(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.
§ 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.