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The Model 9054 RPM AutoAdjust CPAP is intended for use in treating obstructive sleep apnea in patients 30 Kg and above.

The DeVilbiss Model 9054 AutoAdjust CPAP is intended for use in treating OSA in spontaneously breathing patients 30 Kg and above by means of application of positive air pressure. The device is to be used in home and clinical environments.

The new DeVilbiss Mode! 9054 AutoAdjust CPAP is an AC powered blower designed to be used in providing CPAP therapy to the spontaneously breathing (>30kg) patient population with Obstructive Sleep Apnea. The benefit of autoadjusting technology is that it reacts to obstructive events, i.e. apnea, hyponnea. and snoring, by increasing and decreasing pressures as needed, rather than providing a constant level of continuous positive airway pressure. Auto-adjusting units are used over conventional CPAP units due to high pressures, positional or REM related sleep apnea and/or patient intolerance to continuous pressure. Pressure regulation is achieved by monitoring a pressure and flow transducer in the patient air stream. The net result of the compensation activities is a motor control signal that produces a pressure change that closely maintains the prescribed or required patient pressures during patient respiratory activities, environmental conditions, and moderate system leak conditions. The operating software monitors the flow transducer signal to detect fluctuations in the patient system flow, caused by patient inhalation and exhalation. The operating software in the device analyzes the patient flow signal during device operation in order to detect patient respiratory events such as apneas, hypopneas, mixed apneas, snoring, and exhale puffing. These respiratory events are defined by programmable settings. In AutoAdjust mode the pressure adjustment algorithm evaluates these respiratory events and makes pressure adjustments in response. The output pressure is increased when a series of events is detected. Events that cause a pressure increase are apneas, hypopneas and snoring. Events scored as mixed do not cause a pressure increase. The pressure is decreased on a regular timed interval.

Electrical power is supplied to the unit using an AC line cord (100 - 240 VAC. 50/60Hz, 400 Hz). The AC input voltage is converted to a DC voltage by an internal switch-mode power supply. The DC voltage is used to power the internal electronics of the product (microcontroller, motor control circuitry, blower, LCD display, etc.). Positive pressure is produced by spinning a reverse-curved impeller with a brushless DC motor. Room air is drawn into the blower through a filter, pressurized in the blower, and then discharged through a 22 mm ID tube.

I am sorry, but the provided text does not contain the acceptance criteria or a study proving the device meets said criteria. The document is a 510(k) premarket notification for a medical device (DeVilbiss Model 9054 RPM AutoAdjust CPAP), which focuses on demonstrating substantial equivalence to legally marketed predicate devices.

It discusses the device's intended use, a general description of its function, and states that it is equivalent in function and indications for use to other existing devices. However, it does not explicitly define acceptance criteria (e.g., specific performance metrics with numerical targets) or report the results of a study designed to demonstrate the device's performance against such criteria.

Therefore, I cannot provide the requested table or detailed study information.

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