The MRIaudio PREM System with MRIview is intended to provide audio and visual entertainment to patients and facilitate patient communication in MRI environments up to, and including, 3.0 Tesla. The product is not intended for medical diagnosis or treatment. Technologist control units are intended to be used outside of the MRI scan room.

Device Description

The MRIaudio PREM System with MRIview is an MRI conditional audio and video solution that provides MRI patients with music, direct communication, and hearing protection. With the addition of the MRIview technology, the system provides MRI patients with video and allows technologists to view the patient.

AI/ML Overview

The provided document is a 510(k) summary for the MRIaudio PREM System with MRIview. This document primarily focuses on establishing substantial equivalence to a predicate device and does not detail specific acceptance criteria for a new performance claim or a comprehensive study proving a device meets such criteria in the way typically seen for AI/CADe devices.

In this case, the device is an MRI conditional audio and video solution intended to provide entertainment and communication in MRI environments, not for medical diagnosis or treatment. The performance data presented focuses on safety and not on diagnostic accuracy metrics.

Here's a breakdown based on the information provided, addressing your requested points directly where possible, and noting where the information is not applicable or unavailable in this document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (related to device safety/functionality)	Reported Device Performance
Magnetic Field Interactions at 3-Tesla: No adverse interaction.	No interaction
Electrical Safety (IEC 60601-1): Meets general requirements for basic safety and essential performance.	Compliant
Electromagnetic Compatibility (IEC 60601-1-2): Meets requirements and tests for electromagnetic disturbances.	Compliant
Effect on MR Image Quality: No adverse effect on MR image production in worst-case environment.	No adverse events reported, no adverse effect on MR image production.

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

Sample Size: Not explicitly stated for each test. For the "Magnetic field interactions at 3-Tesla" and electrical/EMC testing, these are typically conducted on a limited number of device units (prototypes or production samples). For the "clinical images," it's mentioned that "sample clinical images submitted exhibit a mix of pulse sequences and imaging options," but a specific number is not provided, implying this was a qualitative assessment rather than a quantitative study with a defined test set.
Data Provenance: Not specified. The clinical images seem to have been used to assess the device's impact on MRI image quality, but details regarding their origin (country, retrospective/prospective) are absent.

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

Not Applicable. The device is not intended for medical diagnosis or treatment, so there is no diagnostic "ground truth" to establish through expert review for its primary function. The assessment of MR image quality implies expert review, but the number and qualifications of experts are not mentioned.

4. Adjudication Method for the Test Set

Not Applicable. As there's no diagnostic ground truth derived from expert review mentioned, an adjudication method is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. An MRMC study is not mentioned as this device is not a diagnostic aid.

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

No. This device is an audio/video system, not an algorithm, so a standalone performance study in the context of diagnostic algorithms is not applicable.

7. The Type of Ground Truth Used

For the safety and performance tests (magnetic interactions, electrical safety, EMC), the "ground truth" is defined by the standards and test protocols themselves, which specify passing/failing criteria.
For the assessment of MR image quality, the "ground truth" is based on qualitative expert assessment that the device does not adversely affect MR image production. This is inferred from the statement "No adverse events were reported; therefore, the subject MRIaudio PREM System with MRIview does not adversely affect MR image production in the worst-case environment."

8. The Sample Size for the Training Set

Not Applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not Applicable. As this device does not use an AI/ML algorithm requiring a training set, ground truth for a training set was not established.

Summary

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January 6, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

MRIaudio, Inc. % Mr. Joseph Caruso Operations Manager 5909 Sea Lion Place, Suite F CARLSBAD CA 92010

Re: K193102

Trade/Device Name: MRIaudio PREM System with MRIview Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: November 6, 2019 Received: November 8, 2019

Dear Mr. Caruso:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS)

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regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name

MRIaudio PREM System with MRIview

Indications for Use (Describe)

The MRIaudio PREM System with MRIview is intended to provide audio and visual entertainment to patients off 'trekkeyg r clegveqo o wplecyq in MRI environments up to, and including, 3.0 Tesla. The product is not intended for medical"diagnosis or treatment. Technologist control units are intended to be used outside of the MRI scan room.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for MRIaudio. The text "MRIaudio" is in bold, black letters. To the right of the text is a circular graphic in teal, divided into four sections by white lines.

