Product Classification

Device

esophageal thermal regulation and gastric suctioning device

Definition

The device is used to control a patient's temperature, while simultaneously maintaining access to the stomach to allow gastric decompression and drainage.

Physical State

The device is a tube with three lumens made of standard medical-grade silicone. A connector allows the device to interface with an external controller, and another connector connects to wall suction.

Technical Method

The device is inserted into the esophagus, and is attached to an external controller that provides heated or cooled water, which flows in a closed loop through two lumens. A third central lumen connects to wall suction for gastric decompression/suctioning.

Target Area

The device is inserted into the esophagus and the tip reaches the stomach. The entire body is affected by the temperature of the fluid flowing through the device.

Regulation Medical Specialty

Cardiovascular

Review Panel

Cardiovascular

Product Code

PLA

Premarket Review

Circulatory Support, Structural and Vascular Devices (DHT2B)
Circulatory Support, Structural and Vascular Devices (DHT2B)

Submission Type

510(k)

Regulation Number

870.5910