iSyncWave

K220056 · iMediSync, Inc. · GWQ · Aug 10, 2022 · Neurology

Device Facts

• Record ID: K220056
• Device Name: iSyncWave
• Applicant: iMediSync, Inc.
• Product Code: GWQ · Neurology
• Decision Date: Aug 10, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

iSyncWave is a wireless, dry-electrode EEG headset compliant with the international 10-20 system. It measures 19-channel EEG in real-time, sampling at 250 Hz with 24-bit resolution. The device uses an analog front-end (AFE) preamplifier to reduce noise and improve signal quality. Data is transmitted via BLE to the iSyncWave App, which displays and records the signals. The app also facilitates secure cloud storage via Wi-Fi. Used by trained medical personnel in clinical settings, the device allows real-time signal quality monitoring and impedance checking. Clinicians use the displayed EEG waveforms to support clinical decision-making. The device benefits patients by enabling rapid, gel-free EEG setup compared to traditional systems.

Clinical Evidence

Bench testing only. Testing included electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), particular requirements for EEG (IEC 80601-2-26), usability (IEC 60601-1-6), software lifecycle (IEC 62304), and biocompatibility (ISO 10993-1, -5, -10, -23). No clinical data was provided.

Technological Characteristics

Wireless dry-electrode EEG headset; 19 channels; Ag/AgCl coated electrodes; 250 Hz sampling rate; 24-bit A/D conversion; BLE V5.0 and Wi-Fi connectivity; 2950 mAh Li-Ion battery; hardware LPF/HPF filters; software-based 50/60 Hz notch filters; expandable headset structure for 10-20 system compliance.

Indications for Use

Indicated for prescription use in health care facilities to acquire, transmit, display, and store EEG and optional auxiliary signals for adults and children (excluding newborns).

Regulatory Classification

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.

Predicate Devices

• WR19 System by Zeto Inc. (K172735)

Submission Summary (Full Text)

{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 ([e-mail]) or phone [phone] 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)

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.

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

| Prescription Use (Part 21 CFR 801 Subpart D) | <div> <span> <span></span> </span> </div> |
|----------------------------------------------|-------------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <div> <span> <span></span> </span> </div> |

