NeuroCap

K172866 · Memory MD, Inc. · GXY · Apr 27, 2018 · Neurology

Device Facts

• Record ID: K172866
• Device Name: NeuroCap
• Applicant: Memory MD, Inc.
• Product Code: GXY · Neurology
• Decision Date: Apr 27, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2

Intended Use

The NeuroCap (model DEC18) is an Electroencephalogram (EEG) electrode array intended for use in ER (emergency room), ICU (intensive care unit) and OR (operating room) for recording of STAT EEGs in patients of 18 years of age and older.

Device Story

NeuroCap (model DEC18) is a disposable 16-channel EEG electrode array; consists of polycarbonate film with conductive paths, sensors, sponges, and conductive gel; fixed to patient via adhesive tape. Device connects to external medical signal amplifiers directly or via adapter for EEG acquisition and recording. Used in ER, ICU, and OR by trained technicians. Provides electrical signal interface for EEG monitoring; facilitates rapid EEG setup for clinical decision-making. Benefits include streamlined electrode application for urgent neurological assessment.

Clinical Evidence

Bench testing only. Evaluated via biocompatibility testing (ISO 10993-5, ISO 10993-10), risk management (ISO 14971:2012), and performance testing per ANSI/AAMI EC12:2000 for disposable ECG electrodes.

Technological Characteristics

Polycarbonate-based film electrode array; 16 channels; Ag/AgCl sensors with conductive gel-filled sponges; adhesive fixation. Disposable, non-sterile. Connects to external amplifiers. Complies with ISO 10993 (biocompatibility), ISO 14971 (risk management), and ANSI/AAMI EC12:2000 (performance).

Indications for Use

Indicated for patients 18 years of age and older requiring STAT EEG recordings in emergency, intensive care, or operating room settings.

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

• StatNet (K092828)

Reference Devices

• Neuro EEG device (K173460)

Submission Summary (Full Text)

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April 27, 2018

Memory MD INC % Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. Suite 306, Kecheng Mansion, No.121 Science Road Guangzhou Science Park Guangzhou, Guangdong, 510006 Cn

Re: K172866

Trade/Device Name: NeuroCap Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: February 7, 2018 Received: February 12, 2018

# Dear Cassie Lee:

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. 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

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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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Vivek J. Pinto -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K172866

Device Name NeuroCap

Indications for Use (Describe)

The NeuroCap (model DEC18) is an Electroencephalogram (EEG) electrode array intended for use in ER (emergency room), ICU (intensive care unit) and OR (operating of STAT EEGs in patients of 18 years of age and older.

| 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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# 510(k) Summary

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

## 1. Submitter's Information

510(k) Owner's Name: MemoryMD INC Establishment Registration Number: Applying Address: 205 E 42nd Street, 14th Floor New York, New York 10017 USA Phone: [phone] Fax: [phone] Contact Person: Abdus-Salaam Muwwakkil, Chief Quality Officer E-mail: [e-mail]

## Application Correspondent:

Application Correspondent: Contact Person: Ms. Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Address: Suite 306, Kecheng Mansion, No.121 Science Road, Guangzhou Science Park, Guangzhou 510663, China Tel: [phone] Email: [e-mail]

### 2. Subject Device Information

Trade Name: NeuroCap Model: DEC18 Common Name: Cutaneous electrode Disposable Classification name: Cutaneous electrode Disposable Review Panel: Neurology Product Code: GXY Regulation Class: 2 Regulation Number: 882.1320

### 3. Predicate Device Information

510(K) Number: K092828 Company Name: HydroDot, Inc. Trade/Device Name: StatNet Regulation Number: 882.1320 Requlatory Class: 2 Product Code: GXY

### 4. Device Description

The NeuroCap (model DEC18) is an Electroencephalogram (EEG) electrode array intended for use in ER (emergency room), ICU (intensive care unit) and OR (operating room) for recording of STAT EEGs in

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| Sponsor: | Memory MD INC |
|-----------------|------------------------------|
| Subject Device: | NeuroCap, Model: DEC18 |
| Document Name: | FDA 510(k) Submission Report |

patients of 18 years of age and older. NeuroCap is intended for use with amplifiers of medical signals equipped with appropriate plug or by special adapter will not be included in subject device). NeuroCap is a disposable electrodes system made of polycarbonate based film with applied conductive paths and sensors. Each sensor is equipped with a sponge with a conductive gel for providing sensor contact with the skin surface. NeuroCap is fixed on the patient by means of adhesive tape. NeuroCap could be connected to amplifier directly or via a special adapter.

