The nordicMEDiVA software is an advanced visualization and processing platform with a specific focus on providing algorithms designed to analyze functional and dynamic MRI data of the brain. The software runs on a server in a networked environment and is accessed by users via a standard web browser. It can communicate with other imaging platforms that support DICOM, and process medical image data acquired through DICOM-compliant imaging devices and modalities.

nordicMEDiVA is indicated for image analysis and visualization of functional and dynamic MRI data of the brain, presenting derived properties and parameters from the input image data in a clinically useful context.

Device Description

nordicMEDIVA is a software as a medical device (SaMD) for processing of MR images of the brain. Users will configure analysis pipelines, which are executed automatically when image data is received or manually by a user. The user can choose to send the results to other DICOM nodes for review or use nordicView for their review and export the results to PACS, neuro navigation systems, or other DICOM-compliant modalities.

nordicMEDIVA is a server-client solution and can be installed on a local server at the customer's location or in a cloud-based setup. The software is containerized with Docker technology and operates on a GPU-enabled Linux host. This allows customers to manage the server environment themselves or use it as a Service (SaaS) hosted by NordicimagingLab AS in the cloud. Customers can install the server on physical hardware, virtual machines, or in their own cloud infrastructure.

The device comprises a database, DICOM functionality, various APIs, a visualization engine, and medical image analysis modules. The device is not intended for long-term persistent storage of medical diagnostic data.

The device incorporates rule-based algorithms for the calculation of metrics from dynamic MRI data. The device does not incorporate AI algorithms based on neural networks.

The device connects to other imaging modalities, such as MR scanners, PACS, and surgical navigation systems.

The following modules provide the main functions of the device.

nordicView: A browser-based user interface accessed from desktop clients that provides tools for general image visualization, export, and relevant analysis tools for BOLD-fMRI and DSC-perfusion.

nordicBOLD: BOLD task-based fMRI anall magnetic susceptibility changes in the human brain in areas with altered blood flow resulting from neuronal activity. The image processing requires the definition of a so-called design matrix which is used to calculate voxel-wise statistics conveying information about the probability of the execution of the qiven task.

The design matrix is is defined such that the task or stimulation that was presented to the patient during the scan. The task or stimulation presented during scan time is often refered to as "the paradigm". The design matrix can be defined manually by the user, or a paradigm from nordicAktiva - another product from NordicNeuroLab - can be used.

nordicAktiva is a software, marketed by NordicNeuroLab, that may be used during scan time to present the patient or subject being scanned. The use of nordicAktiva is not required.

nordicDSC: Calculations of perfusion-related parameters that provide information about the blood vessel structure and characteristics. Such maps include blood volume, blood flow, time to peak, mean transit time, and leakage.

Platform: The platform includes a database, DICOM functionality, various APls, processing pipelines for the medical image analysis modules. Serves as a backbone component for the other modules of nordicMEDiVA.

Dashboard: a browser-based user interface accessed from desktop clients for administration and configuration.

AI/ML Overview

The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the nordicMEDiVA software.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

Module/Test	Acceptance Criteria	Reported Device Performance
Usability	All scenarios from summative usability test meet acceptance criteria.	All scenarios from the summative usability test met the acceptance criteria completely; no new risks were found, and existing risk control measures were proven to be effective.
nordicBOLD	Results proven to be as effective as the predicate device (nordicBrainEx).	The results from nordicBOLD were evaluated in comparison with equivalent results from the predicate device, nordicBrainEx (K163324). The results were reviewed by internal and external clinical experts and proven to be as effective as the predicate device.
nordicDSC	Lin's Concordance Correlation Coefficient (CCC) of enhancing voxels >= 0.8.	The results from the nordicDSC were confirmed to be the same as the predicate (nordicDSC K212720) where a Lin's Concordance Correlation Coefficient of enhancing voxels was calculated with an acceptance criterion being greater than or equal to 0.8 was applied. (Note: Specific CCC value achieved is not explicitly stated, only that it met the criteria).
Cybersecurity	Conforms to cybersecurity requirements.	nordicMEDIVA conforms to cybersecurity requirements by implementing a means to prevent unauthorized access, modification, misuse, denial of use of information stored, accessed or transferred from a medical device to an external recipient.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the numerical sample size for the test set. For nordicBOLD and nordicDSC, the comparison was made against existing predicate devices with existing data. The data provenance (country of origin, retrospective/prospective) is also not specified beyond the fact that it was compared against previously cleared devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

