(29 days)
The subject device of this premarket notification submission is indicated for use as an electrosurgical accessory for removal by scraping of eschar build up on the electrosurgical electrode. This product is designed for use with all stainless steel electrodes and is not indicated for use with coated "reduced stick" electrodes.
Electrosurgical Tip Cleaner
The provided document is a 510(k) clearance letter from the FDA for the "AARON Electrosurgical Tip Cleaner." It indicates that the device has been found substantially equivalent to a predicate device for its indicated use. However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.
The letter explicitly states: "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..." This means the device was cleared based on its similarity to existing, legally marketed devices, rather than requiring a new, specific performance study with defined acceptance criteria and statistical analysis as would be detailed in a clinical trial report or a more comprehensive premarket approval (PMA) submission.
Therefore, I cannot populate the requested tables and information based on the content of this document.
§ 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.