MEDICAL VISORS MV100

K103507 · Medical Visors, Inc. · LNH · Feb 8, 2011 · Radiology

Device Facts

• Record ID: K103507
• Device Name: MEDICAL VISORS MV100
• Applicant: Medical Visors, Inc.
• Product Code: LNH · Radiology
• Decision Date: Feb 8, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

Medical Visors MV100 is intended for use in an MRI environment to provide audio-visual entertainment in order to improve patient comfort and calm patients. The Medical Visors MV100 have been shown to be "MR Conditional" for field strengths up to (and including) 3T and with the MR system operating in the Normal Operating Mode (average WB SAR <2W/kg) only. Medical Visor MV100 is not recommended for diagnostic exams of the eyes, eye canal, ear, ear canal and nose. The user is instructed to keep the control unit outside of the imaging field of view. The patient must be given the standard ear plug hearing protection for the MRI used. The MV100 is not a hearing protection device. The MV100 should not be used if the MR noise level with ear plug protection is within 6dB of noise limit. The MV100 should not be used if the technician has critical communication with the patient, such as a lung scan.

Device Story

Self-contained audio-visual entertainment system for MRI patients; consists of video glasses, headphones, and handheld controller. Inputs: media stored on semiconductor memory card. Operation: battery-powered (3.2 Ah 3.8 V Li-ion) system worn by patient inside MRI bore. Output: audio and video content to patient. Used in MRI suite; operated by patient. Healthcare providers use device to improve patient comfort/compliance during imaging. Benefits: reduced patient anxiety/fear. Safety features: RF metal shielding, 3/8-inch thick insulating foam for heat protection, non-magnetic speakers. Device is MR Conditional up to 3T.

Clinical Evidence

Bench testing only. Independent testing by Exponent confirmed MR Conditional status. Results: no torque or displacement in 3.0T static field or 5 T/m spatial gradient; metal surface temperature rise <2ºC at 2W/kg SAR; device uses FDA-approved materials for patient-contact components. Conforms to IEC 60601-1 and IEC 60601-2-33.

Technological Characteristics

Materials: FDA-approved plastics, 3/8-inch silicone foam insulation. Power: 3.2 Ah 3.8 V Li-ion battery. Components: LCD video glasses, non-magnetic headphones, handheld controller. Connectivity: Semiconductor memory card (standalone). Safety: RF metal shielding. Standards: IEC 60601-1, IEC 60601-2-33 (2008).

Indications for Use

Indicated for patients undergoing MRI procedures to provide audio-visual entertainment for comfort and anxiety reduction. Contraindicated for diagnostic exams of eyes, eye canal, ears, ear canal, and nose; not for use if MR noise levels exceed safety limits or when critical patient communication is required.

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

• M.R. Vision 2000 Ultra (K994351)

Submission Summary (Full Text)

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K103507

p /3

FEB - 8 2011

## 5. 501(k) Summary:

## 510(k) Section E:

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

Medical Visors Inc. Submitter: 3834 Orchid Lane, Suite B Calabasas, CA 91302 Phone: [phone] Fax: [phone]

Contact: Brian Hughes, President

Preparation date: 12/29/10

## Product name (trade & common):

Proprietary: Medical Visors MV100 Common: Accessory to MRI

#### Classification name:

System: Nuclear Magnetic Resonance Imaging Regulatory: Class II, CRF 892.1000 Product code: 90 LHN

#### Predicate device:

M.R. Vision 2000 Ultra, Resonance Technologies, Inc. K-994351

#### Device description:

Medical Visors MV100 is a self-contained video and audio entertainment system to be worn by patients during an MRI procedure. A patient wears a system comprised of video glasses and headphones unit on their head and holds a controller in their hand.

#### Intended use:

Medical Visors MV100 is intended for use in an MRI environment to provide audio-visual entertainment to improve patient comfort and calm patients.

The product has no medical purpose. The product operates with battery power and requires no modification to MRI facilities. The product operates in an MRI environment with no significant influence on an MRI image when used as directed, and with no harm to patients.

