(177 days)
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.
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.
Here's an analysis of the provided text regarding the iSyncBrain-C device, focusing on acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes the iSyncBrain-C as a software program for post-hoc statistical analysis of human EEG. The performance data section primarily discusses software validation in accordance with FDA guidance, rather than specific diagnostic performance metrics like sensitivity or specificity. The substantial equivalence argument is based on functional and technical similarity to a predicate device (qEEG-Pro), not on meeting specific quantitative clinical performance thresholds.
Therefore, the "acceptance criteria" appear to be focused on software functionality and safety, and substantial equivalence to a predicate device in terms of features and intended use. Specific quantitative performance metrics for disease detection or classification are not explicitly stated as acceptance criteria in this document.
| Acceptance Criteria (Implied from the document) | Reported Device Performance |
|---|---|
| Software functionality (e.g., data upload, analysis, storage, display) | "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..." |
| Safety of operation | "iSyncBrain-C passed all testing and supported the claims of substantial equivalence and safe operation." |
| Substantial Equivalence to Predicate Device (qEEG-Pro) | "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 users/operators." |
| Age Range for Statistical Evaluation | Statistical evaluation for patients aged 4.5 to 81 years. The normative database covers 4 to 82 years, aligning with the indication. |
| Frequency Bands for Analysis | 8 specified frequency bands (Delta, Theta, Alpha1, Alpha2, Beta1, Beta2, Beta3, Gamma). |
| Indicators Provided | Absolute power, Relative power, Power ratio, ICA component, Power spectrum, Occipital alpha peak, Source ROI power (sLORETA) & Connectivity (iCoh). |
| Compatibility with EEG equipment | Can upload and analyze EEG data in EDF files. Includes an EEG amplifier matching module to adjust frequency spectra. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a test set specifically for evaluating the performance of the iSyncBrain-C algorithm against a clinical ground truth. The "Performance Data" section primarily refers to "software validation" against Software Design Specifications.
However, the document mentions statistics regarding the normative database used by the device for comparison:
-
Sample size for Normative Database (used for comparison during analysis):
- Eyes closed: 1289 samples
- Eyes Open: 1288 samples
-
Data Provenance: Not explicitly stated (e.g., country of origin). The document mentions "carefully constructed and statistically controlled age-regressed, normative database," but details about its collection (retrospective/prospective) and origin are absent.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The document refers to software validation and substantial equivalence claims, not a clinical study where experts establish ground truth for a test set. The normative database used for comparison is mentioned, but how its "ground truth" (i.e., "normal" characteristics) was established, or by whom, is not detailed.
4. Adjudication Method for the Test Set
This information is not provided as there is no mention of a clinical test set requiring expert adjudication in the context of performance evaluation for the iSyncBrain-C algorithm itself.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned in the provided document. The device is described as a "software program for the post-hoc statistical analysis of the human electroencephalogram (EEG)" and its primary evaluation was software validation and substantial equivalence. There is no information about human readers' performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
A standalone performance study of the algorithm's diagnostic accuracy (e.g., identifying specific EEG abnormalities or conditions) is not explicitly described in the provided text. The "Performance Data" section focuses on software validation against design specifications and claims of substantial equivalence based on functionality. While it performs analyses independently, the document does not present data from a study measuring its standalone clinical diagnostic performance against a ground truth.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
For the software validation, the ground truth appears to be the Software Design Specifications (SDS). The device was tested to ensure it met these specifications.
For the normative database against which individual patient EEGs are compared, the "ground truth" is implied to be a statistically controlled dataset representing "normal" age-regressed EEG patterns. However, the specific method used to establish this "normalcy" (e.g., expert review of all samples, lack of clinical symptoms/diagnoses) is not detailed. It's not a ground truth for a diagnostic task for the iSyncBrain-C itself, but rather a reference.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" for the iSyncBrain-C algorithm. This suggests that if machine learning is involved in the analytical processes (beyond statistical comparisons to a normative database), the training data details are not provided. The reference to the "normative database" with 1289 (eyes closed) and 1288 (eyes open) samples is a reference database for comparison, not necessarily a training set for the algorithm's core functions.
9. How the Ground Truth for the Training Set Was Established
Since a "training set" is not explicitly mentioned or detailed, the method for establishing its ground truth is not provided.
{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)
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.qov
"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}------------------------------------------------
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}------------------------------------------------
| [' Table1 | ] |
|---|---|
| ------------------- | --- |
| Item | Subject Device | Predicate Device 1 | Remark |
|---|---|---|---|
| Manufacturer | iMediSync Inc. | Brainmaster Technologies,Inc. | - |
| Product Name | Normalizing QuantitativeElectroencephalographsoftware | Normalizing QuantitativeElectroencephalographsoftware | - |
| Brand Name | iSyncBrain-C | qEEG-pro | - |
| CertificationStatus | 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 beused by qualified medicalor qualified clinicalprofessionals for thestatistical evaluation of thehumanelectroencephalogram(EEG) in patients aged 4.5to 81 years. | The qEEG-Pro system is tobe used by qualifiedmedical and qualifiedclinical professionals forthe post-hoc statisticalevaluation of the humanelectroencephalogram(EEG). | Equivalent to predicate 1 |
| OperatingSystem | 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 ROIpower(sLORETA) &Connectivity (iCoh) | - Absolute power- Relative power- Power ratio- Alpha peak frequency- Asymmetry- Coherence | Equivalent to predicate 1The iSyncBrain-C indicatorsare similar with qEEG-Pro. |
| Sourceestimationmethods: | Dipole fit: Yes Linear inversemethods: sLORETA | Dipole fit: Yes Linear inversemethods: sLORETA | Equivalent to predicate 1The iSyncBrain-C use thesLORETA for Linear inversemethods. |
| EEG spectralanalysis | 8 frequency bands:- Delta (1 | 8 frequency bands:- Delta (1 | Equivalent to predicate 1Most gamma frequencybands are 30 -45 Hz, but30-45 Hz may not beselected according to themanufacturer. |
| EEG datacomparisonagainst Norm DB | Eyes closed (1289 samples)Eyes Open (1288 samples) | Eyes closed (1482 samples)Eyes Open (1231 samples) | Equivalent to predicate 1The database size issimilar. |
| Age rangeincluded in theNorm 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.
§ 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).