Definition: The Device Is Used To Control A Patient's Temperature, While Simultaneously Maintaining Access To The Stomach To Allow Gastric Decompression And Drainage.
| Device Type ID | 967 |
| Device Name | Esophageal Thermal Regulation And Gastric Suctioning Device |
| 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/sucti |
| 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 Description | Esophageal Thermal Regulation Device. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Circulatory Support Devices Branch (CSDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.5910 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PLA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 967 |
| Device | Esophageal Thermal Regulation And Gastric Suctioning Device |
| Product Code | PLA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Esophageal Thermal Regulation Device. |
| CFR Regulation Number | 870.5910 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ADVANCED COOLING THERAPY, LLC | ||
GRANTED | 1 | |
SUBSTANTIALLY EQUIVALENT | 2 | |
ATTUNE MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Fluid Leak | 2 |
Improper Or Incorrect Procedure Or Method | 1 |
| Total Device Problems | 3 |