LifeVac LLC has announced that the U.S. Food and Drug Administration has granted De Novo classification for its LifeVac device under 21 CFR 874.5400.
The decision establishes a new medical device category described as a “suction anti-choking device” designed for use as a second-line treatment.
Under this order, LifeVac is classified as a Class II medical device. The FDA defines this type of device as one that uses suction to help remove an obstruction in a choking victim with a completely blocked airway.
It is intended to be used in emergency situations only after standard basic life support choking procedures have been attempted without success.
The approved indications state that LifeVac is a non-powered, non-invasive airway clearance device designed for single use.
It may be used for both adults and children aged one year and above. The device can be used by either trained medical personnel or adults aged 18 and over who are not healthcare professionals.
The device is intended for use in various locations, including homes, care facilities, restaurants and schools.
The FDA concluded that the Class II classification, together with required safety and performance controls, provides reasonable assurance that the device is safe and effective for its intended purpose.
The De Novo decision also creates a regulatory pathway for suction-based anti-choking devices that are used after standard choking response methods fail. Following the order, LifeVac is permitted to market the device in accordance with the conditions and controls specified by the FDA.
