(153 days)
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.
Disposable EEG Needle Electrode
This document is an FDA 510(k) clearance letter for a medical device: a Disposable EEG Needle Electrode. It primarily focuses on the regulatory determination of substantial equivalence to a predicate device.
Therefore, the document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a new device.
The letter states that the FDA has "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." This means the manufacturer demonstrated that their device is as safe and effective as a device already on the market, usually by comparing its technological characteristics and intended use.
In summary, none of the requested information regarding acceptance criteria and device performance studies can be extracted from this document because it is a regulatory clearance letter, not a clinical study report or technical specification document.
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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
§ 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).