Amydi-med Disposable Non-invasive EEG Sensor is applied directly to an adults/pediatrics patient's skin to record physiological signals (e.g., the electroencephalogram, EEG) in the healthcare facility / hospital.

Device Description

Amydi-med Disposable Non-invasive EEG Sensor is a low impedance, single patient use, disposable, non-sterile provided sensor that is designed for application to the sites including forehead, temporal, above eyebrow, and mastoid process. It is designed to provide ease of use and accurate electrode placement.

The main components of this sensor are the flexible PCB with electrodes, polyethylene base pad with medical grade pressure sensitive adhesive on its double sides, nylon plastic tine disks, polyurethane foam disks, aqueous gel ( , and cable connector. Each sensor has three (3) to six (6) electrodes on the flexible PCB for different application sites.

AI/ML Overview

The provided text describes the 510(k) summary for the Amydi-med Disposable Non-invasive EEG Sensor (K240668), focusing on its substantial equivalence to a predicate device (K220448). The document highlights performance data for safety and electrical characteristics.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test Category	Acceptance Criteria (Standard)	Reported Device Performance
Biocompatibility	ANSI/AAMI/ISO 10993-1: 2018 (Cytotoxicity, Irritation, Skin Sensitization)	Subject device successfully passed the above tests.
Electrical Performance	ANSI/AAMI EC12: 2000 (R2015) Disposable ECG Electrodes	Subject device complies with ANSI/AAMI EC12: 2000 (R2015).
Adhesive Performance	IEC 60601-2-2 Ed. 6.0 b:2017 (a) Pull Test, (b) Conformability Test, (c) Fluid Tolerance Test	Subject device passed all specified adhesive tests.
Shelf Life	Supported by Accelerated aging test (60°C, 46 days) and Real time stability testing	Demonstrated a shelf life of 1 year.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not specify the sample size used for the test sets in the biocompatibility, electrical, adhesive, or shelf-life testing. It also does not provide information on the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This section is not applicable as the device is a medical sensor (hardware) undergoing performance and safety testing, not an AI/software device requiring expert consensus for ground truth establishment.

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

This section is not applicable for the type of device and testing described. Adjudication methods are typically relevant for studies involving human interpretation or assessments where discrepancies need resolution.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or interpretive tools, not for a disposable non-invasive EEG sensor.

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

A standalone performance evaluation (algorithm only) was not done. This refers to AI algorithm performance without human intervention, which is not applicable to a physical medical device like an EEG sensor.

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

The concept of "ground truth" as typically applied to AI/diagnostic studies is not directly applicable here. For hardware testing:

Biocompatibility: Ground truth is established by the specified standards (e.g., cell viability for cytotoxicity, skin reaction for irritation) and determined by laboratory tests.
Electrical Performance: Ground truth is defined by the parameters and limits specified in the ANSI/AAMI EC12 standard.
Adhesive Performance: Ground truth is defined by the parameters and limits specified in the IEC 60601-2-2 standard.
Shelf Life: Ground truth is determined by the device's ability to meet its performance specifications over time following accelerated aging and real-time stability testing.

8. The sample size for the training set

The document does not mention a training set. This is a physical medical device, not an AI/machine learning model that typically undergoes training.

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

This question is not applicable as there is no mention of a training set for this device.

Summary

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Image /page/0/Picture/0 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 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.

March 19, 2024

Shenzhen Amydi-med Electrics Tech Co., Ltd. Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059

Re: K240668

Trade/Device Name: Amydi-med Disposable Non-invasive EEG electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY Dated: August 21, 2023 Received: March 8, 2024

Dear Dave Yungvirt:

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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Tushar Bansal -S

for Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices

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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) K240668

Device Name

Amydi-med Disposable Non-invasive EEG Sensor

(Models: AMD-DE-AF0001-1, AMD-DE-AF0002-1, AMD-DE-AF0004-1, AMD-DE-AF0004-1, AMD-DE-AF0005-1, AMD-DE-AF0006-1,AMD-DE-AF0007-1, AMD-DE-PF0001-1, AMD-DE-PF0004-1)

Indications for Use (Describe)

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 K240668

The 510(k) summary is submitted in accordance with the requirements of 21 CFR 807.92.