#### 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: [phone]

# 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: [phone] Email: [e-mail]

# 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™ | - |
| Certification<br>Status | FDA 510(K)/K172735 | On going | - |
| [Overview] | | | |
| Design | Image: WR19 System | Image: iSyncWave System | Equivalent as predicate |
| Indications for<br>Use | The WR19 System is<br>intended for prescription<br>use in a health care<br>facility to acquire,<br>transmit, display and<br>store primarily EEG and<br>optional auxiliary signals<br>for adults and children,<br>not including newborns. | The iSyncWave™ is<br>intended for prescription<br>use in a health care<br>facility to acquire,<br>transmit, display and<br>store primarily EEG and<br>optional auxiliary signals<br>for adults and children,<br>not including newborns. | Same as predicate |
| User Interface | Operator control, visual<br>indicators | Operator control, visual<br>indicators | Equivalent as predicate |
| System<br>Components | • Headset<br>• Electrodes<br>• Charger<br>• Charging cable<br>• Software | - Headset<br>- Electrode<br>- Software | Equivalent as predicate<br>Charger is not included in the<br>iSyncWave™. |
| Signals<br>Acquired | • Scalp EEG<br>• Accelerometer | - Scalp EEG | Equivalent as predicate |
| Power Supply | 1 x 2050mAh 3.7V<br>Lithium-Ion battery | 2950 mAh 3.7V Lithium-<br>Ion battery | Equivalent as predicate<br>iSyncWave™ has 50% higher<br>battery capacity. |
| Battery<br>Charging | Via USB connector<br>connected to USB wall<br>charger. | Via USB connector<br>connected to USB wall<br>charger. | Equivalent as predicate |
| Typical<br>Charging Time | 0.5 - 6.0 hours | 0.5 - 2.5 hours | Equivalent as predicate<br>iSyncWave™ speedy charging. |
| Operating<br>Time | 6 - 7 hours | 7 hours | Equivalent as predicate |
| Typical Use<br>Duration | 20 - 60 minutes | 10 - 20 minutes | Equivalent as predicate<br>iSyncWave™ is optimized for quick |
| Dimensions | 8.5 x 10.8 x 5.7" or 214 x<br>274 x 144 mm (Complete<br>headset with electrodes) | 250 x 243 x 150 (mm) | No significant difference |
| Weight | < 650g or 23oz with<br>battery (Complete<br>headset with electrodes) | 1.59 kg | No significant difference<br>Through complex mechanical<br>structure, stable contact quality is<br>guaranteed. |
| Cleaning | Cleaned and disinfected<br>by rubbing with isopropyl<br>alcohol | Cleaned and disinfected<br>by rubbing with isopropyl<br>alcohol | Equivalent as predicate |
| [Data Transfer and Storage] | | | |
| Internal Data<br>Storage | SD card, Minimum 8GB<br>memory capacity | N/A (No internal data<br>storage) | No significant difference<br>iSyncWave™ do not need internal<br>data storage. |
| File Size per<br>8 hr Recording | 1.5 GB | 0.5 GB | No significant difference<br>iSyncWave™ use lower data<br>storage. |
| Wireless Data<br>Transfer | 802.11 b/g/n Wi-Fi | BLE V5.0, 802.11 b/g/n<br>Wi-Fi | No significant difference |
| Maximum<br>Wireless<br>Transfer<br>Distance | Headset includes<br>commercially available,<br>FCC-certified, Wi-Fi<br>module that works for<br>standard transfer<br>distance from Wi-Fi<br>Router, typically up to 30<br>meters. | Headset includes<br>commercially available,<br>FCC-certified, BLE module<br>that works for standard<br>transfer distance from<br>BLE Router, typically up<br>to 10 meters.<br>In order to save the<br>measured data,<br>iSyncWave™ application<br>transfer data via Wi-Fi | Equivalent as predicate<br>iSyncWave™ use only BLE and<br>tablet use the Wi-Fi. |
| [EEG Measurements] | | | |
| Definition | Up to 19 referential<br>channels | Up to 19 referential<br>channels | Equivalent as predicate |
| Signal<br>Processing | Sampling Rate: 500 Hz | Sampling Rate: 250 Hz | Equivalent as predicate<br>250 Hz sample rate is sufficient for<br>routine EEG analysis reviewing<br>delta to gamma (1.0 ~ 50.0 Hz)<br>frequency analysis. |
| Techniques | No hardware<br>LPF/HPF/Notch<br>filters. | Hardware LPF/HPF | Equivalent as predicate<br>iSyncWave™'s hardware filter gives<br>cleaner signal to the amplifier. |
| | Software Filtering:<br>Following are optional: | Software Filtering:<br>50 Hz, 60 Hz notch filters | Equivalent as predicate<br>iSyncWave™ LPF and HPF is |
| | LPF and HPF (Cutoff<br>frequency selectable by<br>operator), 50 Hz, 60 Hz<br>notch | | hardwired while notch filter is<br>implemented on the software. |
| Accuracy,<br>Performance<br>(EEG) | Sampling rate: 500 Hz<br>Dynamic range: ± 375 mV<br>Resolution: 0.044 μV<br>Peak to peak noise: 4 μV<br>(typical)<br>Common Mode Rejection<br>Ratio: > 120 dB (typical)<br>Input Impedance: 1000<br>GOhm<br>Noise: 1μV RMS<br>A/D Conversion: 24 Bit | Sampling rate: 250 Hz<br>Dynamic range: ± 1 mV<br>Resolution: 0.3 nV<br>Peak to peak noise: 4 μV<br>(typical)<br>Common Mode Rejection<br>Ratio: > 89 dB (typical)<br>Input Impedance: 1000<br>GOhm<br>A/D Conversion: 24 Bit | Equivalent as predicate Sampling<br>rate: 250 Hz sample rate is<br>sufficient for routine EEG analysis<br>reviewing delta to gamma (1.0 ~ 50<br>Hz) frequency analysis.<br>- Dynamic Range : iSyncWave™ add<br>an analog front end(AFE) as a<br>preamplifier, on conventional EEG<br>design. The AFE has a gain over a<br>hundred which reduces the<br>dynamic range of the EEG<br>amplifier, but the AFE significantly<br>reduces measurement noises and<br>finally gives a good signal quality.<br>At the same time, even severe<br>abnormal EEG amplitudes are<br>mostly less than ± 1 mV<br>- Resolution: Since the dynamic<br>range is reduced and the signal is<br>quantized by the same 24 bit, the<br>resolution is quite reduced down<br>to 0.1nV.<br>-Common mode rejection: The<br>common mode rejection as a<br>hardware rejection ratio, is less<br>than the predicate device. But<br>iSyncWave™ acquisition software<br>inherently adds another 50/60 Hz<br>notch filter with around 70 dB<br>attenuation for reviewing the EEG<br>in a noisy environment. The notch<br>filter is automatically set by the<br>GPS signal on the acquisition<br>software. |
| Electrode Type | Active, dry | Dry | No significant difference<br>Instead of active electrode, analog<br>front end design is added to the<br>conventional EEG amp. |
| Contact<br>Quality/<br>Impedance | Contact quality<br>monitoring performed | Contact quality<br>monitoring performed | No significant difference |
| Measurement | real time throughout the<br>recording/ test | real time throughout the<br>test | During the recording, all<br>computing resource is dedicated to<br>the EEG acquisition. |
| [Accelerometer] | | | |
| Scope of Use | Used primarily as an aid<br>for motion detection and<br>hence finding EEG<br>artifacts | N/A | No significant difference<br>Accelerate motion detection is not<br>available. |
| Channels | Dynamic Range:<br>-180° to 180° Three<br>channels (X, Y, Z) used by<br>software to measure<br>movement and position | N/A | No significant difference<br>Same as reason above. |
| [Software Characteristics] | | | |
| Firmware | WR19 headset is<br>controlled by a firmware. | iSyncWave™ headset is<br>controlled by a firmware. | Equivalent as predicate…