21 CFR 868.2250 — Monitor For Opioid Induced Impairment Of Oxygenation
Anesthesiology (AN) · Part 868 Subpart C—Monitoring Devices · § 868.2250
Identification
A monitor for opioid induced impairment of oxygenation is a device that uses sensor hardware and software algorithms to detect desaturations of arterial oxygen saturation resulting from opioid overdose. The Masimo SafetyNet Opioid System is intended for the non-invasive continuous monitoring of individuals 15 years and older for the identification of when they may be experiencing a substance induced impairment of oxygenation (e.g., opioid induced respiratory depression (OIRD) caused by oral or injectable opioids) in hospital and home environments.
Classification Rationale
Class II (special controls). The device is granted under De Novo classification (21 CFR 868.2250) as the probable benefits outweigh the probable risks, and the risks can be mitigated by the use of general controls and the identified special controls.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| QVT | Monitor For Opioid Induced Impairment Of Oxygenation | 2 | 1 | SaMD |
Special Controls
QVT — Monitor For Opioid Induced Impairment Of Oxygenation
In combination with the general controls of the FD&C Act, the monitor for opioid induced impairment of oxygenation is subject to the following special controls:
De Novo Order DEN200011
