(177 days)
Not Found
No
The description focuses on standard statistical analysis of EEG data (FFT, spectral power, z-scores against a normative database) and does not mention AI or ML techniques.
No
The device is described as a software program for the post-hoc statistical analysis of EEG data, providing statistical evaluations and comparisons against a normative database. It does not actively treat or alleviate a disease or condition, but rather aids in diagnosis or assessment.
Yes
The device performs "statistical evaluation of the human electroencephalogram (EEG)" and compares "the differences between the subject and an appropriate sex/aqematched reference group in the form of z-scores," which are activities that support diagnosis. Its intended use states "statistical evaluation," which implies assessing a medical condition or disease.
Yes
The device description explicitly states "iSyncBrain-C is a software program" and describes its function as analyzing EEG data from various EEG equipment. It does not mention any accompanying hardware components provided by the manufacturer.
Based on the provided information, the iSyncBrain-C is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. This testing is performed in vitro (outside the body).
- iSyncBrain-C Function: The iSyncBrain-C analyzes electroencephalogram (EEG) signals. EEG measures electrical activity within the brain, which is a physiological signal recorded from the body, not a specimen taken from the body for in vitro analysis.
- Intended Use: The intended use is for the "statistical evaluation of the human electroencephalogram (EEG)". This is an analysis of a physiological measurement, not an in vitro test.
Therefore, the iSyncBrain-C falls under the category of a medical device that analyzes physiological signals, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The iSyncBrain-C is to be used by qualified medical or qualified clinical professionals for the statistical evaluation of the human electroencephalogram (EEG) in patients aged 4.5 to 81 years.
Product codes
OLU
Device Description
iSyncBrain-C is a software program for the post-hoc statistical analysis of the human electroencephalogram (EEG).
EEG signals can be measured by various EEG equipment, and the measured EEG data is saved in EDF files. iSyncBrain-C can upload, and analyze these EDF files, and personal information or results are automatically stored in AWS (Amazon Web Serve).
The analysis consists of the Fast-Fourier Transformation (FFT) of the data to extract the spectral power for each of the designated frequency bands (e.g., Delta, Theta, Alpha, Alpha2, Beta2, Beta3, Gamma) and frequency information from the EEG. These analysis results are displayed in statistical tables and topographical brain maps of absolute and relative power, power ratio, ICA components, power spectrum, occipital alpha peak, source ROI power(sLORETA) & connectivity(iCoh).
All EEG devices has its own frequency characteristics which should be included for any data comparisons coming from different devices. iSyncBrain-C has an EEG amplifier matching module where frequency spectra are adjusted with calibration table between database amplifier and recording amplifier.
In all over 33,000 measures are derived for comparison against carefully constructed and statistically controlled age-regressed, normative database in which the variables have been transformed and validated for their Gaussian distribution.
Each variable extracted by the analysis is compared to the database using parametric statistical procedures that express the differences between the subject and an appropriate sex/aqematched reference group in the form of z-scores.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human electroencephalogram (EEG)
Indicated Patient Age Range
4.5 to 81 years
Intended User / Care Setting
qualified medical or qualified clinical professionals
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)
The iSyncBrain-C's software validation was performed in accordance with FDA quidance. The software was tested according to Software Design Specifications(SDS) as intended. The testing results support that all the software specifications have met each module's acceptance criteria and interaction of processes. The iSyncBrain-C passed all testing and supported the claims of substantial equivalence and safe operation. These types of devices, including the predicate devices, have been on the market for many years with proven safety and effectiveness for using the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
0
March 16, 2023
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 the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
iMediSync Inc. Young-Geun Kim Quality Manager 3F, 175. Yeoksam-ro. Gangnam-gu Seoul. 06247 South Korea
Re: K222838
Trade/Device Name: iSyncBrain-C Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLU Dated: December 16, 2022 Received: December 16, 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 medical devices and radiation-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).
Sincerelv.
Xiaolin Zheng -S
Xiaolin Zheng, Ph.D. 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) K222838
Device Name iSyncBrain-C
Indications for Use (Describe)
The iSyncBrain-C is to be used by qualified medical or qualified clinical professionals for the statistical evaluation of the human electroencephalogram (EEG) in patients aged 4.5 to 81 years.
| 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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3
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part. Date: 2022.12.15
I. 510K Applicant / Submitter:
(Legal Manufacturer) iMediSync Inc. 3F, 175, Yeoksam-ro, Gangnam-qu, Seoul, Republic of Korea Tel: +82-2-747-7422
II. Submission Contact Person (Primary Correspondent Person)
Young Geun Kim / Quality management representative iMediSync Inc. 3F, 175, Yeoksam-ro, Gangnam-gu, Seoul, Republic of Korea Tel: +82-2-747-7422 Email: yqkim@imedisync.com
III. Subject Device
- Trade/Proprietary Name: iSyncBrain-C
- . Common Name: Electroencephalograph
- . Classification Name: Electroencephalograph, Class II
- Regulation: 21 CFR 882.1400 .
- Product Code: OLU .
IV. Predicate Device
qEEG-Pro (K171414)
V. Description
iSyncBrain-C is a software program for the post-hoc statistical analysis of the human electroencephalogram (EEG).
4
EEG signals can be measured by various EEG equipment, and the measured EEG data is saved in EDF files. iSyncBrain-C can upload, and analyze these EDF files, and personal information or results are automatically stored in AWS (Amazon Web Serve).
