T-WALL UNCUFFED TRACHEAL TUBE

• K Number: K970196
• Device Name: T-WALL UNCUFFED TRACHEAL TUBE
• Manufacturer: VITAL SIGNS, INC.
• Date Cleared: 1997-08-21 ( 212 days)
• Product Code: BTR
• Regulation Number: 868.5730
• Type: Traditional
• Panel: AN
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The T-Wall™ Uncuffed Tracheal Tube is indicated for tracheal intubation and airway management.

Device Description

T-Wall™ Uncuffed Tracheal Tube

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (T-Wall™ Uncuffed Tracheal Tube). This type of document primarily confirms that a device has been found substantially equivalent to a predicate device and allows it to be marketed.

It does not contain the detailed information necessary to answer your specific questions regarding acceptance criteria, study design, expert qualifications, or AI-related metrics. The letter focuses on regulatory approval rather than a scientific study report.

Therefore, I cannot provide the requested table and information based solely on the text you provided.

Regulation Number and Section

§ 868.5730 Tracheal tube.

(a)
Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.(b)
Classification. Class II (performance standards).