(265 days)
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None
No
The summary explicitly states that the device "does not analyze or interpret EEG data in any manner" and that "all such EEG analysis and interpretation is performed by a medical professional/clinician." There are no mentions of AI, ML, or related concepts.
No
The device collects and transfers EEG data but does not analyze, interpret, or provide any therapy or treatment. Its function is limited to data acquisition.
No
The device collects and transfers EEG data but does not analyze or interpret it. Analysis and interpretation are performed by a medical professional, meaning the device itself doesn't provide a diagnosis.
No
The device description explicitly states it is a "portable 26 channel digital electroencephalography (EEG) collection and wireless data transfer device" that digitizes and amplifies signals, indicating it includes hardware components beyond just software.
Based on the provided information, the microEEG® system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. They perform tests in vitro (in a test tube or outside the body).
- microEEG® Function: The microEEG® system collects and transfers electrical signals from the brain (EEG data) from the body. It does not analyze or interpret these signals, nor does it process biological specimens.
- Intended Use: The intended use clearly states it's for collecting and transferring EEG data, with analysis and interpretation performed by a medical professional.
Therefore, the microEEG® system falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The microEEG® system is a portable 26 channel digital electroencephalography (EEG) collection and wireless data transfer device that is designed for use in hospitals and other medical environments. The system digitizes analogue EEG signals collected by 3rd party electrodes, amplifies them, and uses Bluetooth® wireless connectivity to transfer the EEG data to a dedicated host computer. It is important to note that the microEEG® system collects and manages EEG data only. The system does not analyze or interpret EEG data in any manner. Rather, all such EEG analysis and interpretation is performed by a medical professional/clinician.
Product codes
GWQ
Device Description
The microEEG® system is a portable 26 channel digital electroencephalography (EEG) collection and wireless data transfer device that is designed for use in hospitals and other medical environments. The system digitizes analogue EEG signals collected by 3rd party electrodes, amplifies them, and uses Bluetooth® wireless connectivity to transfer the EEG data to a dedicated host computer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professional/clinician; hospitals and other medical environments
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
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).
0
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Bio-Signal Group Corporation c/o Anderson I. Micu Chief Operations Officer 760 Parkside Avenue Brooklyn. NY 11226
K112817 Re:
Trade/Device Name: MicroEEGTM System Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWQ Dated: May 31, 2012 Received: June 1, 2012
JUN 1 9 2012
Dear Mr. Micu:
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 or comply with all the Act's requirements, including, but not limited to: registration and listing (21
1
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
E. le. Krum MD
Malvina B. Eydelman, M/D
Malvina B. Eydelman, M Director Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known):
Device Name:
microEEG® system
Indications For Use:
The microEEG® system is a portable 26 channel digital electroencephalography (EEG) collection and wireless data transfer device that is designed for use in hospitals and other medical environments. The system digitizes analogue EEG signals collected by 3rd party electrodes, amplifies them, and uses Bluetooth® wireless connectivity to transfer the EEG data to a dedicated host computer.
It is important to note that the microEEG® system collects and manages EEG data only. The system does not analyze or interpret EEG data in any manner. Rather, all such EEG analysis and interpretation is performed by a medical professional/clinician.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
nrimes,
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K112817
Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1