The NeuroCap disposable electrode system is 16 channels. The headband is non-sterile and disposable for single patient use and designed to be used with the Neuro EEG device (K173460) for EEG acquisition and recording. NeuroCap is intended for prescription use in healthcare facilities, or clinical research environments.

# 5. Intended Use / Indications for Use

The NeuroCap (model DEC18) is an Electroencephalogram (EEG) electrode array intended for use in ER (emergency room), ICU (intensive care unit) and OR (operating room) for recording of STAT EEGs in patients of 18 years of age and older.

## 6. Test Summary

The proposed NeuroCap has been evaluated the safety and performance by lab bench testing as following:

- � Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards
- � Risk management according to ISO 14971:2012 standards
- � Performance test according to ANSI/AAMI EC12:2000 Disposable ECG electrodes standards

### 7. Comparison to predicate device and conclusion

The technological characteristics, features, specifications, materials, mode of operation, and intended use of the proposed NeuroCap is substantially equivalent to the predicate devices quoted below. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.

| Elements of<br>Comparison | Subject Device | Predicate Device | Remark |
|---------------------------|-------------------------|-----------------------------|--------|
| Device Name<br>and Model | NeuroCap (Model: DEC18) | StatNet (model: 3100, 3110) | -- |
| 510(k) Number | Applying | K092828 | -- |
| Product Code | GXY | GXY | SE |

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| Sponsor: | Memory MD INC |
|-----------------|------------------------------|
| Subject Device: | NeuroCap, Model: DEC18 |
| Document Name: | FDA 510(k) Submission Report |

| Intended Use /<br>Indications for<br>Use | The NeuroCap (model<br>DEC18) is an<br>Electroencephalogram<br>(EEG) electrode array<br>intended for use in ER<br>(emergency room), ICU<br>(intensive care unit) and OR<br>(operating room) for<br>recording of STAT EEGs in<br>patients of 18 years of age<br>and older. | An Electroencephalogram<br>(EEG) electrode array intended<br>for use in the ER, ICU and OR<br>for recording of STAT EEGs in<br>patients of 18 years of age and<br>older. | SE |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Patient<br>population | Adults only (>18 years old) | Adults only (>18 years old) | SE |
| User | Trained Technician | Trained Technician | SE |
| Number of<br>electodes | 18 | 18 | SE |
| Electrode<br>material | Ag/AgCl | Ag/AgCl | SE |
| Type of<br>conducting<br>medium | Conductive gel | Conductive gel | SE |
| Sizes of EEG -<br>caps (by head<br>circumference) | S (47-53 cm)<br>M (50-56 cm)<br>L (56-62 cm) | M (50-56)<br>L (56-62) | SE<br>Note 1 |
| Surface area of<br>each electrode | 1.13 cm² | 1.56 cm² | SE<br>Note 1 |
| Work duration<br>after the<br>package<br>opening | 4 hours | 4 hours | SE |
| Storage life | 18 months | 18 months | SE |
| Package<br>dimensions | less 490x460x15 mm | less 520x290x15 mm | SE<br>Note 1 |
| Net Weight | less 25 grams | less 40 grams | SE<br>Note 1 |
| Gross Weight | less 200 grams | less 80 grams | SE<br>Note 1 |

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* SE means " substantially equivalent".

#### Comparison in Detail(s):

Note 1: The "Sizes of EEG-caps", "Surface area of each electrode", "Net Weight", "Gross Weight", "Package Dimensions" have little difference between the subject device and the predicate one. They are all the appearance specifications and complying with the ISO 10993 biocompatibility requirements and ISO14971:2012 harm control application to medical device. Therefore, the differences between the two have no impacts on the safety and effect.

#### Finial Conclusion:

The subject product the NeuroCap is Substantial Equivalent to the predicate product.

8. Date of the summary prepared: April 27, 2018