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 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.

AI/ML Overview

The provided document is a 510(k) summary for the Medical Visors MV100. It focuses on demonstrating substantial equivalence to a predicate device and MRI compatibility rather than clinical performance or diagnostic accuracy. Therefore, several aspects of the requested information, such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, and ground truth types for clinical performance, are not applicable or not provided in this regulatory submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this device is an accessory to MRI for patient comfort and has "no medical purpose," the acceptance criteria are related to its safety and compatibility within an MRI environment, rather than typical diagnostic performance metrics (e.g., sensitivity, specificity, accuracy).

Acceptance Criteria Category	Specific Criteria/Requirement	Reported Device Performance (Medical Visors MV100)
MRI Compatibility	Torque and Displacement: No significant torque or displacement within the static magnetic field or spatial gradient (for 3.0T MRI, 5 T/m spatial gradient).	"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."
	Image Artifacts: Acceptable impact on MRI image quality.	"The Medical Visors MV100 can reduce MRI image intensity by more than 20% in localized areas for the MRI images." (Note: The context implies this level of reduction is considered acceptable given the device's non-diagnostic purpose, and the overall conclusion is that it's equivalent to an MRI without the device for regulatory class 892.1000).
	RF Heating: Acceptable temperature rise of metallic components due to RF pulses.	"The metal surface rises less than 2ºC from RF pulses of a SAR of 2W/Kg."
	Patient Contact Materials: Materials in contact with patients must be FDA approved and provide insulation from heated components.	"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."
Safety Standards Conformance	Conformance with relevant medical electrical equipment safety standards for general safety and particular requirements for MR equipment.	"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.'"
MRI Conditional Labeling	Device must be determined "MR Conditional" for specified field strengths and operating modes.	Labeled as "MRI Conditional" with safety warnings for abnormal operation. "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."
Functional Equivalence	The device's use in an MRI environment should be equivalent to an MRI without the device, for the purposes of regulatory classification (i.e., not introducing unacceptable risks or interference that would change its classification).	"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." This is a general statement summarizing the findings related to MRI safety and compatibility, ensuring the device doesn't negatively impact the MRI's primary diagnostic function beyond acceptable limits.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated as a "sample size" in the context of patient data. The tests were likely conducted on the device itself and its components in an MRI environment.
Data Provenance: The study was conducted by "Exponent" (www.exponent.com), an independent testing lab. The location/country of the testing is not specified, but the submission is from the USA. These are engineering/physics tests, not clinical patient studies. The data is prospective (tests performed specifically for this submission).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable in the conventional sense. The "ground truth" here is compliance with engineering standards and pre-defined safety limits for MRI compatibility. The experts would be the engineers and scientists at Exponent performing the tests and comparing results against established international standards (IEC 60601-1, IEC 60601-2-33) and MRI safety guidelines. Their specific qualifications (e.g., MR physicists, biomedical engineers) are not listed.

4. Adjudication Method for the Test Set

Not applicable. This was not a subjective review of images or diagnoses requiring adjudication. It was objective physical testing against performance criteria.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an entertainment system, not an AI-powered diagnostic tool, and no MRMC study was performed. It doesn't assist human readers in interpretation.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The device is a hardware system for entertainment, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's acceptance is based on:

Established engineering safety standards (e.g., IEC 60601-1, IEC 60601-2-33).
Pre-defined safety limits and thresholds for MRI compatibility (e.g., torque, displacement, temperature rise, image artifact levels considered acceptable for a non-diagnostic accessory).
Material compatibility (FDA-approved materials).

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning or AI that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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

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: (818) 961-4622 Fax: (818) 880-8310

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:

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.

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

Device Comparison 21 CFR 807.92(a)(4)

Device	Proposed DeviceMEDICAL VISORS MV100	Predicate DeviceM.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-magneticcompatibility	RF metal shielding	RF metal shielding
Protection fromheating	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."

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

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)

{3}------------------------------------------------

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

{4}------------------------------------------------

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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 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

{5}------------------------------------------------

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.

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.

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

Page 1 of

Regulation Number and Section

§ 892.1000 Magnetic resonance diagnostic device.

(a)
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).(b)
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.