(103 days)
Not Found
No
The summary describes a system for presenting stimuli and collecting responses during fMRI, with no mention of AI or ML for data analysis or interpretation.
No.
The device's description explicitly states, "It is not intended for the diagnosis of disease or for the direct treatment of conditions," which indicates it is not a therapeutic device.
No
The text explicitly states: "It is not intended for the diagnosis of disease or for the direct treatment of conditions."
No
The device description explicitly states that the system consists of five subsystems, including hardware components like the AudioSystem, ResponseGrip, and SyncBox, in addition to the nordicAktiva software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Definition of IVD: An IVD is a medical device used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device's Intended Use: The intended use of this device is to facilitate auditory and visual stimulation and collect responses during fMRI examinations. It is used in conjunction with fMRI, which is an imaging technique, not a test performed on a biological sample.
- Lack of Sample Analysis: The device description clearly states it presents stimuli and records responses. There is no mention of analyzing biological samples.
- Exclusion of Diagnosis: The intended use explicitly states it is "not intended for the diagnosis of disease." While the information gathered from fMRI using this system can be part of a diagnostic process, the device itself is not performing the diagnostic test.
Therefore, this device falls under the category of a medical device used in imaging, specifically fMRI, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The fMRI Hardware System is a stimulus presentation and response collection system intended to be used by trained professionals to facilitate auditory and visual stimulation to be used in functional MR Imaging (fMRI) based on BOLD contrast.
nordicAktiva is a stimulus presentation software intended to be used by trained professionals to facilitate auditory and visual stimulation to be used in functional MR maging (fMRI)based on BOLD contrast. In addition, it records responses from the NordicNeuroLab ResponseGrips.
The device is indicated for use during BOLD fMRI examinations of individuals over 2 years of age. It is not intended for the diagnosis of disease or for the direct treatment of conditions.
nordicAktiva would be used in an MRI department of a hospital or clinic, when a functional MRI exam based on BOLD contrast is required involving the provision of visual or auditory stimulation to a subject inside the MRI scanner.
Product codes
LNH
Device Description
The System consists of five subsystems: AudioSystem, ResponseGrip, SyncBox and nordicAktiva. The system presents auditory and visual stimulus to the patient gives feedback through a pair of handheld grips. A synchronizes the stimulus presentation software with the MR scanner.
The system is used for fMRI studies. fMRI stands for functional Magnetic Resonance Imaging. This technique is primarily used for determining which area of the brain is responsible for specific processes controlling essential functions such as movement, speech, hearing, and vision. This information can form part of the pre-operative planning process in patients with brain tumors, for example. Functional MRI can also be used for research into specific neurological conditions or investigating cognitive function and networks in general.
The System is used to present the stimulus necessary to provoke physiological processes in the brain. Visual [VisualSystem] and auditory [AudioSystem] stimulus and manual responses from the patient [ResponseGrips] are of primary interest. The timing of the visual and auditory stimulation is critical to make sure that the correct MR image of the activated brain is linked to the stimulus presented. A synchronization unit [SyncBox], connected between the MR-scanner and the stimulus presentation software [nordicAktiva], is included in the system to make sure that the synchronization is correct.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
functional MR Imaging (fMRI) based on BOLD contrast
Anatomical Site
brain
Indicated Patient Age Range
over 2 years of age
Intended User / Care Setting
trained professionals / MRI department of a hospital or clinic
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)
The fMRI Hardware System has been tested for function and safety and fulfills all requirement specifications.
Non-clinical performance testing has been performed on the nordicAktiva 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
The nordicAktiva 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.
The test results in this 510(k) premarket notification demonstrates that nordicAktiva:
- Complies with the aforementioned international and FDA-recognized consensus standards and FDA guidance document, and
- Meets the acceptance criteria and is adequate for its intended use and specifications.
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
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 13, 2023
Chandana Gurung Bhandari VP Quality Møllendalsveien 1 Bergen, Vestland 5009 Norway
Re: K232680
Trade/Device Name: fMRI Hardware System (nordicAktiva) Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: August 29, 2023 Received: September 18, 2023
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 (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.
1
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).
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.
2
For comprehensive regulatory information about medical devices and radiation-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
Enclosure
3
Indications for Use
510(k) Number (if known) K232680
Device Name fMRI Hardware system (nordicAktiva)
Indications for Use (Describe)
The fMRI Hardware System is a stimulus presentation and response collection system intended to be used by trained professionals to facilitate auditory and visual stimulation to be used in functional MR Imaging (fMRI) based on BOLD contrast.
nordicAktiva is a stimulus presentation software intended to be used by trained professionals to facilitate auditory and visual stimulation to be used in functional MR maging (fMRI)based on BOLD contrast. In addition, it records responses from the NordicNeuroLab ResponseGrips.
