Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes a disposable EEG electrode array and its intended use for acquiring and recording EEG signals. There is no mention of any software, algorithms, or data processing capabilities that would suggest the use of AI or ML. The device is a passive component for signal acquisition.

Therapeutic

No
The NeuroCap is an EEG electrode array used for recording brain activity, not for treating any condition. Its intended use is diagnostic, for routine clinical and research settings where recording of STAT EEGs is desired.

Diagnostic

No

The NeuroCap is an electrode array for recording EEGs. While EEG acquisition can be part of a diagnostic process, the device itself is a data acquisition tool and does not interpret or diagnose conditions. It is stated to be used with a separate "Neuro EEG Device" for acquisition and recording.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "disposable electrodes system made of polycarbonate-based film with applied conductive paths and sensors," which are physical hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, the NeuroCap (Model DEC22) is not an IVD (In Vitro Diagnostic) device.

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
NeuroCap's Function: The NeuroCap is an electrode array that is placed on the scalp (cutaneous surface) to record electrical activity of the brain (EEG). This is a non-invasive procedure that measures signals directly from the body.
Intended Use: The intended use is for recording STAT EEGs in clinical and research settings. This is a diagnostic procedure performed on the patient, not on a specimen taken from the patient.

Therefore, the NeuroCap falls under the category of a medical device used for physiological measurement, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The NeuroCap (Model DEC22) is an Electroencephalogram (EEG) electrode array intended for use in routine clinical and research settings where recording of STAT EEGs is desired.

Product codes

GXY

Device Description

NeuroCap is a disposable electrodes system made of polycarbonate-based film with applied conductive paths and sensors. Each Ag/AgCl sensor is equipped with a sponge that is coated with a conductive gel for providing sensor contact with the scalp (cutaneous) surface. NeuroCap is fixed on the patient by means of adhesive tape and Velcro. NeuroCap could be connected to a signal amplifier directly or via a special adapter. (The adapter will not be included in the subject device.) The practical application of the NeuroCap is in electroencephalography.

The NeuroCap disposable electrode system has 19 active channels. The headband of the device is nonsterile and disposable for single patient use. The NeuroCap is designed to be used with the Neuro EEG Device (K173460) for EEG acquisition and recording. The Neuro EEG Device is sold separately.

NeuroCap is intended for prescription use in healthcare facilities or clinical research environments. NeuroCap is not intended for current stimulation and must be used by qualified personnel.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

scalp (cutaneous) surface

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Prescription Use
routine clinical and research settings
healthcare facilities or clinical research environments.
qualified personnel
Trained Technician

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The proposed NeuroCap has been evaluated for safety and performance using the 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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K172866, K162460

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

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March 5. 2021

Memory MD Inc % Mike Corcoran Principle Mtak LLC 8241 Enclave Cove Woodbury, Minnesota 55125

Re: K202913

Trade/Device Name: NeuroCap (Model DEC22) Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: December 8, 2020 Received: December 9, 2020

Dear Mike Corcoran:

We have reviewed vour 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/cfpmp/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

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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 mediation-emitting products, including information about labeling regulations, please see Device (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,

Heather Dean, PhD Assistant Director. 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) K202913

Device Name NeuroCap (Model DEC22)

Indications for Use (Describe)

The NeuroCap (Model DEC22) is an Electroencephalogram (EEG) electrode array intended for use in routine clinical and research settings where recording of STAT EEGs is desired.

Type of Use (Select one or both, as applicable)

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 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: 3014403523 Address: 125 Wilbur Place, Suite 170, Bohemia, NY, USA Postal Code: 11716 Phone: (215) 341-6373 Contact Person (including title): Vadim Sakharov, Chief Technology Officer E-mail: vadim@memorymd.com

Application Correspondent:

Contact Person: Mike Corcoran Phone: 612-226-2915 Email: mcorcoran@memorymd.com

2. Subject Device Information

Common Name: Cutaneous electrode Classification Name: Electrode, Cutaneous Trade Name: NeuroCap Model Name: DEC22 Product Code: GXY Regulation Number: 882.1320 Regulatory Class: II Review Panel: Neurology

