(148 days)
The O2PAK™ Portable Oxygen Generator, Model P26029 is intended to provide oxygen for emergency use; the O2PAK™ is currently offered to be used under the Direction of trained medical military personnel in support for disaster relief, crisis response, wartime operations, deterrence and contingency operations, humanitarian relief situations or peacetime engagements.
The O2PAK™ is designed to be compact, lightweight, portable, durable and easy to carry for emergency use. O2PAK™ Model P26029 is the only O2PAK™ model currently available. Its principle of operation is the same as standard chemical oxygen generators. Oxygen is administered to the patient through a nasal cannula or an equivalent device.
Here's a breakdown of the acceptance criteria and study information for the O2PAK™ Portable Oxygen Generator, Model P26029, based on the provided document.
Acceptance Criteria and Device Performance
| Feature | Acceptance Criteria (Predicate Device K052396) | Reported Device Performance (O2PAK™ Model P26029) |
|---|---|---|
| Intended uses | Emergency oxygen | Emergency oxygen under supervision of trained personnel. Fits in C-Toms Medical Ruck Sack, or equivalent |
| Environments of use | Not specified | Locations where emergency oxygen may be needed. |
| Patient populations | Not specified | Adult individuals requiring oxygen in an emergency setting. |
| Solid state chemical oxygen generation | Yes | Yes |
| Portable | Yes | Yes |
| Flow rate | Approximately 6.5 liters per minute | 4 to 8 liters per minute |
| Flow Delivery Accuracy | 6 liters per minute for 15 minutes | Minimum 4 liters per minute for minimum of 22 minutes |
| Total Oxygen Capacity | Approximately 90 liters | Minimum of 90 liters |
| Medically pure [USP] oxygen | USP 99% | USP 99% Oxygen |
| Oxygen Outlet Temperature | Unknown | Maximum 6°C above ambient (at patient) |
| Oxygen Outlet Pressure | Unknown | 30 psig maximum during initial surge, 3 psig maximum during operation |
| Single use, disposable | Not specified | Yes |
| Self-contained | Not specified | Yes (Cannula NOT included) |
| Generator storage life | Not specified | 48 months |
| Weight | Not specified |
§ 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).