Airway Clearance System (K031876) Phase IV Device Efficacy

Phase IV interventional study, of participants with cystic fibrosis with mild, moderate or
severe conditions, for the efficacy of the Electro Flo Percussor, Model 5000 (K031876),
Regulation Number: 21 CFR 868.5665, with current FDA indication of: provide airway clearance
therapy when external manipulation of the thorax is the physician's choice of treatment.
Indications for this form of therapy are described by the American Association for
Respiratory Care (AARC) in the Clinical Practices Guidelines for Postural Drainage Therapy (
I ) (1991). According to AARC guidelines, specific indications for external manipulation of
the thorax include evidence or a suggestion of retained secretions, evidence that the patient
is having difficulty with the secretion clearance, or presence of atelectasis caused by mucus
plugging. In addition, the Med Systems Electro Flo Percussor Model 5000 is also indicated for
external manipulation of the thorax to promote airway clearance or improve bronchial drainage
for purposes of collecting mucus for diagnostic evaluation.

Inclusion Criteria:

- Previously diagnosed with cystic fibrosis (mild, moderate or severe)

- Prescribed (licensed medical provider) airway clearance device/system for at home,
self-treatment for airway clearance

- Physically able to perform self-treatment or treatment by an at home medical provider

Exclusion Criteria:

- History of tobacco use

- History of excessive alcohol consumption, more than 2 drinks per day, 10 per week

- Any other medical condition that would preclude use of an airway clearance device

- Previously diagnosed with major cardiological disease