(90 days)
The Pali-Trode™ Depth Electrode is indicated where intra-operative, short-term recording of multi-unit neural activity is required.
Semi-Micro Depth Electrode
I am sorry, but the provided text describes a 510(k) clearance letter from the FDA for a device called "Semi-Micro Depth Electrode." This document is a regulatory approval, and it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other specific details requested in your prompt.
The letter confirms that the device is substantially equivalent to a predicate device and can be marketed. It lists the trade name, regulatory class, product code, and indications for use.
Therefore, I cannot fulfill your request as the necessary information is not present in the provided text.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the circle is an abstract image of an eagle.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 6 1998
Charles W. Scouten, Ph.D. President Preferred Instruments 5202 Washington Street, Suite 4 Downers Grove, Illinois 60515
Re: K981015 Semi-Micro Depth Electrode Trade Name: Requlatory Class: II Product Code: GZL Dated: March 15, 1998 Received: March 18, 1998
Dear Dr. Scouten:
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 The general controls provisions of the Act 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. ਜ 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 GMF requlation may result in requlatory 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 requlations.
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Page 2 - Charles W. Scouten, Ph.D.
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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) 594-4659. 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" (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,
Celia M. Witten, Ph.D., M.D.
Cella M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2019
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7:39PM PREFERRED 10 Jun, 1998
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్రాల్లో ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్ర
Attachment I b
Page _ of _
510(k) Number (if known): K984015
Pali-Trode
8301 594 2358
Device Name:
ాలాలూ
భారతా
06/09/98
Indications For Use:
The Pali-Trode™ Depth Electrode is indicated where intra-operative, short-term recording of multi-unit neural activity is required. .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRII, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K981015 |
|---|---|
| --------------- | --------- |
| Prescription Use(Per 21 CFR 801.109) | X |
|---|---|
| ------------------------------------------ | --- |
OR
| Over-The-Counter Use | _________________ |
|---|---|
| ---------------------- | ------------------- |
(Optional Format 1-2-96)
§ 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).