e-CFR banner

Home
gpo.gov
govinfo.gov

e-CFR Navigation Aids

Browse

Simple Search

Advanced Search

 — Boolean

 — Proximity

 

Search History

Search Tips

Corrections

Latest Updates

User Info

FAQs

Agency List

Incorporation By Reference

eCFR logo

Related Resources

 

Electronic Code of Federal Regulations

e-CFR data is current as of February 19, 2020

Title 21Chapter ISubchapter HPart 870Subpart F → §870.5910


Title 21: Food and Drugs
PART 870—CARDIOVASCULAR DEVICES
Subpart F—Cardiovascular Therapeutic Devices


§870.5910   Esophageal thermal regulation device.

(a) 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.

(b) 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.

[80 FR 49896, Aug. 18, 2015]

Need assistance?