The device is indicated for use during BOLD fMRI examinations of individuals over 2 years of age. It is not intended for the diagnosis of disease or for the direct treatment of conditions.
nordicAktiva would be used in an MRI department of a hospital or clinic, when a functional MRI exam based on BOLD contrast is required involving the provision of visual or auditory stimulation to a subject inside the MRI scanner.
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) | ||
|---|---|---|---|
| --------------- | ---------------------------------------------- | --------------- | --------------------------------------------- |
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510(k) Summary NordicNeuroLab AS fMRI hardware System (nordicAktiva)
| 510(k) Type: | Traditional: Device Modification |
|---|---|
| Submission Date: | 29th August 2023 |
| Submitter: | NordicNeuroLab AS |
| Møllendalsveien 1 | |
| N-5009 Bergen | |
| Norway | |
| Phone: +47 55 70 70 95 | |
| E-mail: chandana@nordicneurolab.com | |
| Establishment Registration Number: 3006738448 | |
| Contact: | Chandana Gurung Bhandari |
| Møllendalsveien 1 | |
| N-5009 Bergen | |
| Norway | |
| Direct: +47 41 76 62 39 | |
| Phone: +47 55 70 70 95 | |
| E-mail: chandana@nordicneurolab.com | |
| Device Name: | fMRI Hardware System (nordicAktiva) |
| Device common Name: | Accessory to MRI System, Nuclear magnetic Resonance Imaging |
| Basis for submission: | Device modification with an update software (nordicAktiva) |
| Classification Regulation: | 21 CFR 892.1000 |
| Class: | II |
| Panel: | Radiology |
| Product Code: | LNH |
| Trade/Proprietary Name: | fMRI Hardware System |
| Predicate device name: | fMRI Hardware System (K191032) |
NordicNeuroLab AS – Traditional 510(k) fMRI Hardware System (nordicAktiva)
5
Device Description
Indication for use 1.1
The fMRI Hardware System is a stimulus presentation and response collection system intended to be used by trained professionals to facilitate auditory and visual stimulation to be used in functional MR Imaging (fMRI) based on BOLD contrast.
nordicAktiva is a stimulus presentation software intended to be used by trained professionals to facilitate auditory and visual stimulation to be used in functional MR imaging (fMRI)based on BOLD contrast. In addition, it records responses from the NordicNeuroLab ResponseGrips.
The device is indicated for use during BOLD fMRI examinations of individuals over 2 years of age. It is not intended for the diagnosis of disease or for the direct treatment of conditions.
nordicAktiva would be used in an MRI department of a hospital or clinic, when a functional MRI exam based on BOLD contrast is required involving the provision of visual or auditory stimulation to a subject inside the MRI scanner.
System Description 1.2
The system presents auditory and visual stimulus to the patient gives feedback through a pair of handheld grips. A synchronizes the stimulus presentation software with the MR scanner. The System consists of five subsystems: AudioSystem, ResponseGrip, SyncBox and nordicAktiva.
The system is used for fMRI studies. fMRI stands for functional Magnetic Resonance Imaging. This technique is primarily used for determining which area of the brain is responsible for specific processes controlling essential functions such as movement, speech, hearing, and vision. This information can form part of the pre-operative planning process in patients with brain tumors, for example. Functional MRI can also be used for research into specific neurological conditions or investigating cognitive function and networks in general.
The System is used to present the stimulus necessary to provoke physiological processes in the brain. Visual [VisualSystem] and auditory [AudioSystem] stimulus and manual responses from the patient [ResponseGrips] are of primary interest. The timing of the visual and auditory stimulation is critical to make sure that the correct MR image of the activated brain is linked to the stimulus presented. A synchronization unit [SyncBox], connected between the MR-scanner and the stimulus presentation software [nordicAktiva], is included in the system to make sure that the synchronization is correct.
6
Image /page/6/Figure/0 description: This image shows a diagram of a system with several components. The components include a SyncBox, Nordic Aktiva, Communication Console, Trigger Pulse (MR scanner), ResponseGrip Interface, and LCD. The diagram also shows the flow of audio and video signals between the components, as well as the location of the Technical Room.
Figure 1 presents the complete configuration of the fMRI Hardware System. All signals entering or leaving the scanner room are received and transmitted by use of fiber optics. The system allows video and audio signals from the stimulus PC to enter the shielded scanner room and to be presented to the subject hing inside the MR. The subject may be asked to respond to the stimulus by using handheld grips.
1.3 Sub-system components and description
1.3.1 VisualSystem
The VisualSystem allows video signals from the stimulus presentation PC to enter the shielded scanner room and to be presented to the patient through a set of coil-mounted displays [VisualSystem HD] or by an in-room LCD monitor, which they can see through a mirror mounted above their eyes.
