The iSyncWave is intended for prescription use in a health care facility to acquire, transmit, display and store primarily EEG and optional auxiliary signals for adults and children, not including newborns.

Device Description

iSyncWave™ is a wireless EEG measurement device that applies dry EEG measurement technology to an international 10-20 system compliant size-adjustable headset. iSyncWave™ measures 19 channel EEG in real time and transfers the data through BLE wireless connection to the iSyncWave™ App. The data is displayed and recorded via the iSyncWave™ App. iSyncWave™ uses dry electrode technology, which doesn't require a preparation process(e.g., applyinq conductive gel), to obtain high quality EEG signals. Before measuring the EEG, you can check the impedance of each electrode under the impedance check screen in the iSyncWave™ app. An EEG amplifier, analog-to-digital converter and Bluetooth are built in the device. All EEG signal is sampled at 250 Hz and then converted to digital data at 24-bit resolution. This device measures overall EEG data using 19 EEG electrodes, 1 Reference cable and 1 ground electrode. The measured data can be digitally converted to common average, longitudinal and transverse montage. The measured data is automatically uploaded to a secure cloud server via Wi-Fi connection and saved securely. The data saved in the cloud server can be seen on the iSyncWave™ app.

AI/ML Overview

The iSyncWave is an electroencephalograph (EEG) device intended for prescription use in healthcare facilities to acquire, transmit, display, and store EEG and optional auxiliary signals for adults and children (excluding newborns). The primary study proving the device meets its acceptance criteria is a non-clinical bench test comparison to a predicate device, the WR19 System by Zeto Inc. (K172735).

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the iSyncWave are primarily demonstrated through a substantial equivalence comparison to its predicate device, the WR19 System (K172735), and compliance with various international standards for medical electrical equipment. The "reported device performance" entries below reflect how the iSyncWave either matches or is deemed equivalent to the predicate, or meets the technical requirements of the standards.

