M.R. VISION 2000 ULTRA AUDIO VISUAL SYSTEM / COMMANDER X6 SYSTEM

K994351 · Resonance Technology, Inc. · LNH · Mar 22, 2000 · Radiology

Device Facts

• Record ID: K994351
• Device Name: M.R. VISION 2000 ULTRA AUDIO VISUAL SYSTEM / COMMANDER X6 SYSTEM
• Applicant: Resonance Technology, Inc.
• Product Code: LNH · Radiology
• Decision Date: Mar 22, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The M.R. Vision 2000 Ultra Audio Visual System / Commander X6 System is intended for use in the MRI environment to provide audio and visual to patients and thus improve patient comfort and aid in eliminating fear associated with MRI use.

Device Story

The M.R. Vision 2000 Ultra/Commander X6 is an MRI-compatible audio-visual accessory. It consists of specialized glasses for visual display and an audio transducer with a noise-canceling headset. The system provides 3D video (180,000 pixels) simulating a 60-inch screen and includes a microphone for two-way communication between the patient and the MRI technologist. The headset reduces gradient noise by up to 30 dB. Used in the MRI suite, the device is operated by clinical staff to enhance patient comfort and mitigate claustrophobia or anxiety during imaging sessions.

Clinical Evidence

Bench testing only. A study conducted by the UCLA Department of Neurology concluded the system is MRI compatible and MRI safe.

Technological Characteristics

MRI-compatible audio-visual system. Components include glasses for visual display, audio transducer, and noise-canceling headset. Features include 3D video capability (180,000 pixels) and two-way microphone communication. Noise reduction up to 30 dB.

Indications for Use

Indicated for patients undergoing MRI procedures to provide audio and visual stimulation, improve comfort, and reduce anxiety/fear associated with the MRI environment.

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

• Avocet Silent Scan (K921891)

Submission Summary (Full Text)

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K994357/

## Attachment I 510(K) Summary Resonance Technology, Inc M.R. Vision 2000 Ultra audio visual system

This 510(K) Summary of safety and effectiveness for the Resonance Technology, Inc M.R. Vision 2000 Ultra audio visual system is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.

| Applicant: | Resonance Technology, Inc. |
|--------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 18121 Parthenia Street<br>Northridge, CA 91325 |
| Contact Person: | Mokhtar Ziarati<br>President |
| Telephone: | [phone] - Phone<br>[phone] - Fax |
| Preparation Date: | December 12, 1999 |
| Device Trade Name: | M.R.Vision 2000 Ultra |
| Common Name:<br>Classification Name: | Accessory to MRI<br>System, Nuclear Magnetic Resonance Imaging<br>Product Code: LNH |
| Legally Marketed Predicate Device: | Avocet Silent Scan<br>K number K921891 |
| Description of the M.R. Vision 2000 Ultra<br>Audio Visual System / Commander X6<br>System | The system consists of a pair of glasses coupled with an<br>audio transducer and noise canceling headset. The headset<br>decreases gradient noise by up to 30 dB and includes a<br>microphone that permits two way communication between<br>the technologist and the patient. |
| | The video option provides an illusion of viewing a 60" screen<br>and can be viewed in 3D. Television can be viewed with<br>180,000 pixels. |
| Intended use of the M.R. Vision 2000<br>Ultra Audio Visual System / Commander<br>X6 System | The . M.R. Vision 2000 Ultra Audio Visual System /<br>Commander X6 System is intended for use in the MRI<br>environment to provide audio and visual to patients and thus<br>improve patient comfort and aid in eliminating fear<br>associated with MRI use. |
| Performance Data: | Study conducted by UCLS Dept of Neurology concludes<br>M.R. Vision 2000 Ultra Audio Visual System / Commander<br>X6 System is MRI Compatible and MRI Safe. |
| Conclusion: | The . M.R. Vision 2000 Ultra Audio Visual System /<br>Commander X6 System is substantially equivalent to other<br>existing audio visual systems used in the MRI environment in<br>commercial distribution. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 2 2000

Mokhtar Ziarati President Resonance Technology, Inc. 18121 Parthenia Street Northridge, CA 91325

Re:

K994351 M.R. Vision 2000 Ultra Audio Visual System/ Commander X6 System Dated: December 20, 1999 Received: December 23, 1999 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH

Dear Mr. Ziarati:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 pror 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). 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 recistration, listing of devices, good manufacturing and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either 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 895. A substantially equivalion assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notfication submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/odrh/dsmaldsmamain.html".

Sincerely yours,

Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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## INDICATION FOR USE STATEMENT

Pending K 994 351 510(k) Number: _______________________________________________________________________________________________________________________________________________________________

## Device Name M.R. Vision 2000 Ultra Audio Visual System / Commander X6 System

Indications for Use:

The M.R. Vision 2000 Ultra Audio Visual System / Commander X6 System is indicated for use as an accessory to the MRI environment to provide audio and visual to patients and thus improve patient comfort and aid in eliminating fear associated with MRI use.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_V (per 21 CFR 801.109)

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OR

Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT
and Radiological Devices

510(k) Number K994351