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AG 100s 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.

The AG100s system is comprised of the following main components:

• The AG100s control unit
• The AnapnoGuard connection kit/harness (AG Connection Kit) connecting a cuffed airway to the AG100s control unit.
• The AnapnoGuard endotracheal tube (ETT) or another FDA cleared cuffed Airway.
• Accessories: including cart, secretions canister (Trap Bottle), ● rinsing fluid (saline) bag and antibacterial air filter.

AG100s, 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.

The provided text describes the Hospitech Respiration Ltd. AG100s device, an airway management system. The document is a 510(k) premarket notification to the FDA, asserting substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria and reported device performance from a test set. Instead, it compares the characteristics of the AG100s system to its predicate device, the AnapnoGuard 100 System (K150157). The "Comparison" column in the table on pages 6-7 serves to highlight similarities and differences, and performance tests are mentioned to support substantial equivalence where differences exist.

Below is a summary of the performance-related comparison provided in the document:

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