(141 days)
Emergency Use - OTC: Intended to produce oxygen for emergency use. There is a minimum 6 LPM flow rate for at least 15 minutes established a minimum total oxygen capacity of 90 liters. Environment of use - locations where emergency oxygen maybe needed.
Rx use: A portable oxygen generator intended to produce oxygen to provide supplemental oxygen as prescribed by a physician. Environment of use – Home, institutional, travel / mobile environments.
A portable oxygen generator that utilizes a chemical reaction to generate oxygen. It is available in two versions: Emergency Use - OTC and Rx use. The Emergency Use version provides a minimum flow rate of 6 LPM for at least 15 minutes with a total oxygen capacity of 90 liters. The Rx use version provides variable flow rates (0.5 LPM for 60 minutes/30 liters capacity and 3 LPM for 30 minutes/90 liters capacity) as prescribed by a physician. Both versions are single use and disposable and use a standard oxygen mask or nasal cannula for patient interface.
The provided text describes two devices, O2-in-a-box™ for Emergency Use (OTC) and O2-in-a-box™ for Rx Use, which are portable oxygen generators. The document focuses on demonstrating substantial equivalence to predicate devices rather than independent performance studies with detailed acceptance criteria. However, based on the comparative tables and performance testing sections, we can infer acceptance criteria and reported performance.
1. Table of Acceptance Criteria and Reported Device Performance
Here's a table summarizing the acceptance criteria (primarily based on predicate device specifications and stated minimums) and the reported performance of the O2-in-a-box™ devices.
| Feature / Metric | Acceptance Criteria (Emergency Use - OTC) | Reported Device Performance (Emergency Use - OTC) | Acceptance Criteria (Rx Use) | Reported Device Performance (Rx Use) |
|---|---|---|---|---|
| % Oxygen | > 99% | > 99% | 89% +/- 3% (from predicate, but proposed device states > 99%) | > 99% |
| Flow rate minimum | 6 LPM | > 6 LPM | Variable flow rates (0.5 LPM, 3.0 LPM) | 0.5 LPM and 3.0 LPM |
| Duration of flow | At least 15 minutes | At least 15 minutes | 0.5 LPM for 60 minutes; 3.0 LPM for 30 minutes | 0.5 LPM for 60 minutes; 3.0 LPM for 30 minutes |
| Total Oxygen Capacity | 90 liters | 90 liters | 0.5 LPM: 30 liters; 3.0 LPM: 90 liters | 0.5 LPM: 30 liters; 3.0 LPM: 90 liters |
| VOC / PM2.5 | Within acceptable limits (based on EPA TO-15 VOC and NIOSH 0500 PM2.5) | Met and passed testing; demonstrated within acceptable limits | Within acceptable limits (based on EPA TO-15 VOC and NIOSH 0500 PM2.5) | Met and passed testing; demonstrated within acceptable limits |
| Bacteria / Mold Testing | Passed testing (implied by "met and passed all performance testing") | Met and passed testing | Passed testing (implied by "demonstrate safety we have performed the following bench tests") | Met and passed testing |
| Environmental Testing (Temp) | Passed high and low temperature conditions (implied) | Met and passed testing | Passed high and low temperature conditions (implied) | Met and passed testing |
| Mechanical Testing (Vibration) | Passed vibration testing (implied) | Met and passed testing | Passed vibration testing (implied) | Met and passed testing |
| External Container Temp | Not explicitly stated as criterion, but tested ("including external container temperature") | Not explicitly stated, but results passed "all performance testing" |
§ 868.5440 Portable oxygen generator.
(a)
Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).(b)
Classification. Class II (performance standards).