21 CFR 872.5595 — Intraoral Phototherapy Device
Dental (DE) · De Novo Classifications · § 872.5595
Identification
The MuReva OM™ is an intraoral, non-ionizing, light-based device intended for use during radiation treatment to lower the severity of oral mucositis and associated complications with radiation-induced oral mucositis in adult patients receiving radiation to less than 75% of their oral cavity with or without chemotherapy.
Classification Rationale
FDA has determined that the device can be classified in Class II with the establishment of special controls for Class II, which provide reasonable assurance of the safety and effectiveness of the device type.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| SGQ | Intraoral Phototherapy Device | 2 | 1 |
Special Controls
SGQ — Intraoral Phototherapy Device
In combination with the general controls of the FD&C Act, the intraoral phototherapy device is subject to the following special controls: (1) Clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. Data must evaluate treatment outcomes for the specified indications for use. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must include: (i) Optical radiation testing, including: (A) Wavelength specifications, output radiant power, irradiance range, spatial beam distribution and homogeneity, and radiant dose range delivered to oral cavity treatment areas; (B) Testing of safety features protecting against optical radiation hazards and unintended output; (ii) Thermal testing of operating temperatures for all conditions of use throughout treatment duration; and (iii) Testing of material integrity and mechanical durability for the expected lifecycle duration. (3) Software verification, validation, and hazard analysis must be performed. (4) Performance testing must demonstrate electrical safety, electromagnetic compatibility (EMC), and wireless coexistence of the device in the intended use environment. (5) Performance testing must validate the reprocessing instructions for the reusable components of the device. (6) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (7) Labeling must include: (i) Information on the patient population for which the device has demonstrated to be effective based on clinical performance data for the specified indications for use; (ii) Identification of the optical radiation output specifications, including peak wavelength, output radiant power, mode of operation (e.g., continuous or pulsed), and optical radiation safety classification; (iii) A recommendation of the treatment schedule including the duration per use, daily frequency, and total treatment period; and (iv) Warnings to avoid eye exposure and instructions regarding appropriate eye protection by both the operator and the patient.
De Novo Order DEN240077