3. Predicate Device Information

Predicate Device 1:

510(K) Number: K172866 Company Name: Memory MD INC Common Name: Cutaneous electrode Classification Name: Electrode, Cutaneous Trade Name: NeuroCap Model: DEC18 Regulation Number: 882.1320 Regulatory Class: II Product Code: GXY

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Predicate Device 2:

510(K) Number: K162460 Company Name: WAVi Co. Common Name: Cutaneous electrode Classification Name: Electrode, Cutaneous Trade Name: WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts Model: WH-100: XS Headset, WH-200: S Headset, WH-300: M Headset, WH-400: L Headset, WH-500: XL Headset Regulation Number: 882.1320 Regulatory Class: II Product Code: GXY

4. Device Description

NeuroCap is a disposable electrodes system made of polycarbonate-based film with applied conductive paths and sensors. Each Ag/AgCl sensor is equipped with a sponge that is coated with a conductive gel for providing sensor contact with the scalp (cutaneous) surface. NeuroCap is fixed on the patient by means of adhesive tape and Velcro. NeuroCap could be connected to a signal amplifier directly or via a special adapter. (The adapter will not be included in the subject device.) The practical application of the NeuroCap is in electroencephalography.

The NeuroCap disposable electrode system has 19 active channels. The headband of the device is nonsterile and disposable for single patient use. The NeuroCap is designed to be used with the Neuro EEG Device (K173460) for EEG acquisition and recording. The Neuro EEG Device is sold separately.

NeuroCap is intended for prescription use in healthcare facilities or clinical research environments. NeuroCap is not intended for current stimulation and must be used by qualified personnel.

5. Intended Use / Indications for Use

The NeuroCap (Model: DEC22) is an Electroencephalogram (EEG) electrode array intended for use in routine clinical and research settings where recording of STAT EEGs is desired.

6. Test Summary

The proposed NeuroCap has been evaluated for safety and performance using the 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, 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.

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| Elements of

Comparison	Subject Device	Predicate Device 1	Predicate Device 2	Remark
Device Name
and Model	NeuroCap (model DEC

                                                                                                                                                                           | NeuroCap (model DEC

                                                                                                                                                                                                                                            | WAVI™ Headset and

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SE means "substantially equivalent".

Comparison in Detail(s):

Note 1: (Indications for Use)

Although there are some slight differences in the "Indications for Use" between the subject device and predicate devices, all devices are indicated for use in patients that need the rapid placement of electrodes for EEG. No significant differences exist between the subject and predicate devices.

Note 2: (Intended Use)

Although there are some slight differences in the wording of the "Intended Use" between the subject device and predicate devices are used for similar purposes in similar patient populations. No significant differences exist between the subject and predicate devices.

Note 3: (Number of Contacts)

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The subject device has 22 contacts. The NeuroCap DEC18 (predicate #1) has 18 contacts. The electrode material of these contacts is identical. The second predicate device (WAVi™ Headset ) was included in this submission because it contains 22 contacts which is the same number as the subject device. The differences in the number of contacts listed above do not represent a significant difference between the subject and predicate devices.

Note 4: (Number of Recording Channels)

Like the explanation in Note 3 above; the subject device has 19 recording channels. The NeuroCap DEC18 (predicate #1) has 16 recording channels. The second predicate device (WAVI™ Headset) has 19 recording channels which is the same number as the subject device. The differences in the number of recording channels listed above do not represent a significant difference between the subject and predicate devices.

Note 5: (Electrode Material)

Some differences exist between the materials of the subject device and predicate devices. Although differences in materials exist, the function of the electrodes in each device is the same. These differences are not significant and do not raise any new safety or effectiveness concerns.

Conclusion :

The subject device has all features of the predicate devices. The slight differences between subject device and predicate devices do not raise any new safety and effectiveness concerns. Therefore, the subject device is substantially equivalent to the predicate devices (K172866 and K162460).

Date of the summary prepared: February 15, 2021