(72 days)
No
The summary describes a hardware system for presenting stimuli and collecting responses during fMRI, with no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is used to facilitate auditory and visual stimulation for fMRI, which is a diagnostic imaging technique, not a therapeutic intervention.
No
Explanation: The device is described as a "stimulus presentation and response collection system" used to "facilitate auditory and visual stimulation" in fMRI. Its purpose is to present stimuli to the patient and collect feedback, not to interpret or diagnose medical conditions itself. It's a tool for data collection in fMRI studies, which can be used for research or diagnostic purposes, but the device itself is not a diagnostic device.
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 fMRI Hardware System is described as a "stimulus presentation and response collection system" used to facilitate auditory and visual stimulation during fMRI. It interacts with the patient directly by presenting stimuli and collecting responses via handheld grips.
- Lack of Sample Analysis: The description does not mention the analysis of any biological samples taken from the patient. The system's function is to provide input (stimuli) and collect output (responses) during an imaging procedure.
Therefore, the device's purpose and operation do not align with the definition of an in vitro diagnostic. It is a system used in conjunction with an imaging modality (fMRI) to gather data about brain activity in response to stimuli.
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.
Product codes
LNH
Device 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 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. 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 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
Not Found
Intended User / Care Setting
trained professionals
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.
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
NordicNeuroLab AS Bergen, Norway
510(k) Summary
Special: Device Modification 510(k) Type: July 20th, 2009 Submission Date:
- Submitter:
NordicNeuroLab AS · Møllendalsveien 65C N-5009 Bergen Norway
Phone: +47 55 70 70 95 +47 55 70 70 96 Fax: E-mail: chandana@nordicneurolab.com Establishment Registration Number: 3006738448
Contact:
Chandana Gurung Bhandari 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: chandana@nordicneurolab.com
Legally marketed Device name and 510(k) number: fMRI Hardware System. K080515
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: Product Code:
Radiology LNH
ll
Trade/Proprietary Name:
fMRI Hardware System
page 1 of 4
510(k) Summary Attachment 1
Special 510(k) fMRI Hardware System
OCT - 8 2009
:
1
Device Description
3.1. Intended 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.
This is the same intended use as previously cleared for the fMRI Hardware System, K080515.
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 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. 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 software (nordicAktiva), is included in the system to make sure that the synchronization is correct.
page 2 of 4
510(k) Summary Attachment 1
Special 510(k) fMRI Hardware System
2
NordicNeuroLab AS Bergen, Norway
Image /page/2/Figure/1 description: The image shows a diagram of a system with several components. The components include a SyncBox, Nordic Aciva, Communication Console, ResponseGrip Interface, and an LCD screen. The diagram also shows the flow of audio and video signals between the components, as well as a trigger pulse from an MR scanner.
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.
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 or an in-room LCD monitor.
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 sound 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 patient can respond to the presented stimulus. The ResponseGrip is connected to an optical-electrical adapter which converts
Special 510(k) fMRI Hardware System
510(k) Summary
3
light to electrical signals. The 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
The VisualSystem will be expanded with the option of using an in-room LCD monitor instead of the coilmounted display. The LCD monitor is placed outside magnets bore behind the MR scanner and is in no physical contact with the patient. The same video signal can be presented on the coil-mounted display and the in-room LCD-monitor. The operator has the choice to use either the coil mounted display or the in-room LCD monitor.
3.5. Statement of Substantial Equivalence
To summarize, the modified fMR! 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.
3.6. Summary of Testing
The fMRI Hardware System has been tested for function and safety and fulfills all requirement specifications.
page 4 of 4
510(k) Summary Attachment 1
Special 510(k) fMRI Hardware System
4
Image /page/4/Picture/0 description: The image shows a logo with three curved lines stacked on top of each other. The lines are thicker at the bottom and become thinner as they rise. To the left of the lines, there is a partial word that appears to be vertically oriented. The logo is simple and abstract.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mrs. Chandana Gurung Bhandari Quality Manager NordicNeuroLab Møllendalsveien, Bergen, Hordaland, N-5009 NORWAY
OCT - 8 2009
Re: K092253
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: September 9, 2009 Received: September 14, 2009
Dear Mrs. 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. 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 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
5
Page 2 -
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourceforYou/Industry/default.htm
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
NordicNeuroLab AS Bergen, Norway
Indications for Use
510(k) Number (if known): K092253
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)
510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Norm M. Khan
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device
Special 510(k) fMRI Hardware System
Indications for Use Attachment 2