(153 days)
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No
The summary describes a simple needle electrode for sensing electrical signals, with no mention of AI, ML, or any data processing beyond the basic function of an EEG accessory.
No
The device is described as an accessory to an electroencephalograph machine, which is used to sense electrical signals of the brain for neurological studies. It is a diagnostic tool, not intended to treat or cure a condition.
Yes
The device, an EEG needle electrode, is described as sensing electrical signals of the brain for use with an electroencephalograph machine "which is for use in connection with neurological studies." Neurological studies are conducted to diagnose neurological conditions.
No
The device description explicitly states it is a "Disposable EEG Needle Electrode," which is a physical hardware component. The intended use also describes insertion into subdermal tissue, confirming it is a physical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices 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).
- This Device's Function: The description clearly states that these electrodes are inserted into the subdermal tissue of the scalp to sense electrical signals from the brain. This is a direct interaction with the body to measure physiological activity, not an examination of a specimen taken from the body.
Therefore, based on the provided information, this device falls under the category of a medical device used for physiological measurement, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Electroencephalograph (EEG) needle electrodes are needles intended to be inserted into the subdermal tissue of the scalp to sense the minute electrical signals (waveforms) of the brain. This device is an accessory to the electroencephalograph machine, which is for use in connection with neurological studies. EEG electrodes are indicated for use by or on the order of a licensed physician and intended for single patient use, only.
Product codes
GXZ
Device Description
Disposable EEG Needle Electrode
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
subdermal tissue of the scalp
Indicated Patient Age Range
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Intended User / Care Setting
licensed physician
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 882.1350 Needle electrode.
(a)
Identification. A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines beneath them. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 8 2003
Ms. Samantha L. Draper Quality Assurance Manager Class A Enterprises, Inc. P.O. Box 401964 16039 Walnut Street, Ste. C Hesperia, California 92340
Re: K023472
Trade/Device Name: Disposable EEG Needle Electrode Regulation Number: 21 CFR 882.1350 Regulation Name: Needle electrode Regulatory Class: II Product Code: GXZ Dated: January 14, 2003 Received: January 17, 2003
Dear Ms. Draper:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Samantha L. Draper
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Muriam C. Provost
for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(K) NUMBER: K 023 472
DEVICE NAME: Disposable EEG Needle Electrode
INDICATIONS FOR USE: Electroencephalograph (EEG) needle electrodes are needles intended to be inserted into the subdermal tissue of the scalp to sense the minute electrical signals (waveforms) of the brain. This device is an accessory to the electroencephalograph machine, which is for use in connection with neurological studies. EEG electrodes are indicated for use by or on the order of a licensed physician and intended for single patient use, only.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use × (Per 21 CFR 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K023472