MRI MULTI-CHANNEL OPTICAL COMMUNICATION (MOC) SYSTEM IMROC/IMROC IR WIRLESS OPTOACTIVE

K121239 · Optoacoustics, Ltd. · LNH · May 24, 2012 · Radiology

Device Facts

• Record ID: K121239
• Device Name: MRI MULTI-CHANNEL OPTICAL COMMUNICATION (MOC) SYSTEM IMROC/IMROC IR WIRLESS OPTOACTIVE
• Applicant: Optoacoustics, Ltd.
• Product Code: LNH · Radiology
• Decision Date: May 24, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

Optoacoustic's MRI Multi-Channel Optical Communication System (MOC) is intended to facilitate audio communications and stimulation during a scanning session. System devices provide real-time Scanner noise reduction and/or noise cancellation, while enabling multiple concurrent dialogs.

Device Story

MRI Multi-Channel Optical Communication System (MOC) facilitates audio communication and stimulation during MRI scanning. Inputs include voice signals from medical staff/technologists and audio/music stimulation; system uses fiber optic cables and infrared (IR) technology to transmit signals, avoiding electrical interference in the MRI environment. The Electro-Optical Unit (EOU) performs signal transduction, noise cancellation, and enhancement. Output is delivered via optical headsets to patients and staff. Operated by technologists in the control room via a mixing console to manage dialogs and noise reduction levels. Benefits include real-time gradient noise reduction, improved sound quality, and concurrent multi-channel communication, enhancing patient comfort and clinical workflow efficiency during MRI procedures.

Clinical Evidence

Bench testing only. Performance evaluation included electrical safety and electromagnetic compatibility testing per IEC 60601-1 and IEC 60601-1-2. Risk analysis conducted per ISO 14971. No clinical trial data required for this communication accessory.

Technological Characteristics

System utilizes optical laser and optical transduction (light modulation to sound) and diffuse infrared (IR) for wireless components. Components include optical headsets, control/mixing console, EOU, and IR transceivers. Connectivity via fiber optic cables. Materials include passive noise-reducing casings and disposable earpads. Non-computer-based system; continuous mode of operation.

Indications for Use

Indicated for patients undergoing functional, interventional, and clinical MRI scans, as well as for use by doctors and technologists in these environments to facilitate audio communication and stimulation.

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

• fMRI Hardware System, Nuclear Magnetic Resonance Imaging System (NordicNeuroLab AS.) (K073099)
• Silent Scan, Nuclear Magnetic Resonance Imaging (Avotec Inc) (K921891)

Submission Summary (Full Text)

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21239

Optoacoustics Ltd.

| 510(k) Summary |
|----------------|
| Page 1 of 5 |
| 18-May-2012 |

MAY 2 4 2012

| Official Contact: | Dr. Yuvi Kahana, CEO<br>Optoacoustics Ltd.<br>17 Hanotea St.<br>Mazor 73160, Israel<br>Tel: [phone]<br>Fax: [phone] | | | |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|
| | Proprietary or Trade Name: MRI Multi-Channel Optical Communication System (MOC) | | | |
| Common/Usual Name: | · System, Nuclear Magnetic Resonance Imaging (Accessory) | | | |
| Classification Name: | System, Nuclear Magnetic Resonance Imaging (Accessory)<br>Product code - LNH<br>21 CFR 892.1000<br>Class II | | | |
| Predicate Devices: | fMRI Hardware System, Nuclear Magnetic Resonance Imaging<br>System (NordicNeuroLab AS.) K073099<br>Silent Scan, Nuclear Magnetic Resonance Imaging (Avotec Inc)<br>K921891 | | | |

#### Device Description:

Optoacoustic's MRI Multi-Channel Optical Communication System (MOC) is intended to facilitate audio communications and stimulation during a scanning session. System devices provide real-time Scanner noise reduction and/or noise cancellation, while enabling multiple concurrent dialogs. The MRI MOC comprises the following main component devices:

| Component | Description |
|------------|------------------------------------------------------------------------|
| IMROC | IMROC is a two-way optical communication device that enables |
| | multi-channel dialogs in real time between the MRI Patient, medical |
| | Staff and technologists. Communication transmission is based solely |
| | on fiber optic cables. IMROC also enables the Patient to listen to |
| | music and/or other audio stimulation (e.g., voice commands from the |
| | Scanner computer or personnel) during a Scanning session. |
| IMROC IR | IMROC IR Wireless is identical in design and function to the |
| Wireless | IMROC, except that communication transmission is based on wireless |
| | infrared (IR) technology as well as fiber optic cables. There are no |
| | active components in this device, there are no patient applied parts. |
| OptoACTIVE | OptoACTIVE is a real-time active noise-cancelling headset that |
| | enables two-way communications with the MRI Patient or with MRI |
| | Staff while significantly reducing MRI EPI main gradient noise and |
| | providing excellent sound quality. OptoACTIVE also enables the |
| | Patient to listen to music and/or other audio stimulation (e.g., voice |
| | commands from the Scanner computer or personnel) during a |
| | Scanning session. |
| | |

