(81 days)
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No
The document describes a hardware system for presenting stimuli and collecting responses during fMRI. It focuses on synchronization and signal transmission, with no mention of AI or ML for data analysis or interpretation.
No.
The device is intended to facilitate stimulation and collect responses to assist in the diagnosis of brain pathology and for planning and monitoring of medical treatments, but it does not directly treat or cure any condition.
Yes
The fMRI Hardware System is intended to "assist in the diagnosis of brain pathology" when its data is "interpreted by a trained physician," explicitly stating a diagnostic purpose.
No
The device description explicitly lists multiple hardware components (AudioSystem, VisualSystem, ResponseGrip, SyncBox) in addition to the software (nordicAktiva).
Based on the provided information, the fMRI Hardware System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: An IVD is a medical device that is used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- fMRI Hardware System function: The fMRI Hardware System is a stimulus presentation and response collection system. It facilitates auditory and visual stimulation and collects behavioral responses from the patient directly, not from a specimen taken from the patient.
- Role in diagnosis: While the data collected by the system may assist in the diagnosis of brain pathology when interpreted by a trained physician, the system itself is not performing the diagnostic test on a biological sample. It's providing input and collecting output related to the patient's physiological response in vivo during an fMRI scan.
The system's function is to interact with the patient and the fMRI scanner to acquire data related to brain activity, which is then interpreted by a physician. This is distinct from the function of an IVD, which analyzes biological samples.
N/A
Intended Use / Indications for Use
The NordicNeuroLab 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 evoke physiological processes detectable by the MRI scanner and to collect behavioral responses from the patient. These data, when interpreted by a trained physician, may assist in the diagnosis of brain pathology and may be used in the planning and monitoring of medical treatments.
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.
Product codes (comma separated list FDA assigned to the subject device)
LNH
Device Description
The NordicNeuroLab fMRI Hardware System is a stimulus presentation and response collection system. The system presents auditory and visual stimulus to the patient gives feedback through a pair of handheld grips. A synchronization module synchronizes the nordicAktiva stimulus presentation software with the MR scanner. The System consists of five subsystems: AudioSystem, VisualSystem, ResponseGrip, SyncBox and nordicAktiva. The system allows video and audio signals from the stimulus PC to enter the shielded scanner room and to be presented to the subject lying inside the MR. The subject responds to the stimulus by using the handheld grips. All signals entering or leaving the scanner room are received and transmitted by use of fiber optics. The stimulus presentation PC hardware is not a part of the system.
Sub-system components and description:
- 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.
- 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 sounds from the PC and to speak directly to the patient through a built-in microphone.
- ResponseGrip: Collects patient responses during an fMRI study. Consists of two hand-held grips with two buttons each. Connected to an optical-electrical adapter which converts light to electrical signal fed to the Stimulus PC by using standard PC communication interfaces.
- SyncBox: 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 to ensure synchronization of stimulus presentation software with MRI image recordings.
- nordicAktiva: 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
functional Magnetic Resonance Imaging (fMRI)
Anatomical Site
Brain
Indicated Patient Age Range
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Intended User / Care Setting
Trained professionals / Not Found
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 and safety and fulfills all requirement specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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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510(k) Summary
| 510(k) Type: | Special: Device Modification | MAY 16 2008 |
|---|---|---|
| Submission Date: | 02.18.2008 | |
| Submitter: | NordicNeuroLab AS | |
| Møllendalsveien 65C | ||
| N-5009 Bergen | ||
| Norway |
Phone: +47 55 70 70 95
Fax: +47 55 70 70 96
E-mail: stian@nordicneurolab.com | |
| Contact: | Stian Scisly Sagevik
Møllendalsveien 65C
N-5009 Bergen
Norway
Direct: +47 95 20 37 87
Phone: +47 55 70 70 95
Fax: +47 55 70 70 96
E-mail: stian@nordicneurolab.com | |
| Legally marketed Device name and 510(k) number: fMRI Hardware System. K073099 | | |
| Modified Device Name | fMRI Hardware System |
|---|---|
| Device Common Name: | Accessory to MRI System, Nuclear Magnetic Resonance Imaging |
| Basis for Submission: | Device Modification with a new software |
| Classification Regulation: | 21 CFR 892.1000 |
| Class: | II |
| Panel: | Radiology |
| Product Code: | LNH |
| Trade/Proprietary Name: | fMRI Hardware System |
:
Special 510(k) fMRI Hardware System
:
510(k) Summary Attachment 1
:
1
Device Description
3.1. Intended Use
The NordicNeuroLab 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 evoke physiological processes detectable by the MRI scanner and to collect behavioral responses from the patient. These data, when interpreted by a trained physician, may assist in the diagnosis of brain pathology and may be used in the planning and monitoring of medical treatments.
