21 CFR 870.2720 — Hyperoxia Monitoring Device Adjunct To Pulse Oximetry

Anesthesiology (AN) · Part 870 Subpart C—Cardiovascular Monitoring Devices · § 870.2720

Identification

A hyperoxia monitoring device adjunct to pulse oximetry is a device that monitors elevated hemoglobin oxygen saturation levels as an adjunct to arterial oxygen saturation monitoring. The ORi feature is intended to be used in patients undergoing surgery as an adjunct to SpO2 for increased monitoring resolution of elevated hemoglobin oxygen saturation levels (e.g., due to the administration of supplemental oxygen) in patients 18 years and older on supplemental oxygen during no-motion conditions perioperatively in hospital environments.

Classification Rationale

Class II (special controls). The device is classified as Class II because 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