Acceptance Criteria Category	Acceptance Criteria (from predicate/standards)	Reported iSyncWave Performance	Remark/Conclusion (from study)
Indications for Use	Intended for prescription use in a healthcare facility to acquire, transmit, display and store primarily EEG and optional auxiliary signals for adults and children, not including newborns.	Same as predicate.	Equivalent as predicate
User Interface	Operator control, visual indicators.	Operator control, visual indicators.	Equivalent as predicate
System Components	Headset, Electrodes, Charger, Charging cable, Software.	Headset, Electrode, Software.	Equivalent as predicate (Charger not included in iSyncWave™ but functionality achieved)
Signals Acquired	Scalp EEG, Accelerometer.	Scalp EEG.	Equivalent as predicate (Accelerometer not included but not considered a significant difference)
Power Supply	1 x 2050mAh 3.7V Lithium-Ion battery.	2950 mAh 3.7V Lithium-Ion battery.	Equivalent as predicate (iSyncWave™ has 50% higher battery capacity)
Battery Charging	Via USB connector connected to USB wall charger.	Via USB connector connected to USB wall charger.	Equivalent as predicate
Typical Charging Time	0.5 - 6.0 hours.	0.5 - 2.5 hours.	Equivalent as predicate (iSyncWave™ speedy charging)
Operating Time	6 - 7 hours.	7 hours.	Equivalent as predicate
Typical Use Duration	20 - 60 minutes.	10 - 20 minutes.	Equivalent as predicate (iSyncWave™ optimized for quick usage)
Dimensions	214 x 274 x 144 mm (Complete headset with electrodes).	250 x 243 x 150 (mm).	No significant difference
Weight	< 650g or 23oz with battery (Complete headset with electrodes).	1.59 kg.	No significant difference (Through complex mechanical structure, stable contact quality is guaranteed)
Cleaning	Cleaned and disinfected by rubbing with isopropyl alcohol.	Cleaned and disinfected by rubbing with isopropyl alcohol.	Equivalent as predicate
Internal Data Storage	SD card, Minimum 8GB memory capacity.	N/A (No internal data storage).	No significant difference (iSyncWave™ does not need internal data storage)
File Size per 8 hr Recording	1.5 GB.	0.5 GB.	No significant difference (iSyncWave™ use lower data storage)
Wireless Data Transfer	802.11 b/g/n Wi-Fi.	BLE V5.0, 802.11 b/g/n Wi-Fi.	No significant difference
Maximum Wireless Transfer Distance	Up to 30 meters (Wi-Fi).	Up to 10 meters (BLE), Wi-Fi via application.	Equivalent as predicate (iSyncWave™ uses BLE to headset, then tablet uses Wi-Fi)
EEG Definition	Up to 19 referential channels.	Up to 19 referential channels.	Equivalent as predicate
Sampling Rate	500 Hz.	250 Hz.	Equivalent as predicate (250 Hz sufficient for routine EEG analysis reviewing delta to gamma (1.0 ~ 50.0 Hz) frequency analysis)
Hardware Filtering	No hardware LPF/HPF/Notch filters.	Hardware LPF/HPF.	Equivalent as predicate (iSyncWave™'s hardware filter gives cleaner signal to the amplifier)
Software Filtering	Optional LPF and HPF (Cutoff frequency selectable by operator), 50 Hz, 60 Hz notch.	50 Hz, 60 Hz notch filters.	Equivalent as predicate (iSyncWave™ LPF and HPF is hardwired while notch filter is implemented on the software)
Dynamic Range (EEG)	± 375 mV.	± 1 mV.	Equivalent as predicate (AFE reduces dynamic range but improves signal quality; severe abnormal EEGs mostly less than ±1mV)
Resolution (EEG)	0.044 μV.	0.3 nV.	Equivalent as predicate (Reduced dynamic range with 24-bit quantization results in reduced resolution to 0.1nV, which is claimed acceptable)
Peak to peak noise (EEG)	4 μV (typical).	4 μV (typical).	Equivalent as predicate
Common Mode Rejection Ratio (EEG)	> 120 dB (typical).	> 89 dB (typical).	Equivalent as predicate (Although lower hardware CMRR, software implements additional 50/60 Hz notch filter with ~70 dB attenuation)
Input Impedance (EEG)	1000 GOhm.	1000 GOhm.	Equivalent as predicate
A/D Conversion (EEG)	24 Bit.	24 Bit.	Equivalent as predicate
Electrode Type	Active, dry.	Dry.	No significant difference (Instead of active electrode, AFE is added to conventional EEG amp)
Contact Quality/Impedance	Contact quality monitoring performed.	Contact quality monitoring performed.	No significant difference
Measurement (Real-time)	Real time throughout the recording/test.	Real time throughout the test.	(During recording, all computing resource is dedicated to EEG acquisition)
Firmware	WR19 headset is controlled by a firmware.	iSyncWave™ headset is controlled by a firmware.	Equivalent as predicate
Data Center Application	WR19 sends data to the data center application in the cloud.	iSyncWave™ sends data to the data center application in the cloud.	Equivalent as predicate
Client Application	Presents waveforms, controls EEG session, and offers standard EEG transformations; records and retrieves EEG waveforms.	Presents waveforms, controls EEG session, and offers standard EEG transformations; records and retrieves EEG waveforms.	Equivalent as predicate
Electrode Material	Ag/AgCl coated.	Ag/AgCl coated.	Equivalent as predicate
Electrode Mounting Mechanism	Semi-rigid wearable headset with adjustable electrode positions.	Electrode position can be adjusted to International 10-20 electrode location on the expandable headset structure.	No significant difference (Special mechanical structure maintains 10-20 system and contact pressure)
Typical Usage Setting	Intended for use for Routine clinical EEG where rapid placement of EEG electrodes as per the 10-20 EEG system is required.	Intended for use for Routine clinical EEG where rapid placement of EEG electrodes as per the 10-20 EEG system is required.	Equivalent as predicate
Regulatory Compliance Standards Adherence	Basic safety and essential performance, EMC, Usability, Software lifecycle, Biocompatibility.	Adherence to IEC 60601-1, IEC 60601-1-2, IEC 80601-2-26, IEC 60601-1-6, IEC 62304, ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-23.	None of the testing demonstrated any design characteristics that violated the requirements of the standards or resulted in any safety hazard.

