MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE, VERSION 1.0

K043290 · Neurognostics, Inc. · LNH · Jan 28, 2005 · Radiology

Device Facts

• Record ID: K043290
• Device Name: MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE, VERSION 1.0
• Applicant: Neurognostics, Inc.
• Product Code: LNH · Radiology
• Decision Date: Jan 28, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The MindState Functional Data Acquisition Device (fDAD) is used as a data acquisition tool in the MRI environment to perform functional MRI (fMRI) procedures based on Blood Oxygen Level Dependent (BOLD) contrast. fDAD presents a stimulus to the patient and collects the patient's responses from a button (response) device. Execution of specific cognitive or motor activation tasks by the patient in response to a set of stimuli creates the necessary behavioral data. The fMRI data comprised of the MR images (in DICOM format) sent from the MR scanner control station, and the behavioral response (binary) data are archived to a removable media by fDAD. The fDAD-PT (fDAD Personal Trainer) is used to train the patient in the use of the four button response device and to ensure their understanding and ability to perform the specific task. A short activation task is presented on the fDAD-PT control station and the patient is allowed to become familiar with the nature of the activation task and the nature of the response to be provided.

Device Story

MindState fDAD functions as data acquisition tool within MRI environment; facilitates fMRI procedures using BOLD contrast. Device presents visual/auditory stimuli to patient; collects behavioral responses via four-button input device. fDAD-PT (Personal Trainer) component trains patients on task performance and button usage prior to scanning. System integrates MR images (DICOM format) from scanner control station with binary behavioral response data; archives combined dataset to removable media. Used by clinicians to standardize patient activation tasks during fMRI; ensures patient compliance and understanding of cognitive/motor protocols. Output provides synchronized behavioral and imaging data for subsequent clinical analysis; benefits patient by ensuring high-quality, reliable functional data acquisition during neuroimaging.

Clinical Evidence

No clinical data provided; device is a data acquisition tool for fMRI environments.

Technological Characteristics

System includes fDAD acquisition unit and fDAD-PT training station. Interfaces with standard MRI scanners via DICOM. Utilizes four-button response device for patient input. Data output via removable media. Software-based stimulus presentation and data synchronization.

Indications for Use

Indicated for patients undergoing functional MRI (fMRI) procedures requiring cognitive or motor activation tasks to generate BOLD contrast data. Used in the MRI environment to facilitate stimulus presentation and behavioral response collection.

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.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. In the center of the circle is an abstract symbol that resembles a bird or a stylized human figure.

JAN 2 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Hrishikesh Gadagkar, Ph.D. Director of Product Development and Manufacturing Neurognostics, Inc. 10437 Innovation Drive, Suite 309 MILWAUKEE WI 53226

Re: K043290 Trade/Device Name: MindState Functional Data Acquisition Device (fDAD) Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: November 26, 2004 Received: December 10, 2004

Dear Dr. Gadagkar:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have levice your becaller better by probation (for the indications for use stated in above and nave decemined the ad predicate devices marketed in interstate commerce prior to the cliciosure) to regarly manusical Device Amendments, or to devices that have been May 20, 1770, the citted in accordance of the Federal Food, Drug, and Cosmetic Act (Act) that reclassified in accondation warmarket approval application (PMA). You may, therefore, market the do not require approval of a premance 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 (Premarket rryour de rice is classilled (000 as 11 additional controls. Existing major regulations affecting your Apployal), It inal 60 babyer to and Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA device ban of tound mouncements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination docs not mean that Ficast be advised that i 271 o total 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 I cacrat statues and regulaing, but not limited to registration and listing (21 CFR Part 807); labeling ACC S requirements, metading, bactive practice requirements as set forth in the quality systems (QS) (21 CFR Part 801); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

{1}------------------------------------------------

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to ocgin marketing your antial equivalence of your device to a legally premarket notification. The FDA Inding of substantial organities 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), pleased If you desire specific advice for your device on our laceming regains. In ( 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 the Also, please note the regulation entitled, "Thisoration on your responsibilities under the Act from the 807.97). You may outler general meanal on on your Assistance at its toll-free number (800).
Division of Small Manufacturers, International and Consumer Assistance at and 1711sion of 301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/dsmadsmamain.html

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows a logo for a company called "Neurognostics". The logo includes an image of a human head on the left side. Below the company name is the text "Functional MR imaging".

Section D - 1

## SECTION D - STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: MindState Functional Data Acquisition Device (fDAD)

## Indications for Use:

The MindState Functional Data Acquisition Device (fDAD) is used as a data acquisition tool in the MRI environment to perform functional MRI (fMRI) procedures based on Blood Oxygen Level Dependent (BOLD) contrast.

fDAD presents a stimulus to the patient and collects the patient's responses from a button (response) device. Execution of specific cognitive or motor activation tasks by the patient in response to a set of stimuli creates the necessary behavioral data. The fMRI data comprised of the MR images (in DICOM format) sent from the MR scanner control station, and the behavioral response (binary) data are archived to a removable media by fDAD.

The fDAD-PT (fDAD Personal Trainer) is used to train the patient in the use of the four button response device and to ensure their understanding and ability to perform the specific task. A short activation task is presented on the fDAD-PT control station and the patient is allowed to become familiar with the nature of the activation task and the nature of the response to be provided.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

text
Nancy Brogdon
(Division Sign-Off)
sion of Reproductive, Abdominal,
Radological Devices

*
*

C Neurognostics, Inc. 2004

5 F(x) Number _

MindState fDAD 510(k)