AMSINO ENDOTRACHEAL TUBE

• K Number: K050785
• Device Name: AMSINO ENDOTRACHEAL TUBE
• Manufacturer: AMSINO INTERNATIONAL, INC.
• Date Cleared: 2005-07-15 ( 109 days)
• Product Code: BTR
• Regulation Number: 868.5730
• Type: Traditional
• Panel: AN
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The AMSINO ® Endotracheal Tube is intended for use in airway management by oral/nasal intubation of the trachea. The cuff inflation system (where applicable) is used to establish a seal between the tube and the trachea.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification letter from the FDA to Amsino International, Inc. regarding their AMSINO™ Endotracheal Tube. It states that the device is substantially equivalent to legally marketed predicate devices.

The document does not contain any information regarding acceptance criteria, device performance, study details, sample sizes, expert qualifications, adjudication methods, or specific study types (MRMC or standalone). This type of detailed performance data is typically found in the 510(k) submission itself, not in the FDA's decision letter.

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

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).