(153 days)
The Invacare Flyer (Model XPO100) is intended to be used by patients with respiratory disorders who require supplemental oxygen. It supplies a high concentration of supplemental oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Invacare Flyer can be used in a home, institution, vehicle and various mobile environments. The Invacare Flyer does not nor is it intended to sustain or support life.
The Invacare Flyer is used by patients with respiratory disorders who require supplemental oxygen. The device can be used in the home, an institutional environment or in a vehicle or other mobile environment. The device is not intended to sustain or support life. The device is used with a nasal cannula to direct oxygen from the device to the patient.
The Invacare Flyer provides oxygen in pulsed demand flow dosages at settings of 1 through 5. The oxygen concentration level of the output gas ranges from 87% to 95.6%.
Standard power options include an AC to DC switching power supply operating from AC power outlet (120 VAC/ 60 Hertz nominal), a DC to DC switching power supply operating from accessory outlets typically found in a mobile vehicle type environment (12 VDC nominal) and an external rechargeable battery.
The Invacare Flyer uses a molecular sieve and pressure swing adsorption methodology to produce the oxygen gas output. Ambient air enters the device, is filtered and then compressed. This compressed air is then directed toward one of two nitrogen adsorbing sieve beds. Concentrated oxygen exits the opposite end of the active sieve bed and is directed into an oxygen reservoir where it is delivered to the patient in specific volumes during the inhalation portion of a detected breath.
The basic technology of the Invacare Flyer is equivalent to other approved oxygen concentrators. The principles of operation are equivalent to the noted predicate device.
The provided document is a 510(k) summary for the Invacare Flyer, Model XPO100, an oxygen concentrator. It establishes substantial equivalence to a predicate device, the Inogen One Oxygen Concentrator (K032818). This type of regulatory submission focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than performing de novo clinical studies with acceptance criteria in the way one might for a novel AI/ML device.
Therefore, the following information about acceptance criteria and studies (especially those relating to AI/ML device performance) is not applicable in this context. The "study" here is generally a comparison to a predicate and adherence to recognized standards.
Here's an analysis based on the provided text, addressing the points where information is available or noting its N/A status:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device, "acceptance criteria" are not reported as specific performance metrics with thresholds in the way a diagnostic AI might have. Instead, substantial equivalence is demonstrated through comparative features and adherence to recognized standards. The "reported device performance" is implicitly shown by meeting these standards and having comparable features to the predicate.
| Feature/Standard | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Functional | ||
| Intended Use | Same as predicate (supplemental oxygen for respiratory disorders) | Meets intended use |
| Oxygen Purity | Comparable to predicate ("Approximately 90%") | 87% minimum at all flow rates |
| Flow Rates | Same as predicate (Pulse Flow - 1, 2, 3, 4, 5) | Pulse Flow - 1, 2, 3, 4, 5 |
| Technology | Same as predicate (molecular sieve, pressure swing adsorption) | Molecular sieve, pressure swing adsorption |
| Safety/EMC | Adherence to listed standards | Tested in accordance with listed standards (e.g., IEC 60601-1, IEC 60601-1-2) |
| Physical | Similar to predicate (weight, size) | Weight |
§ 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).