(201 days)
The "AERO PEP™ combination Valved Holding Chamber (VHC) and Positive Expiratory Pressure (PEP) device can be used as a PEP device alone or in conjunction with the r roosal of aerosolized medication from a pressurized metered dose inhaler (pMDI) as prescribed by a physician or health care provider .
AeroPEP™ combination Valved Holding Chamber (VHC) and Positive Expiratory Pressure (PEP) device
I am sorry, but the provided text does not contain information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. This document is a clearance letter from the FDA regarding a 510(k) premarket notification for a medical device called AeroPEP™. It establishes substantial equivalence to a predicate device and provides regulatory information, but it does not include the specifics of performance testing or clinical studies.
§ 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).