QUA · Intraoral Cooling Device
Dental · 21 CFR 872.5590 · Class 2
Overview
| Product Code | QUA |
|---|---|
| Device Name | Intraoral Cooling Device |
| Regulation | 21 CFR 872.5590 |
| Device Class | Class 2 |
| Review Panel | Dental |
Identification
The Cooral System is an intraoral cooling device, which is a prescription device intended to cool the oral mucosa during chemotherapy treatments to reduce the likelihood and severity of chemotherapy-induced oral mucositis in adult patients. The device consists of an energy control unit (ECU 200) with a computerized control system, plastic tubing, and a removable intraoral mouthpiece that circulates sterile water coolant to cool the oral mucosal surfaces.
Classification Rationale
Class II (special controls). The device is classified as Class II because general controls alone are insufficient to provide reasonable assurance of safety and effectiveness, and there is sufficient information to establish special controls to mitigate the risks to health.
Special Controls
In combination with the general controls of the FD&C Act, the intraoral cooling device is subject to the following special controls: - (1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: - Thermal testing to evaluate cooling consistency and performance; and (i) - Physical Testing of the device to demonstrate material integrity. (ii) - (2) Electromagnetic compatibility (EMC) and electrical safety testing must be performed for any electrical components. - Software verification, validation, and hazard analysis must be performed for any software (3) components of the device. - (4) The patient contacting components of the device must be demonstrated to be biocompatible. - Labeling must include the following: (5) - (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.
Cleared Devices (2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K232917 | Chemo Mouthpiece | Chemo Mouthpiece, LLC | Jan 23, 2024 | SESE |
| DEN210027 | The Cooral System | Braincool AB | Oct 14, 2022 | DENG |
Top Applicants
- Chemo Mouthpiece, LLC — 1 clearance
- Braincool AB — 1 clearance
