The Innovision Audio system is intended to provide entertainment and facilitate communication from the operator to the patient in the MRI scanner environment. The system is intended for "MR Conditional" use during supine MRI examinations at 1.5T and 3.0T.

Device Description

Innovision Audio is a wireless device intended to provide entertainment and facilitate communication from the operator to the patient in the MRI scanner environment. The Innovision Audio system is intended to be used by healthcare professionals.

Innovision Audio is a multi-component system comprised of a wireless patient pillow, wireless bridges (data relays), and a Console Unit (entertainment control centre).

AI/ML Overview

This document describes the Innovision Audio system, a device intended to provide entertainment and facilitate communication for patients within an MRI scanner environment, and its substantial equivalence to a predicate device.

Acceptance Criteria and Device Performance:

The document outlines acceptance criteria as "Pre-defined performance standards" for various tests and confirms that the Innovision Audio device "PASSes" all of them. The reported device performance is explicitly stated for each test.

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria	Reported Device Performance
MR Safety	Pre-defined performance standards	PASS: RF, gradient and combined fields heating of applied parts is not greater than 41°C.
NEMA MS 1 (SNR)	Pre-defined performance standards	PASS: Innovision Audio has no appreciable effect on MR image quality through assessment of image SNR.
NEMA MS 2 (Geometric Distortion)	Pre-defined performance standards	PASS: Innovision Audio has no appreciable effect on MR image quality through assessment of geometric distortion.
NEMA MS 3 (Image Uniformity)	Pre-defined performance standards	PASS: Innovision Audio has no appreciable effect on MR image quality through assessment of signal uniformity.
MR Immunity	Pre-defined performance standards	PASS: Innovision Audio is immune to the fields generated during MR imaging.
Usability of Device	Pre-defined performance standards	PASS: Innovision Audio is usable and minimally disruptive to the MRI workflow.

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

The document does not explicitly state the sample size used for the test set in terms of human subjects or distinct MRI scans. The testing summarized is categorized as "Performance Testing - Bench" and "Published Standards Testing." This suggests the tests were primarily laboratory-based, focused on the device's physical and electrical characteristics and its interaction with MRI fields, rather than human trials.

Regarding data provenance, the document does not provide details like country of origin or whether the data was retrospective or prospective. Given the nature of bench testing and compliance with published standards, the data would originate from controlled experimental environments.

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

The document does not mention the use of experts to establish a "ground truth" for the test set in the conventional sense of clinical interpretation (e.g., radiologist reads of images). The tests are primarily objective measurements of physical and performance criteria (e.g., temperature rise, SNR, distortion, immunity, usability). Therefore, no specific number or qualification of experts like radiologists is stated as being involved in establishing ground truth for these types of tests. The "ground truth" is defined by the objective pass/fail criteria of the specified standards and performance metrics.

4. Adjudication Method for the Test Set:

No adjudication method (e.g., 2+1, 3+1) is mentioned, as the data collection and evaluation appear to be based on objective bench testing against pre-defined performance standards. Such adjudication methods are typically relevant for human reader studies or where subjective interpretation is involved.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study is mentioned. The device is for "entertainment and communication" within the MRI environment and is classified under "Magnetic resonance diagnostic device" (21 CFR 892.1000), but its function, as described, is not directly diagnostic. The testing focuses on its safety and a lack of interference with MRI image quality, not its impact on human diagnostic accuracy. Therefore, a study comparing human readers with and without AI assistance is not applicable to the device's stated function and the provided testing summary.

6. Standalone (Algorithm-Only) Performance:

The Innovision Audio device is a hardware system for entertainment and communication during MRI scans. It is not an algorithm or AI software for image analysis or diagnosis. Therefore, a standalone (algorithm-only) performance evaluation is not relevant or described for this device.

7. Type of Ground Truth Used:

The "ground truth" for the testing conducted (bench and standards testing) is based on objective, pre-defined performance standards and measurable parameters. This is not based on expert consensus, pathology, or outcomes data, as these types of ground truth are typically used for diagnostic or clinical efficacy studies. For example, for "MR safety," the ground truth is that the heating of applied parts must not be greater than 41°C. For "NEMA MS" tests, the ground truth relates to the device having "no appreciable effect" on image quality parameters like SNR, signal uniformity, and geometric distortion.

8. Sample Size for the Training Set:

The document does not describe any training set or machine learning components for the Innovision Audio device. The device is a physical system, and its evaluation relies on direct performance testing against established standards, not on a machine learning model that would require a training set.

