Innovision Audio

K193218 · Innovere Medical, Inc. · LNH · Apr 7, 2020 · Radiology

Device Facts

• Record ID: K193218
• Device Name: Innovision Audio
• Applicant: Innovere Medical, Inc.
• Product Code: LNH · Radiology
• Decision Date: Apr 7, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

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 Story

Innovision Audio is a wireless system providing entertainment and communication between MRI operators and patients. Components include a wireless patient pillow, wireless bridges (data relays), and a Console Unit. Used in MRI scanner environments by healthcare professionals. The system transmits audio to the patient via the pillow, replacing traditional headphones. It is MR Conditional at 1.5T and 3.0T. Benefits include patient comfort and improved communication during imaging. The device is designed to be minimally disruptive to MRI workflows and does not interfere with MR image quality (SNR, uniformity, geometric distortion).

Clinical Evidence

Bench testing only. Testing included MR safety (RF/gradient heating <41°C), MR immunity, and NEMA MS 1, MS 2, and MS 3 standards to assess impact on image quality (SNR, uniformity, geometric distortion). Usability testing confirmed minimal disruption to MRI workflow. Compliance with IEC 60601-1, IEC 60601-1-2, and ISO 10993-1 was demonstrated.

Technological Characteristics

Wireless multi-component system (pillow, bridges, console). MR Conditional at 1.5T and 3.0T. Noise reduction rating >32dB. Complies with IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), ISO 10993-1 (biocompatibility), and NEMA MS 1-3 (MR image quality).

Indications for Use

Indicated for patients undergoing supine MRI examinations at 1.5T and 3.0T requiring entertainment or communication with the operator.

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

• Wireless Audio System (K173409)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 | [e-mail] |

#### 5.3 Date of Preparation

| Date of Preparation | : 12/13/2019 |
|---------------------|--------------|
|---------------------|--------------|

#### 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 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).

#### 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

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.

#### 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 | PASS<br>RF, gradient and combined fields<br>heating of applied parts is not greater<br>than 41°C. |
| NEMA MS 1<br>NEMA MS 2<br>NEMA MS 3 | Pre-defined performance standards | PASS<br>Innovision Audio has no appreciable<br>effect on MR image quality through<br>assessment of image SNR, signal<br>uniformity, geometric distortion. |
| MR Immunity | Pre-defined performance standards | PASS<br>Innovision Audio is immune to the<br>fields generated during MR imaging. |
| Usability of device | Pre-defined performance standards | PASS<br>Innovision Audio is usable and<br>minimally disruptive to the MRI<br>workflow. |

#### 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.