(a) Identification. An intraoral cooling device is a prescription use device that is intended to cool the mouth for patients to reduce the likelihood of oral mucositis. The device consists of a removable mouthpiece that cools the oral mucosal surfaces.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:

(i) Thermal testing to evaluate cooling consistency and performance; and

(ii) Testing of the device to demonstrate material integrity.

(2) Electromagnetic compatibility and electrical safety testing must be performed for any electrical components.

(3) Software verification, validation, and hazard analysis must be performed for any software components of the device.

(4) The patient contacting components of the device must be demonstrated to be biocompatible.

(5) Labeling must include the following:

(i) A summary of the device specifications, including temperature cooling range and duration of cooling; and

(ii) Instructions to stop the use of the device if skin irritation or sensitivities develop, or if the device leaks or does not maintain its material integrity.