nordicBOLD: "internal and external clinical experts" were used to review the results. The exact number and specific qualifications (e.g., "radiologist with 10 years of experience") are not specified.
nordicDSC: The ground truth for nordicDSC seems to be based on direct comparison to the predicate device (nordicDSC K212720) through a statistical measure (Lin's CCC), rather than expert adjudication of a new test set.

4. Adjudication Method for the Test Set

nordicBOLD: Reviewed by "internal and external clinical experts." While experts were involved, a specific adjudication method (e.g., 2+1, 3+1 consensus) is not explicitly stated. It implies a qualitative "proven to be as effective" rather than a strict quantitative adjudication.
nordicDSC: Adjudication method is not applicable in the traditional sense, as it was a quantitative comparison using Lin's CCC against a predicate.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study explicitly designed to show how much human readers improve with AI vs. without AI assistance was not described in the provided text. The evaluation focused on the performance of the software (nordicBOLD and nordicDSC) in comparison to predicate devices, and usability, not on human reader performance with AI assistance. The device does not incorporate AI algorithms based on neural networks, limiting the scope for typical AI-assisted MRMC studies.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, from the descriptions of the nordicBOLD and nordicDSC evaluations, they appear to be standalone performance assessments of the algorithms' output compared to predicate devices. The "results from nordicBOLD were evaluated in comparison with equivalent results from the predicate device" and "results from the nordicDSC were confirmed to be the same as the predicate" indicates an algorithm-only evaluation, followed by expert review for nordicBOLD.

7. The Type of Ground Truth Used

nordicBOLD: The ground truth appears to be established by comparison to the results generated by the predicate device (nordicBrainEx) and reviewed by "internal and external clinical experts." This suggests a comparative ground truth based on established clinical performance of a cleared device, with expert consensus on equivalency.
nordicDSC: The ground truth for comparison was the output of the predicate device (nordicDSC K212720), with equivalency quantified by Lin's Concordance Correlation Coefficient.

8. The Sample Size for the Training Set

The document does not specify the sample size for the training set. It states that the device does not incorporate "AI algorithms based on neural networks," implying that traditional machine learning (which often requires training data) or deep learning was not the primary methodology. The device uses "rule-based algorithms for the calculation of metrics from dynamic MRI data."

9. How the Ground Truth for the Training Set was Established

Given that the device "does not incorporate AI algorithms based on neural networks" and uses "rule-based algorithms," the concept of a "training set" with established ground truth as typically understood for deep learning models is likely not applicable. The algorithms are rule-based, meaning their performance depends on the pre-defined rules, which are likely derived from scientific principles, clinical knowledge, and established methodologies for fMRI and DSC analysis, rather than learned from a labeled training dataset.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

June 28, 2024

NordicNeuroLab AS % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K241608

Trade/Device Name: nordicMEDiVA Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: June 4, 2024 Received: June 4, 2024

Dear Prithul Bom:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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

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Indications for Use

Submission Number (if known)

K241608

Device Name

nordicMEDiVA

Indications for Use (Describe)

Intended use

Intended users

nordicMEDiVA must be operated according to its intended purpose and only by qualified medical personnel with the necessary knowledge in accordance with country-specific requlations, such as trained radiological technicians or physicians. Users must have received training in applicable areas, such as in MR technology and neuroanatomy.

