(70 days)
The intended use of our µEEG™ Pro System 5000 is for temporary recording of intractanial neural activity, temporary intracranial stimulation of neurons, and mapping of neural activity and evoked potentials.
uEEG™ Pro System 5000 Is indicated for use during intracranial neurophysiological recording and stimulation during deep brain stimulation, epilepsy surgery, and other procedures where it is appropriate to perform intracranial depth or subdural electrode recordings.
Not Found
I am sorry, but the provided text does not contain information about the acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria. The document is a 510(k) clearance letter from the FDA for the µEEG™ Pro System 5000, indicating that the device has been found substantially equivalent to a predicate device.
It primarily details:
- The FDA's decision to clear the device for marketing.
- The device's intended use, duration of use, and environment of use.
- The regulatory classification and general controls applicable to the device.
- Contact information for various FDA offices.
Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving the device meets them based on the provided text.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 9 1999
Robert L. Rogers, Ph.D. Chief Scientist Microrecording Systems Consultants 2842 East Foothill Boulevard Pasadena, California 91107
Re: K991077 Trade Name: μEEG™ Pro System 5000 Regulatory Class: II Product Code: GZL, GWQ, GWL, or MNR Dated: March 26, 1999 Received: March 31, 1999
Dear Dr. Rogers:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Robert L. Rogers, Ph.D.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
Sincerely yours,
~ Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) NUMBER (IF KNOWN): 991077
DEVICE NAME: EEG Pro System 5000
INDICATIONS FOR USE:
Intended Use
The intended use of our µEEG™ Pro System 5000 is for temporary recording of intractanial neural activity, temporary intracranial stimulation of neurons, and mapping of neural activity and evoked potentials.
Duration of Use
Our wEEG™ Pro System 5000 is intended to be used during neurosurgical procedures for an amount of time that is sufficient to obtain the necessary information. During recording procedures, the required time duration is between 30 minutes to several hours. During this time, an electrode with tissue for no longer than about 30 minutes.
Environment of Use
The μEEG™ Pro System 5000 is designed for use in operating rooms appropriate for functional neurosurgery. (Waning Labels are attached to machine indicating that it is not to be used in the presence of flammable anesthelics).
dications for Use
uEEG™ Pro System 5000 Is indicated for use during intracranial neurophysiological recording and stimulation during deep brain stimulation, epilepsy surgery, and other procedures where it is appropriate to perform intracranial depth or subdural electrode recordings.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109
OR
Over - The - Counter - Use (Optional Format 1-2-
cstela
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K991077
§ 882.1330 Depth electrode.
(a)
Identification. A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.(b)
Classification. Class II (performance standards).