(93 days)
The TAGA Velocity™ Passover humidifier is a respiratory positive airway pressure accessory intended to add moisture to the airstream gases for administration to the patient. The humidifier increases the vapor content of the air as it passes through the device (Passover) and is directed by the array of baffles over the surface of a body of water. The humidifier can be used with standard CPAP and or Bi-level Positive Airway Pressure (BiPAP) devices which have a maximum operating pressure of 20 cm H2O, and do not have automatic pressure titration capabilities.
The TAGA Velocity Passover Humidifier is a plastic housing comprised of two (2) halves permanently joined to form an enclosed reservoir. The reservoir has two ports, an inlet and an outlet, on the upper portion, both being 22 mm conical connectors, which allow for the connection of commonly used respiratory CPAP flexible tubing. The inlet and outlet port are clearly identified on the device. The inlet port is typically attached to the pressure generating CPAP unit by means of a short piece (12" to 24") of tubing that is supplied with the humidifier. The air entering the humidifier is directed over the surface of the water in the basin through a series of baffles. The design intent of the baffles shape and placement is to create turbulence in the airflow over the water surface. The baffles also create an eddy effect, which in turn increase the duration that the air is exposed and travels across the surface of the water. The combination of both of these effects maximizes the evaporation process thereby elevating the humidity level of the gas before exiting the device. The air exits the device through the outlet port into a second piece of tubing supplied by the user that is connected the patients' mask.
The humidifier is filled with distilled or sterile water through either the inlet or outlet ports with the unit held in an upright position. The humidifier has a window with markings to allow the user to fill with the appropriate volume. The unit is manufactured out of a transparent plastic that allows the user to visually verify the volume level at all times. The volume of water is sufficient to provide 10 hours minimum use at 70 °F and 25% RH ambient conditions and a patient flow rate of 90 LPM. The humidifier is filled only when removed from the CPAP system.
The humidifier is used in a horizontal position and will act as a base for most marketed CPAP systems. This feature ensures that the water level is below the outlet port on the CPAP system to eliminate the potential hazard of water reaching any CPAP electrical components. The humidifier's moisture gain output exceeds 10mg H2O/L as required by ASTM F1690-96 and ISO 8185:1997. The maximum pressure drop throughout the range of flow rates does not exceed 2kPa per ASTM F1690-96 and ISO 8185:1997.
The Velocity humidifier will be cleaned daily by hand washing with a mild dish washing and warm water solution and weekly by soaking in a 25% vinegar/water solution for 30 minutes, both followed by a clean water rinse.
The TAGA Velocity™ Humidifier has the following acceptance criteria and reported performance:
A multicenter, prospective, clinical study was not mentioned in the provided text. The study proving the device meets its acceptance criteria is based on engineering testing and comparison to standards.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Moisture gain output >= 10 mg H2O/L (as required by ASTM F1690-96 and ISO 8185:1997) | Exceeds 10 mg H2O/L |
| Maximum pressure drop 25% | > 25% |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified in terms of clinical subjects. The testing appears to be primarily engineering-based, conducted on the device itself under controlled conditions.
- Data Provenance: Not explicitly stated as retrospective or prospective. Given the nature of the device (humidifier) and the standards cited (ASTM and ISO), the data likely originated from bench testing and laboratory measurements of the device's performance against defined parameters and environmental conditions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. The "ground truth" for this device appears to be the standards themselves (ASTM and ISO) and direct measurements of the humidifier's physical performance (e.g., moisture output, pressure drop, operating duration). The document does not describe a process involving human expert consensus for establishing ground truth, as would be common for diagnostic imaging devices, for example.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. This device's acceptance is based on meeting technical specifications derived from established standards, not on human interpretation or adjudication of outputs.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is a medical device (humidifier) and not an AI-assisted diagnostic tool for which MRMC studies would typically be conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a hardware device, not an algorithm. Its performance is inherent to its design and function.
7. The type of ground truth used:
The ground truth used consists of established engineering standards and physical measurements. Specifically:
- ASTM F1690-96
- ISO 8185:1997
- Measured physical parameters: moisture gain output, pressure drop, reservoir capacity, relative humidity output, and operating duration under specified environmental conditions.
8. The sample size for the training set:
Not applicable. This device is not an AI/ML product that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. This device is not an AI/ML product that requires a training set.
§ 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).