K193102

Traditional 510(k) Premarket Notification MRIaudio PREM System with MRIview

510(k) Summary

In accordance with Title 21 of the Code of Federal Regulations, Part 807, and 21 CFR §807.92, the following summary of information is provided:

A. Submitted by:

Joseph Caruso Operations Manager MRlaudio, Inc. 5909 Sea Lion Place, Suite F Carlsbad, CA 92010 Telephone: (858) 427-0679 Date Prepared: December 16, 2019

B. Device Name

Trade or Proprietary Name: Classification Name: Classification Regulation: Classification Panel: Device Class: Product Code:

MRIaudio PREM System with MRIview Magnetic Resonance Diagnostic Device 21 CFR § 892.1000 Radiology Class II LNH

C. Predicate Device

Trade or Proprietary Name: Maufacturer: 510(k) Clearance: Classification Regulation: Classification Name: Classification Panel: Device Class: Product Code:

MRIaudio PREM System MRlaudio K180100 21 CFR § 892.1000 Magnetic Resonance Diagnostic Device Radiology Class II LNH

D. Reference Device

Trade or Proprietary Name:

Maufacturer: 510(k) Clearance: Classification Regulation: Classification Name: Classification Panel: Device Class: Product Code:

M.R. VISION 2000 ULTRA AUDIO VISUAL SYSTEM / COMMANDER X6 SYSTEM Resonance Technology, Inc. K994351 21 CFR § 892.1000 Magnetic Resonance Diagnostic Device Radiology Class II LNH

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Image /page/4/Picture/0 description: The image shows the logo for MRLaudio. The logo consists of the text "MRLaudio" in a bold, sans-serif font, with the letters "MRL" being larger than the letters "audio". To the right of the text is a circular graphic that is divided into four quadrants by two intersecting lines. The graphic is teal in color and has a white circle in the center.

E. Device Description

F. Indications for Use

G. Technological Characteristics

As was established in this submission, the subject MRIaudio PREM System with MRlview is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have the same technological characteristics to its predicate device through comparison in areas including design, intended use, material composition, and function.

H. Performance Data

Testing was performed to demonstrate that the subject MRIaudio PREM System with MRIview is substantially equivalent to other predicate devices. The following bench testing was performed:

Test	Result
Magnetic field interactions at 3-Tesla	No interaction

The subject MRIaudio PREM System with MRIview has also been evaluated to the following standards:

Electrical Safety/Electromagnetic Compatibility
IEC 60601-1	Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
IEC 60601-1-2	Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests

The results of performance testing demonstrate that the subject MRIaudio PREM System with MRIview presents no adverse effect within the intended environment, and the subject device was therefore found to be substantially equivalent to the predicate.

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Image /page/5/Picture/0 description: The image shows the logo for MRLaudio. The logo consists of the text "MRLaudio" in a bold, sans-serif font, followed by a circular graphic. The graphic is divided into four quadrants, each filled with a teal color, creating a stylized, modern design.

Futher, sample clinical images submitted exhibit a mix of pulse sequences and imaging options in the axial, sagittal and coronal planes as recommended in FDA guidance, Submission Of Premarket Notifications for Magnetic Resonance Diagnostic Devices, issued November 18, 2016. No adverse events were reported; therefore, the subject MRIaudio PREM System with MRIview does not adversely affect MR image production in the worstcase environment.

l. Conclusions

Based on the indications for use, technological characteristics, and comparison to the predicate device, the subject MRIaudio PREM System with MRIview has been shown to be substantially equivalent to legally marketed predicate device.

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.