(80 days)
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Not Found
No
The summary describes a basic EEG electrode array and provides no information suggesting the use of AI or ML for data processing or analysis.
No.
The device is described as an EEG electrode array for recording STAT EEGs. This indicates a diagnostic or monitoring function, not a therapeutic one.
Yes
The device is an electroencephalogram (EEG) electrode array used for recording STAT EEGs. EEG recordings are diagnostic tools used to assess brain activity and diagnose neurological conditions.
No
The device description explicitly states it is an "electroencephalogram (EEG) electrode array," which is a hardware component used to acquire physiological signals.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of this device is to record electrical activity directly from the patient's scalp (an in vivo measurement), not to analyze a sample taken from the body.
- The description focuses on the recording of electrical signals. There is no mention of analyzing blood, urine, tissue, or any other biological specimen.
Therefore, this device falls under the category of a medical device used for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
GXY
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
18 years of age and older
Intended User / Care Setting
ER, ICU, and OR
Description of the training set, sample size, data source, and annotation protocol
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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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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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