(89 days)
The PrimeAire is an accessory device for use with a metered dose inhaler (MDI) canister and nozzle/mouthpiece provided by the MDI drug manufacturer. It is designed to be used with virtually all MDI nozzles/mouthpieces. The PrimeAire is a dual-valved holding chamber. It is a non-sterile device for single-patient use,
The PrimeAire is a dual-valved holding chamber. It is a non-sterile device for single-patient use.
This document is a 510(k) premarket notification from the FDA regarding the "PrimeAire" device. It is a letter confirming that the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria. The document is a regulatory approval letter, not a performance study report.
Therefore, I cannot provide the requested information based on the input.
To answer your request, I would need a document that describes the design verification and validation testing for the PrimeAire device, including its performance characteristics and the studies conducted to demonstrate its safety and effectiveness.
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).