(225 days)
The Single Patient EEG/EP Cup Electrode is intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals for example: Electroencephalograph (EEG) and Nerve potentials signals. The electrodes are for single patient use only.
Not Found
Based on the provided document, the "Single Patient EEG/EP Cup Electrode" received 510(k) clearance (K032278) from the FDA on March 5, 2004. This document is a clearance letter and an "Indications for Use" statement, not a detailed study report. Therefore, it does not contain the specific information requested regarding acceptance criteria, study design, sample sizes, ground truth establishment, or expert qualifications.
The letter states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for 510(k) clearance. This means the device demonstrated that it is as safe and effective as a device already on the market. However, the details of the testing performed to demonstrate this substantial equivalence are not present in this document.
To answer your request, an extensive search for the 510(k) premarket notification (K032278) and its supporting documentation would be required. This usually involves reviewing the full submission made by Ambu, Inc. to the FDA, which is typically not publicly available in this level of detail without a Freedom of Information Act (FOIA) request.
Therefore, I cannot provide a table of acceptance criteria and reported device performance and other study details based solely on the provided FDA clearance letter and Indications for Use.
The document only confirms:
- Trade/Device Name: Single Patient EEG/EP Cup Electrode
- Regulation Number/Name: 21 CFR 882.1320, Cutaneous electrode
- Regulatory Class: II
- Product Code: GXY
- Indications For Use: The Single Patient EEG/EP Cup Electrode is intended for use with recording, monitoring, and stimulation equipment for the purpose of recording of biopotential signals, for example: Electroencephalograph (EEG) and Nerve potentials signals. The electrodes are for single patient use only.
- Predicate Device: Not explicitly named in this document but would have been part of the 510(k) submission.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 5 2004
Mr. Sanjay Parikh Technical and Regulatory Affairs Manager Ambu, Inc. 611 North Hammonds Ferry Road Linthicum, Maryland 21090-1356
Re: K032278
Trade/Device Name: Single Patient EEG/EP Cup Electrode Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: II Product Codc: GXY Dated: March 1, 2004 Reccived: March 2, 2004
Dear Mr. Parikh:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bectorn 310(a) per device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regard the Medical Device Amendments, or to commerce prior to May 20, 1776, the enaoceance with the provisions of the Federal Food, Drug, devices that have been roomsoned in assee approval of a premarket approval application (PMA). alle Cosmetic Act (Act) that to not requesubject to the general controls provisions of the Act. The 1 ou may, therefore, market of the Act include requirements for annual registration, listing of general controls provisions of the recorplabeling, and prohibitions against misbranding and adultcration.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it If your device is classimod (600 abs. Existing major regulations affecting your device can may be subject to suen addrenial comlations, Title 21, Parts 800 to 898. In addition, FDA may oc found in the Oour acements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does no/1 F Icase of advised that I Drivisation over device complies with other requirements of the Act that 117A has made a actornations administered by other Federal agencies. You must of any I coclar statutes and regaranents ancluding, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as sch CFA Fart 807), idocing (21 OFF Part 820); and if applicable, the clectronic forth in the quality bystems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Sanjay Parikh
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter witi anow you to begin mailioning of substantial equivalence of your device to a legally premaired 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 If you desire specific at novies your (301) 594-4659. Also, please note the regulation entitled, Colliaci the Office of Compullier and (SSL notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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/dsmaldsmamain.html
Sincerely yours,
Miriam C. Provost
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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Indications for Use
510(k) Number (if known): K032278
Device Name:__ Single Patient EEG/EP Cup Electrode
Indications For Use:
The Single Patient EEG/EP Cup Electrode is intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals for example: Electroencephalograph (EEG) and Nerve potentials signals. The electrodes are for single patient use only.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
Division Sign Division of General, Restorative. and Neurological Devices
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510(k) Number_________________________________________________________________________________________________________________________________________________________________
§ 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).