(216 days)
Not Found
No
The summary describes a standard EEG acquisition and transmission device. There is no mention of AI, ML, or any algorithms that would process the EEG data beyond basic signal processing (montage conversion). The performance studies focus on safety and basic functionality, not algorithmic performance.
No
The Intended Use/Indications for Use section states that the device is for acquiring, transmitting, displaying, and storing EEG signals, which are diagnostic functions, not therapeutic ones.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is intended "to acquire, transmit, display and store primarily EEG and optional auxiliary signals," which are then used for diagnostic purposes by healthcare professionals. While it does not explicitly state "diagnosis," the acquisition and display of physiological signals like EEG in a healthcare setting are fundamental steps within the diagnostic process.
No
The device description explicitly details a physical headset with electrodes, an amplifier, analog-to-digital converter, and Bluetooth, indicating it is a hardware device with accompanying software.
Based on the provided information, the iSyncWave is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for acquiring, transmitting, displaying, and storing EEG and optional auxiliary signals. This is related to measuring electrical activity of the brain, which is a physiological process within the body.
- Device Description: The description details how the device measures EEG signals using electrodes placed on the scalp. This is an in-vivo measurement (within a living organism).
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The iSyncWave does not interact with or analyze such specimens.
Therefore, the iSyncWave falls under the category of a medical device used for physiological measurement, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GWQ, GXY
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., applying 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Scalp
Indicated Patient Age Range
Adults and children, not including newborns.
Intended User / Care Setting
Prescription use in a health care facility. 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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical bench tests were performed based on the following standards:
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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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
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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) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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
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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.
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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 | |||
| Status | FDA 510(K)/K172735 | On going | - |
| [Overview] | |||
| Design | Image: WR19 System | Image: iSyncWave System | Equivalent as predicate |
| Indications for | |||
| Use | The WR19 System 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. | 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. | Same 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 is not included in the
iSyncWave™. |
| Signals
Acquired | • Scalp EEG
• Accelerometer | - Scalp EEG | Equivalent as predicate |
| 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™ is optimized for quick |
| Dimensions | 8.5 x 10.8 x 5.7" or 214 x
274 x 144 mm (Complete
headset with electrodes) | 250 x 243 x 150 (mm) | No significant difference |
| Weight | 120 dB (typical)
Input Impedance: 1000
GOhm
Noise: 1μV RMS
A/D Conversion: 24 Bit | Sampling rate: 250 Hz
Dynamic range: ± 1 mV
Resolution: 0.3 nV
Peak to peak noise: 4 μV
(typical)
Common Mode Rejection
Ratio: > 89 dB (typical)
Input Impedance: 1000
GOhm
A/D Conversion: 24 Bit | Equivalent as predicate Sampling
rate: 250 Hz sample rate is
sufficient for routine EEG analysis
reviewing delta to gamma (1.0 ~ 50
Hz) frequency analysis. - Dynamic Range : iSyncWave™ add
an analog front end(AFE) as a
preamplifier, on conventional EEG
design. The AFE has a gain over a
hundred which reduces the
dynamic range of the EEG
amplifier, but the AFE significantly
reduces measurement noises and
finally gives a good signal quality.
At the same time, even severe
abnormal EEG amplitudes are
mostly less than ± 1 mV - Resolution: Since the dynamic
range is reduced and the signal is
quantized by the same 24 bit, the
resolution is quite reduced down
to 0.1nV.
-Common mode rejection: The
common mode rejection as a
hardware rejection ratio, is less
than the predicate device. But
iSyncWave™ acquisition software
inherently adds another 50/60 Hz
notch filter with around 70 dB
attenuation for reviewing the EEG
in a noisy environment. The notch
filter is automatically set by the
GPS signal on the acquisition
software. |
| Electrode Type | Active, dry | Dry | No significant difference
Instead of active electrode, analog
front end design is added to the
conventional EEG amp. |
| Contact
Quality/
Impedance | Contact quality
monitoring performed | Contact quality
monitoring performed | No significant difference |
| Measurement | real time throughout the
recording/ test | real time throughout the
test | During the recording, all
computing resource is dedicated to
the EEG acquisition. |
| [Accelerometer] | | | |
| Scope of Use | Used primarily as an aid
for motion detection and
hence finding EEG
artifacts | N/A | No significant difference
Accelerate motion detection is not
available. |
| Channels | Dynamic Range:
-180° to 180° Three
channels (X, Y, Z) used by
software to measure
movement and position | N/A | No significant difference
Same as reason above. |
| [Software Characteristics] | | | |
| 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 | Client application
presents waveforms,
controls EEG session, and
offers standard EEG
transformations such as
low-pass,high-pass, notch
filters and montage
transformations. | Client application
presents waveforms,
controls EEG session, and
offers standard EEG
transformations such as
low-pass,high-pass, notch
filters and montage
transformations. | Equivalent as predicate |
| | Client application records
and retrieves EEG
waveforms. | Client application records
and retrieves EEG
waveforms. | Equivalent as predicate |
| [Reference Device] | | | |
| Electrode
Material | Ag/AgCl coated | Ag/AgCl coated | Equivalent as predicate |
| Type of
Electrodes | Active, dry | Dry | No significant difference
Instead of active electrode, analog
front end design is added to the
conventional EEG amp. |
| Electrode
Mounting
Mechanism | Semi-rigid wearable
headset with certain
electrode positions.
Electrode positions can
be adjusted to a limited
extent. | Electrode position can be
adjusted to International
10-20 electrode location
on the expandable
headset structure. | No significant difference
Special mechanical structure can
maintain international 10-20
system during wearing headset
and can keep the contact pressure
during recording. |
| Typical Usage
Setting | Intended for use for
Routine clinical EEG | Intended for use for
Routine clinical EEG | Equivalent as predicate |
| | where rapid placement of
EEG electrodes as per the
10-20 EEG system is
required. | where rapid placement of
EEG electrodes as per the
10-20 EEG system is
required. | |
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മ്മ iMediSync
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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.
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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.
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