(18 days)
The Electrosurgical Pencils and Electrodes are used for the cutting and coagulation of soft tissue. The Intended Use of the modified device, as described in its labeling, has not changed as a result of the modifications and do not alter the scientific technology of the device.
The Electrosurgical Pencils are for the cutting and coagulation of soft tissue and have a 3-pin connector attached to a 10 foot conductive cable and are designed for use with standard electrosurgical generators (ESU). The connector or plug fits into the monopolar side of a standard electrosurgical unit. The handpieces are made of plastic with two buttons or a rocker switch toward the distal part of the pencil in the case of the hand-controlled pencils, while the foot-controlled pencil that is connected to the generator by means of an adapter activated by a monopolar footswitch. One button or switch is to control the CUT mode of the ESU while the other controls the COAG mode.
The Holster is intended to store the pencil while it is not actively in use that attaches to a surgical drape and avoids accidental activation when not in use
The Tip Cleaner is intended to be used for eschar removal that tends to build up on an uncoated electrode by gently scraping it along the aggressive surface. The Tip Cleaner attaches to a surgical drape by an adhesive backing.
The Coated Electrode is an electrode use to cut and coagulate soft tissue coated with a material intended to reduce the build up of eschar usually eliminating the need for a Tip Cleaner.
Pencils packaged with Coated Electrodes will not have a Tin Cleaner.
This document, K993647, is a 510(k) premarket notification for "Disposable Hand and Foot-Switching Pencils with Holster, Non-Coated Electrode and Tip Cleaner" and "Disposable Hand and Foot-Switching Pencils with Holster and Coated Electrode." The purpose of this submission is to demonstrate substantial equivalence to legally marketed predicate devices, not to present a study proving the device meets acceptance criteria through performance data.
Therefore, the requested information regarding acceptance criteria and a study proving their fulfillment cannot be extracted from the provided text. The document primarily focuses on:
- Device Classification: Class II.
- Materials: Non-toxic materials used in previously legally marketed devices.
- Description: Detailed explanation of the electrosurgical pencils, holster, tip cleaner, and coated electrode.
- Intended Use: Cutting and coagulation of soft tissue.
- Regulatory Decision: A determination of substantial equivalence to predicate devices, allowing the device to be marketed.
Key points from the document regarding the regulatory process:
- The FDA reviewed the 510(k) submission and determined the device is substantially equivalent to devices marketed prior to May 28, 1976.
- This determination is based on the comparison to predicate devices, not on a new study demonstrating performance against specific acceptance criteria.
- The letter states that the "Intended Use of the modified device, as described in its labeling, has not changed as a result of the modifications and do not alter the scientific technology of the device." This reinforces that the submission is about equivalence, not a novel performance study.
In summary, the provided text does not contain a study demonstrating the device meets acceptance criteria. It is a regulatory approval document based on substantial equivalence, which typically relies on comparisons to well-established predicate devices and adherence to general controls, rather than new clinical or performance studies with acceptance criteria as described in your request.
{0}------------------------------------------------
NOV I 6 1999
Safety and Effectiveness Summary
| Common / Usual Names: | Disposable Hand and Foot-Switching Pencilswith Holster, Non-Coated Electrode and TipCleanerDisposable Hand and Foot-Switching Pencilswith Holster and Coated Electrode |
|---|---|
| Classification:Materials: | Class IIAll materials used in the manufacture of theUnimed Pencil combinations are non-toxicand been used in previously legally marketeddevices. |
| Description: | The Electrosurgical Pencils are for the cuttingand coagulation of soft tissue and have a 3-pin connector attached to a 10 footconductive cable and are designed for usewith standard electrosurgical generators(ESU). The connector or plug fits into themonopolar side of a standard electrosurgicalunit. The handpieces are made of plasticwith two buttons or a rocker switch toward thedistal part of the pencil in the case of thehand-controlled pencils, while the foot-controlled pencil that is connected to thegenerator by means of an adapter activatedby a monopolar footswitch. One button orswitch is to control the CUT mode of the ESUwhile the other controls the COAG mode.The Holster is intended to store the pencilwhile it is not actively in use that attaches to asurgical drape and avoids accidentalactivation when not in useThe Tip Cleaner is intended to be used foreschar removal that tends to build up on anuncoated electrode by gently scraping it alongthe aggressive surface. The Tip Cleanerattaches to a surgical drape by an adhesivebacking.The Coated Electrode is an electrode use tocut and coagulate soft tissue coated with amaterial intended to reduce the build up ofeschar usually eliminating the need for a TipCleaner.Pencils packaged with Coated Electrodes willnot have a Tin Cleaner. |
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a bird or a human figure in profile, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 6 1999
Mr. Lee Alexander President and Chief Executive Officer Unimed Surgical Products, Inc. 10401 Belcher Road Largo, Florida 33777
K993647 Re:
Trade Name: Disposable Hand and Foot-Switching Pencils Regulatory Class: II Product Code: GEI Dated: October 28, 1999 Received: October 29, 1999
Dear Mr. Alexander:
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 (OS) 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.
{2}------------------------------------------------
Page 2 - Mr. Lee Alexander
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 vours.
Stipt Rhodu
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
ം Intended Use
Intended / Indication for Use. The Electrosurgical Pencils and Electrodes are used for the cutting and coagulation of soft tissue. The Intended Use of the modified device, as described in its labeling, has not changed as a result of the modifications and do not alter the scientific technology of the device.
(Division Sign-Off) Division of General Restorative Devices 993647
510(k) Number .
Over-the-Counter Use,
Prescription Use J (Per 21 CFR 801.109)
§ 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.