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

As there is no mention of a training set or machine learning model, the establishment of ground truth for a training set is not applicable to this device description.

Summary

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April 7, 2020

Innovere Medical Inc. % Ms. Lynsie Thomason Regulatory & Operations Lead 6-250 Shields Court Markham, Ontario L3R 9W7 CANADA

Re: K193218

Trade/Device Name: Innovision Audio Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: March 6, 2020 Received: March 9, 2020

Dear Ms. Thomason:

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

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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) 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)

K193218

Device Name

Innovision Audio

Indications for Use (Describe)

The Innovision Audio system is intended to provide entertainment and facilitate communication from the MRS scanner environment. The system is intended for "MR Conditional" use during supine MRI examinations at 1.5T and 3.0T.

Type of Use (Select one or both, as applicable)

Z Prescription Use (Part 21 CFR 801 Subpart D) [ ] Over-The-Counter Use (21 CFR 801 Subpart C)

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SECTION 5 : 510(k) Summary

5.1 Applicant/Submitter

Company Name	Innovere Medical Inc.
Establishment Registration Number
Phone Number	1-888-262-0408
Company Street Address	6-250 Shields Court
Fax Number
City	Markham
State	ON
Country	Canada
Zip Code	L3R 9W7
5.2 Contact Person
Full Name	Lynsie Thomason
Job Title	Regulatory & Operations Lead
Phone	1-888-262-0408 (x104)
Email	lynsie.thomason@innoveremedical.com

5.3 Date of Preparation

Date of Preparation	: 12/13/2019
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5.4 Device Information

Table - 5.1 Device Information

Trade Name	Innovision Audio
Common or Usual Name	Magnetic resonance diagnostic device.
Classification Name	21 CFR 892.1000
Regulatory Class	2
Product Code	LNH

5.5 Device Description

Innovision Audio is a multi-component system comprised of a wireless patient pillow, wireless bridges (data relays), and a Console Unit (entertainment control centre).

5.6 Predicate Device(s)

Table - 5.2 Predicate Device(s)

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Predicate Type	510(k) Number	Device Name	Manufacturer
Primary Device	K173409	Wireless Audio System	NeoCoil, LLC

5.7 Comparison of Technological Characteristics with Predicate

Based on the evidence provided, the Innovision Audio System is substantially equivalent to the legally marketed device NeoCoil Wireless Audio System (K173409, cleared on 02/16/2018).

Use of the devices with the MRI scanner is similar.

The Innovision Audio system differs from the predicate in the following ways:

· Innovision Audio has a higher Noise Reduction Rating of >32dB
· Innovision Audio delivers audio to the patient through a pillow instead of traditional headphones/earbuds
· Innovision Audio includes an entertainment audio source with the device

Bench testing demonstrates that the use of the Innovision Audio system is safe and effective and does not affect the safety or effectiveness of the MRI system when used as intended.

5.8 Indications for Use

5.9 Testing

The testing summarized in Table - 5.3 Performance Testing - Bench and Table - 5.4 Published Standards Testing have been submitted, referenced or relied on to demonstrate the safety and effectiveness of Innovision Audio. The device performs as intended.

Test	Pass/Fail Criteria	Results
MR safety	Pre-defined performance standards	PASSRF, gradient and combined fieldsheating of applied parts is not greaterthan 41°C.
NEMA MS 1NEMA MS 2NEMA MS 3	Pre-defined performance standards	PASSInnovision Audio has no appreciableeffect on MR image quality throughassessment of image SNR, signaluniformity, geometric distortion.
MR Immunity	Pre-defined performance standards	PASSInnovision Audio is immune to thefields generated during MR imaging.
Usability of device	Pre-defined performance standards	PASSInnovision Audio is usable andminimally disruptive to the MRIworkflow.

Table - 5.3 Performance Testing - Bench

Table - 5.4 Published Standards Testing

Standard

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IEC 60601-1	Electrical safety
IEC 60601-1-2	Electromagnetic compatiblity
ISO 10993-1	Biocompatiblity
NEMA MS 1	Signal-to-Noise Ratio (SNR) in MR images
NEMA MS 2	2-Dimensional geometric distortions in MR images
NEMA MS 3	Image uniformity of MR images

5.10 Conclusion

This submission demonstrates that for the specified indications for use the Innovision Audio system is as safe and effective as the predicate device, NeoCoil Wireless Audio System, K173406, as cleared on 02/16/2018.

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.