(35 days)
This device is intended for the cutting and removal of bone and tissues in ENT, otolaryngology / head and neck surgical procedures.
The TreBay Microdebrider system is comprised of the Power Control unit, foot pedal and three (3) types of motorized, reusable electric handpieces that use various intercrangable cutter blades and/or bur tips. The system can operate one , two or all three handpieces (one at a time) with suction and/or irrigation, depending on the handpiece. The Microdebrider System is intended for use by health care professionals and is labeled as a restricted device.
The provided 510(k) summary for the Trebay Microdebrider does not contain any information regarding acceptance criteria or a study proving the device meets them.
This document describes a conventional surgical device (microdebrider) and focuses on its design, intended use, and substantial equivalence to existing devices. It is not a submission for an AI/ML-based medical device, which would typically require performance data against defined acceptance criteria.
Therefore, I cannot populate the requested table and answer the subsequent questions based on the provided input. The prompt's questions are designed for AI/ML device submissions, which include specific studies to evaluate algorithm performance.
§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.
(a)
Identification. An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.(b)
Classification. Class II.