Search Results

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.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a sample size for a "test set" in the context of human subjects or a clinical study. The tests described are non-clinical, focusing on device mechanics and material compatibility.

The data provenance is from non-clinical tests conducted by SensorMedics Corporation. There is no mention of country of origin for any human data, as no human data is presented for performance testing. All data is retrospective to the submission date of December 9, 2003.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as the document describes non-clinical engineering and material compatibility tests, not evaluations by medical experts to establish ground truth from patient data.

4. Adjudication Method for the Test Set

This information is not applicable as there is no human-based test set or ground truth requiring adjudication described. The tests are laboratory-based measurements and observations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not done. The device is an accessory to an oxygen mask and nebulizer, and the evaluation focuses on its mechanical performance and compatibility rather than its impact on diagnostic interpretation or a human reader's performance.

6. Standalone (Algorithm Only) Performance Study

This information is not applicable. The device is a physical medical accessory, not a software algorithm. Therefore, "standalone" algorithm performance is not a relevant concept for this device.

7. Type of Ground Truth Used

The "ground truth" for the tests described is based on the physical characteristics and performance of the device itself as measured in a laboratory setting. This includes:

• Measured flow resistance of the one-way valves.
• Observed functionality of the valves after exposure to nebulized pharmaceutical solutions.

8. Sample Size for the Training Set

This information is not applicable as no "training set" for an algorithm or a clinical study is described. The device is a physical product, not an AI or machine learning system.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as #8. No training set or associated ground truth establishment process for a training set is mentioned.

Ask a specific question about this device