumes of interest<br>Measurement tools<br>DICOM compliant node<br>Reporting tool | 2D MPR visualization<br>3D Visualization<br>Regions of interest<br>Measurement tools<br>DICOM compliant node |
| Dynamic analyses | BOLD<br>DTI<br>DSC<br>DCE | BOLD<br>DWI<br>DTI<br>DSC<br>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.