Disposable Non-invasive EEG Sensor is a sensor assembly with pre-gelled electroencephalogram (EEG) electrodes. The Sensor is applied to the skin of the patient to record electrophysiological (such as EEG) signals. It is a low impedance, single patient use, non-sterile disposable electrode sensor that is designed for application to areas including forehead, temporal, above eyebrow and mastoid process. The Sensor is designed to provide ease of use and electrode placement accuracy. It is used in conjunction with a monitor with an EEG module.

The sensor design is constructed using FPC (Flexible Printed Circuit Board) and medical foam. Place the foam plate and conductive gel on the FPC board. The bottom of the foam is covered with medical grade pressure sensitive adhesive for skin adhesion. A printed circuit board, which is part of the FPC board and printed with conductive silver chloride, is pasted on the other side of the foam. The flexible foam wrapped with conductive gel is used to contact the skin. When the flexible foam contacts the skin, the conductive gel will connect the skin with the FPC board to form a conductive bridge. The silver/silver chloride circuit provides signal continuity from each electrode to the monitor. The FPC board is attached to site like forehead and transmits EEG signals.

AI/ML Overview

The company, Shenzhen Med-link Electronics Tech Co., Ltd., is seeking 510(k) clearance for their Disposable Non-invasive EEG Sensor. The device is a non-sterile, single-patient use electrode sensor designed to record electrophysiological (EEG) signals. The indications for use state that the sensor is "applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals."

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria / Performance Aspect	Predicate Device Standards	Proposed Device Performance
Electrical Safety	Adherence to 60601-1 standards (GE Entropy Sensor)	Complies with ANSI/AAMI ES60601-1
Performance	Complies with ANSI/AAMI EC12	Complies with ANSI/AAMI EC12
Biocompatibility	Adherence to ISO10993-5, ISO 10993-10 (GE Entropy Sensor)	All patient-contacting materials evaluated by ISO10993-5, ISO 10993-10
Package Integrity & Functional Performance	Not explicitly stated for predicates	Completed on subject device following Accelerated aging test to support proposed shelf life.

2. Sample size used for the test set and the data provenance:

The document mentions "bench testing," "electrical safety and performance tests," "biocompatibility tests," and "package integrity and functional performance testing." However, specific sample sizes for these tests are not provided in the summary. The provenance of the data (country of origin, retrospective/prospective) is also not explicitly stated beyond the manufacturer being in China.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable to the data provided. The studies described are bench tests and engineering performance evaluations of a physical medical device (EEG sensor), not studies that require expert-established ground truth for diagnostic accuracy or clinical outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable as the described tests are technical performance evaluations, not studies involving human interpretation or 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:

This is not applicable. The device is an EEG sensor, a hardware component for recording signals, not an AI-powered diagnostic tool requiring human reader studies.

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

This is not applicable. The device is a sensor, not an algorithm. The performance tests are focused on the hardware's ability to accurately record signals and meet safety standards.

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

The "ground truth" for the tests performed is based on established industry standards and regulatory requirements for electrical safety, performance, biocompatibility, and material properties. For example, ANSI/AAMI ES60601-1 for electrical safety, ANSI/AAMI EC12 for EEG electrode performance, and ISO10993 series for biocompatibility.

8. The sample size for the training set:

This is not applicable. The device is a hardware sensor, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established:

This is not applicable as there is no training set for this device.

Summary

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January 19, 2023

Shenzhen Med-link Electronics Tech Co., Ltd. Yi Liu Regulatory Affairs Specialist 4th and 5th Floor, Building Two, Hualian Industrial Zone, Xinshi Community, Dalang Street Shenzhen, Guangdong 518109 China

Re: K220448

Trade/Device Name: Disposable Non-invasive EEG Sensor (Models: B-BIS-6A, B-BIS-6A-02, B-BIS-6A-01, B-BIS-6A-03, B-BIS-5A, B-BIS-5A-01, B-BIS-4A, B-BIS-4A-01, B-BIS-4P, B-BIS-4P-01, B-BIS-3A, B-BIS-3A-02, B-BIS-3A-01, B-BIS-3A-03, B-BIS-3AL, B-BIS-3AL-01, B-BIS-3AR, B-BIS-3AR-01) Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY Dated: February 11, 2022 Received: February 16, 2022

Dear Yi Liu:

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.

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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 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).

