fMRI Hardware System
Device Facts
| Record ID | K191032 |
|---|---|
| Device Name | fMRI Hardware System |
| Applicant | Nordicneurolab AS |
| Product Code | LNH · Radiology |
| Decision Date | Nov 27, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1000 |
| Device Class | Class 2 |
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. The visual system 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 (VisualSystemHD) or by an in-room LCD monitor.
Device Story
System facilitates fMRI studies by providing synchronized auditory/visual stimuli and collecting patient responses. Components: AudioSystem (headphones/mic), VisualSystem (coil-mounted displays or LCD monitor), ResponseGrips (handheld buttons), SyncBox (timing synchronization), and nordicAktiva (stimulus presentation software). Used in MRI suites by trained professionals (technicians/physicians). SyncBox connects to MR scanner to receive timing pulses, ensuring stimulus presentation aligns with image acquisition. Patient responses via grips are recorded by nordicAktiva. Fiber optics transmit signals into shielded scanner rooms. Output allows clinicians to provoke brain activity for BOLD contrast imaging, aiding in cognitive function investigation and pre/post-operative brain tumor mapping.
Clinical Evidence
Bench testing only. Functional testing performed per internal protocols. Biocompatibility testing for rubber eye guard conducted per ISO 10993-5:2009 (cytotoxicity) and ISO 10993-10:2010 (skin irritation and sensitization). Electrical safety and EMC testing performed per IEC 60601-1 and IEC 60601-1-2.
Technological Characteristics
System uses fiber optics for signal transmission. VisualSystem HD features 1920x1200 resolution, HDMI input, and integrated eye-tracking. Biocompatible rubber eye guards tested per ISO 10993. SyncBox provides hardware-level synchronization with MR scanner timing pulses. System operates via stimulus PC running nordicAktiva software.
Indications for Use
Indicated for use by trained professionals to facilitate auditory and visual stimulation during functional MR Imaging (fMRI) based on BOLD contrast for patients undergoing brain imaging, including those with brain tumors for pre-operative and post-operative assessment.
Regulatory Classification
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).
Special Controls
*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.
Predicate Devices
- fMRI Hardware System (K092253)
Submission Summary (Full Text)
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November 27, 2019
NordicNeurolab AS Chandana Bhandari VP Quality Mollendalsveien 1 5009 BERGEN, NORWAY
Re: K191032
Trade/Device Name: fMRI Hardware System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: October 29, 2019 Received: October 31, 2019
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. 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 located 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.
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
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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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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,
Thalia Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known) K191032
#### Device Name
fMRI Hardware System (VisualSystem HD)
Indications for Use (Describe)
#### fMRI Hardware System
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.
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.
| Type of Use (Select one or both, as applicable) | <table style="border:none;"><tr><td><span> <span style="border: 1px solid black; padding: 0px 2px;"><b>X</b></span> Prescription Use (Part 21 CFR 801 Subpart D) </span></td><td><span style="padding-left:10px;"> <span style="border: 1px solid black; padding: 0px 2px;"></span> Over-The-Counter Use (21 CFR 801 Subpart C) </span></td></tr></table> | <span> <span style="border: 1px solid black; padding: 0px 2px;"><b>X</b></span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="padding-left:10px;"> <span style="border: 1px solid black; padding: 0px 2px;"></span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
|--------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span> <span style="border: 1px solid black; padding: 0px 2px;"><b>X</b></span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="padding-left:10px;"> <span style="border: 1px solid black; padding: 0px 2px;"></span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | | |
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# 510(k) Summary NordicNeuroLab AS fMRI Hardware System
| 510(k) Type: | Traditional: Device Modification |
|----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submission Date: | 25 November 2019 |
| Submitter: | NordicNeuroLab AS<br>Møllendalsveien 1<br>N-5009 Bergen<br>Norway<br>Phone: +47 55 70 70 95<br>E-mail: chandana@nordicneurolab.com<br>Establishment Registration Number: 3006738448 |
| Contact: | Chandana Gurung Bhandari<br>Møllendalsveien 1<br>N-5009 Bergen<br>Norway<br>Direct: +47 41 76 62 39<br>Phone: +47 55 70 70 95<br>E-mail: chandana@nordicneurolab.com |
| Legally marketed Device name and 510(k) number: | fMRI Hardware System. K092253 |
| Modified Device Name<br>Device Common Name:<br>Basis for Submission: | fMRI Hardware System<br>Accessory to MRI System, Nuclear Magnetic Resonance Imaging<br>Device Modification |
| Classification Regulation: | 21 CFR 892.1000 |
| Class:<br>Panel: | ll<br>Radiology |
Product Code: LNH
Trade/Proprietary Name: fMRI Hardware System
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# Device Description
## 9.1 Intended Use
#### fMRI Hardware system
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.
### Visual system
The visual system 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 (VisualSystemHD) or by an in-room LCD monitor.
