(75 days)
The DeVilbiss Heated Humidifier System, consisting of the 9100D DeVilbiss CPAP Humidifier and the 9200 DeVilbiss Humidifier Heater, is to be used in conjunction with most positive airway pressure devices that require humidity to be added to the circuitry.
The DeVilbiss Heated Humidifier System is not intended to be used with auto-adjusting CPAP devices unless the labeling for the CPAP machine states that the CPAP machine will function in autoset mode when used with the 9200 heated humidifier system. The heated humidifier system may adversely affect the operation of certain CPAP machines that have automated pressure setting.
The DeVilbiss Heated Humidifier System is for use in the home environment and is to be used only on the order of a physician. The humidifier can be used with CPAP and Bilevel devices, which have a maximum operating pressure of 20 cm H20. The humidifier can also be used with noninvasive ventilation devices that have a maximum operating pressure of 40 cmH20.
Model 9200D Heated Humidifier
The provided text is a 510(k) premarket notification letter from the FDA to Sunrise Medical HHG, Inc. regarding the DeVilbiss Model 9200D Heated Humidifier. It does not contain information about acceptance criteria, device performance, or details of a study that proves the device meets specific criteria for an AI/ML device.
The document is a regulatory approval letter stating that the device is "substantially equivalent" to legally marketed predicate devices. It discusses the device's indications for use and regulatory classification, but not performance metrics or study designs for validating AI/ML software.
Therefore, I cannot provide the requested information based on the given text. The text does not describe an AI/ML device or its associated studies and acceptance criteria.
§ 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).