(149 days)
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.
The MRIaudio PREM system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and hearing protection.
The provided text describes the 510(k) premarket notification for the MRIaudio PREM System, a device intended to provide audio entertainment and facilitate patient communication in MRI environments. It is important to note that this device is not an AI-powered diagnostic tool, but rather an accessory for MRI machines. Therefore, the typical acceptance criteria and study designs used for AI/ML-based medical devices (such as those involving sensitivity, specificity, MRMC studies, expert adjudication, and large training/test sets for image analysis) are not applicable here.
The performance data presented focuses on the device's physical and electrical characteristics and its compatibility with MRI environments, rather than its diagnostic accuracy or AI performance.
Here's a breakdown based on the information provided, framed to address the original request topics where relevant, but highlighting the fundamental difference in the device type:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is an accessory device, the "acceptance criteria" relate to safety, functionality within an MRI environment, and compliance with general medical device standards. There are no performance metrics related to diagnostic accuracy, sensitivity, or specificity as it is not a diagnostic device.
| Acceptance Criteria (Proxy for "Performance Goal") | Reported Device Performance (Result) |
|---|---|
| Noise Reduction (to ANSI S3.19-1974) | 29 dBA NRR (Noise Reduction Rating) |
| 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 |
| Electrical Safety (IEC 60601-1) | Compliant ("results of performance testing demonstrate... substantially equivalent") |
| Electromagnetic Compatibility (IEC 60601-1-2) | Compliant ("results of performance testing demonstrate... substantially equivalent") |
| Biocompatibility (ISO 10993-1) | Compliant ("results of performance testing demonstrate... substantially equivalent") |
| No adverse effect on MR image production | No adverse events reported; does not adversely affect MR image production in the worst-case environment. |
2. Sample Size Used for the Test Set and Data Provenance
The "test set" here refers to the physical units of the MRIaudio PREM System that underwent bench and clinical testing. The document does not specify a numerical "sample size" in the context of patients or data points for diagnostic purposes, because the device is an accessory, not a diagnostic tool.
- Sample Size: Not applicable in the context of an AI device's test dataset (e.g., number of images, patients). Refers to the physical units tested to ensure MR compatibility, safety, and performance. The document implies that the testing was performed on the device itself.
- Data Provenance: Not applicable in the context of patient data provenance for an AI model. The "clinical data" section refers to the evaluation of the device's impact on MR image production, not data used to train or test a diagnostic algorithm. The document states "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...". This refers to the environment in which the device was evaluated, rather than a patient dataset collected retrospectively or prospectively from specific countries.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This device does not generate diagnostic interpretations requiring expert ground truth establishment. The "clinical data" involved assessing the device's impact on image quality, which would typically be done by qualified MR technologists or radiologists, but this is not about establishing a "ground truth" for a diagnosis.
4. Adjudication Method for the Test Set
Not applicable. There is no diagnostic "ground truth" to adjudicate.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No. This type of study is for evaluating the impact of an AI diagnostic aid on human reader performance. The MRIaudio PREM System is an accessory for patient comfort and communication, not a diagnostic aid.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No. This device does not contain an AI algorithm for standalone diagnostic performance.
7. The Type of Ground Truth Used
Not applicable. There is no diagnostic "ground truth" for this device. The "ground truth" for its acceptance is based on engineering specifications, safety standards compliance, and non-interference with MRI image quality.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML system that undergoes a training phase with a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no AI training set or associated ground truth.
Summary regarding the device:
The MRIaudio PREM System is an MRI-conditional audio solution intended for patient entertainment and communication during MRI scans. Its acceptance criteria and testing focused on:
- Its ability to provide noise reduction.
- Its compatibility and safety within strong magnetic fields (MR Conditional rating).
- Compliance with electrical safety and electromagnetic compatibility standards.
- Biocompatibility of materials.
- Demonstrating that it does not adversely affect the quality of MR images.
The study that "proves the device meets the acceptance criteria" consists of bench testing (e.g., noise reduction, magnetic field interaction) and clinical evaluation demonstrating no adverse effects on MR image production. No AI/ML performance metrics are involved as it is not an AI-powered diagnostic device.
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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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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
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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: (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.
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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.
§ 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.