QWE · Hyperoxia Monitoring Device Adjunct To Pulse Oximetry
Anesthesiology · 21 CFR 870.2720 · Class 2
Overview
| Product Code | QWE |
|---|---|
| Device Name | Hyperoxia Monitoring Device Adjunct To Pulse Oximetry |
| Regulation | 21 CFR 870.2720 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
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.
Special Controls
(1) Clinical performance testing under anticipated conditions of use must evaluate the accuracy of hyperoxia monitoring by the device and evaluate all adverse events. (2) Human factors/usability testing must demonstrate that the user can correctly use the device, based solely on reading the instructions for use. (3) Performance data must demonstrate the electromagnetic compatibility (EMC) and electrical safety of the device. (4) The patient-contacting components of the device must be demonstrated to be biocompatible. (5) Performance testing must validate the reprocessing instructions for the device. including demonstration of device performance after repeated cleaning and disinfection. (6) Software verification, validation, and hazard analysis must be performed. Performance testing must demonstrate compatibility with pulse oximeter devices labeled to be compatible with the device. (7) Labeling must include: - (i) Cleaning and disinfection instructions: - A summary of the clinical performance testing with the device: (ii) - (iii) A warning against over-reliance on device output without using arterial blood gas values for confirmation; and - (iv) Instructions to monitor oxygen delivery and patient clinical/cardiovascular status when device output changes.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| DEN200076 | ORi | Masimo Corporation | Oct 12, 2023 | DENG |
Top Applicants
- Masimo Corporation — 1 clearance
