ELOQUENCE, INTEGRATED FUNCTIONAL IMAGING SYSTEM

K023130 · Mri Devices Corp. · LNH · Oct 11, 2002 · Radiology

Device Facts

• Record ID: K023130
• Device Name: ELOQUENCE, INTEGRATED FUNCTIONAL IMAGING SYSTEM
• Applicant: Mri Devices Corp.
• Product Code: LNH · Radiology
• Decision Date: Oct 11, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

To be used in conjunction with a Magnetic Resonance Scanner to analyze data acquired using Blood Oxygen Level Dependent (BOLD) contrast techniques, such analysis that can be interpreted by a trained physician. The device provides dedicated visualization and analysis of MRI studies based on Blood Oxygen Level Dependent (BOLD) contrast which are useful for quantifying and visualizing small susceptibility changes in the human brain, created by the execution of specific tasks. These susceptibility images can presentation of information to support the diagnostic process. These images, when interpreted by a trained physician, vield information that may assist in diagnosis. Eloquence may also be used as a patient entertainment system, via its ability to deliver high quality audio and video to the patient.

Device Story

Eloquence is a stand-alone workstation for experiment presentation and post-processing of MRI data. It accepts BOLD contrast MRI data as input; processes data using standard statistical methods to quantify and visualize susceptibility changes in the brain resulting from specific tasks (e.g., finger tapping). Output consists of visualized images for physician interpretation to assist in diagnosis. Device also functions as a patient entertainment system delivering audio/video content. Used in clinical settings; operated by trained medical personnel. Benefits include enhanced visualization of functional brain activity to support diagnostic decision-making.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Stand-alone workstation for MRI data post-processing and experiment presentation. Supports BOLD contrast analysis. Includes integrated audio/video delivery system for patient entertainment. Software-based statistical analysis of susceptibility changes.

Indications for Use

Indicated for use with MRI scanners to analyze BOLD contrast data for visualization and quantification of susceptibility changes in the human brain during task execution. Intended for interpretation by trained physicians to assist in diagnosis. Includes patient entertainment functionality (audio/video).

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.

Predicate Devices

• IFIS-SA, Integrated Functional Imaging System (K003899)

Submission Summary (Full Text)

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## OCT 11 2002

510(K) Application. New Device, K003505 Model IFIS-SA Integrated Functional Imaging System,

Page- 28a 9/26/2002

## Section M - Special 510(k) Summary

K023130

## Special 510(K) Summary

This summary of this Special 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

- MRI Devices Corporation Company Name: 1515 Paramount Drive Waukesha, WI 53186
- Registration Number: 2184005
- William Jace Dinehart Contact Person: [e-mail]
- Telephone Number: 352.336.0010 X 154
- Prepared: September 26, 2002
- Eloquence, Integrated Functional Imaging System Device Name:
- Classification Name: Medical Specialty: Radiology,
- Class I (LNH) Classification:
- Functional Imaging System for Magnetic Resonance Imaging Common Name: System
- Predicate Devices: IFIS-SA, Integrated Functional Imaging System
- Device Description: Eloquence is a stand-alone experiment presentation and post-processing workstation. The Eloquence package supports the visualization and analysis of MRI studies based on Blood Oxygen Level Dependent (BOLD) contrast. The image contrast differs between scans as a result of the variation of blood oxygenation through task performance by the subject (e.g., finger tapping). BOLD data can be processed with Eloquence to provide analysis based on standard statistical methods.
- Eloquence, described in this submission, Intended Use: The device. provides dedicated visualization and analysis of MRI studies based on Blood Oxygen Level Dependent (BOLD) contrast which are useful for quantifying and visualizing small susceptibility changes in the human brain, created by the execution of specific tasks. These susceptibility images can

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Page- 28b 9/26/2002

presentation of information to support the diagnostic process. These images, when interpreted by a trained physician, vield information that may assist in diagnosis.

Eloquence may also be used as a patient entertainment system, via its ability to deliver high quality audio and video to the patient.

Safety Information:

No new safety hazards are introduced by the use of Eloquence.

William J. Dinkelaker

Dihehart Manager, Functional Imaging Business September 26, 2002

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Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN" written around the top half of the circle. Inside the circle is a stylized image of an eagle with three curved lines representing its wings. The eagle is facing left and appears to be in flight.

OCT 1 1 2002

Food and Drug Administration, 9200 Corporate Boulevard Rockville MD 20850

Mr. William J. Dinehart Manager MRI Devices Corporation 1515 Paramount Drive WAUKESHA WI 53186

Re: K023130

Trade/Device Name: Eloquence, Integrated Functional Imaging System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II

Product Code: 90 LNH Dated: September 26, 2002 Received: October 1, 2002

Dear Mr. Dinehart:

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 adultcration.

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); 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 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 Office of Compliance at one of the following numbers, based on the regulation . number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Nancy C. Snogdon

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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Special 510(K) Application, Device Modification Model Eloquence, Integrated Functional Imaging System, Page- 4 -09/18/02

## Section C – Statement of Indications for Use:

This statement of Indications for use of this device is unchanged from that of the predicate device IFIS-SA, Integrated Functional Imaging System - K003899

MRI Devices Corporation Applicant: KO23130 510(k) number (if known):_ Eloquence, Integrated Functional Imaging System Device Name:

Indications for use:

:

To be used in conjunction with a Magnetic Resonance Scanner to analyze data acquired using Blood Oxygen Level Dependent (BOLD) contrast techniques, such analysis that can be interpreted by a trained physician.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ XX (Per 21 CFR 801.109)

or

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

David A. Bergman