Wireless Audio System

K173409 · Neocoil, LLC · LNH · Feb 16, 2018 · Radiology

Device Facts

• Record ID: K173409
• Device Name: Wireless Audio System
• Applicant: Neocoil, LLC
• Product Code: LNH · Radiology
• Decision Date: Feb 16, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The NeoCoil Wireless Audio System is intended to provide entertainment and facilitate patient communication in MRI environments. The product is not intended for medical diagnosis or treatment. The product is intended for "MR Conditional" use in MRI environments at 3 Tesla and below. Technologist control units are intended to be used outside the MRI scan room. Wireless receivers are intended for use outside the imaging field of view.

Device Story

Modular system providing entertainment and patient-operator communication in MRI environments (up to 3T). Components include wireless patient headphones, remote audio data source, and communication infrastructure (transmitters, routers, interface modules). Operated by healthcare professionals (technologists) outside the scan room. System transmits audio signals wirelessly to headphones worn by the patient; facilitates two-way communication and entertainment delivery. Benefits include improved patient comfort and reduced anxiety during scanning. Does not affect MR image quality (SNR/uniformity) or introduce artifacts. Designed for MR conditional use.

Clinical Evidence

Clinical performance testing conducted using a mix of pulse sequences and imaging options (axial, sagittal, coronal) per FDA guidance for MR diagnostic devices. Results showed no adverse events and no adverse impact on MR image production in worst-case environments. Bench testing confirmed NRR ≥29 dBA (ANSI S3.19-1974), RF heating ≤41°C, and compliance with NEMA MS 6-2008 for SNR and uniformity.

Technological Characteristics

Modular wireless audio system for MRI environments. Components: headphones, transmitters, routers, interface modules. MR Conditional (≤3T). Connectivity: wireless, wired, or pneumatic. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-1-6/62366 (usability), IEC 60601-2-33 (MR safety), ISO 10993-1 (biocompatibility), NEMA MS6 (coil characterization).

Indications for Use

Indicated for patients undergoing MRI procedures at 3 Tesla field strength or below to provide entertainment and facilitate 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

• Patient Communication and Entertainment System (K133670)

Submission Summary (Full Text)

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February 16, 2018

NeoCoil, LLC Michael Leigh Director. Regulatory Affairs N27 W23910A Paul Rd. Pewaukee, Wisconsin 53072

Re: K173409

Trade/Device Name: Wireless Audio System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: January 22, 2018 Received: January 24, 2018

Dear Michael Leigh:

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 - Michael Leigh

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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael D. O'Hara 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 (if known)

#### K173409

Device Name NeoCoil Wireless Audio System

Indications for Use (Describe)

The NeoCoil Wireless Audio System is intended to provide entertainment and facilitate patient communication in MRI environments at 3 Tesla field strength and below.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

- Over-The-Counter Use (21 CFR 801 Subpart C)

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### FOR FDA USE ONLY

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# 5. Traditional 510(k) Summary

# 5.1. Applicant

NeoCoil, LLC N27 W23910A Paul Rd Pewaukee, WI 53072 USA

### 5.2. Contact

Michael Leigh Director, Regulatory 262-347-1250 (office) 261-347-1251 (fax) [e-mail]

### 5.3. Preparation Date

### 5.4. Name of Device

●

●

- Proprietary Name: ● Common Name:
Classification:

NeoCoil Wireless Audio System

- Nuclear Magnetic Resonance System 21 CFR 892.1000, Product Code LNH
- 5.5. Model Numbers

| NeoCoil Model Number | NeoCoil Model Name |
|----------------------|--------------------------------|
| NC069201 | Technologist Console Interface |
| NC079202 | Penetration Panel Transmitter |
| NC071200 | Wireless Patient Headphones |
| NC075200 | Wireless Audio Interface |
| NC107200 | S1 Audio Interface Module |
| NC130200 | S2 Audio Interface Module |
| NC130202 | P2 Audio Interface Module |
| NC126200 | Scan Room Module |
| NC126201 | Wireless Router |
| NC126202 | Technologist Console Interface |

### 5.6. Device Description

The NeoCoil Wireless Audio System is intended to provide entertainment and facilitate communications between the patient and the operator in a Magnetic Resonance Imaging (MRI) scanner environment. The Wireless Audio System is intended to be used by healthcare professionals.

