MRIaudio PREM System

K180100 · Mriaudio · LNH · Jun 14, 2018 · Radiology

Device Facts

• Record ID: K180100
• Device Name: MRIaudio PREM System
• Applicant: Mriaudio
• Product Code: LNH · Radiology
• Decision Date: Jun 14, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The MRlaudio PREM system is intended to provide audio entertainment 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 Story

MRIaudio PREM system provides audio entertainment, patient-technologist communication, and hearing protection for patients in MRI environments up to 3.0 Tesla. System consists of patient-side audio components and technologist control units located outside the MRI scan room. Device facilitates communication and patient comfort during scanning; does not perform medical diagnosis or treatment. Technologist operates control unit to manage audio input and communication. System provides 29 dBA NRR noise reduction. Device is MR conditional.

Clinical Evidence

Bench testing included noise reduction (29 dBA NRR) and MR conditional safety evaluation (no field interaction up to 2 feet from bore/1 foot from side). Electrical safety and EMC testing performed per IEC 60601-1 and IEC 60601-1-2. Biocompatibility evaluated per ISO 10993-1. Clinical data submitted demonstrated no adverse effects on MR image production across various pulse sequences and imaging planes (axial, sagittal, coronal).

Technological Characteristics

MR conditional audio system for 3.0 Tesla environments. Provides 29 dBA NRR noise reduction. Complies with IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), and ISO 10993-1 (biocompatibility).

Indications for Use

Indicated for patients undergoing MRI procedures (up to 3.0 Tesla) requiring audio entertainment, communication, or hearing protection. Not for medical diagnosis or treatment.

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

• Patient Communication and Entertainment System (K133670)

Submission Summary (Full Text)

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June 14, 2018

MRIaudio Joe Caruso Chief Operations Officer 2720 Loker Ave., Suite N CARLSBAD, CA 92010

Re: K180100

Trade/Device Name: MRIaudio PREM System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: May 14, 2018 Received: May 21, 2018

Dear Joe 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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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# Page 2 - Joe Caruso

K180100

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jeff Radigan

for Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

### 510(k) Number K180100

Device Name

MRlaudio PREM system

Indications for Use

The MRlaudio PREM system is intended to provide audio entertainment 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.

| Type of Use |
|-------------|
|-------------|

● 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 MRlaudio. The logo consists of the text "MRlaudio" in a bold, sans-serif font, followed by a stylized circular graphic. The graphic is divided into four sections, each with a slightly different shade of teal, creating a sense of depth and movement.

## 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:

Joe Caruso Chief Operations Officer MRlaudio, Inc. 2720 Loker Avenue West, Suite N Carlsbad, CA 92010 Telephone: [phone] Date Prepared: May 14, 2018

#### B. Device Name

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

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

#### C. Predicate Devices

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

Patient Communication and Entertainment System NeoCoil, LLC K133670 21 CFR § 892.1000 Magnetic Resonance Diagnostic Device Radiology Class II LNH

#### D. Device Description

The MRIaudio PREM system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and hearing protection.

#### E. Indications for Use

The MRlaudio PREM system is intended to provide audio entertainment 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.

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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 "MRl" portion being larger than the "audio" portion. To the right of the text is a circular graphic composed of four teal-colored segments, resembling a stylized speaker or sound wave.

#### F. Technological Characteristics

As was established in this submission, the subject MRIaudio PREM system 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 devices through comparison in areas including design, intended use, material composition, and function.

#### G. Performance Data

Testing was performed to demonstrate that the subject MRIaudioPREM system is substantially equivalent to other predicate devices. The following bench and clincal testing was performed:

| Test | Result |
|--------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| Noise Reduction to ANSI S3.19-1974 | 29 dBA NRR |
| Magnetic field attraction/MR Conditional rating (3-Tesla field strength) | No field interaction up to two (2) feet from bore and one (1) foot from the side of magnet |

The subject MRIaudioPREM system 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 |
| Biocompatibility | |
| ISO 10993-1 | Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process |

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

Futher, clinical data submitted exhibits a mix of pulse sequences and imaging options in the axial, sagittal and coronal planes as recommended in the FDA guidance, Guidance for the Submission Of Promarket Notifications for Magnetic Resonance Diagnostic Devices, issued November 14, 1998. No adverse events were reported; therefore, the subject MRIaudioPREM system does not adversely affect MR image production in the worst-case environment.

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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 stylized circular graphic. The graphic is divided into four sections, each with a slightly different shade of teal, creating a sense of depth and movement.

#### H. Conclusions

Based on the indications for use, technological characteristics, and comparison to predicate devices, the subject MRIaudioPREM system has been shown to be substantially equivalent to legally marketed predicate devices.