(230 days)
Intended to produce oxygen for emergency use at 6 lpm flow rate for at least 15 minutes (90 liters).
The ROGS is a chemical based portable oxygen generator which generates 99% oxygen for at least 15 minutes at a flow rate of at least 6 lpm. It is a self-contained device with the oxygen delivered via standard oxygen face mask or nasal cannula.
The provided text describes the ROGS portable oxygen generator, a chemical-based device intended for emergency oxygen production. The acceptance criteria and the study proving it meets these criteria are outlined through a comparison to a predicate device (Molecular Products - POGS - K062153) and performance testing.
Here's an organized breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature | Acceptance Criteria (Predicate/Proposed Device) | Reported Device Performance (ROGS) |
|---|---|---|
| % Oxygen | 99% | >99% generated |
| Flow Rate minimum | 6 lpm | > 6 lpm |
| Duration of flow | At least 15 minutes | At least 15 minutes |
| Total Oxygen generated | 90 liters (implied from 6 lpm for 15 minutes) | At least 90 liters (6 lpm for at least 15 minutes) |
| Time to start of gas flow | 60 seconds (Predicate) | 5 seconds |
| VOC / PM2.5 / Ozone | Yes (tested) | Met and passed criteria; does not generate unwanted particulate matter or undesirable gases |
| Environmental testing | High and low temperature conditions | Met and passed criteria (Storage: -20° to +40°C; Operating: 0° to +40°C) |
| Mechanical testing | Vibration | Met and passed criteria |
| External container temperature |
§ 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).