MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE (FDAD), VERSION 1.0

K052571 · Neurognostics, Inc. · LNH · Oct 17, 2005 · Radiology

Device Facts

• Record ID: K052571
• Device Name: MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE (FDAD), VERSION 1.0
• Applicant: Neurognostics, Inc.
• Product Code: LNH · Radiology
• Decision Date: Oct 17, 2005
• Decision: SESE
• Submission Type: Special
• 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 functional Magnetic Resonance Imaging (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 tasks by the patient in response to the stimulus generates the functional 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 use of the four button response device and to ensure their understanding and the patient is allowed to practice the specific task. A short activation task is presented on the fDAD-PT control status of the present to be short activation task is presented on the fDAD-PT to ensure the patient is aware of the nature of the response to be provided.

Device Story

fDAD functions as data acquisition tool for fMRI procedures; integrates stimulus presentation with behavioral response collection. Device presents cognitive stimuli to patient; records binary responses from button input device. System ingests MR images in DICOM format from scanner control station; archives combined fMRI image data and behavioral response data to removable media. fDAD-PT module provides patient training on button response device and task execution prior to imaging. Used in clinical imaging environments; operated by healthcare professionals. Facilitates functional brain mapping by synchronizing behavioral data with BOLD-contrast MR imaging.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Data acquisition system for fMRI; inputs include DICOM images from MR scanner and binary behavioral responses from button interface. Outputs archived to removable media. Includes fDAD-PT training module. Connectivity via standard MR scanner interface.

Indications for Use

Indicated for use as a data acquisition tool in fMRI procedures based on BOLD contrast to collect patient behavioral responses to cognitive stimuli.

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)

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OCT 17 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Hrishikesh Gadagkar Director of Product Development and Manufacturing Neurognostics, Inc. 10437 W Innovation Way MILWAUKEE WI 53226

Re: K052571 Trade/Device Name: MindState Functional Data Acquisition Device (IDAD) Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: September 16, 2005 Received: September 21, 2005

Dear Mr. Gadagkar:

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 (Premarket Approval), 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.

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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin maneting your antial equivalence of your device to a legally premarket nothication. The I DA miding of bassification 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 If you desire specific advice for your device 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 notifications the Allso, please note the regulation entired, "Theoration on your responsibilities under the Act from the 807.97). You may obtain other general manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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

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Section D

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## Section D - Statement of Indications for Use

510(k) Number (if known): _K052571_

Device: Name: MindState Functional Data Acquisition Device (IDAD)

## Indications for Use:

The MindState Functional Data Acquisition Device (fDAD) is used as a data acquisition tool in The MindSuite Punctional Data requisition better (RMRI) 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 IDAD presents it summus to the patient and schools the nasks by the patient in response) device. Execution of specific cognitional data. The MMI data comprised of the MR images (in DICOM format) sent from the MR seanner control station, and the behavioral response (binary) data arc archived to a removable media by fDAD.

The IDAD-PT (fDAD Personal Trainer) is used to train the use of the four button The fDAD-P i (1DAD Personal Traner) is used is necessful the specific task. A
response device and to ensure their understanding and the patient is allowed to response device and to ensure men understanding and the patient is allowed to
short activation task is presented on the fDAD-PT control status of the present to be short activation task is presented on the IDAD I v essme of the nature of the response to be provided.

Preseription Use -× (Part 21 CFR 801 Subpart D)

Over-The-Counter Usc ANDIOR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BEJ.OW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

> ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Hymer

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K052571