1.3.2 Audio System
The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scanner room and to be presented to the patient wearing a set of headphones. Connection via a communication console provided by the MR vendor allows the operator to adjust the sound from the PC and to speak directly to the patient through an intercom system.
1.3.3 ResponseGrip
The purpose of this component is to collect patient responses during an fMRI study. The ResponseGrip consists of two hand-held grips with two buttons each. By pressing the patient can respond to the presented stimulus. These responses could be used to monitor the level of engagement and
NordicNeuroLab AS – Traditional 510(k) fMRI Hardware System (nordicAktiva)
510(k) Summary Page 3
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understanding during a task, or they could be used subsequently in the analysis of the BOLD imaging data. The ResponseGrip is connected to an optical-electrical adapter which converts light to electrical signals. The electrical signal is fed back to the Stimulus PC via the SyncBox, using standard PC communication interfaces.
1.3.4 Sync Box
The SyncBox receives a signal input (e.g. optical or TTL) from the MRI scanner at various times during a BOLD fMRI scan. It demodulates this signal before it is forwarded to the stimulus PC in order to start the presentation of stimuli. In this way one can ensure that the stimulus presentation software is synchronized with the MRI image recordings.
1.3.5nordicAktiva
nordicAktiva is a software that generates visual and auditory stimulus to the patient. The stimulus presentation is synchronized with the scanner through the SyncBox, and presented to the patient through the VisualSystem and AudioSystem. nordicAktiva records the responses fed to the Stimulus PC from ResponseGrip, as well as the synchronization pulses from the SyncBox. It also allows for the creation and modification of stimulus experiments, or 'paradigms', according to the user's needs.
1.4 Identification of Change to Unmodified Device
nordicAktiva will be updated with a new version.
1.4.1 Technological Characteristics and Substantial Equivalence
To summarize, the modified fMRI Hardware System is found substantially equivalent to the previously cleared device. The indications for use for the modified fMRI Hardware System have remained unchanged.
| Changes: | fMRI Hardware System,
K191032 [nordicAktiva] | Modified fMRI Hardware System
[nordicAktiva] |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Development framework | Embarcadero C++ Builder 2010 | Electron (back-end), Aurora (front
end) |
| Programming language | C++ | JavaScript |
| Operating environment | Windows 7, 8, 10 | Windows 10, 11 |
| Input data | Pulses from SyncBox
Paradigms coded in XML format
including media files for stimuli
(pictures, videos audio) | Pulses from SyncBox
Paradigms coded in XML format for
conversion to JSON
Media files for stimuli (pictures,
videos audio) |
| General software
functionality | Register patient
Select and run paradigm
containing stimuli (open source,
editable) | Select and run paradigm containing
stimuli
Test connections to system
hardware components (visual) |
NordicNeuroLab AS – Traditional 510(k) fMRI Hardware System (nordicAktiva)
8
| | Test connections to system
hardware components (visual
system, audio, ResponseGrip,
SyncBox)
Log responses from
ResponseGrip
Send design files to external
workstation | system, audio, ResponseGrip,
SyncBox)
Log responses from ResponseGrip
Create paradigms within the user
interface |
|--------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Output | Log files
Design files | Log files
Design files
Exported paradigms |
The rationale for determining the substantial equivalence between the previously cleared device and the modified fMRI Hardware System is based on the defined intended use, indications for use, and the technical and operational characteristics. To verify that the modified device fulfils the defined characteristics and requirements, it has been subject to extensive in-house testing. The successful completion of said tests verifies the claimed characteristics of the modified fMRI Hardware System, and thus supports the determination of substantial equivalence.
1.5 Summary of Testing
The fMRI Hardware System has been tested for function and safety and fulfills all requirement specifications.
1.5.1 Performance Testing
Prospectively defined verification activities for the nordicAktiva assure that the product meets design and performance specifications as well as user needs when operated according to the operating instructions.
Brief discussion of the nonclinical tests submitted, referenced, or relied on
Non-clinical performance testing has been performed on the nordicAktiva 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
The nordicAktiva 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.
The test results in this 510(k) premarket notification demonstrates that nordicAktiva:
NordicNeuroLab AS – Traditional 510(k) fMRI Hardware System (nordicAktiva)
9
- . Complies with the aforementioned international and FDA-recognized consensus standards and FDA guidance document, and
- . Meets the acceptance criteria and is adequate for its intended use and specifications.
Overall conclusion
The nordicAktiva is substantially equivalent to the identified predicate device, fMRI Hardware System nordicAktiva Software (K191032) in terms of core features, fundamental scientific technology, indications for use, and safety and effectiveness. Additionally, verification testing demonstrate the safety and efficacy of the device to meet its intended use and specifications.
NordicNeuroLab AS believes that the proposed device, nordicAktiva, is substantially equivalent to its identified predicate device and is as safe and effective as its predicate device without raising any new safety and/or effectiveness concerns.