(247 days)
The new intended use of this product is to assist the patient in the coordination of breathing during nebulization treatments via hooking the device up with medication delivery systems. i.e., metered dose inhalers, electronic nebulization therapy. It is to be used in addition to and not in place of the delivery device provided by the manufacturer.
The Breather (Inspiratory/Expiratory Muscle Trainer)
I am sorry, but based on the provided document, there is no information available regarding the acceptance criteria, study details, or performance of "The Breather (Inspiratory/Expiratory Muscle Trainer)".
The document is a US FDA 510(k) clearance letter for the device, indicating that it has been found substantially equivalent to a predicate device. It specifies the regulatory class, product code, and a new intended use for the device (to assist in breathing coordination during nebulization treatments). However, it does not include any performance data, study results, or specific acceptance criteria for the device itself.
Therefore, I cannot provide the requested table and study details based on the given text.
§ 868.5690 Incentive spirometer.
(a)
Identification. An incentive spirometer is a device that indicates a patient's breathing volume or flow and that provides an incentive to the patient to improve his or her ventilation.(b)
Classification. Class II (performance standards).