This is the same intended use as previously cleared for the fMRI Hardware System, K073099.
3.2. 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 nordicAktiva stimulus presentation software with the MR scanner. The System consists of five subsystems: AudioSystem, VisualSystem, ResponseGrip, SyncBox and nordicAktiva.
The intended use of the system is to support 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 to patients suffering from a brain tumor in both the pre-operative and post-operative stage by examining the area of the brain affected.
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. As the timing of the data is critical to make sure that the correct MR image of the brain activity is linked to the stimulus presented, a synchronization unit [SyncBox] connected between the MR-scanner and the PC running nordicAktiva, a stimulus presentation software, is included in the System to make sure that the synchronization is correct.
The stimulus presentation PC hardware is not a part of the system.
Figure 1 presents the complete configuration of the fRMI 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 lying inside the MR. The subject responds to the stimulus by using the handheld grips.
2
Image /page/2/Figure/1 description: The image shows a diagram of a technical room setup with various components. A stimulus PC is connected to a SyncBox and an optical electrical adapter. The PC is also connected to a communication console via audio and VGA cables, which is further connected to a fiber optic transmitter. The technical room contains a rack with components such as an electrostatic energizer, fiber optic receiver, OLED interface, and power supply, along with a trigger pulse (MR scanner) and penetration panel.
Figure 2: Complete configuration
3.3. Sub-system components and description
3.3.1. VisualSystem
The VisualSystem allows video signals from the stimulus presentation PC to enter the shielded scanner room and to be presented to the patient trough a set of coil-mounted displays.
3.3.2. AudioSystem
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 sounds from the PC and to speak directly to the patient through a built-in microphone.
3.3.3. 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 buttons the patient can respond to the presented stimulus. The ResponseGrip is connected to an optical-
3
electrical adapter which converts light to electrical signal is fed to the Stimulus PC by using standard PC communication interfaces.
3.3.4. SyncBox
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.
3.3.5. nordicAktiva
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.
3.4. Identification of Change to Unmodified Device
Special presentation software running on a PC connected to the fRMI Hardware System is required to run the stimulus presentation and to record and collect data on responses from the patient. Previously the end-user have been required to attain such software to be used with the system
Now such stimulus presentation software have been amended to the fMRI Hardware System as a subsystem and named nordicAktiva. This software provides the same basic functionality for stimulus presentation and data recording of the software currently used with the system.
The addition of the software nordicAktiva to run stimulus and record responses on the stimulus presentation PC is the only modification made to the fMRI Hardware System.
3.5. Statement of Substantial Equivalence
To summarize, the modified fMRI Hardware System is found substantial equivalent to the previously cleared device. The modified system only amends a software package that the end users are required to attain from other 3'rd party software vendors today, and with that the indications for use have remained unchanged for the modified fMRI Hardware System.
3.6. Summary of Testing
The fMRI Hardware System has been tested for function and safety and fulfills all requirement specifications.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 6 2008
Mr. Stian Scisly Sagevik Quality Manager NordicNeuroLab AS Møllendalsveien 56C N-5009 Bergen NORWAY
Re: K080515
Trade/Device Name: fMRI Hardware System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: April 2, 2008 Received: April 7, 2008
Dear Mr. Sagevik:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and. adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/odrb/industry/support/index.html.
Sincerely yours,
Nancy Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Enclosure
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Indications for Use
510(k) Number (if known): K0805/5
Device Name: fMRI Hardware System
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.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
forni M. Khan
Page of of
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K080515 Indications for Use
Special 510{k) fMRI Hardware System
Attachment 2