Indications for use

nordicMEDIVA is indicated for image analysis and visualization of functional and dynamic MRI data
of the brain, presenting derived properties and parameters from the input image data in a clinically
useful context.

Contraindications

The software is not be used as an archiving device for patients' image data.

The software is not to be used as a sole basis for clinical decisions, but further evidence has to be taken into account.

The software is not to be used as a sole basis in emergency care applications.

The software is not to be used for applications other than the analysis and visualization of MR data, or data derived thereof, of the human brain.

Patient target population

nordicMEDiVA has no limitation concerning the patient population.

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.

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510(k) #: Unkown

510(k) Summary

Prepared on: 2024-05-24

Contact Details

21 CFR 807.92(a)(1)

Applicant Name	NordicNeuroLab AS
Applicant Address	Mollendalsveien 1 Bergen 5009 Norway
Applicant Contact Telephone	+47 55 70 70 95
Applicant Contact	Mrs. Chandana Gurung Bhandari
Applicant Contact Email	chandana@nordicneurolab.com
Correspondent Name	NordicImagingLab AS
Correspondent Address	Mollendalsveien 1 Bergen 5009 Norway
Correspondent Contact Telephone	+47 95 17 53 14
Correspondent Contact	Mr. Ole Gunnar Johansen
Correspondent Contact Email	ole.gunnar@nordicimaginglab.com
Device Name21 CFR 807.92(a)(2)
Device Trade Name	nordicMEDIVA
Common Name	Medical image management and processing system
Classification Name	System, Image Processing, Radiological
Regulation Number	892.2050
Product Code(s)	LLZ
Legally Marketed Predicate Devices21 CFR 807.92(a)(3)
Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K163324	nordicBrainEx	LLZ
K212720	nordicDSC	LLZ
Device Description Summary21 CFR 807.92(a)(4)
nordicMEDIVA is a software as a medical device (SaMD) for processing of MR images of the brain. Users will configure analysis pipelines,which are executed automatically when image data is received or manually by a user. The user can choose to send the results to otherDICOM nodes for review or use nordicView for their review and export the results to PACS, neuro navigation systems, or other DICOM-compliant modalities.

nordicMEDNA is a server-client solution and can be installed on a local server at the customer's location or in a cloud-based setup. The software is containerized with Docker technology and operates on a GPU-enabled Linux host. This allows customers to manage the server environment themselves or use it as a Service (SaaS) hosted by NordicimagingLab AS in the cloud. Customers can

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install the server on physical hardware, virtual machines, or in their own cloud infrastructure.

The device incorporates rule-based algorithms for the calculation of metrics from dynamic MRI data. The device does not incorporate Al algorithms based on neural networks.

The device connects to other imaging modalities, such as MR scanners, PACS, and surgical navigation systems.

The following modules provide the main functions of the device.

nordicView: A browser-based user interface accessed from desktop clients that provides tools for general image visualization, export, and relevant analysis tools for BOLD-fMRI and DSC-perfusion.

nordicAktiva is a software, marketed by NordicNeuroLab, that may be used during scan time to present the patient or subject being scanned. The use of nordicAktiva is not required.

Dashboard: a browser-based user interface accessed from desktop clients for administration and configuration.

Intended Use/Indications for Use

21 CFR 807.92(a)(5)

Intended use

The nordicMEDiVA software is an advanced visualization with a specific focus on providing algorithms designed to analyze functional and dynamic MRI data of the brain. The software runs on a server in a networked environment and is accessed by users via a standard web browser. It can communicate with other imaging platforms that support DICOM, and process medical image data acquired through DICOM-compliant imaging devices and modalities.

Intended users

nordicMEDVA must be operated according to its intended purpose and only by qualified medical personnel with the necessary knowledge in accordance with country-specific regulations, such as trained radiological technicians or physicians. Users must have received training in applicable areas, such as in MR technology and neuroanatomy.

Indications for use

nordicMEDVA is indicated for image analysis and visualization of functional and dynamic MRI data of the brain, presenting derived properties and parameters from the input image data in a clinically useful context.

