(149 days)
No
The summary describes a system for providing audio entertainment and communication in an MRI environment. There is no mention of AI, ML, or any related concepts in the intended use, device description, or performance studies. The testing focuses on noise reduction and MRI compatibility, not algorithmic performance.
No
The Intended Use section explicitly states, "The product is not intended for medical diagnosis or treatment." It also describes the system's purpose as providing "audio entertainment and facilitate patient communication."
No
The "Intended Use / Indications for Use" section explicitly states, "The product is not intended for medical diagnosis or treatment."
No
The device description explicitly states it is an "MRI conditional audio solution" and describes components like "Technologist control units" and "hearing protection," indicating it includes hardware components beyond just software. The performance studies also include testing related to noise reduction and magnetic field interaction, which are hardware-related characteristics.
Based on the provided information, the MRIaudio PREM system is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the product is "not intended for medical diagnosis or treatment." IVDs are specifically designed for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Function: The device provides audio entertainment, patient communication, and hearing protection. These are supportive functions within the MRI environment, not diagnostic tests performed on biological samples.
- Lack of Diagnostic Information: The device does not analyze biological samples or produce data used for diagnosing a medical condition.
Therefore, the MRIaudio PREM system falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MRIaudio 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.
Product codes
LNH
Device Description
The MRIaudio PREM system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and hearing protection.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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: Noise Reduction to ANSI S3.19-1974, Result: 29 dBA NRR
Test: Magnetic field attraction/MR Conditional rating (3-Tesla field strength), Result: 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.
Key Metrics
29 dBA NRR (Noise Reduction)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services, which features a stylized human figure. To the right is the logo for the U.S. Food & Drug Administration (FDA). The FDA logo includes the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with "ADMINISTRATION" written below in a smaller font.
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
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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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: (858) 914-4217 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.
5
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.