QXN · Suction Anti-Choking Device As A Second-Line Treatment

Ear, Nose, Throat · 21 CFR 874.5400 · Class 2

Overview

Identification

The LifeVac is a non-powered, non-invasive, single-use-only airway clearance device intended to resolve choking in a victim with a complete airway obstruction when a current choking protocol has been followed without success. It is intended for use on adult or pediatric choking victims who are at least 1 year of age and can be administered by a lay person or a medical professional (18 years or older) in various settings including at home or nursing homes, restaurants, schools, and other outside environments.

Classification Rationale

FDA has determined that the device can be classified in Class II with the establishment of special controls for Class II. FDA believes that Class II (special) controls provide reasonable assurance of the safety and effectiveness of the device type.

Special Controls

In combination with the general controls of the FD&C Act, the suction anti-choking device as a second-line treatment is subject to the following special controls: (1) Premarket clinical information, or a combination of premarket clinical information and postmarket surveillance (in accordance with special control (2)), must demonstrate, in the intended patient population: (i) How often the device is used consistent with anticipated conditions of use, including how often the device is used after unsuccessful use of a BLS choking protocol and how often the device is used on patients experiencing a complete airway obstruction; (ii) The delay in initiating a BLS choking protocol due to use of the device; (iii) The rate of successful device use to resolve choking; and (iv) The adverse event profile of the device, including injuries and device malfunctions. (2) Information obtained from postmarket surveillance must demonstrate the information described in special control (1)(i)-(iv), in consideration of the premarket information obtained in accordance with special control (1), unless FDA determines, based on the totality of the premarket information, that information from postmarket surveillance is not required for such demonstration. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA for such demonstration (in consideration of the premarket information obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on postmarket surveillance progress and outcomes. (3) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including the following: (i) Verification of device performance in dislodging a complete obstruction in representative simulated airway models; (ii) Verification of pressures generated; and (iii) Verification of device and material durability. (4) The patient/user-contacting components of the device must be demonstrated to be biocompatible. (5) Human factors testing must demonstrate that the device can be used as intended based on the device user interface and directions for use. (6) Training must be included with sufficient educational elements so that upon training completion, the user can correctly use the device, including identification of a complete airway obstruction and performance of a BLS choking protocol. (7) Labeling must include the following: (i) Instructions to use the device only in the event of complete airway obstruction and after a BLS choking protocol fails; (ii) Description and access to the training required in special control (6); and (iii) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.

Recent Cleared Devices (1 of 1)

Top Applicants

• Lifevac, LLC — 1 clearance