Contraindications

The software is not be used as an archiving device for patients' image data.

The software is not to be used as a sole basis for clinical decisions, but further evidence has to be taken into account.

The software is not to be used as a sole basis in emergency care applications.

The software is not to be used for applications other than the analysis and visualization of MR data, or data derived thereof, of the human brain.

Patient target population nordicMEDiVA has no limitation concerning the patient population.

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Indications for Use Comparison

The primary medical purpose conveyed in the intended use of both the predicates and the subject device is the same.

Although the wording of the intended use statements is slightly different from the predicate devices, the primary intention is the same. Both the subject, the predicate device and reference device combined enable dynamic susceptibility contrast-enhanced (DSC) and BOLD magnetic resonance imaging (MR) data analysis, presenting the derived properties and parameters in a clinically valuable context. We identified no difference in the intended use statements that impacts the safety and effectiveness of the subject device.

Technological Comparison

nordicMEDIVA has the same technological characteristics as the predicate device nordicBrainEx (K163324). Both the subject device and the predicate device:

Allow for the import and export of MR DICOM images from other DICOM-compliant imaging devices such as MR scanner, PACS and surgical navigation systems
Has a graphical user interface for the clinical evaluation of analysis results.
Allow for co-registration of functional MRI data to structural MRI data.
Allow for region of interest analysis (ROI), distance measurements, and the export of these measurements to PACS.
Allow for the generation of secondary data for use in surgical navigation systems.
Contain analysis for BOLD fMRI image processing.

The subject device differs from the predicate device in its technological characteristics in that:

The subject device is a thin client application deployed in a server environment, and the graphical user interface is a web browser. The predicate device is a deskop (thick client) application. The human-computer-computer interfaces are

equivalent in the subject device and therefore do not impact the safety or effectiveness of the subject device.

The subject device contains user-defined automated image data analysis, while in the predicate device, a user has to initiate image analysis manually. In both cases, the provided by a user, and the way the clinically relevant information is displayed to a user is equivalent.

The DSC analysis of the subject device has technological characteristics identical to those of the reference device, nordicDSC (K212720).

These differences do not raise additional questions about the safety or effectiveness of the subject device.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CER 807.92(b)

Non-clinical performance testing has been performed on the nordicMEDiVA software and demonstrates compliance with the following International and FDA-recognized consensus standards and FDA guidance document:

ISO 14971 Medical devices Application of risk management to medical devices
IEC 62304 Medical device software Software life cycle processes
IEC 62366-1 Medical devices Part 1: Application of usability engineering to medical devices
IEC 82304-1 Health software Part 1: General requirements for product safety

nordicMEDiVA was tested in accordance with verification processes. Verification and Validation tests have been performed to address intended use, the technological characteristics claims, requirement specifications and the risk management results.

Formative and summative usability studies have been performed with users from the intended audience.

The test results are summarized below:

All scenarios from the summative usability test met the acceptance criteria completely, no new risks were found and existing risk control measures were proven to be effective.
The results from nordicBOLD were evaluated in comparison with equivalent results from the predicate device, nordicBrainEx (K163324), The results were reviewed by internal and external clinical experts and proven to be as effective as the predicate device
The results from the nordicDSC was confirmed to be the same as the predicDSC K212720) where a Lin's Concordance Correlation Coefficient of enhancing voxels was calculated with acceptance criteria being greater than or equal to 0.8 was applied.

Cybersecurity considerations related to nordicMEDiVA are included within this submission. nordicMEDVA conforms to cybersecurity requirements by implementing a means to prevent unauthorized access, modification, misuse, denial of use of

21 CFR 807.92(a)(5)

21 CFR 807.92(a)(6)

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information stored, accessed or transferred from a medical device to an external recipient.

We believe that nordicMEDiVA is as safe and effective as the identified predicate devices and does not introduce new safety and effectiveness concerns.

Regulation Number and Section

§ 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).