2. Sample Size Used for the Test Set and the Data Provenance

The provided document does not specify a separate "test set" in terms of patient data for evaluating diagnostic performance. The studies cited are primarily non-clinical bench tests focused on verifying compliance with various electrical, safety, software, and biocompatibility standards. The data provenance is related to these engineering and safety tests, not patient data from a specific country or whether it was retrospective/prospective.

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 regulatory submission focuses on engineering and safety compliance, and substantial equivalence to a predicate device, rather than a clinical performance study requiring expert ground truth assessment for a diagnostic task.

4. Adjudication Method for the Test Set

This information is not applicable as there is no described clinical test set involving patient data and multiple expert readings for adjudication.

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

There is no mention of a Multi Reader Multi Case (MRMC) comparative effectiveness study being performed or any assessment of human reader improvement with or without AI assistance. The device functions as an EEG acquisition and display system; the document does not describe AI-driven interpretation or assistance in EEG reading for diagnostic purposes.

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

There is no mention of a standalone algorithm performance study. The device is described as an EEG acquisition and display system, not one that performs automated diagnostic interpretation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth used for the non-clinical bench tests would be the established technical specifications and performance limits defined by the international standards (e.g., IEC 60601-1 for basic safety, IEC 80601-2-26 for electroencephalographs performance), and the technical characteristics of the predicate device. This is not a clinical "ground truth" derived from patient outcomes or expert reads.

8. The Sample Size for the Training Set

This information is not provided as the submission describes a medical device for acquiring and displaying physiological signals (EEG), not a machine learning or AI algorithm that requires a training set of data.

9. How the Ground Truth for the Training Set was Established

This information is not applicable as there is no described training set for a machine learning or AI algorithm.

Summary

{0}------------------------------------------------

August 10, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

iMediSync Inc. Young-Geun Kim Deputy Manager 3rd Fl. 175 Yeoksam-ro. Gangnam-gu Seoul. Korea. 06247

Re: K220056

Trade/Device Name: iSyncWave Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWQ, GXY Dated: January 6, 2022 Received: January 6, 2022

Dear Young-Geun Kim:

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

{1}------------------------------------------------

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K220056

Device Name

iSyncWave

Indications for Use (Describe)

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

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image contains the logo for iMediSync. The logo consists of three shapes: a green square, a blue square, and a gray circle. The text "iMediSync" is written in gray next to the shapes.

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92 Date: June 30, 2022

I. 510K Applicant / Submitter:

(Legal Manufacturer) iMediSync Inc. 3rd Fl. 175 Yeoksam-ro, Gangnam-qu, Seoul, Republic of Korea Tel: +82-2-747-7422

II. Submission Contact Person (Primary Correspondent Person)

Young Geun Kim / Deputy manager iMediSync Inc. 3rd Fl. 175 Yeoksam-ro, Gangnam-gu, Seoul, Republic of Korea Tel: +82-2-747-7422 Email: yqkim@imedisync.com

III. Subject Device

Trade/Proprietary Name: iSyncWave™ .
. Common Name: Full-montage standard electroencephalograph
Classification Name: Electroencephalograph .
Requlation: 21 CFR 882.1400 .
Product Code: GWQ, GXY .