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#### 510(k) Summary Page 2 of 5 18-May-2012

#### Sub-Component Devices

The MRI MOC System devices include the following sub-component devices:

:

く i

| Sub-<br>Component | Description |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Optical<br>Headsets | Each Headset includes left-and-right high fidelity optical speakers inside a passive<br>noise-reducing casing, coupled with a dual-channel noise-cancelling optical<br>microphone and enables full duplex communications among Staff and Patient. The<br>Headset is fitted with noise-reducing disposable earpads.<br>IMROC/IMROC IR Wireless OptoACTIVE – The Headset interfaces directly with the System EOU via<br>fiber optic cable. The Headset is available in an optional Ultra-Slim form<br>factor, designed for use in 32-channel head coils. |
| Control/Mixing<br>Console | The Control and Mixing Console is operated by the technologist in the Control<br>Room to manage the interactive communications environment (e.g., turning off<br>specific headsets, muting Staff/Patient's speaker, adjusting noise cancelling and<br>noise reduction levels, Patient's music volume, etc.).<br><br>The Console features an MP4 format player to enable selection of appropriate<br>music for a Patient. In addition, the Console enables direct music input from a<br>compatible external player, brought by a Patient.<br><br>The Console contains a built-in microphone and speaker for direct communications<br>between the technologist and the medical Staff. The Console contains electronic<br>parts and is attached directly to the EOU via electrical cable. |
| Electro-Optical<br>Unit (EOU) | The Electro-Optical Unit (EOU) is the main processing unit of the System. It<br>receives inputs from the optical Headsets, performs required optical to electrical<br>signal transduction, noise-cancelling and signal enhancement processing, and<br>redistributes communications to Staff and Patient according to current settings on<br>the Control/Mixing Console. |
| IR Transceiver<br>Unit | (IMROC IR Wireless Component Only) A stationary, wall-mounted unit in the<br>Scanner Room which exchanges wireless infrared (IR) signals with the Optical<br>Headsets of each Staff member. It interfaces with the System EOU via fiber optic<br>cable. |
| Battery<br>Recharging<br>Unit | (IMROC IR Wireless Component Only) A stationary, tabletop unit that is intended<br>to be used in the Control Room, where it is easily accessible to Staff responsible fo<br>routine System operation. It recharges batteries that are used in the Personal<br>Control Unit, as required. Multiple batteries can be recharged simultaneously. |
| Hygienic Pop<br>Screens | Specially-fitted pop-screens can be attached to the microphone on the Optical<br>Headset The screens are designed to be used once per Scanning session, and are<br>disposable. |
| Hygienic<br>Earpad Covers | Industry standard disposable earpad covers are mounted on left and right earphones<br>on the Optical Headset and are disposable. |

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#### 510(k) Summary Page 3 of 5 18-May-2012

r

#### Indications for Use:

Optoacoustic's MRI Multi-Channel Optical Communication System (MOC) is intended to facilitate audio communications and stimulation during a scanning session. System devices provide real-time Scanner noise reduction and/or noise cancellation, while enabling multiple concurrent dialogs.

#### Patient Population:

The MOC System is designed and intended for use by Patients undergoing functional, interventional and clinical MRI scans. As described above, the System is also used by Doctors and Technologists in these environments.

#### Environment of Use:

The MOC System is designed and intended for use only in functional, interventional and clinical MRI environments.

#### Contraindications:

There are no special precautions, warnings or contraindications for using the MOC System.

#### Comparison to Predicates and Substantial Equivalence:

The following table provides a comparison of the proposed device to the predicates.

The MRI Multi-Channel Optical Communication (MOC) System is viewed as substantially equivalent to the predicate devices because:

Indications - Equivalent to predicates - NordicNeuroLab fMRI Hardware System (K073099) and Avotec Silent Scan (K921891).

Technology - Equivalent technology and design - NordicNeuroLab fMRI Hardware System (K073099) and Avotec Silent Scan (K921891).

