(203 days)
The Hi-Ox® High FiO2 Mask with the Aerosol Adapter is intended as an accessory for compatible nebulizers. The mask with adaptor is intended to enable the delivery of nebulized drugs to patients who also require elevated inspired oxygen concentrations.
The Aerosol Adapter for the Hi-Ox® is an adapter that enables standard small-volume nebulizers (use only cup type, gas driven nebulizers without tee-fittings or air entrainment ports) with either 18 mm OD or 22 mm ID outlet ports to be adapted to the Hi-Ox®. This will enable patients to be treated with nebulized products while receiving high concentrations of oxygen at moderate flow rates of 8 -10 lpm. The valves in the Hi-Ox® have been tested and found to function normally after nebulization of some commonly nebulized drugs in aqueous formulations. However, the valves could malfunction if the prescribed drug creates a sticky residue on the valves. The practitioner should observe the patient's respiration and the function of the Hi-Ox valves during and after nebulization of drugs via the Hi-Ox80. The Aerosol Adapter is a simple right angle fitting made of Santoprene, a medical grade thermoplastic elastomer material. The adapter can be snapped into a normally plugged port on the Hi-Ox® just below the mask and between the inhalation-exhalation valves. This location for the adapter places nothing between the nebulizer and the patient's airway so as to not impact any of the particles produced by the nebulizer. The qas driving the nebulizer can supplement the normal oxygen supply for the Hi-Ox®, and any flow in excess of what is required by the patient can exit the mask via the normal exhalation pathway. There is no risk of pressure buildup beyond that of the cracking pressure and flow resistance of the exhalation valve (~ 1 cmH2O/L/sec). This enables the patient to receive their nebulizer treatments while maintaining an elevated FiO2.
This document describes the Hi-Ox® High FiO2 Oxygen Mask with the Aerosol Adapter, a Class II medical device. The information provided focuses on its safety and effectiveness, leading to its clearance by the FDA. As such, the "study" referenced in the prompt may not be a traditional clinical trial but rather a series of non-clinical tests and a comparison to predicate devices, which is common for 510(k) clearances.
Here's the breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present acceptance criteria in a table format with corresponding device performance metrics. Instead, it describes a "design target" for flow resistance and the results of nebulization tests.
| Acceptance Criteria (Design Target) | Reported Device Performance |
|---|---|
| Flow resistance |
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).