(62 days)
The Tula Tube Delivery System is intended to provide a means to create a myringotomy with insertion of a preloaded Grommet type tympanostomy tube.
The Tula Tube Delivery System (TDS) is a device that penetrates the tympanic membrane and inserts the Grommet type tympanostomy tube with a button controlled activation. It is intended to provide a means to create a myringotomy with insertion of a preloaded grommet type tympanostomy tube.
This document describes the TULA Tube Delivery System, a medical device intended to create a myringotomy and insert a tympanostomy tube. The document is primarily a 510(k) summary for FDA clearance, focusing on demonstrating substantial equivalence to a predicate device. As such, it does not contain information related to software performance, AI algorithms, or clinical study results with acceptance criteria typical for AI/ML devices.
The provided text focuses on the device's mechanical functions, sterilization, and biocompatibility, which are assessed through bench verification testing. Therefore, I cannot generate the requested table and information about acceptance criteria, study design, and AI performance from the given text.
The information provided pertains to the regulatory clearance of a physical medical device, not a diagnostic AI system.
§ 874.3880 Tympanostomy tube.
(a)
Identification. A tympanostomy tube is a device that is intended to be implanted for ventilation or drainage of the middle ear. The device is inserted through the tympanic membrane to permit a free exchange of air between the outer ear and middle ear. A type of tympanostomy tube known as the malleous clip tube attaches to the malleous to provide middle ear ventilation. The device is made of materials such as polytetrafluoroethylene, polyethylene, silicon elastomer, or porous polyethylene.(b)
Classification. Class II.