## 9.2 System Description
The system presents auditory and visual stimulus to the patient gives feedback through a pair of handheld grips. A synchronization module synchronizes the stimulus presentation software with the MR scanner. The System consists of five subsystems: AudioSystem, VisualSystem, ResponseGrip, SyncBox and nordicAktiva.
The system is used for fMRI studies. fMRI stands for functional Magnetic Resonance Imaging. This technique is useful when determining certain diseases, gaining more information about a patient's condition or investigating cognitive functions. The technique is also used for examining the area of the brain affected in patients suffering from a brain tumor in both the pre-operative and post-operative stages.
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 audio stimulation is critical to make sure that the correct MR image of the brains activity is linked to the stimulus presented. A synchronization unit [SyncBox], connected between the MR-scanner and the stimulus presentation
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software [nordicAktiva], is included in the system to make sure that the synchronization is correct.
Image /page/5/Figure/1 description: The image shows a diagram of a system with several components, including a SyncBox, nordic Aciva, ResponseGrip Interface, and Communication Console. The SyncBox is connected to a "Trigger Pulse (MR scanner)" within a "Technical Room". The nordic Aciva is connected to the SyncBox, ResponseGrip Interface, and Communication Console, with "Audio" and "Video" connections to the console. The diagram also shows an LCD screen and a person inside a scanner, with "Video" and "Audio" connections to the Communication Console.
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 MR. The subject responds to the stimulus by using the handheld grips.
## 9.3 Sub-system components and description
#### 9.3.1 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.
#### 9.3.2 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. A communication console allows the operator to adjust the sound from the PC and to speak directly to the patient through a built-in microphone.
#### 9.3.3 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. The ResponseGrip is connected to an optical-electrical adapter which converts
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light to electrical signals. The electrical signal is fed to the Stimulus PC by using standard PC communication interfaces.
### 9.3.4SyncBox
The SyncBox is connected directly to the MRI scanner where it receives timing pulses sent out with each image series and demodulates this signal before it's forwarded to the stimulus PC. In this way one can ensure that the stimulus presentation software is synchronized with the MRI image recordings.
## 9.3.5nordicAktiva
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 the ResponseGrip, as well as the synchronization pulses from the SyncBox.
# 9.4 Identification of Change to Unmodified Device
The VisualSystem will be updated with a new version of the coil mounted displays [VisualSystem HD] for attachment to the MR head coil. The brand name for the new version is VisualSystem HD. The same video signal can be presented on the VisualSystem HD and the in-room LCD-monitor that was cleared in K092253. The operator has the choice to use either the VisualSystem HD or the in-room LCD monitor as before.
## 9.4.1 Technological Characteristics and Substantial Equivalence
To summarize, the modified fMRI Hardware System is found substantial equivalent to the previously cleared device. The modified system only has a new device added to display video. The indications for use for the modified fMRI Hardware System have remained unchanged.
| Changes: | fMRI Hardware System,<br>K092253 [Coil Mounted<br>Displays] | Modified fMRI Hardware System<br>[VisualSystem HD] |
|--------------------|-------------------------------------------------------------|----------------------------------------------------|
| Display Resolution | 800x600 pixels | 1920x1200 pixels |
| Video source | VGA - Standard PC video output | HDMI - Standard PC video output |
| EyeTracking | Separate unit | Integrated |
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 and lab 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.
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## 9.5 Summary of Testing
The fMRI Hardware System has been tested for function, biocompatibility and safety and fulfills all requirement specifications.
#### 9.5.1 Functional test
All functional testing was carried out as per internal test protocols. Testing involved performance and bench testing.
#### 9.5.2 Biocompatibility test results
The direct components of applied parts contacting with the users in the VisualSystem HD were tested for the following:
In Vitro cytotoxicity - Cytotoxicity testing was carried out in accordance to ISO 10993-5:2009 Biological Evaluation of Medical Devices – Part 5: Tests for In Vitro Cytotoxicity. Under the study, the test article (rubber eye guard) extract did not show potential toxicity.
Skin irritation - Skin irritation testing was carried out in accordance to ISO 10993-10:2010 Biological Evaluation of Medical Devices – Part 10.Under the conditions of the test article (rubber eye guard) extract did not show any significant evidence of causing skin irritations.
Skin Sensitization testing was carried out with accordance to ISO 10993-10:2010 Biological Evaluation of Medical Devices – Part 10: Under the conditions of the test article (rubber eye guard) extract did not induce signs of general toxicity. In coherence with the negligible proliferation response of the Lymph Node Cells (LNCs), the test items (rubber eye guard) was identified as a non-sensitizing agent in the LocaL Lymph Node Assay.
#### 9.5.3 Safety tests
Electrical safety and EMC safety testing was performed to, and passed, the following standards
- IEC 60601-1 Medical electrical equipment –Part 1: General requirements for basic safety and essential performance.
- IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance –Collateral standard: electromagnetic compatibility – Requirements and tests
