(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.
§ 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.