(72 days)
This grounding pad, also know as dispersive, neutral, or return electrode, is applied to the patient's skin during surgery to reliably conduct the required surgical R.F. current with minimal rise in skin temperature, thereby reducing the risk of electrosurgical effect or burns to the patient.
This device is used when electrosurgery generators and pencils with electodes are needed during a surgical procedure. The dispersive electrode is large in area, compared to the active electrode on pencil, thus promoting low current density so burns to the patient do not happen.
The electrosugical generator produces (radio frequency) R.F. current to high-density electrode known as the active electrode. The dispersive electrode reduces the current to low density and returns the current back to the generator. Again reducing the risk for burns to the skin of the patient.
The grounding pad is coupled to the patient usually by direct contact with the skin, and may be used with semi-liquid or conductive gel. This is usually done with the disposable grounding pad.
Not Found
This document is a 510(k) clearance letter from the FDA for a disposable electrosurgery grounding pad. It states that the device is substantially equivalent to legally marketed predicate devices.
However, the provided document does not contain any information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
The document is purely a regulatory clearance and does not include the technical study details that would typically be found in a more comprehensive submission or performance report.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 0 1999
Mr. Roger Strube E & M Engineering, Inc. 1705 Dabney Road Richmond, Virginia 23230
K984276 Re: Trade Name: Disposable Electrosurgery Grounding Pad Regulatory Class: II Product Code: GEI Dated: November 24, 1998 Received: November 30, 1998
Dear Mr. Strube:
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 (OS) 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 - Mr. Roger Strube
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,
Celia M. Witten, Ph.D., M.D.
Director
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 2 of 2
510 ( k ) NUMBER (IF KNOWN) : _ _ K984276
DISPOSABLE ELECTROSURGERY GROUNDING PAD DEVICE NAME :
INDICATIONS FOR USE:
This grounding pad, also know as dispersive, neutral, or return electrode, is applied to the patient's skin during surgery to reliably conduct the required surgical R.F. current with minimal rise in skin temperature, thereby reducing the risk of electrosurgical effect or burns to the patient.
This device is used when electrosurgery generators and pencils with electodes are needed during a surgical procedure. The dispersive electrode is large in area, compared to the active electrode on pencil, thus promoting low current density so burns to the patient do not happen.
The electrosugical generator produces (radio frequency) R.F. current to high-density electrode known as the active electrode. The dispersive electrode reduces the current to low density and returns the current back to the generator. Again reducing the risk for burns to the skin of the patient.
The grounding pad is coupled to the patient usually by direct contact with the skin, and may be used with semi-liquid or conductive gel. This is usually done with the disposable grounding pad.
Roger Strube
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTIUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use(per 21 CFR 801.109) | X | or | Over - the - Counter- Use(Optional Format 1-2-96) |
|---|---|---|---|
| ------------------------------------------ | --- | ---- | ------------------------------------------------------- |
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K984276 |
|---|---|
| --------------- | --------- |
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.