(59 days)
No
The summary describes a system for providing audio and visual entertainment and communication in an MRI environment. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies. The focus is on the system's functionality and MRI compatibility.
No.
The product explicitly states, "The product is not intended for medical diagnosis or treatment."
No
The "Intended Use / Indications for Use" section explicitly states, "The product is not intended for medical diagnosis or treatment." The device provides entertainment and communication in an MRI environment.
No
The device description explicitly states it is an "MRI conditional audio and video solution" and mentions "Technologist control units," indicating the presence of hardware components beyond just software.
Based on the provided information, this device 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." IVD devices are specifically designed for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The description focuses on providing audio and visual entertainment, communication, and hearing protection in an MRI environment. This aligns with patient comfort and communication, not diagnostic testing.
- Lack of Diagnostic Function: There is no mention of analyzing biological samples, providing diagnostic information, or being used in a diagnostic workflow.
The device's purpose is to improve the patient experience during an MRI scan, which is a medical imaging procedure, but the device itself does not perform any diagnostic function on biological samples.
N/A
Intended Use / Indications for Use
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.
Product codes
LNH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Technologists in MRI environments
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
Bench testing was performed:
- Magnetic field interactions at 3-Tesla: No interaction
The device was evaluated to the following standards:
- 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
Results: The subject MRIaudio PREM System with MRIview presents no adverse effect within the intended environment.
Sample clinical images submitted exhibit a mix of pulse sequences and imaging options in the axial, sagittal and coronal planes. No adverse events were reported; therefore, the subject MRIaudio PREM System with MRIview does not adversely affect MR image production in the worstcase environment.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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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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.
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
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.
F. Indications for Use
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.
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.