(56 days)
For the removal of soft tissue and bone in the ear, nose & throat.
Promex ENT Tissue Removal System
The provided text is a 510(k) premarket notification letter from the FDA for the Promex ENT Tissue Removal System, dated September 29, 1997. This document approves the device for marketing and confirms its substantial equivalence to previously marketed devices.
This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any of the other specific details requested in your prompt.
The letter explicitly states that the device is approved "for the indications for use stated in the enclosure," which on the second page is "For the removal of soft tissue and bone in the ear, nose & throat."
Since the document is a regulatory approval letter and not a study report, it does not provide the requested information regarding the performance study that would typically establish acceptance criteria and demonstrate device effectiveness.
§ 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.