Performance - Equivalent to the predicates - NordicNeuroLab fMRI Hardware System (K073099) and Avotec Silent Scan (K921891).

#### Performance Testing -

A comprehensive performance testing and evaluation program was developed in order to verify that the MRI MOC System meets its specifications and does not raise any new safety and effectiveness issues in comparison to the predicate devices. The main parts of the testing program were:

- The Electrical Safety and Electromagnetic compatibility of the MOC were tested by . external laboratories and testing results demonstrate that the System is in compliance with the requirements of the IEC 60601-1 (and amendments), and IEC 60601-1-2 standards.
- Comprehensive performance evaluation studies were conducted to ensure that the MOC ■ meets its specifications.

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#### 510(k) Summary Page 4 of 5 18-May-2012

- Comprehensive clinical performance studies were conducted to ensure that the MOC 트 performs effectively, in full accordance with its indications and intended use.
- . Risk analysis activities were conducted in accordance with requirements of ISO 14971 "Medical devices - Application of risk management to medical devices" (2007). As concluded from the Risk Analysis procedure, the potential risks of the MOC have been reduced to pre-determined acceptance criteria and the residual risk deemed acceptable.
- . Based on these performance testing results, as well the verification and validation processes and an analysis of the similarities and differences presented above, it can be concluded that the MOC is substantially equivalent to the predicate devices without raising new issues of safety or effectiveness.

#### Conclusion

The MRI Multi-Channel Optical Communication (MOC) System is substantially equivalent to the predicates NordicNeuroLab fMRI Hardware System (K073099) and Avotec Silent Scan (K921891) in indications for use, patient population, and environment for use, technology characteristics, specifications / performance and compliance with international standards.

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## Premarket Notification 510(k)
Section 5 – 510(k) Summary

# 510(k) Summary

・・ . "

.

. 8-May-2012

| Manufacturer | Optoacoustics Ltd | NordicNeuroLab AS | Avotec |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Description | MRI Multichannel Optical<br>Communication Systems for<br>MRI (MOC) | fMRI Hardware System,<br>Nuclear Magnetic Resonance<br>Imaging System | Silent Scan - (Hearing<br>Protection and Communication<br>System) |
| Device<br>Manufacturer | Optoacoustics Ltd. | NordicNeuroLab AS. | Avotec, Inc. |
| Intended Use | The MRI Multi-Channel Optical<br>Communication System (MOC)<br>is intended to facilitate audio<br>communications and<br>stimulation during a scanning<br>session. System devices<br>provide real-time Scanner noise<br>reduction and/or noise<br>cancellation, while enabling<br>multiple concurrent dialogs. | The fMRI Hardware System is a<br>stimulus presentation and<br>response collection system<br>intended to be used by trained<br>professionals to facilitate<br>auditory and visual stimulation<br>to be used in functional MR<br>Imaging (fMRI) based on Blood<br>Oxygen Level Dependant<br>(BOLD) contrast. | Silent Scan is a hearing<br>protection and communication<br>system intended to provide two-<br>way audio communications and<br>a music listening experience to<br>patients during MR imaging<br>sessions. |
| Intended<br>Population | The device is intended for use<br>during the MRI procedures as a<br>communication accessory<br>(Patient, Radiologist.<br>Technologists) | The device is intended for use<br>during the MRI procedures as a<br>communication accessory.<br>(subject in fMRI brain studies,<br>not clinical) | The device is intended for use<br>during the MRI procedures as a<br>communication accessory<br>(Patient, Radiologist,<br>Technologists) |
| Location of Use | Hospital environment (MRI<br>facilities) | Hospital environment (MRI<br>facilities) | Hospital environment (MRI<br>facilities) |
| Core Technology | Optical Laser, Optical<br>Transduction (converting light<br>modulation to sound), Diffuse<br>Infrared (IR) | Electrostatic Headphone with<br>Electrical Cable | Pneumatic Audio Transmission<br>with Piezo-Electronics Driver |
| System<br>Components | Patient Optical Headset<br>Staff Optical Headsets<br>Control/Mixing Console<br>Electro-Optical Unit (EOU)<br>IR Transceiver Wall Units<br>Fiber Optic Cables<br>Battery Recharger | Patient Headset<br>Mixing Console<br>Electronic Amplifier<br>Electrical Cables | Patients Headsets<br>Electronic Communication<br>Console with Microphone<br>Electrical Cabling<br>Plastic Tubing Assembly<br>Stereo Interface Box<br>Alarm System (Rubber<br>Squeeze Bulb) |
| Mode of Operation | Continuous | Continuous | Continuous |
| Computer-Based | No | No | No |
| Single Use | The system is reusable | The system is reusable | The system is reusable |
| Mode of Patient<br>contact | Headset | Headset | Headset |
| Anatomical Contact<br>Sites | Head | Head | Head |
| System Accuracy | N/A | N/A | N/A |
| Compatibility with<br>MRI system | Yes | Yes | Yes |

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#### Appendix B

Statement for the Record, K121239

This 510(k) was reviewed under OIVD's Pilot Triage Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant's 510(k) summary for a summary of the information that supports this SE determination.

