HEADPHONES, PATIENT ALERT, STANDALONE INTERFACE

K133670 · Neocoil, LLC · LNH · Jul 24, 2014 · Radiology

Device Facts

• Record ID: K133670
• Device Name: HEADPHONES, PATIENT ALERT, STANDALONE INTERFACE
• Applicant: Neocoil, LLC
• Product Code: LNH · Radiology
• Decision Date: Jul 24, 2014
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The NeoCoil PCE System is intended to provide audio 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 of the MRI scan room. Wireless receivers are intended for use outside of the imaging field of view.

Device Story

Modular system providing audio entertainment and patient-operator communication in MRI environments (up to 3T). Components include wireless headphones, remote audio data source, and patient alert system. Operated by healthcare professionals; technologist control units located outside scan room. System facilitates communication during scanning; provides audio to patient. Benefits include improved patient comfort and communication during MRI procedures. Does not perform medical diagnosis or treatment.

Clinical Evidence

Clinical performance testing was conducted using a mix of pulse sequences and imaging options in axial, sagittal, and coronal planes per FDA guidance. No adverse events were reported. Testing confirmed the device does not adversely affect MR image production in the worst-case environment.

Technological Characteristics

Modular system including wireless headphones, remote audio source, and patient alert. MR Conditional for 3T and below. Complies with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-2-33 (MR safety), ISO 10993-1 (biocompatibility), and NEMA MS6. Noise reduction >20 dBA NRR (ANSI S3.19-1974). RF heating <41°C.

Indications for Use

Indicated for patients undergoing MRI procedures at 3 Tesla field strength or below to provide audio 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

• Medical Visors MV100 (K103507)

Submission Summary (Full Text)

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N27 W23910A Paul Rd Pewaukee, WI 53072 USA Direct: [phone] [phone] Fax:

JJUL 22 2014

NeoCoil

K133670
Page 1 of 3

# 5. Abbreviated 510(k) Summary

- 5.1. Applicant NeoCoil, LLC N27 W23910A Paul Rd Pewaukee, WI 53072 USA
- 5.2. Contact Michael Leigh Director, Regulatory/Quality 262-347-1250 (office) 261-347-1251 (fax) [e-mail]

5.3. Preparation Date 11/27/2013

#### 5.4. Name of Device

- Proprietary Name: ●
- Common Name
- Classification:

Patient Communication and Entertainment System Nuclear Magnetic Resonance System 21 CFR 892.1000, Product Code LNH

- 5.5. Model Numbers

| NeoCoil Model Number | NeoCoil Model Name |
|----------------------|------------------------------------------------|
| NC077000 | Patient Communication and Entertainment System |
| NC078000 | MR compatible Headphones |
| NC076000 | Wireless Patient Alert |

#### 5.6. Device Description

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

The NeoCoil Patient Communication and Entertainment System is a modular system comprised of wireless patient headphones, a remote audio data source unit, patient alert, and communications infrastructure.

### 5.7. Predicate Device

- Medical Visors MV100 (K103507), cleared on 02/08/2011 .
#### 5.8. Comparison to Predicate

The NeoCoil Patient Communication and Entertainment System is similar in physical. performance, design and material characteristics to the legally marketed device Medical Visors MV100, K103507, as cleared on 02/08/2011.

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

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

#### © 2013 NeoCoi!, LLC

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N27 W23910A Paul Rd Pewaukee, WI 53072 USA Direct: [phone] [phone] Fax:

Image /page/1/Picture/1 description: The image shows the logo for NeoCoil. The logo consists of a circular design with an arrow pointing to the right, followed by the text "NeoCoil" in a bold, sans-serif font. The circular design appears to be a stylized representation of a coil, with multiple concentric circles forming a spiral shape.

### 5.9. Indications for Use

The NeoCoil PCE System is intended to provide audio entertainment and facilitate patient communication in MRI environments at 3 tesla field strength and below. The product has no medical function or purpose.

#### 5.10. Intended Use

The NeoCoil PCE System is intended to provide audio 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 of the MRI scan room.

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

#### 5.11. Testing

The following data has been submitted, referenced or relied on to demonstrate that the Patient Communication and Entertainment 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: Patient Communication and<br>Entertainment System does not arc or show<br>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: Patient Communication and<br>Entertainment System does not adversely<br>impact MR image SNR and Uniformity |
| Coherent Noise Test | Pre-defined<br>performance standards | PASS: Patient Communication and<br>Entertainment System does not introduce<br>image artifacts noise in center frequency range<br>of compatible field strengths. |
| Noise Reduction | Pre-defined<br>performance standards | PASS: >20 dBA NRR (ANSI S3.19-1974) |
| Quality of Service<br>and Coexistence<br>Test | Pre-defined<br>performance standards | PASS: Patient Communication and<br>Entertainment System provides adequate<br>quality of service for patient communication<br>during MRI scanning. |

#### Performance Testing - Bench:

### Published Standards Testing:

The Patient Communication and Entertainment System has been evaluated to the following standards:

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N27 W23910A Paul Rd Pewaukee, WI 53072 USA Direct: [phone] [phone] Fax:

Page 3 of 3

NeoCoil

| Standard | Purpose |
|----------------|---------------------------------------------------------------------------------------|
| IEC 60601-1 | Electromechanical safety |
| IEC 60601-1-2 | Electromagnetic Compatibility |
| IEC 60601-2-33 | Electromechanical safety for magnetic resonance equipment |
| 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, Guidance for the Submission Of Premarket Notifications for Magnetic Resonance Diagnostic Devices, issued November 14, 1998.

No adverse events were reported during clinical performance testing; the Patient Communication and Entertainment 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 Patient and Communication Entertainment System are as safe and effective as the predicate device, Medical Visors MV1000 K103507, as cleared on 02/08/2011. As such, the Patient Communications and Entertainment system is equivalent to its predicate, Medical Visors MV100 (K103507), cleared on 02/08/2011.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 24, 2014

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/4 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines extending from its body, representing the department's commitment to health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.

NeoCoil, LLC % Mr. Michael Leigh Director, Regulatory/Quality N27 W23910A Paul Road PEWAUKEE WI 53072

Re: K133670

Trade/Device Name: Headphones, Patient Alert, Standalone Interface Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: June 20, 2014 Received: June 23, 2014

Dear Mr. 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. Iisting 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2-Mr. Leigh

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Michael D. O'Hara for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

# 510(k) Number (if known)

K133670

# Device Nama

Patient Communication and Entertainment System

Indications for Use (Describe)

The NeoColl PCE system is intended to provide audio entertainment and facilitate patient communication in MBL 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)

## PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (1/14)

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