IV. Predicate Device

WR19 System by Zeto Inc. (K172735)

V. Description:

iSyncWave™ is a wireless EEG measurement device that applies dry EEG measurement technology to an international 10-20 system compliant size-adjustable headset.

iSyncWave™ measures 19 channel EEG in real time and transfers the data through BLE wireless connection to the iSyncWave™ App. The data is displayed and recorded via the iSyncWave™ App. iSyncWave™ uses dry electrode technology, which doesn't require a

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image contains the logo for iMediSync. The logo consists of a green square, a blue square, and a gray circle. The text "iMediSync" is written in gray next to the shapes.

preparation process(e.g., applyinq conductive gel), to obtain high quality EEG signals. Before measuring the EEG, you can check the impedance of each electrode under the impedance check screen in the iSyncWave™ app. An EEG amplifier, analog-to-digital converter and Bluetooth are built in the device. All EEG signal is sampled at 250 Hz and then converted to digital data at 24-bit resolution.

This device measures overall EEG data using 19 EEG electrodes, 1 Reference cable and 1 ground electrode. The measured data can be digitally converted to common average, longitudinal and transverse montage. The measured data is automatically uploaded to a secure cloud server via Wi-Fi connection and saved securely. The data saved in the cloud server can be seen on the iSyncWave™ app.

iSyncWave™ can be only used by professional and/or medical personnel with product training and experience in EEG measurement. The professional and/or medical personnel can check the signal quality in real time and refer to the measured data in clinical practice.

IV. Indications for Use

The iSyncWave™ is intended for prescription use in a health care facility to acquire, transmit, display and store primarily EEG and optional auxiliary signals for adults and children, not including newborns.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE VII. DEVICE

The subject device is substantially equivalent to WR19 System(K172735). The subject device has the same indications for use and the technological characteristics as the predicate device. There are no significant differences between the subject device and predicate device [WR19 System(K172735)]. However, these differences do not raise a question in substantial equivalence discussion. Details refer to "Remark" of below table. Based on the comparison and the performance test data, we conclude that the subject device is substantially equivalent to the predicate device.

{5}------------------------------------------------

VIII. Performance Data

Non-clinical bench tests were performed as followings:

ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 । (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)

IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 80601-2-26:2019 Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability - IEC 62304:2006/A1:2015 Medical device software - Software life-cycle processes (IEC 62304:2006)
10993-1 Fifth edition 2018-08 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
10993-23 First edition 2021-01 Biological evaluation of medical devices - Part 23: Tests for irritation

Along with the above tests, Electromagnetic Compatibility and Electrical Safety, Usability, Biocompatibility, Performance, and software validation were also conducted. None of the testing demonstrated any design characteristics that violated the requirements of the standards or resulted in any safety hazard.

X. Conclusions:

Based on the information provided in this premarket notification, iMediSync Inc. concludes that the iSyncWave™ is substantially equivalent to the predicate device as described herein in safety and effectiveness.

