(462 days)
The Respironics Humidifier is intended to add vapor phase moisture to the airstream provided to the patient by the Respironics BiPAP or CPAP systems. The Humidifier is a "passover" style which increases moisture content of the airstream by allowing the airstream to pass over a tray of water by evaporation into the airstream.
The Respironics passover Humidifier is intended to be connected between the outlet port of the Bi-level or CPAP system and the tubing which goes to the patient. Small sections of patient tubing are included with the humidifier to allow the patient to connect the humidifier to the BiPAP. The Humidifier consists of a transparent plastic storage tank with appropriate 22 mm OD connector ports to allow connection of the patient tubing and the BiPAP of CPAP connector tubing. The transparent structure allows the user to monitor the water level in the humidifier also has appropriate markings to allow the user to determine fill levels. A large opening in the center is designed to allow easy illian and cleaning of the humidifier. The Humidifier has been designed to increase the relative humidity of the airstream being supplied to the patient. The unit is designed to have a minimum 8 hours capacity of water when operated at 00% and 25 % relative humidity, and a nominal patient air flow of 30 LPM . Humidfier has a capacity of approximately 25 ml. of water. An optional stand is available for the Humidifier which allows the Humidifier to be mounted beneath the BiPAP or CPAP systems.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Respironics Humidifier, formatted to address your specific points:
Acceptance Criteria and Device Performance for Respironics Humidifier
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Component | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Moisture Capacity | Minimum 8 hours capacity of water when operated at 10% and 25% relative humidity and a nominal patient airflow of 30 LPM. | Humidifier has a capacity of approximately 25 ml of water. (Implied to meet the 8-hour duration, as this is the design capacity). |
| Relative Humidity (RH) Increase (at 30 LPM flow) | Not explicitly stated as a numerical target, but "designed to increase the relative humidity." | Greater changes in relative humidity were found at 30 LPM. (Specific values are presented in the graph but not directly tabulated as criteria/performance in text). |
| Relative Humidity (RH) Increase (at 80 LPM flow) | Not explicitly stated as a numerical target. | Greater changes in relative humidity were found at 80 LPM. (Specific values are presented in the graph but not directly tabulated as criteria/performance in text). |
| Impact Resistance | Satisfactorily withstand a drop from 30" height onto concrete flooring without significantly affecting performance. | Humidifier can satisfactorily withstand a drop from 30" height onto concrete flooring without significantly affecting its performance. |
| Bacterial Reduction (Vinegar Decontamination) | Achieves bacterial reduction for low-level decontamination. | From 1.7 x 10^6 ml to 2.7 / ml bacterial concentration. (Significant reduction) |
| Bacterial Reduction (Quaternary Ammonia Decontamination) | Consistent with guidelines for low-level decontamination as published in the American Journal of Infection Control. | Levels of decontamination achievable are consistent with guidelines for low level decontamination as published in the American Journal of Infection Control. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not explicitly stated for any of the tests. For example, the number of humidifiers dropped for impact testing, or the number of bacteria samples taken for decontamination tests, is not mentioned.
- Data Provenance: The data appears to be prospective testing conducted by the manufacturer, Respironics Inc., specifically for this device (i.e., in-house testing). The country of origin of the data is implied to be the United States (Murrysville, Pa. location).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not applicable. This document describes engineering performance tests and decontamination efficacy tests, not evaluations that require expert consensus on subjective interpretations (like medical image analysis). Ground truth for these tests is based on objective measurements (e.g., humidity sensors, bacterial counts, physical drop tests).
4. Adjudication Method for the Test Set
- Not applicable. As per point 3, the ground truth is based on objective measurements, not expert consensus requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. This is not a diagnostic device or an AI-assisted device requiring a comparison of human readers with and without AI assistance. The study focuses on the physical and performance characteristics of a medical humidifier.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Not applicable. This device is a mechanical humidifier, not an algorithm or AI system.
7. The Type of Ground Truth Used
- The ground truth for the various tests is based on objective physical and microbiological measurements:
- Moisture Capacity/RH Increase: Measured using instruments that quantify relative humidity and airflow.
- Impact Resistance: Observed physical integrity and functional performance after a controlled drop.
- Bacterial Reduction: Laboratory-measured bacterial concentrations before and after decontamination procedures.
8. The Sample Size for the Training Set
- Not applicable. This is not a machine learning or AI device that requires a training set. The descriptions relate to the physical design, testing, and performance validation of a mechanical device.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As per point 8, there is no training set for this type of device.
§ 868.5450 Respiratory gas humidifier.
(a)
Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.(b)
Classification. Class II (performance standards).