Search Results

AnapnoGuard 100 Respiratory Guard System is intended for airway management by oral/nasal intubation while providing continuous endotracheal cuff pressure control using non-invasive measurement and monitoring of carbon dioxide concentration in the subglottic space and evacuation of secretions from above the endotracheal tube's cuff.

AnapnoGuard 100 Respiratory Guard System is comprised of the following three main components: The AnapnoGuard endotracheal tube (ETT) with inflatable cuff (FDA cleared under K093126). The AnapnoGuard 100 Respiratory Guard System interconnection harness of tubes, connecting the ETT to the AnapnoGuard 100 control unit The AnapnoGuard 100 Respiratory Guard System control unit which consists of the following main modules: Host computer (PC) Microcontroller (MCU) Suction module (regulator and flow potency meter): including . a set of valves and pipes controlling the secretions suction/evacuation from above the ETT cuff. Rinsing module: Pumps saline to rinse the Suction and Vent/ ● CO2 lumens. CO2 analyzer module: including CO2 analyzer assembly, ● pump, valve and flow filter which sucks air from the subglottic space above the ETT cuff into the CO2 analyzer. . Cuff pressure module: includes two pressure gauges which monitor cuff pressure, a miniature air pump and two valves. Pneumatic module: valves, pipes and filters . Connectors panel for connecting the interconnection harness . (ETT), vacuum, trap bottle, rinsing fluid and filters. Operation buttons panel and navigation wheel . I/O communication panel . Display monitor . AnapnoGuard 100 Respiratory Guard System, including its three components monitors leak between the endotracheal tube's cuff and the trachea by measuring the Carbon Dioxide levels in the subglottic area above the cuff through a dedicated lumen in the endotracheal tube. Detection of a high level of Carbon Dioxide is an objective indicator for a leak (improper sealing of the trachea by the endotracheal tube cuff). The system continuously monitors and adjusts the cuff pressure to prevent a leak at minimum possible pressure (all within pressure limits preset by the user). Preventing a leak reduces the likelihood of aspiration of secretions from the upper airways into the lungs and increases the likelihood for no loss of ventilation and delivery of anesthetic and nebulized drugs into the lungs. Keeping the cuff pressure as low as possible reduces the mechanical pressure of the cuff on the tracheal tissue throughout the intubation period. The system also performs evacuation of secretions from above the endotracheal tube's cuff through a dedicated lumen at the dorsal side of the endotracheal tube.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The document describes several performance criteria derived from a comparison with predicate devices and specific performance bench tests. The clinical study primarily focuses on the effectiveness of the AnapnoGuard 100 Respiratory Guard System in optimizing cuff pressure and reducing CO2 leakage.

Table 1: Acceptance Criteria and Reported Device Performance

Ask a specific question about this device