The analysis consists of the Fast-Fourier Transformation (FFT) of the data to extract the spectral power for each of the designated frequency bands (e.g., Delta, Theta, Alpha, Alpha2, Beta2, Beta3, Gamma) and frequency information from the EEG. These analysis results are displayed in statistical tables and topographical brain maps of absolute and relative power, power ratio, ICA components, power spectrum, occipital alpha peak, source ROI power(sLORETA) & connectivity(iCoh).
All EEG devices has its own frequency characteristics which should be included for any data comparisons coming from different devices. iSyncBrain-C has an EEG amplifier matching module where frequency spectra are adjusted with calibration table between database amplifier and recording amplifier.
In all over 33,000 measures are derived for comparison against carefully constructed and statistically controlled age-regressed, normative database in which the variables have been transformed and validated for their Gaussian distribution.
Each variable extracted by the analysis is compared to the database using parametric statistical procedures that express the differences between the subject and an appropriate sex/aqematched reference group in the form of z-scores.
IV. Indications for Use
The iSyncBrain-C is to be used by qualified medical or qualified clinical professionals for the statistical evaluation of the human electroencephalogram (EEG) in patients aged 4.5 to 81 years.
VIII. Performance Data
The iSyncBrain-C's software validation was performed in accordance with FDA quidance. The software was tested according to Software Design Specifications(SDS) as intended. The testing results support that all the software specifications have met each module's acceptance criteria and interaction of processes. The iSyncBrain-C passed all testing and supported the claims of substantial equivalence and safe operation. These types of devices, including the predicate devices, have been on the market for many years with proven safety and effectiveness for using the device.
IX. Equivalent device
The information provided in this submission supports that iSyncBrain-C is the substantial equivalence to qEEG-Pro(K171414) and that the system is safe and effective for the
5
users/operators.
X. Conclusions:
Based on the information provided in this premarket notification, iMediSync Inc. concludes that the iSyncBrain-C is substantially equivalent to the predicate device as described herein in safety and effectiveness.
6
| [
' Table
| 1 | ] |
|---|---|
| ------------------- | --- |
| Item | Subject Device | Predicate Device 1 | Remark |
|---|---|---|---|
| Manufacturer | iMediSync Inc. | Brainmaster Technologies, | |
| Inc. | - | ||
| Product Name | Normalizing Quantitative | ||
| Electroencephalograph | |||
| software | Normalizing Quantitative | ||
| Electroencephalograph | |||
| software | - | ||
| Brand Name | iSyncBrain-C | qEEG-pro | - |
| Certification | |||
| Status | FDA 510(K) / K222838 | FDA 510(K) / K171414 | - |
| Product code | OLU | OLU | - |
| Classification | CFR 21 882.1400 | CFR 21 882.1400 | Equivalent to predicate 1 |
| OTC and/or Rx | Rx Only | Rx Only | Equivalent to predicate 1 |
| Indication of Use | The iSyncBrain-C is to be | ||
| used by qualified medical | |||
| or qualified clinical | |||
| professionals for the | |||
| statistical evaluation of the | |||
| human | |||
| electroencephalogram | |||
| (EEG) in patients aged 4.5 | |||
| to 81 years. | The qEEG-Pro system is to | ||
| be used by qualified | |||
| medical and qualified | |||
| clinical professionals for | |||
| the post-hoc statistical | |||
| evaluation of the human | |||
| electroencephalogram | |||
| (EEG). | Equivalent to predicate 1 | ||
| Operating | |||
| System | Window, Mac Os | Window, Mac Os | Equivalent to predicate 1 |
| Indicator | - Absolute power |
- Relative power
- Power ratio
- ICA component
- Power spectrum
- Occipital alpha peak
- Source ROI
power(sLORETA) &
Connectivity (iCoh) | - Absolute power - Relative power
- Power ratio
- Alpha peak frequency
- Asymmetry
- Coherence | Equivalent to predicate 1
The iSyncBrain-C indicators
are similar with qEEG-Pro. |
| Source
estimation
methods: | Dipole fit
: Yes Linear inverse
methods
: sLORETA | Dipole fit
: Yes Linear inverse
methods
: sLORETA | Equivalent to predicate 1
The iSyncBrain-C use the
sLORETA for Linear inverse
methods. |
| EEG spectral
analysis | 8 frequency bands: - Delta (1~4Hz)
- Theta (4~8Hz)
- Alpha1 (8~10Hz)
- Alpha2 (10~12Hz)
- Beta1 (12~15Hz)
- Beta2 (15~20Hz)
- Beta3 (20~30Hz)
- Gamma (30~45Hz) | 8 frequency bands:
- Delta (1~3Hz)
- Theta (4~8Hz)
- Alpha (8~10Hz)
- Alpha2 (10~12Hz)
- loBeta (12~15Hz)
- Beta (15~20Hz)
- hiBeta (20~30Hz)
- Gamma (35~45Hz) | Equivalent to predicate 1
Most gamma frequency
bands are 30 -45 Hz, but
30-45 Hz may not be
selected according to the
manufacturer. |
| EEG data
comparison
against Norm DB | Eyes closed (1289 samples)
Eyes Open (1288 samples) | Eyes closed (1482 samples)
Eyes Open (1231 samples) | Equivalent to predicate 1
The database size is
similar. |
| Age range
included in the
Norm DB | 4 to 82 years | 2 months to 82 years | Equivalent to predicate 1 |
7
iMediSync Inc. Traditional 510(k) Submission iSyncBrain®-C
Image /page/7/Picture/1 description: The image shows the logo for iMediSync. The logo consists of a green square, a blue square, a gray circle, and the text "iMediSync" in gray. The squares and circle are arranged to the left of the text.