(70 days)
The Medline Silicone Cautery Electrode is intended to cut and/or coagulate soft tissues by means of high frequency electrical current during electrosurgical procedures.
Not Found
Based on the provided text, it is not possible to describe the acceptance criteria and the study that proves the device meets the acceptance criteria.
The document is a 510(k) clearance letter from the FDA for a device named "Medline Cautery Electrode (silicone)". This letter confirms that the device has been found substantially equivalent to a legally marketed predicate device.
However, the letter itself does not contain the detailed technical performance data, acceptance criteria, or a description of any clinical or bench studies that were conducted to demonstrate performance. Such information would typically be found in the 510(k) submission itself, which is not provided in your input.
The document only states:
- Device Name: Medline Cautery Electrode (silicone)
- Regulation Number: 21 CFR 878.4400
- Regulation Name: Electrosurgical cutting and coagulation device and accessories
- Regulatory Class: Class II
- Product Code: GEI
- Indications for Use: "The Medline Silicone Cautery Electrode is intended to cut and/or coagulate soft tissues by means of high frequency electrical current during electrosurgical procedures."
To answer your request, I would need access to the actual 510(k) submission document or a summary thereof, which would detail the testing and performance characteristics.
Therefore, I cannot populate the table or provide information for points 1-9 as the necessary data is not present in the given text.
§ 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.