Sincerely,

Tushar Bansal -S

for Heather Dean, PhD Assistant Director THT5B3: Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine 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) K220448

Device Name

Disposable Non-invasive EEG Sensor (Device Models: B-BIS-6A-02, B-BIS-6A-01, B-BIS-6A-03, B-BIS-5A, B-BIS-5A, 01. B-BIS-4A. B-BIS-4A-01, B-BIS-4P. B-BIS-4P-01. B-BIS-3A, B-BIS-3A-01, B-BIS-3A-03. B-BIS-3AL, B-BIS-3AL-01, B-BIS-3AR, B-BIS-3AR-01)

Indications for Use (Describe)

Disposable Non-invasive EEG Sensor is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92. Type of submission: Traditional The assigned 510(k) number is: K220448

1. Submitter information

Manufacturer Name: Shenzhen Med-link Electronics Tech Co., Ltd. Address: 4th and 5th Floor, Building Two, Hualian Industrial Zone, Xinshi Community, Dalang Street, Longhua District, 518109 Shenzhen, PEOPLE'S REPUBLIC OF CHINA Tel: 0086-755-61568825 Fax: 0086-755-61120055 Establishment Registration Number: 3006636961

2. Correspondent

Yi Liu (Regulatory Affairs Specialist) E-mail: user22(@med-linket.com

3. Data of Preparation

Feb. 2022

4. Identification of the Device

Trade Name: Disposable Non-invasive EEG Sensor (Device Models: B-BIS-6A-02, B-BIS-6A-01, B-BIS-6A-03, B-BIS-5A, B-BIS-5A-01, B-BIS-4A, B-BIS-4A-01, B-BIS-4P-01, B-BIS-3A, B-BIS-3A-02, B-BIS-3A-01, B-BIS-3A-03, B-BIS-3AL, B-BIS-3AL-01, B-BIS-3AR, B-BIS-3AR-01)

Common Name: EEG Sensor

Classification Regulation: 21 CFR 882.1320

Regulation Name: Cutaneous electrode

Product Code: GXY

Class: II

Review Panel: Neurology

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5. Identification of the Predicate Device

No.	DeviceName	CommonName	Manufacturer	Classificationand ProductCode	ClassificationRegulation	510(k)Number
1	CovidienBIS Sensors(BIS QuatroSensor, BISExtend, BISPediatricSensor, BISBilateralSensor)	Electrode,CutaneousElectrode	Medtronic Plc	Class II,GXY	21 CFR882.1320	K143506
2	GE EntropySensor	EntropySensor	GE Healthcare	Class II,GXY	21 CFR882.1320	K062580

Table 1 Predicate Device Information

6. Intended Use and Indications for Use of the Subject Device

Disposable Non-invasive EEG Sensor is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals.

7. Device Description

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Medlinket

flexible foam wrapped with conductive gel is used to contact the skin. When the flexible foam contacts the skin, the conductive gel will connect the skin with the FPC board to form a conductive bridge. The silver/silver chloride circuit provides signal continuity from each electrode to the monitor. The FPC board is attached to site like forehead and transmits EEG signals.

Item	Proposed Device	Predicate Device #1	Predicate Device #2	Discussion
Tradename	DisposableNon-invasive EEGSensor	Covidien BIS Sensors(BIS Quatro Sensor,BIS Extend, BISPediatric Sensor, BISBilateral Sensor)	GE Entropy Sensor	N/A
510(K)Submitter	Shenzhen Med-linkElectronics Tech Co.,Ltd.	Medtronic Plc	GE Healthcare	N/A
510(K)Number	K220448	K143506	K062580	N/A
ClassificationRegulation	21 CFR 882.1320	21 CFR 882.1320	21 CFR 882.1320	Same
Classificationand Code	Class II,GXY	Class II,GXY	Class II,GXY	Same
CommonName	EEG sensor	Electrode, CutaneousElectrode	Entropy sensor	N/A
Type of Use	Prescription	Prescription	Prescription	Same
Indications forUse	Disposable Non-invasive EEG Sensor isapplied directly to thepatient's skin toenable recordings ofelectrophysiological(such as EEG) signals.	The BIS Sensor isapplied directly to thepatient's skin to enablerecordings ofelectrophysiological(such as EEG) signals.	The GE Entropy Sensoris intended to be usedfor adults with GEEntropy measurementdevices to enablerecording ofphysiological signals(such as EEG). Toconnect this sensor to themeasurement device,use the GE EntropyCable.	Same

