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 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.

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 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.

AI/ML Overview

The provided 510(k) summary (K080515) describes modifications to an fMRI Hardware System, specifically the addition of software named nordicAktiva. However, the document does not contain any information regarding specific acceptance criteria, device performance metrics (e.g., sensitivity, specificity, accuracy), or a detailed study proving the device meets these criteria in the context of an AI/algorithm-driven medical device submission.

The submission focuses on establishing substantial equivalence for a hardware system with an added software module that provides "the same basic functionality for stimulus presentation and data recording of the software currently used with the system."

Therefore, based solely on the provided text:

1. Table of acceptance criteria and the reported device performance:
Not applicable. The document does not specify quantitative acceptance criteria (e.g., performance metrics like sensitivity, specificity, or accuracy) for the device's diagnostic capabilities or define how the added software module's "performance" was measured against such criteria. The "Summary of Testing" merely states the system "has been tested for function and safety and fulfills all requirement specifications," which is a general statement rather than specific performance numbers against defined acceptance criteria.

2. Sample size used for the test set and the data provenance:
Not applicable. No sample size for a test set (e.g., patient cases, images) is mentioned because no clinical performance study demonstrating diagnostic efficacy against specific metrics for the added software is detailed. The testing described is functional and safety-related for the hardware system.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No ground truth establishment is described, as no clinical performance study requiring such a process is detailed.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. No adjudication method is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. The document does not describe an AI/algorithm for diagnostic interpretation. It is a stimulus presentation and response collection system. Therefore, no MRMC study or AI assistance effect size is discussed.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is a hardware system with software for stimulus presentation and data collection. It is not an AI algorithm intended for standalone diagnostic performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. No ground truth for diagnostic purposes is mentioned. The system's function is to present stimuli and collect responses for fMRI studies, which a trained physician then interprets.

8. The sample size for the training set:
Not applicable. There is no mention of a "training set" as the device does not employ machine learning or AI algorithms requiring such a set for its operation.

9. How the ground truth for the training set was established:
Not applicable. As there is no training set for an AI/ML algorithm, there is no description of how ground truth for such a set was established.

Summary based on the document:

The 510(k) submission for the fMRI Hardware System (K080515) is a "Special: Device Modification" focused on integrating a software module (nordicAktiva) into an existing, previously cleared hardware system (K073099). The core claim is that the added software provides "the same basic functionality for stimulus presentation and data recording" as third-party software previously used with the system. The submission relies on establishing substantial equivalence to the predicate device, with functional and safety testing for the hardware system being the primary evidence presented. It does not detail a clinical performance study with quantitative acceptance criteria typically associated with AI/algorithm-driven diagnostic devices.

Summary

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K080515

510(k) Summary

510(k) Type:	Special: Device Modification	MAY 16 2008
Submission Date:	02.18.2008
Submitter:	NordicNeuroLab ASMøllendalsveien 65CN-5009 BergenNorwayPhone: +47 55 70 70 95Fax: +47 55 70 70 96E-mail: stian@nordicneurolab.com
Contact:	Stian Scisly SagevikMøllendalsveien 65CN-5009 BergenNorwayDirect: +47 95 20 37 87Phone: +47 55 70 70 95Fax: +47 55 70 70 96E-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

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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 stimulus presentation PC hardware is not a part of the system.

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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-

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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

Page 2

Enclosure

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Indications for Use

510(k) Number (if known): K0805/5

Device Name: fMRI Hardware System

Indications for Use:

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

Regulation Number and Section

§ 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.