Amydi-med Disposable Non-invasive EEG electrodes

K240668 · Shenzhen Amydi-Med Electrics Tech Co., Ltd. · GXY · Mar 19, 2024 · Neurology

Device Facts

• Record ID: K240668
• Device Name: Amydi-med Disposable Non-invasive EEG electrodes
• Applicant: Shenzhen Amydi-Med Electrics Tech Co., Ltd.
• Product Code: GXY · Neurology
• Decision Date: Mar 19, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

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 Story

Disposable, non-invasive EEG sensor; applied to patient skin (forehead, temporal, above eyebrow, mastoid process) to record physiological signals (EEG). Device consists of flexible PCB with 3-6 electrodes, polyethylene base pad with pressure-sensitive adhesive, nylon tine disks, polyurethane foam disks, and aqueous gel. Used in healthcare facilities/hospitals by neurologists or clinicians. Provides interface between patient skin and EEG monitoring equipment. Benefits include ease of use and accurate electrode placement for signal acquisition. Single-patient use; non-sterile; maximum 24-hour duration.

Clinical Evidence

Bench testing only. Biocompatibility testing per ISO 10993-1, -5, -10 (cytotoxicity, irritation, sensitization). Electrical performance testing per ANSI/AAMI EC12:2000 (R2015). Adhesive performance testing per IEC 60601-2-2 (pull, conformability, fluid tolerance). Shelf life validated via accelerated aging (60°C, 46 days) and real-time testing to support 1-year duration.

Technological Characteristics

Flexible PCB with Ag/AgCl electrodes; polyethylene base pad with medical-grade pressure-sensitive adhesive; nylon tine disks; polyurethane foam disks; aqueous gel (water, NaCl, gums, glycerin, preservatives); polycarbonate cable connector. Non-sterile. 3-6 electrodes. Complies with ANSI/AAMI EC12:2000 and IEC 60601-2-2.

Indications for Use

Indicated for adult and pediatric patients in healthcare facilities/hospitals for recording physiological signals, specifically EEG.

Regulatory Classification

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.

Predicate Devices

• Disposable Non-invasive EEG Sensor (K220448)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

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 | [e-mail] |
| Tel: | [phone] |
| Primary Correspondent: | Maple Chen (RA Consultant) |
| Email: | [e-mail] |
| Tel: | 610-451-7988 |
| Date Prepared: | March 14, 2024 |
| 2. DEVICE | |
| Name of Device: | Amydi-med Disposable Non-invasive EEG Sensor<br>(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-<br>01, B-BIS-6A-03, B-BIS-5A, B-BIS-5A-01, B-<br>BIS-4A, B-BIS-4A-01, B-BIS-4P, B-BIS-4P-01,<br>B-BIS-3A, B-BIS-3A-02, B-BIS-3A-01, B-BIS-<br>3A-03, B-BIS3AL, B-BIS-3AL-01, B-BIS-3AR,<br>B-BIS-3AR-01) | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| 510(k) Number: | K220448 |
| Submitter of Predicate Device: | Shenzhen Med-link Electronics Tech Co., Ltd. |

### 4. 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.

## 5. INDICATIONS FOR USE

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.

# 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)<br>Submitter | Shenzhen Amydi-med<br>Electrics Tech Co., Ltd. | Shenzhen Med-link<br>Electronics Tech Co.,<br>Ltd. | N/A |
| Classification /<br>Regulation | Class II, 21 CFR 882.1320 | Class II, 21 CFR<br>882.1320 | Same |
| Product Code | GXY | GXY | Same |
| Common<br>Name | EEG Sensor | EEG sensor | Same |
| Indications<br>for Use | Amydi-med Disposable<br>Non-invasive EEG Sensor<br>is applied directly to an<br>Adults/pediatrics patient's<br>skin to record physiological<br>signals (e.g., the<br>electroencephalogram,<br>EEG) in the healthcare<br>facility/hospital. | Disposable Non-<br>invasive EEG Sensor is<br>applied directly to the<br>patient's skin to enable<br>recordings of<br>electrophysiological<br>(such as EEG) signals. | Similar, Note 1 |
| Environment<br>of Use | Prescription | Prescription | Same |
| Target User | Neurologists | N/A | Similar, Note 1 |
| Target Patient | Adults and pediatric | Adult and pediatric | Similar, Note 1 |
| Application<br>Sites | Forehead/temporal/above<br>eyebrow/mastoid process | Forehead/temporal/abo<br>ve eyebrow/mastoid<br>process | Same |
| Material | Flexible printed circuit<br>board, electrodes screen-<br>printed with cured<br>Ag/AgCl and dielectric ink,<br>polyethylene base pad with<br>medical grade pressure<br>sensitive adhesive, nylon<br>plastic tine disks,<br>polyurethane foam disks,<br>aqueous gel (Water,<br>Sodium Chloride, Gum<br>Acacia, Guar Gum,<br>Xanthan Gum, Potassium<br>Bitartrate, Glycerin,<br>Methylparaben and<br>Propylparaben), and cable<br>connector (polycarbonate). | Flexible printed circuit<br>board, 3M Foam Tape<br>(Silicone coated paper<br>liner, Foam backing,<br>Acrylate Adhesive),<br>AgCl electrode, and<br>conductive gel (a<br>mixture of the<br>following components:<br>Water, Sodium<br>Chloride, Gum Acacia,<br>Guar Gum, and<br>Xanthan Gum,<br>Potassium Bitartrate,<br>Glycerin,<br>Methylparaben and<br>Propylparaben.) | Note 2 |
| Number of<br>Electrodes | 3/4/6 | 3/4/5/6 | Note 3 |
| Duration of<br>Use | Maximum 24 hours | Maximum 24 hours | Same |
| Usage | Disposable | Disposable | Same |
| How to Be<br>Supplied | Non-Sterile | Non-Sterile | Same |
| Biocompatibi<br>lity<br>Performance | ISO 10993-1<br>ISO 10993-5<br>ISO 10993-10 | ISO 10993-1<br>ISO 10993-5<br>ISO 10993-10 | Same |
| Electrical<br>Safety | Not Tested | Complies with<br>ANSI/AAMI | Note 4 |
| | | ES60601-1 | |
| Electrical<br>Performance | Comply with the<br>ANSI/AAMI EC12: 2000<br>(R2015) Disposable ECG<br>Electrodes. | Complies with<br>ANSI/AAMI EC 12 | Same |
| Adhesive<br>Performance | IEC 60601-2-2 Ed. 6.0<br>b:2017 Medical Electrical<br>Equipment – Part 2-2:<br>Particular Requirements for<br>The Basic Safety and<br>Essential Performance of<br>High Frequency Surgical<br>Equipment and High<br>Frequency Surgical<br>Accessories, (a) Pull Test,<br>(b) Conformability Test, (c)<br>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.