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: IMROC, IMROC IR Wireless, and OptoACTIVE. Sub-component devices include Optical Headsets, Control/Mixing Console, Electro-Optical Unit (EOU), IR Transceiver Unit, Battery Recharging Unit, Hygienic Pop Screens, and Hygienic Earpad Covers.

AI/ML Overview

The provided document describes the Optoacoustics Ltd. MRI Multi-Channel Optical Communication System (MOC). It does not present specific acceptance criteria or a detailed study proving the device meets those criteria with numerical performance values. Instead, it describes a comprehensive performance testing program that was conducted to ensure the system meets its specifications and does not raise new safety or effectiveness issues compared to predicate devices. The document also states that clinic performance studies were performed but does not elaborate on the results.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Inferred from context)	Reported Device Performance (as stated in the document)
Electrical Safety and Electromagnetic Compatibility (e.g., compliance with IEC 60601-1 and IEC 60601-1-2 standards)	"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."
Device meets its specifications (e.g., facilitating audio communications, stimulation, real-time scanner noise reduction/cancellation, multiple dialogs)	"Comprehensive performance evaluation studies were conducted to ensure that the MOC meets its specifications." "Comprehensive clinical performance studies were conducted to ensure that the MOC performs effectively, in full accordance with its indications and intended use." "The MRI Multi-Channel Optical Communication (MOC) System is substantially equivalent to the predicates... in indications for use, patient population, and environment for use, technology characteristics, specifications / performance and compliance with international standards."
Reduced potential risks to pre-determined acceptance criteria (ISO 14971 compliance)	"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."
Substantial Equivalence to Predicate Devices (for safety and effectiveness)	"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."

2. Sample size used for the test set and the data provenance:

The document mentions "Comprehensive clinical performance studies were conducted," but does not specify the sample size for any test set (clinical or otherwise) or provide details on the data provenance (e.g., country of origin, retrospective or prospective nature).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The device is for communication and noise reduction, not diagnostic imaging, so traditional "ground truth" established by experts for image interpretation wouldn't typically apply in the same way.

4. Adjudication method for the test set:

This information is not provided in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable as the device is not designed for diagnostic image interpretation by human readers with or without AI assistance. It is a communication system accessory for MRI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The document implies that "Comprehensive performance evaluation studies" and "Comprehensive clinical performance studies" were conducted. However, it does not explicitly detail a "standalone" performance study in the context of an algorithm's performance without human interaction. The device's nature (communication system) inherently involves human interaction.

7. The type of ground truth used:

The document does not explicitly state the "type of ground truth used." For a communication and noise reduction system, "ground truth" would likely relate to objective measurements of audio clarity, noise reduction levels, and successful communication, rather than pathology or outcomes data in a diagnostic sense.

8. The sample size for the training set:

This information is not provided. Given the nature of the device as a communication system and not an AI/machine learning diagnostic tool, a "training set" in the traditional sense might not be applicable or explicitly mentioned.

9. How the ground truth for the training set was established:

This information is not provided and is likely not relevant in the context of this device.

Summary

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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, CEOOptoacoustics Ltd.17 Hanotea St.Mazor 73160, IsraelTel: (+972) 3-634-4488Fax: (+972) 3-634-9292
	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)Product code - LNH21 CFR 892.1000Class II
Predicate Devices:	fMRI Hardware System, Nuclear Magnetic Resonance ImagingSystem (NordicNeuroLab AS.) K073099Silent Scan, Nuclear Magnetic Resonance Imaging (Avotec Inc)K921891

Device Description:

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-Component	Description
OpticalHeadsets	Each Headset includes left-and-right high fidelity optical speakers inside a passivenoise-reducing casing, coupled with a dual-channel noise-cancelling opticalmicrophone and enables full duplex communications among Staff and Patient. TheHeadset is fitted with noise-reducing disposable earpads.IMROC/IMROC IR Wireless OptoACTIVE – The Headset interfaces directly with the System EOU viafiber optic cable. The Headset is available in an optional Ultra-Slim formfactor, designed for use in 32-channel head coils.
Control/MixingConsole	The Control and Mixing Console is operated by the technologist in the ControlRoom to manage the interactive communications environment (e.g., turning offspecific headsets, muting Staff/Patient's speaker, adjusting noise cancelling andnoise reduction levels, Patient's music volume, etc.).The Console features an MP4 format player to enable selection of appropriatemusic for a Patient. In addition, the Console enables direct music input from acompatible external player, brought by a Patient.The Console contains a built-in microphone and speaker for direct communicationsbetween the technologist and the medical Staff. The Console contains electronicparts and is attached directly to the EOU via electrical cable.
Electro-OpticalUnit (EOU)	The Electro-Optical Unit (EOU) is the main processing unit of the System. Itreceives inputs from the optical Headsets, performs required optical to electricalsignal transduction, noise-cancelling and signal enhancement processing, andredistributes communications to Staff and Patient according to current settings onthe Control/Mixing Console.
IR TransceiverUnit	(IMROC IR Wireless Component Only) A stationary, wall-mounted unit in theScanner Room which exchanges wireless infrared (IR) signals with the OpticalHeadsets of each Staff member. It interfaces with the System EOU via fiber opticcable.
BatteryRechargingUnit	(IMROC IR Wireless Component Only) A stationary, tabletop unit that is intendedto be used in the Control Room, where it is easily accessible to Staff responsible foroutine System operation. It recharges batteries that are used in the PersonalControl Unit, as required. Multiple batteries can be recharged simultaneously.
Hygienic PopScreens	Specially-fitted pop-screens can be attached to the microphone on the OpticalHeadset The screens are designed to be used once per Scanning session, and aredisposable.
HygienicEarpad Covers	Industry standard disposable earpad covers are mounted on left and right earphoneson the Optical Headset and are disposable.

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

Indications for Use:

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 OpticalCommunication Systems forMRI (MOC)	fMRI Hardware System,Nuclear Magnetic ResonanceImaging System	Silent Scan - (HearingProtection and CommunicationSystem)
DeviceManufacturer	Optoacoustics Ltd.	NordicNeuroLab AS.	Avotec, Inc.
Intended Use	The MRI Multi-Channel OpticalCommunication System (MOC)is intended to facilitate audiocommunications andstimulation during a scanningsession. System devicesprovide real-time Scanner noisereduction and/or noisecancellation, while enablingmultiple concurrent dialogs.	The fMRI Hardware System is astimulus presentation andresponse collection systemintended to be used by trainedprofessionals to facilitateauditory and visual stimulationto be used in functional MRImaging (fMRI) based on BloodOxygen Level Dependant(BOLD) contrast.	Silent Scan is a hearingprotection and communicationsystem intended to provide two-way audio communications anda music listening experience topatients during MR imagingsessions.
IntendedPopulation	The device is intended for useduring the MRI procedures as acommunication accessory(Patient, Radiologist.Technologists)	The device is intended for useduring the MRI procedures as acommunication accessory.(subject in fMRI brain studies,not clinical)	The device is intended for useduring the MRI procedures as acommunication accessory(Patient, Radiologist,Technologists)
Location of Use	Hospital environment (MRIfacilities)	Hospital environment (MRIfacilities)	Hospital environment (MRIfacilities)
Core Technology	Optical Laser, OpticalTransduction (converting lightmodulation to sound), DiffuseInfrared (IR)	Electrostatic Headphone withElectrical Cable	Pneumatic Audio Transmissionwith Piezo-Electronics Driver
SystemComponents	Patient Optical HeadsetStaff Optical HeadsetsControl/Mixing ConsoleElectro-Optical Unit (EOU)IR Transceiver Wall UnitsFiber Optic CablesBattery Recharger	Patient HeadsetMixing ConsoleElectronic AmplifierElectrical Cables	Patients HeadsetsElectronic CommunicationConsole with MicrophoneElectrical CablingPlastic Tubing AssemblyStereo Interface BoxAlarm System (RubberSqueeze 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 Patientcontact	Headset	Headset	Headset
Anatomical ContactSites	Head	Head	Head
System Accuracy	N/A	N/A	N/A
Compatibility withMRI 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
(800) 638-2041 or (301) 796-7100 or attitudes html (800) 056-2041 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:

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

Page 1 of 1

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.