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#### Device Comparison 21 CFR 807.92(a)(4)

| Device | Proposed Device<br>MEDICAL VISORS MV100 | Predicate Device<br>M.R. VISION 2000 ULTRA |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Medical Visors MV100 is intended for use in an MRI environment in order to provide audio-visual entertainment to improve patient comfort and calm patients. | The M.R Vision 2000 Ultra Audio Visual System/ Commander X6 System is intended for use in an MRI environment to provide audio and visual to patients and thus improve patient comfort and aid in eliminating fear associated with MRI use. |
| Use environment | On patients in MRI magnetic bore. | On patients in MRI magnetic bore. |
| Visual display | LCD screen | LCD screen |
| Audio speakers | Non-magnetic speaker in headphones | Non-magnetic speaker in headphones |
| Electro-magnetic<br>compatibility | RF metal shielding | RF metal shielding |
| Protection from<br>heating | 3/8 inch thick insulating foam | Insulating foam |
| Exterior material | FDA approved plastic | Unknown plastic |
| Entertainment source | Semiconductor memory card | External player in control room |
| Power source | 3.2 Ah 3.8 V Li-ion battery | External power supply |
| Labeling | "MRI Conditional" Safety warning for abnormal operation | Unknown |

### Performance Data:

Study conducted by "Exponent" (www.exponent.com), an independent testing lab, concluded the Medical Visors MV100 System is MRI compatible and MRI Conditional. The Medical Visors MV100 did not exhibit any torque or displacement effects within the influence of the 3.0T static field or the spatial gradient of 5 T/m associated with the 3.0T static field. The Medical Visors MV100 can reduce MRI image intensity by more than 20% in localized areas for the MRI images. The metal surface rises less than 2ºC from RF pulses of a SAR of 2W/Kg. No metal surface comes into contact with the patients; all metal surface are heat insulated by 34 inch silicone foam or hard plastic. The body and cable of Medical Visors MV100 System, which does come in contact with the patients, are fabricated from FDA approved materials.

An MRI with Medical Visors MV100 is equivalent to a MRI without a Medical Visors MV100, which conforms to standard for a regulatory class 892.1000 device. Medical Visors MV100 conforms to standard IEC 60601-1, "Medical Electrical Equipment—Part 1: General Requirements for Safety" and IEC 60601-2-33 (2008) "Medical Electrical Equipment - Part 2-33: Particular Requirements for the Safety of Magnetic Resonance Equipment for Medical Diagnosis."

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## Conclusion:

The Medical Visors MV100 is substantially equivalent to other existing audiovisual systems used in the MRI environment in commercial distribution.

(Signature)
```

Brian Hughes
`(Typed Name)`

11/28/10
```
(Date)

Not issued, New product ___*(Premarket Notification [510(k)] Number)

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The logo is black and white.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

FEB - 8 201

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Brian Hughes, PhD. President Medical Visors, Inc. 3834 Orchid Lane. Suite B CALABASAS CA 91302

Re: K103507

Trade/Device Name: Medical Visors MV100 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: November 7, 2010 Received: November 29, 2010

#### Dear Dr. Hughes:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html,

Sincerely Yours.

Mary S Postel

Mary Pastel, ScD. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K103507

Device Name: Medical Visors MV100

Indications for Use:

Medical Visors MV100 is intended for use in an MRI environment to provide audio-visual entertainment in order to improve patient comfort and calm patients.

The Medical Visors MV100 have been shown to be "MR Conditional" for field strengths up to (and including) 3T and with the MR system operating in the Normal Operating Mode (average WB SAR <2W/kg) only.

Medical Visor MV100 is not recommended for diagnostic exams of the eyes, eye canal, ear, ear canal and nose. The user is instructed to keep the control unit outside of the imaging field of view.

The patient must be given the standard ear plug hearing protection for the MRI used. The MV100 is not a hearing protection device. The MV100 should not be used if the MR noise level with ear plug protection is within 6dB of noise limit. The MV100 should not be used if the technician has critical communication with the patient, such as a lung scan.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S. Patel
(Division Size: 082

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Number K103507

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