(223 days)
Not Found
No
The document describes a system for presenting stimuli and collecting responses during fMRI, focusing on hardware components and synchronization. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes.
The device facilitates auditory and visual stimulation, used in fMRI studies to provoke physiological processes in the brain, determining certain diseases, gaining more information about a patient's condition, or investigating cognitive functions, which are therapeutic purposes.
No
Explanation: The device is described as a stimulus presentation and response collection system for fMRI studies. Its purpose is to present stimuli to a patient and collect feedback, which then facilitates the fMRI imaging process. While fMRI is used for diagnostic purposes, this specific device facilitates the imaging and data collection, rather than performing the diagnosis itself by analyzing the fMRI data to identify diseases or conditions. The "Intended Use" explicitly states it is "to facilitate auditory and visual stimulation to be used in functional MR Imaging (fMRI) based on BOLD contrast," not to interpret the fMRI images for diagnosis.
No
The device description explicitly lists multiple hardware components (AudioSystem, VisualSystem, ResponseGrip, SyncBox) in addition to the software (nordicAktiva).
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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device is a hardware system used to present stimuli (auditory and visual) and collect responses during functional Magnetic Resonance Imaging (fMRI). It facilitates the fMRI process itself, which is an in vivo (within the living body) imaging technique.
- Lack of Sample Analysis: The device does not analyze any biological samples taken from the patient. Its function is to interact with the patient during the imaging procedure.
- Focus on Stimulus and Response: The core function is to provide stimuli and collect responses, which are then correlated with the fMRI data acquired by the MR scanner.
The device is a component used in an in vivo diagnostic imaging procedure (fMRI), but it is not an in vitro diagnostic device itself.
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.
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.
Product codes
LNH
Device Description
The fMRI Hardware System is a stimulus presentation and response collection system. It presents auditory and visual stimuli to the patient and collects feedback through a pair of handheld grips. A synchronization module (SyncBox) synchronizes the stimulus presentation software (nordicAktiva) with the MR scanner. The system consists of five subsystems: AudioSystem, VisualSystem, ResponseGrip, SyncBox, and nordicAktiva. 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.
A modification to the VisualSystem has been made, updating it with a new version of coil-mounted displays (VisualSystem HD) for attachment to the MR head coil, increasing the display resolution from 800x600 pixels to 1920x1200 pixels and changing the video source from VGA to HDMI. EyeTracking is also now integrated rather than being a separate unit.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
functional MR Imaging (fMRI) based on BOLD contrast
Anatomical Site
brain
Indicated Patient Age Range
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Intended User / Care Setting
trained professionals
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The fMRI Hardware System has been tested for function, biocompatibility and safety and fulfills all requirement specifications.
Functional test: All functional testing was carried out as per internal test protocols, involving performance and bench testing.
Biocompatibility test results: Direct components of applied parts contacting with the users in the VisualSystem HD (rubber eye guard) were tested for In Vitro cytotoxicity, Skin irritation, and Skin Sensitization.
- In Vitro cytotoxicity: carried out according to ISO 10993-5:2009. The test article extract did not show potential toxicity.
- Skin irritation: carried out according to ISO 10993-10:2010. The test article extract did not show any significant evidence of causing skin irritations.
- Skin Sensitization: carried out according to ISO 10993-10:2010. The test article extract did not induce signs of general toxicity and was identified as a non-sensitizing agent in the LocaL Lymph Node Assay.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health & Human Services logo features a stylized human figure, while the FDA part includes the acronym "FDA" in a blue square, followed by "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
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) | X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) | X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|---|---|
| X 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
| 510(k) Type: | Traditional: Device Modification |
|---|---|
| Submission Date: | 25 November 2019 |
| 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 | |
| Legally marketed Device name and 510(k) number: | fMRI Hardware System. K092253 |
| Modified Device Name | |
| Device Common Name: | |
| Basis for Submission: | fMRI Hardware System |
| Accessory to MRI System, Nuclear Magnetic Resonance Imaging | |
| Device Modification | |
| Classification Regulation: | 21 CFR 892.1000 |
| Class: | |
| Panel: | ll |
| 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,
K092253 [Coil Mounted
Displays] | Modified fMRI Hardware System
[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