8. Comparison to the Predicate Device

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Number ofElectrodes	3/4/5/6	4/6	3	Different note1
Application Site	Forehead/temporal/aboveeyebrow/mastoidprocess	Frontal/temporal area	Frontal/temporal area	Different note2
Duration of Use	Maximum 24 hours	Not publiclyavailable	Not publiclyavailable	Different note3
Usage	Disposable	Disposable	Disposable	Same
ApplicablePopulation	Adult and pediatric	Adult and pediatric	Adults only	Same asPredicateDevice#1
OperationEnvironment	Temperature: 5℃~~40℃Humidity:0~~80%RH, non-condensing atmosphericpressure: 86kPa~106kPa	Not publicly available	Not publicly available	Differentnote 4
StorageEnvironment	Temperature:-10°C~~40°C Humidity:0~~80% RH, non-condensingatmospheric pressure:86kPa〜106 kPa	Not publicly available	Not publicly available	Differentnote 4
Material	FPC, 3M Foam Tape (Siliconecoated paper liner, Foambacking, Acrylate Adhesive),AgCl electrode, and conductivegel (a mixture of the followingcomponents:	Not publicly available	Not publicly available	Differentnote 3

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	Water, Sodium Chloride, Gum Acacia, Guar Gum, and Xanthan Gum, Potassium Bitartrate, Glycerin, Methylparaben and Propylparaben.)
ElectricalSafety	Complies withANSI/AAMIES60601-1	Performed. Specificstandard not specified in510(k) Database.	Complies withEN 60601-1	Differentnote 5
Performance	Complies withANSI/AAMI EC 12	Complies withANSI/AAMI EC 12	Complies withANSI/AAMI EC 12	Same
Biocompatibility	All the patient-contactingmaterials are evaluatedby the biocompatibilitystandards ISO10993-5,ISO 10993-10.	Performed. Specificstandard not specified in510(k) Database.	All the patient-contactingmaterials are evaluatedby the biocompatibilitystandards ISO10993-5.ISO 10993-10.	Same asPredicateDevice #2
Sterilization	Non-sterile	Not publicly available	Non-sterile	Same asPredicateDevice #2

Note 1

The number of 4/6 electrodes is the same as Predicate #1.

The number of 3 electrodes is the same as Predicate #2.

The number of 5 electrodes falls within the possible customizable number of electrodes of Predicate #1 (between 4 to 6 electrodes).

The difference of the number of electrodes of the proposed device does not affect its safe and effective usage in monitoring of EEG signals. The device has been tested in accordance with electrical safety and performance tests, and the tests passed. Thus, such a difference among the proposed device and the predicate devices does not affect substantial equivalence.

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Note 2

Although the description of application sites of the proposed device are different from those of the predicate devices, the application sites are actually the same among three devices regarding frontal area. The actual use and application of the predicate devices on frontal area involve forehead and above eyebrow, with the description of the proposed device being more detailed. Regarding the additional application site of mastoid process that the proposed device specifies, it does not raise different questions of safety and effectiveness as the device meets safety and performance requirements.

Note 3

Although the usage time and material of the two predicate devices are not publicly available in the 510(k) Database, biocompatibility tests have been performed on the proposed device and the tests passed. Therefore, such a difference does not affect substantial equivalence among the proposed device and two predicate devices.

Note 4

The proposed device and the predicate devices all comply with electrical safety standards and performance standards. Therefore, absence of the information concerning Operation and Storage Environment of the two predicate devices does not raise questions of safety and effectiveness for the proposed device.

Note 5

Both the proposed device and the Predicate Device #2 performed electrical safety tests in accordance with 60601-1 standards.. Thus, the difference does not raise different questions of safety and effectiveness. The two devices are substantially equivalent regarding electrical safety.

9. Non-clinical Test

The safety and effectiveness of the subject device are demonstrated through testing following ANSI/AAMI ES60601-1 General requirements for basic safety and essential performance and ANSI/AAMI EC12: 2000/(R)2015 Disposable ECG Electrodes. The results of bench testing provides reasonable assurance that the proposed device has been designed and validated to assure conformance to the requirements for its indication for use. Package integrity and functional performance testing were completed on the subject device following Accelerated aging test to support the proposed shelf life.

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10. Conclusion

Based on the comparison and analysis in this submission, it can be concluded that the Disposable Non-invasive EEG Sensor is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 882.1320 Cutaneous electrode.

(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).