EEG-Now

K180524 · Encephalodynamics, Inc. · GXY · May 18, 2018 · Neurology

Device Facts

• Record ID: K180524
• Device Name: EEG-Now
• Applicant: Encephalodynamics, Inc.
• Product Code: GXY · Neurology
• Decision Date: May 18, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2

Intended Use

An electroencephalogram (EEG) electrode array intended for use in the ER, ICU, and OR for recording of STAT EEGs in patients of 18 years of age and older.

Device Story

EEG-Now is an electroencephalogram (EEG) electrode array; used in ER, ICU, and OR settings; operated by healthcare professionals to facilitate STAT EEG recordings. Device captures electrical brain activity signals via cutaneous electrodes; signals are transmitted to compatible EEG recording equipment. Output provides clinicians with real-time or near-real-time EEG data to assist in neurological assessment and clinical decision-making for patients requiring urgent monitoring.

Clinical Evidence

No clinical data provided; device is a cutaneous electrode array.

Technological Characteristics

Cutaneous electrode array; intended for EEG signal acquisition; Class II device (21 CFR 882.1320, Product Code GXY).

Indications for Use

Indicated for patients 18 years of age and older requiring STAT EEG recordings in ER, ICU, or OR 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.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. The FDA logo is on the right, with the letters "FDA" in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

May 18, 2018

EncephaloDynamics, Inc. J. Chris Sackellares, MD President 4320 NW 23rd Avenue, Suite 1 Gainesville, Florida 32606

Re: K180524

Trade/Device Name: EEG-Now Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: February 19, 2018 Received: February 27, 2018

Dear Dr. Sackellares:

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 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

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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.

## VivekJ. 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) K180524

Device Name EEG-Now

Indications for Use (Describe)

An electroencephalogram (EEG) electrode array intended for use in the ER, ICU, and OR for recording of STAT EEGs in patients of 18 years of age and older.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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