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510(k) Data Aggregation
K Number
K242063Device Name
LibAirty Airway Clearance System
Manufacturer
Synchrony Medical Ltd.
Date Cleared
2024-12-19
(157 days)
Product Code
BYI, SDS
Regulation Number
868.5665Why did this record match?
Applicant Name (Manufacturer) :
Synchrony Medical Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LibAirty Airway Clearance System is intended to provide airway clearance therapy and promote bronchial drainage when external manipulation of the thorax is the physician's choice of treatment. It is indicated for patients having difficulty with secretion clearance, or the presence of atelectasis caused by mucus plugging.
The LibAirty Airway Clearance System is intended for hospital, home, and clinic use.
Device Description
The LibAirty Airway Clearance System is designed to assist in the loosening and elimination of mucus from the lungs. It consists of a vest with inflatable chambers, connected to a control unit (equipped with an air compressor) that inflates and deflates the vest in a pre-defined cycle, and a mobile application.
The LibAirty Airway Clearance System was designed to provide airway clearance therapy when external manipulation of the thorax is the physician's choice or treatment, while using an inflatable vest connected to an air supply unit.
The LibAirty Airway Clearance System is designed to promote breathing at different volumes, as the inflatable vest applies oscillating pressure on the chest and back, to augment peripheral and tracheal mucus movement towards the airway opening. The system's mode of operation is inspired by the principles of the Autogenic Drainage (AD) airway clearance technique, in which adjusting the depth and location of lung volumes during respiration generates shearing forces induced by airflow which loosen, mobilize, and move secretions (i.e., mucus) from the peripheral towards the central airways. Once the mucus reaches the larger airways, it can be expelled through coughing.
The LibAirty™ Airway Clearance System is a mobile, non-sterile, single patient use device, operated by mains power supply only.
The LibAirty™ Airway Clearance System consists of:
- . A control unit equipped with an air compressor that delivers air at regulated pressures to the vest and includes a display screen and operation buttons allowing the user to adjust therapy settings and manage device operation.
- . An inflatable vest (available in different sizes) that is fastened around the chest and consists of several air chambers.
- . A hose bundle that transfers the air from the control unit to the vest's chambers.
- . A Mobile Application (App) that is used to operate the system and provide instructions.
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