(36 days)
The unimed Coated Electrodes are indicated for use in the cutting and coagulation of soft tissue.
The Coated Electrodes are coated with Emralon 333 or Teflon 420-104. Both are dry lubricants which provide a low coefficient of friction and reduce eschar build-up during surgery and the need for higher power settings. Without eschar build-up that takes place with a standard stainless steel tip less scraping and inconvenience takes place resulting in greater OR efficiency. Emralon and Teflon are non-toxic, corrosion resistant, and therefore safe for the patient and the OR staff. The Coated Electrosurgical Electrodes are available in a variety of tip configurations and lengths. The tip configurations include blades, needles, and balls. The blades and needles are also available with the tips only partially exposed. These devices are designed to cut and coagulate soft tissue during surgical procedures. The entire line of electrodes will fit all button, rocker, and footcontrolled pencils. The electrodes are available sterile, single use only.
This document is a 510(k) premarket notification decision letter from the FDA regarding Unimed Surgical Products, Inc.'s Coated Needle Electrode, Coated Blade Electrode, and Coated Ball Electrode. It states that the FDA has found the device substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information about acceptance criteria, a study that proves the device meets acceptance criteria, or any of the detailed study parameters requested in the prompt.
The document primarily focuses on:
- The FDA's decision of substantial equivalence.
- Classification of the device (Class II).
- General controls provisions and existing regulations.
- Indications for Use (cutting and coagulation of soft tissue).
- A brief description of the device materials (Emralon 333 or Teflon 420-104 coating) and benefits (reduced eschar build-up, lower friction, non-toxic, corrosion-resistant).
- The fact that Unimed already supplies these as components and now wants to market them under its own name.
Therefore, I cannot provide the requested information. The document is a regulatory approval letter, not a scientific study report.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a traditional symbol of medicine. The text "OF HEALTH & HUMAN SERVICES • USA" is arranged in a semi-circle around the caduceus. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 1000 SEP
Mr. Ronald R. Froemming Chief Operating Officer Unimed Surgical Products, Inc. 10401 Belcher Road Largo, Florida 34647
Re : K962935 Unimed Coated Needle Electrode, Unimed Coated Blade Electrode, Unimed Coated Ball Electrode Requlatory Class: II Product Code: GEI Dated: July 26, 1996 Received: July 29, 1996
Dear Mr. Froemming:
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 reqistration, listing of devices, qood 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 requlations affecting your device can be found in the Code of Federal Requiations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will Failure to comply with the GMP verify such assumptions. 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 - Mr. Ronald R. Froemming
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 diaqnostic 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 at (301) 443-6597.
Sincerely yours,
Ts. Coello
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
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Enclosure
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Kaeza35
Page 1 of 1
510(k) Number (if known)
Electrosurgical Electrode
Device Name:
Indications For Use:
The unimed Coated Electrodes are indicated for use in the cutting and coagulation of soft tissue.
(PLEASE DO NO WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
to aelvo
eral Restorative Device
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
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SAFETY AND EFFECTIVENESS SUMMARY
COMMON/USUAL NAME: Electrosurgical Electrode
PROPRIETARY NAME: unimed Coated Needle Electrode, unimed Coated Blade Electrode, and unimed Coated Ball Electrode
CLASSIFICATION: CLASS II
MATERIALS: All materials used to manufacture the Coated Electrodes are non-toxic and have been used in previously marketed devices.
DESCRIPTION:
The Coated Electrodes are coated with Emralon 333 or Teflon 420-104. Both are dry lubricants which provide a low coefficient of friction and reduce eschar build-up during surgery and the need for higher power settings. Without eschar build-up that takes place with a standard stainless steel tip less scraping and inconvenience takes place resulting in greater OR efficiency.
Emralon and Teflon are non-toxic, corrosion resistant, and therefore safe for the patient and the OR staff.
The Coated Electrosurgical Electrodes are available in a variety of tip configurations and lengths. The tip configurations include blades, needles, and balls. The blades and needles are also available with the tips only partially exposed.
These devices are designed to cut and coagulate soft tissue during surgical procedures. The entire line of electrodes will fit all button, rocker, and footcontrolled pencils. The electrodes are available sterile, single use only.
SUBSTANTIAL EQUIVALENCE: unimed's electrodes are currently sold in the USA under numerous proprietary names by other medical devine companies. unimed Surgical Products, Inc. is presently a component supplier of these parts. unimed Surgical Products, Inc. now wants to market these Jevices under its own trade name, as well as maintain the component subolier status.
§ 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.