MATRx plus is an AI-enabled medical device from Zephyr Sleep Technologies that the U.S. FDA granted through De Novo DEN170090 on August 23, 2018. Its lead review panel is Dental and its primary product code is QCJ (Closed Loop Auto Titration Device For Oral Appliances).
See also all FDA AI clearances in 2018.
Key facts
| Submission number | DEN170090 |
|---|---|
| Pathway | De Novo |
| Date of final decision | |
| Company (FDA list) | Zephyr Sleep Technologies |
| Lead review panel | Dental |
| Primary product code | QCJ — Closed Loop Auto Titration Device For Oral Appliances |
| Applicant (openFDA) | Zephyr Sleep Technologies |
| Applicant location | Calgary, CA |
| Device class | Class 2 |
| Regulation number | 21 CFR 872.5571 |
| Decision code | DENG |
| Submission type | Direct |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
De Novo is the pathway for novel low-to-moderate-risk devices with no predicate. A granted De Novo creates a new device classification that later devices can use as a predicate. MATRx plus went through this pathway (DEN170090).
openFDA lists it as a Class 2 device under 21 CFR 872.5571. Class II devices are moderate risk and are subject to general and special controls.
Product code QCJ covers 1 device on the FDA AI list. By decision date, this device is #1 of 1 under that code. Zephyr Sleep Technologies has 2 AI-enabled devices on the list, and the Dental panel accounts for 7 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.