1. SUBMITTER

Shenzhen Amydi-med Electrics Tech Co., Ltd.

601, No.15 Building, Xianan No. 3 Industrial Zone, Shangcun, Gongming Street, Guangming District,518106 Shenzhen, Guangdong, PEOPLE'S REPUBLIC OF CHINA

Contact Person:	Cuifang Yuan (Vice General Manager)
Email	2810076565@qq.com
Tel:	+86-755-23408983
Primary Correspondent:	Maple Chen (RA Consultant)
Email:	maple@gvmmedical.com
Tel:	610-451-7988
Date Prepared:	March 14, 2024
2. DEVICE
Name of Device:	Amydi-med Disposable Non-invasive EEG Sensor(Models: AMD-DE-AF0001-1, AMD-DE-AF0002-1, AMD-DE-AF0003-1, AMD-DE-AF0004-1, AMD-DE-AF0005-1, AMD-DE-AF0006-1, AMD-DE-AF0007-1, AMD-DE-PF0001-1, AMD-DE-PF0004-1)
Common Name:	EEG Sensor
Classification Name:	Cutaneous electrode (21 CFR 882.1320)
Regulatory Class:	II
Product Code:	GXY
3. PREDICATE DEVICE

Name of Device: Disposable Non-invasive EEG Sensor

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(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-BIS3AL, B-BIS-3AL-01, B-BIS-3AR,B-BIS-3AR-01)
510(k) Number:	K220448
Submitter of Predicate Device:	Shenzhen Med-link Electronics Tech Co., Ltd.

4. DEVICE DESCRIPTION

5. INDICATIONS FOR USE

6. COMPARISON OF THE SUBJECT DEVICE WITH THE PREDICATE DEVICE

A comparison is performed between the subject device and predicate device. The result is summarized in Table 1.

Table 1 Comparison of the subject device and predicate device

Items	Subject Device	Predicate Device	Discussion
510(k) Number	K240668	K220448	N/A
510(K)Submitter	Shenzhen Amydi-medElectrics Tech Co., Ltd.	Shenzhen Med-linkElectronics Tech Co.,Ltd.	N/A
Classification /Regulation	Class II, 21 CFR 882.1320	Class II, 21 CFR882.1320	Same
Product Code	GXY	GXY	Same
CommonName	EEG Sensor	EEG sensor	Same
Indicationsfor Use	Amydi-med DisposableNon-invasive EEG Sensoris applied directly to anAdults/pediatrics patient'sskin to record physiologicalsignals (e.g., theelectroencephalogram,EEG) in the healthcarefacility/hospital.	Disposable Non-invasive EEG Sensor isapplied directly to thepatient's skin to enablerecordings ofelectrophysiological(such as EEG) signals.	Similar, Note 1
Environmentof Use	Prescription	Prescription	Same
Target User	Neurologists	N/A	Similar, Note 1
Target Patient	Adults and pediatric	Adult and pediatric	Similar, Note 1
ApplicationSites	Forehead/temporal/aboveeyebrow/mastoid process	Forehead/temporal/above eyebrow/mastoidprocess	Same
Material	Flexible printed circuitboard, electrodes screen-printed with curedAg/AgCl and dielectric ink,polyethylene base pad withmedical grade pressuresensitive adhesive, nylonplastic tine disks,polyurethane foam disks,aqueous gel (Water,Sodium Chloride, GumAcacia, Guar Gum,Xanthan Gum, PotassiumBitartrate, Glycerin,Methylparaben andPropylparaben), and cableconnector (polycarbonate).	Flexible printed circuitboard, 3M Foam Tape(Silicone coated paperliner, Foam backing,Acrylate Adhesive),AgCl electrode, andconductive gel (amixture of thefollowing components:Water, SodiumChloride, Gum Acacia,Guar Gum, andXanthan Gum,Potassium Bitartrate,Glycerin,Methylparaben andPropylparaben.)	Note 2
Number ofElectrodes	3/4/6	3/4/5/6	Note 3
Duration ofUse	Maximum 24 hours	Maximum 24 hours	Same
Usage	Disposable	Disposable	Same
How to BeSupplied	Non-Sterile	Non-Sterile	Same
BiocompatibilityPerformance	ISO 10993-1ISO 10993-5ISO 10993-10	ISO 10993-1ISO 10993-5ISO 10993-10	Same
ElectricalSafety	Not Tested	Complies withANSI/AAMI	Note 4
		ES60601-1
ElectricalPerformance	Comply with theANSI/AAMI EC12: 2000(R2015) Disposable ECGElectrodes.	Complies withANSI/AAMI EC 12	Same
AdhesivePerformance	IEC 60601-2-2 Ed. 6.0b:2017 Medical ElectricalEquipment – Part 2-2:Particular Requirements forThe Basic Safety andEssential Performance ofHigh Frequency SurgicalEquipment and HighFrequency SurgicalAccessories, (a) Pull Test,(b) Conformability Test, (c)Fluid Tolerance Test.	Not publicly available	Note 5

