LibAirty Airway Clearance System

The LibAirty Airway Clearance System is a wearable inflatable vest connected to a control unit with an air compressor that provides airway clearance therapy by applying oscillating pressure to the chest and back. It is intended for hospital, home, and clinic use in adult patients with difficulty clearing secretions or atelectasis caused by mucus plugging.

The LibAirty uses an inflatable vest with six air chambers filled by an air compressor (versus the predicate's air generator), operates via mobile app with Bluetooth control, has seven preset pressure levels with adjustable treatment parameters, and produces up to 65 dBA of acoustic energy. It weighs 4.5 kg for the control unit and measures 198 × 340 × 240 mm, compared to the predicate's 8 kg air generator and 241 × 330 × 241 mm dimensions.

IEC 60601-1, IEC 60601-1-11 (home healthcare environment), IEC 60601-1-2 (electromagnetic compatibility), IEC TS 60601-4-2 (electromagnetic immunity), IEEE ANSI C63.27 (wireless coexistence), IEC 62304 (software/firmware cybersecurity), and FDA Human Factors guidance (February 3, 2016).

Both devices perform external chest wall manipulation for airway clearance using an inflatable vest connected to an air supply, have identical intended use and indications, and are both powered AC/DC devices for hospital, home, and clinic use. Although the LibAirty uses Autogenic Drainage technique versus the predicate's high-frequency oscillation, a comparative clinical study in bronchiectasis patients demonstrated the LibAirty achieved superior sputum clearance (mean difference 3.312 grams, p < 0.0001) with no serious adverse events, establishing both non-inferiority and superiority. Minor differences in weight, dimensions, acoustic energy, and control mechanism do not raise new safety or effectiveness concerns.