21 CFR 870.5910 — Esophageal Thermal Regulation And Gastric Suctioning Device
Cardiovascular (CV) · Part 870 Subpart F—Cardiovascular Therapeutic Devices · § 870.5910
Identification
An esophageal thermal regulation device is a prescription device used to apply a specified temperature to the endoluminal surface of the esophagus via an external controller. This device may incorporate a mechanism for gastric decompression and suctioning. The device is used to regulate patient temperature.
Classification Rationale
Class II (special controls). The special controls for this device are:
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| PLA | Esophageal Thermal Regulation And Gastric Suctioning Device | 2 | 9 | 3rd Party |
Special Controls
PLA — Esophageal Thermal Regulation And Gastric Suctioning Device
In combination with the general controls of the FD&C Act, the Esophageal Cooling Device is subject to the following special controls:
De Novo Order DEN140018
PLA — Esophageal Thermal Regulation And Gastric Suctioning Device
*Classification.* Class II (special controls). The special controls for this device are:(1) The patient contacting materials must be demonstrated to be biocompatible. (2) Non-clinical performance evaluation must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Mechanical integrity testing. (ii) Testing to determine temperature change rate(s). (iii) Testing to demonstrate compatibility with the indicated external controller. (iv) Shelf life testing. (3) Animal testing must demonstrate that the device does not cause esophageal injury and that body temperature remains within appropriate boundaries under anticipated conditions of use. (4) Labeling must include the following: (i) Detailed insertion instructions. (ii) Warning against attaching the device to unintended connections, such as external controllers for which the device is not indicated, or pressurized air outlets instead of vacuum outlets for those devices, including gastric suction. (iii) The operating parameters, name, and model number of the indicated external controller. (iv) The intended duration of use.
eCFR
PLA — Esophageal Thermal Regulation And Gastric Suctioning Device
(1) The patient contacting materials must be demonstrated to be biocompatible. (2) Non-clinical performance evaluation must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Mechanical integrity testing. (ii) Testing to determine temperature change rate(s). (iii) Testing to demonstrate compatibility with the indicated external controller. (iv) Shelf life testing. (3) Animal testing must demonstrate that the device does not cause esophageal injury and that body temperature remains within appropriate boundaries under anticipated conditions of use. (4) Labeling must include the following: (i) Detailed insertion instructions. (ii) Warning against attaching the device to unintended connections, such as external controllers for which the device is not indicated, or pressurized air outlets instead of vacuum outlets for those devices, including gastric suction. (iii) The operating parameters, name, and model number of the indicated external controller. (iv) The intended duration of use.
Ecfr Llm