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Note 1. The expression is different, but the facts are the same.

Note 2. The materials and construction are the same. The composition of the materials is the same, though the brand of materials may be different. It will not raise new safety or effective issues. However, a Biocompatibility test was conducted and demonstrated the subject device's safety.

Note 3. The electrodes number of the subject device is covered by the predicate scope. No risks or safety issues will be raised.

Note 4. The requirement is not applied to Disposable Non-invasive EEG Electrodes as per the guidance document titled "Cutaneous Electrodes for Recording Purposes – Performance Criteria for Safety and Performance Based Pathway" (issued on August 14, 2020).

Note 5. The subject device passed one more test than the predicate. No safety or risks issue raised.

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Summary: From the comparison table, the subject device has the same intended use, constructions, materials, and technological characteristics as the predicate device.

7. SAFETY AND PERFORMANCE DATA

According to the Non-invasive EEG Sensor specific guidance document titled "Cutaneous Electrodes for Recording Purposes - Performance Criteria for Safety and Performance Based Pathway" (issued on August 14, 2020), we conducted the following safety and electrical performance assessment using the specified FDA recognized standards (including methods and acceptable criteria).

Biocompatibility Performance i.

The biocompatibility evaluation for the subject device was conducted in accordance with ANSI/AAMI/ISO 10993-1: 2018 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process. The subject device is considered to be surface medical device contacting with intact skin and the contact duration is less than 24 hours. The biocompatibility evaluation endpoints are:

• Cytotoxicity

Irritation and skin sensitization •

The subject device successfully passed the above tests.

ii. Electrical Performance

Electrical testing was conducted on the subject device. The subject device complies with the ANSI/AAMI EC12: 2000 (R2015) Disposable ECG Electrodes.

iii. Adhesive Performance

The subject device has been designed and validated to satisfy the adhesive requirements per IEC 60601-2-2 Ed. 6.0 b:2017 Medical Electrical Equipment - Part 2-2: Particular Requirements for The Basic Safety and Essential Performance of High Frequency Surgical Equipment and High Frequency Surgical Accessories, (a) Pull Test, (b) Conformability Test, (c) Fluid Tolerance Test.

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iv. Shelf Life

Shelf life testing were completed on the subject device following Accelerated aging test (60°C, 46 days) to support the proposed shelf life (1 year). The real time stability testing also demonstrates the shelf life of 1 year.

Summary: The subject device complies with the FDA recognized consensus standards for safety and performance criteria.

8. CONCLUSION

The subject device has the same intended use, constructions, materials, and technological characteristics as the predicate device. The subject device complies with the FDA recognized consensus standards for safety and performance criteria as required in the Non-invasive EEG Sensor specific guidance document titled "Cutaneous Electrodes for Recording Purposes – Performance Criteria for Safety and Performance Based Pathway" (issued on August 14, 2020).

Based on the safety and performance-based pathway, it can be concluded that the subject device 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).