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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Optoacoustics Ltd % Mr. Paul Dryden President ProMedic, Inc. 24301 Woodsage Drive BONITA SPRINGS FL 34134

MAY 2 4 2G12

Re: K121239

K 121239
Trade/Device Name: MRI Multi-Channel Optical Communication System (MOC) Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: April 20, 2012 Received: April 24, 2012

#### Dear Mr. Dryden:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 5 IQ(x) premarket is substantially equivalent (for the indications
referenced above and have determined the devices markets in interstate referenced above and have determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed in interstate for use stated in the enclosure) to legally market producal Device Americe Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food, Drug, commerce prior to May 28, 1976, the enactment use of the Federal Food, Drug, devices that have been reclassince in accordance what or over on and and cation (PMA).
and Cosmetic Act (Act) that do not require approval of a proval applicions of the Act. and Cosmetic Act (Act) that do not require approval or the general controls of the Act. The
You may, therefore, market the device, subject to the general contractors for an You may, therefore, market the device, subject to the sunsul registration, listing of
general controls provisions of the Act include requirements misbranding and general controls provisions of the Act include requirements for alluding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such If your device is classified (see above) into class it (Special Sound in Title 21,
additional controls. Existing major regulations affecting your device can be found in furt additional controls. Existing major regulations and to 895. In addition, FDA may publish further
Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may Code of Pederal Regulations (OFF), Faris (OFF), announcements concerner.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA's issuance of a substantial with over requirements of the Act
that FDA has made a determination that your device complies with of the Act that FDA has made a determination inal your ac-rece complet Federal agencies. You must
or any Federal statutes and regulations adminstered by other to: registration and list or any Federal statutes and regulations and limited to: registration and listing (21
comply with all the Act's requirements, including, but not limited to registing of comply with all the Act's requirements, including, but hot minted to regorting of
CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting of

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#### Page 2

medical device-related adverse events) (21 CFR 803); and good manufacturing practice medical device-related adverse events) (21 CFR 805); and good manager (2). This letter
requirements as set forth in the quality systems (QS) regulation (21 CFR Parket requirements as set forth in the quality systems (QS) regulation (2) extremation (2)
will allow you to begin marketing your device as described in your Section 510(K) prematk will allow you to begin marketing your device of your device to a legally marketed
notification. The FDA finding of substantial equivalence of your device to notification. The FDA finding of substantial equivalence of your device and thus, permits your device to proceed to the market.

providesire specific advice for your device on our labeling regulation (21 CFR Parts 801 and If you desire specific advice for your device on our labeling to release and safety at (301) 796809), please contact the Office of In Vitro Diagnostic Device Evaluation and 809), please contact the Office of In Piro Deliver Device of Proference to premarket.
5450. Also, please note the regulation entitled, "Misbranding by reference overse eve 5450. Also, please note the regulation entitled, "virsonalisms of the reporting of adverse events
notification" (21 CFR Pat 807.97). For questions regarding the reporting of notification (21 CFR Part (21 CFR Part 803), please go to 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 the Market of the intern http://www.fda.gov/MedicalDevices/Devision of Postmarket Surveillance.
of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the You may obtain other general informational and Consumer Assistance at its toll-free number
Division of Small Manufacturers, International and Consumer at its toll-free number Division of Sinan Milliationships at its Internet address
[phone] or [phone] or attitudes html [phone] of (2017-01-15) industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety - Evaluation and Sailty)
Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

K121239 510(k) Number

Device Name

MRI Multi-Channel Optical Communication System (MOC)

#### Indications for Use:

Optoacoustic's MRI Multi-Channel Optical Communication System (MOC) is intended to facilitate audio communications and stimulation during a scanning session. System devices provide real-time Scanner noise reduction and/or noise cancellation, while enabling multiple concurrent dialogs.

Prescription Use V

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

oneurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Shume Shem
Division Sign-off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K121239

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