Sleep Apnea Feature is an AI-enabled medical device from Samsung Electronics Co., Ltd that the U.S. FDA granted through De Novo DEN230041 on February 6, 2024. Its lead review panel is Anesthesiology and its primary product code is QZW (Over-The-Counter Device To Assess Risk Of Sleep Apnea).
See also FDA-cleared AI anesthesiology devices in 2024, all FDA AI clearances in 2024, top anesthesiology AI devices.
Key facts
| Submission number | DEN230041 |
|---|---|
| Pathway | De Novo |
| Date of final decision | |
| Company (FDA list) | Samsung Electronics Co., Ltd |
| Lead review panel | Anesthesiology |
| Primary product code | QZW — Over-The-Counter Device To Assess Risk Of Sleep Apnea |
| Applicant (openFDA) | Samsung Electronics Co., Ltd. |
| Applicant location | Suwon-Si, KR |
| Device class | Class 2 |
| Regulation number | 21 CFR 868.2378 |
| 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. Sleep Apnea Feature went through this pathway (DEN230041).
openFDA lists it as a Class 2 device under 21 CFR 868.2378. Class II devices are moderate risk and are subject to general and special controls.
Product code QZW covers 2 devices on the FDA AI list. By decision date, this device is #1 of 2 under that code. Samsung Electronics Co., Ltd has 2 AI-enabled devices on the list, and the Anesthesiology panel accounts for 30 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.