Item	Predicate Device	Our Device	Remark
Manufacturer	Zeto, Inc.	iMediSync Inc.	-
Product Name	Electroencephalograph	Electroencephalograph	-
Brand Name	WR19 System	iSyncWave™	-
CertificationStatus	FDA 510(K)/K172735	On going	-
[Overview]
Design	Image: WR19 System	Image: iSyncWave System	Equivalent as predicate
Indications forUse	The WR19 System isintended for prescriptionuse in a health carefacility to acquire,transmit, display andstore primarily EEG andoptional auxiliary signalsfor adults and children,not including newborns.	The iSyncWave™ isintended for prescriptionuse in a health carefacility to acquire,transmit, display andstore primarily EEG andoptional auxiliary signalsfor adults and children,not including newborns.	Same as predicate
User Interface	Operator control, visualindicators	Operator control, visualindicators	Equivalent as predicate
SystemComponents	• Headset• Electrodes• Charger• Charging cable• Software	- Headset- Electrode- Software	Equivalent as predicateCharger is not included in theiSyncWave™.
SignalsAcquired	• Scalp EEG• Accelerometer	- Scalp EEG	Equivalent as predicate
Power Supply	1 x 2050mAh 3.7VLithium-Ion battery	2950 mAh 3.7V Lithium-Ion battery	Equivalent as predicateiSyncWave™ has 50% higherbattery capacity.
BatteryCharging	Via USB connectorconnected to USB wallcharger.	Via USB connectorconnected to USB wallcharger.	Equivalent as predicate
TypicalCharging Time	0.5 - 6.0 hours	0.5 - 2.5 hours	Equivalent as predicateiSyncWave™ speedy charging.
OperatingTime	6 - 7 hours	7 hours	Equivalent as predicate
Typical UseDuration	20 - 60 minutes	10 - 20 minutes	Equivalent as predicateiSyncWave™ is optimized for quick
Dimensions	8.5 x 10.8 x 5.7" or 214 x274 x 144 mm (Completeheadset with electrodes)	250 x 243 x 150 (mm)	No significant difference
Weight	< 650g or 23oz withbattery (Completeheadset with electrodes)	1.59 kg	No significant differenceThrough complex mechanicalstructure, stable contact quality isguaranteed.
Cleaning	Cleaned and disinfectedby rubbing with isopropylalcohol	Cleaned and disinfectedby rubbing with isopropylalcohol	Equivalent as predicate
[Data Transfer and Storage]
Internal DataStorage	SD card, Minimum 8GBmemory capacity	N/A (No internal datastorage)	No significant differenceiSyncWave™ do not need internaldata storage.
File Size per8 hr Recording	1.5 GB	0.5 GB	No significant differenceiSyncWave™ use lower datastorage.
Wireless DataTransfer	802.11 b/g/n Wi-Fi	BLE V5.0, 802.11 b/g/nWi-Fi	No significant difference
MaximumWirelessTransferDistance	Headset includescommercially available,FCC-certified, Wi-Fimodule that works forstandard transferdistance from Wi-FiRouter, typically up to 30meters.	Headset includescommercially available,FCC-certified, BLE modulethat works for standardtransfer distance fromBLE Router, typically upto 10 meters.In order to save themeasured data,iSyncWave™ applicationtransfer data via Wi-Fi	Equivalent as predicateiSyncWave™ use only BLE andtablet use the Wi-Fi.
[EEG Measurements]
Definition	Up to 19 referentialchannels	Up to 19 referentialchannels	Equivalent as predicate
SignalProcessing	Sampling Rate: 500 Hz	Sampling Rate: 250 Hz	Equivalent as predicate250 Hz sample rate is sufficient forroutine EEG analysis reviewingdelta to gamma (1.0 ~ 50.0 Hz)frequency analysis.
Techniques	No hardwareLPF/HPF/Notchfilters.	Hardware LPF/HPF	Equivalent as predicateiSyncWave™'s hardware filter givescleaner signal to the amplifier.
	Software Filtering:Following are optional:	Software Filtering:50 Hz, 60 Hz notch filters	Equivalent as predicateiSyncWave™ LPF and HPF is
	LPF and HPF (Cutofffrequency selectable byoperator), 50 Hz, 60 Hznotch		hardwired while notch filter isimplemented on the software.
Accuracy,Performance(EEG)	Sampling rate: 500 HzDynamic range: ± 375 mVResolution: 0.044 μVPeak to peak noise: 4 μV(typical)Common Mode RejectionRatio: > 120 dB (typical)Input Impedance: 1000GOhmNoise: 1μV RMSA/D Conversion: 24 Bit	Sampling rate: 250 HzDynamic range: ± 1 mVResolution: 0.3 nVPeak to peak noise: 4 μV(typical)Common Mode RejectionRatio: > 89 dB (typical)Input Impedance: 1000GOhmA/D Conversion: 24 Bit	Equivalent as predicate Samplingrate: 250 Hz sample rate issufficient for routine EEG analysisreviewing delta to gamma (1.0 ~ 50Hz) frequency analysis.- Dynamic Range : iSyncWave™ addan analog front end(AFE) as apreamplifier, on conventional EEGdesign. The AFE has a gain over ahundred which reduces thedynamic range of the EEGamplifier, but the AFE significantlyreduces measurement noises andfinally gives a good signal quality.At the same time, even severeabnormal EEG amplitudes aremostly less than ± 1 mV- Resolution: Since the dynamicrange is reduced and the signal isquantized by the same 24 bit, theresolution is quite reduced downto 0.1nV.-Common mode rejection: Thecommon mode rejection as ahardware rejection ratio, is lessthan the predicate device. ButiSyncWave™ acquisition softwareinherently adds another 50/60 Hznotch filter with around 70 dBattenuation for reviewing the EEGin a noisy environment. The notchfilter is automatically set by theGPS signal on the acquisitionsoftware.
