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510(k) Data Aggregation
(256 days)
The EMG Tube is indicated for use where continuous monitoring of the nerves supplying the laryngeal musculature is required during surgical procedures. The EMG tube is not intended for postoperative use.
The Medtronic NIM Essence™ EMG Endotracheal Tube (ETT) is a flexible, reinforced PVC endotracheal tube with an inflatable cuff. FPC (Flexible Printed Circuit) is attached and wrapped around the main shaft of the endotracheal tube, and silicone cover tube overlays on the FPC. The FPC electrodes are exposed only for a short distance, approximately 30 mm, slightly superior to the cuff. The electrodes are designed to make contact with the laryngeal muscles around the patient's vocal cords to facilitate electromyographic (EMG) monitoring of the laryngeal musculature during surgery when connected to an EMG monitoring device. Both the tube and the cuff are manufactured from material that allows the tube to readily conform to the shape of the patient's trachea with minimal trauma to tissues. The NIM Essence™ EMG Endotracheal Tube is packaged as a sterile single-use device.
The Medtronic NIM™ 3.0 (cleared via K083124 on February 27, 2009) and NIM Vital™ (cleared via K200759 on October 28, 2020) nerve monitors are the recommended EMG monitors for use with the EMG Endotracheal Tube. All references to connections and technical specifications for EMG monitor contained in the instructions are made with references to the NIM™ family of devices. Medtronic recommends that the user consult the NIM™ User's Guide for determining proper settings of the NIM™ console and instructions for intraoperative EMG monitoring and motor nerve location and stimulation.
The NIM Essence™ EMG Endotracheal Tube is Type BF applied part.
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