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Nasal-Aire is intended for use as an accessory to respiratory ventilators. Ventilation is indicated for patients who require mechanical assistance with breathing.

Nasal Aire is an accessory to positive pressure ventilation devices (e.g. CPAP, Bi-level). It may also be used in respiratory insufficiencies if the patient can tolerate the excess dead space.

The Nasal-Aire cannot exhaust exhaled air therefore this device must be used with a ventilator that contains an active exhalation valve or with an intentional leak port added into the breathing circuit

Nasal-Aire is a nasal insert with attached tubing for connection with non-continuous ventilation devices. The simplicity of the Nasal-Aire design allows easy manipulation of the device. Soft, pliable silicone is used for the nasal insert portion of the device facilitates a comfortable fit of the device when in use.

The Nasal-Aire accessory and associated tubing is intended for use in delivering ventilation to patients. The device consists of a hollow silicone elastomer under nose strip with molded nasal insert sleeves made from silicone elastomer. The under nose strip is fitted bilaterally with 3/8" Tygon® tubing which serves as conduits for ventilation. The tubing is joined to form a single ventilation conduit by a silicone elastomer "Y" coupling. The system is completed by the "Y" coupling connected to an adapter for connection to the main ventilators supply line. When the device is worn by the patient the under nose strip is positioned across the patient's upper lip and the silicone nasal inserts are inserted in the patient's nares. The tubing drapes over the patient's ears in the manner of standard nasal cannulae used for administering oxygen with the "Y" coupling positioned in front of the patient.

This document describes the Nasal-Aire™ ventilator accessory and its clearance through the 510(k) process, which relies on demonstrating substantial equivalence to a predicate device. It does not contain an acceptance criteria table with reported device performance in the way one would typically see for an AI/ML device or a device requiring specific performance metrics against a defined standard.

Instead, the performance evaluation for this medical device focuses on safety and functionality sufficient to demonstrate equivalence for its intended use as a ventilator accessory.

Here's an attempt to extract and infer the requested information based on the provided text, acknowledging that many fields will be "Not Applicable" or "Not Provided" given the nature of a 1999 510(k) summary for a ventilator accessory.

Acceptance Criteria and Study for Nasal-Aire™ Ventilator Accessory

1. Table of Acceptance Criteria and Reported Device Performance:

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