The NeoCoil Wireless Audio System is a modular system comprised of wireless patient headphones, a remote audio data source unit, and communications infrastructure.

### 5.7. Predicate Device

- . Patient Communication and Entertainment System , K133670, as cleared on 07/24/2014
### 5.8. Comparison to Predicate

The NeoCoil Wireless Audio System is similar in physical, performance, design and material characteristics to the legally marketed device Patient Communication and Entertainment System, K133670, as cleared on 07/24/2014.

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Use of the device in conjunction with an MRI scanner is similar.

The NeoCoil Wireless Audio System includes the following differences to the predicate.

- Improved Noise Reduction Rating to 29dBA ●
- Optional Wireless Audio Interface for use with a head coil
- Additional installation options for wired, pneumatic, or wireless communication with ● the control room

Clinical testing demonstrates that use of the NeoCoil Wireless Audio System does not affect the safety and/or the effectiveness of the device when used as labeled.

#### 5.9. Indications for Use

The NeoCoil Wireless Audio System is intended to provide entertainment and facilitate patient communication in MRI environments at 3 Tesla field strength and below.

#### 5.10. Intended Use

The NeoCoil Wireless Audio System is intended to provide entertainment and facilitate patient communication in MRI environments. The product is not intended for medical diagnosis or treatment.

The product is intended for "MR Conditional" use in MRI environments at 3 Tesla and below. Technologist control units are intended to be used outside the MRI scan room.

Wireless receivers are intended for use outside the imaging field of view.

#### 5.11. Testing

The following data has been submitted, referenced or relied on to demonstrate that the NeoCoil Wireless Audio System is safe and effective. The device's performance meets the requirements of pre-defined acceptance criteria and intended uses.

| Test | Pass/Fail Criteria | Result |
|----------------------------------------------------------------|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Max B1 in first fault<br>conditions | Pre-defined<br>performance standards | PASS: Wireless Audio System does not arc or<br>show any signs of voltage breakdown. |
| Surface Temperature<br>in normal and first<br>fault conditions | Pre-defined<br>performance standards | PASS: RF heating is not greater than 41° C. |
| NEMA MS 6-2008 | Pre-defined<br>performance standards | PASS: Wireless Audio System does not<br>adversely impact MR image SNR and<br>Uniformity |
| Coherent Noise Test | Pre-defined<br>performance standards | PASS: Wireless Audio System does not<br>introduce image artifacts noise in center<br>frequency range of compatible field strengths. |
| Noise Reduction | Pre-defined<br>performance standards | PASS: ≥29 dBA NRR (ANSI S3.19-1974) |
| Quality of Service<br>and Coexistence<br>Test | Pre-defined<br>performance standards | PASS: Wireless Audio System provides<br>adequate quality of service for patient<br>communication during MRI scanning. |

### Performance Testing - Bench:

### Published Standards Testing:

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The NeoCoil Wireless Audio System has been evaluated to the following standards:

| Standard | Purpose |
|----------------|---------------------------------------------------------------------------------------|
| IEC 60601-1 | Electromechanical safety |
| IEC 60601-1-2 | Electromagnetic Compatibility |
| IEC 60601-1-6 | Usability |
| IEC 60601-2-33 | Electromechanical safety for magnetic resonance equipment |
| IEC 62366 | Guidance on the application of usability engineering to medical devices |
| ISO 10993-1 | Biocompatibility |
| NEMA MS6 | Characterization of Special Purpose Coils for Diagnostic Magnetic Resonance<br>Images |

### Performance Testing - Clinical:

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, Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices, issued November 18, 2016.

No adverse events were reported during clinical performance testing; the NeoCoil Wireless Audio System does not adversely affect MR image production in the worst-case environment.

#### 5.12. Conclusion

This submission demonstrates that the Indications for Use associated with the NeoCoil Wireless Audio System are as safe and effective as the predicate device, Patient Communication and Entertainment System, K133670, as cleared on 07/24/2014. As such, the NeoCoil Wireless Audio System is equivalent to its predicate, Patient Communication and Entertainment System, K133670, as cleared on 07/24/2014.