Electrode Type	Active, dry	Dry	No significant differenceInstead of active electrode, analogfront end design is added to theconventional EEG amp.
ContactQuality/Impedance	Contact qualitymonitoring performed	Contact qualitymonitoring performed	No significant difference
Measurement	real time throughout therecording/ test	real time throughout thetest	During the recording, allcomputing resource is dedicated tothe EEG acquisition.
[Accelerometer]
Scope of Use	Used primarily as an aidfor motion detection andhence finding EEGartifacts	N/A	No significant differenceAccelerate motion detection is notavailable.
Channels	Dynamic Range:-180° to 180° Threechannels (X, Y, Z) used bysoftware to measuremovement and position	N/A	No significant differenceSame as reason above.
[Software Characteristics]
Firmware	WR19 headset iscontrolled by a firmware.	iSyncWave™ headset iscontrolled by a firmware.	Equivalent as predicate
Data CenterApplication	WR19 sends data to thedata center application inthe cloud.	iSyncWave™ sends datato the data centerapplication in the cloud.	Equivalent as predicate
ClientApplication	Client applicationpresents waveforms,controls EEG session, andoffers standard EEGtransformations such aslow-pass,high-pass, notchfilters and montagetransformations.	Client applicationpresents waveforms,controls EEG session, andoffers standard EEGtransformations such aslow-pass,high-pass, notchfilters and montagetransformations.	Equivalent as predicate
	Client application recordsand retrieves EEGwaveforms.	Client application recordsand retrieves EEGwaveforms.	Equivalent as predicate
[Reference Device]
ElectrodeMaterial	Ag/AgCl coated	Ag/AgCl coated	Equivalent as predicate
Type ofElectrodes	Active, dry	Dry	No significant differenceInstead of active electrode, analogfront end design is added to theconventional EEG amp.
ElectrodeMountingMechanism	Semi-rigid wearableheadset with certainelectrode positions.Electrode positions canbe adjusted to a limitedextent.	Electrode position can beadjusted to International10-20 electrode locationon the expandableheadset structure.	No significant differenceSpecial mechanical structure canmaintain international 10-20system during wearing headsetand can keep the contact pressureduring recording.
Typical UsageSetting	Intended for use forRoutine clinical EEG	Intended for use forRoutine clinical EEG	Equivalent as predicate
	where rapid placement ofEEG electrodes as per the10-20 EEG system isrequired.	where rapid placement ofEEG electrodes as per the10-20 EEG system isrequired.

{6}------------------------------------------------

മ്മ iMediSync

{7}------------------------------------------------

Image /page/7/Picture/1 description: The image contains the logo for iMediSync. The logo consists of a stylized graphic to the left of the company name. The graphic includes a green square, a dark blue square, and a gray circle. The company name "iMediSync" is written in gray.

{8}------------------------------------------------

Image /page/8/Picture/1 description: The image contains the logo for iMediSync. The logo consists of a stylized graphic with a green square, a dark blue square, and a gray circle. To the right of the graphic is the company name, "iMediSync", in gray text. The logo is simple and modern.

{9}------------------------------------------------

Image /page/9/Picture/1 description: The image contains the logo for iMediSync. The logo consists of a stylized graphic to the left of the company name. The graphic includes a green square, a dark blue square, and a gray circle. The company name "iMediSync" is written in gray.

{10}------------------------------------------------

മ്മ iMediSync

Regulation Number and Section

§ 882.1400 Electroencephalograph.

(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).