Xomed-Treace EMG Endotracheal Tubeen

• • Ongoing Z-1520-2022 FDA Class I ·initiated 29 Apr 2022

  The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.

• • Terminated Z-0901-2017 FDA Class II ·initiated 28 Jun 2016

  Wire in tubing can become exposed, posing potential harm to the intubated patient.

• • Terminated Z-0310-05 FDA Unclassified (pre-2012) ·initiated 29 Oct 2004

  The firm received six reports of tubes with wires 'out of channel' two of which involved injuried patients. In one case in Germany it was reported that the patient had soreness of the throat and was discharged after four days. In the next case the patient had a tracheal wound. It was not clear what caused the wound.

510(k) Number

K925640 ↗

FDA Product Code

ETN

Device Class

Class II

Regulation

21 CFR Part 874.1820

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Nerve Integrity Monitor-2 (Nim-2 Xl)

  Class II

  FDA 510(k) K934426 Active Cleared 13 May 1994

• Xomed-Treace Positrol Footpedal Suction Control

  Class II

  FDA 510(k) K912753 Active Cleared 23 Sep 1991

• Battery Powered, Disposable Endoscope Light Source

  Class I

  FDA 510(k) K932771 Active Cleared 24 Aug 1994

• X-T Air Drill

  Class II

  FDA 510(k) K905800 Active Cleared 22 Apr 1991

• Xomed-Treace Alphascope

  Class I

  FDA 510(k) K923830 Active Cleared 9 Nov 1992

• Xomed-Treace Rigid Rod Lens Endoscope

  Class II

  FDA 510(k) K933105 Active Cleared 5 Jan 1994

See all devices from Xomed-Treace, Inc. →

• What is the XOMED-TREACE EMG Endotracheal Tube used for?

  This device is designed for use in ear, nose, and throat (ENT) procedures to assist with intubation or airway management. It incorporates electromyographic (EMG) functionality, allowing clinicians to identify nerves and test their excitability during placement. This helps ensure precise anatomical localization, reducing risks associated with improper tube positioning.

• How is the XOMED-TREACE EMG Endotracheal Tube supplied and what are its sterility conditions?

  The device is supplied sterile, ready for immediate clinical use. No additional sterilization is required before use. Standard medical device storage protocols apply, meaning it should be kept in a clean, dry environment away from direct sunlight or extreme temperatures to maintain its integrity and sterility.

• Is the XOMED-TREACE EMG Endotracheal Tube intended for single-use or reuse?

  This device is explicitly designed for single-use only. After a single clinical procedure, it should be discarded to ensure patient safety and prevent cross-contamination. Reuse is not recommended or supported by the manufacturer.

• What regulatory approval does the XOMED-TREACE EMG Endotracheal Tube hold?

  The device holds FDA 510(k) clearance (K925640) and is classified as a Class II medical device under the regulation 27 CFR 874.1820. This clearance was granted in 1993 and aligns with Ear, Nose, and Throat specialty standards, ensuring its compliance with U.S. regulatory requirements for nerve stimulators used in ENT procedures.

• Are there different sizes or models available for the XOMED-TREACE EMG Endotracheal Tube?

  The device data lists multiple registration numbers, which may correspond to different sizes or variations of the XOMED-TREACE EMG Endotracheal Tube. These variations are likely tailored to accommodate different patient anatomies or procedural needs. For precise sizing, refer to the manufacturer’s catalog or consult with a medical representative to ensure the correct model is selected for the intended use.