(130 days)
The continuous positive airway pressure (CPAP) System is indicated for the treatment of obstructive sleep apnea (OSA) in patients > 661b (30 kg). The Breathe CPAP System is intended for single-patient re-use in the home environment.
The Breathe Technologies™ CPAP system is an AC powered Continuous Positive Airway Pressure (CPAP) device that delivers a physician prescribed pressure during the inspiratory phase and expiratory phases to help maintain airway patency during sleep for patients with obstructive sleep apnea (OSA). The Breathe CPAP System consists of a programmable, microprocessor controlled, flow generator (i.e., blower) and a Nasal Pillows Mask. The flow generator generates CPAP from room air to the patient and transmits it via the attached Nasal Pillows Mask. The end of the patient circuit is a nasal pillows interface which is worn on the nose. The nasal interface is held in place with standard headgear.
The provided text is a 510(k) summary for a CPAP system and does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The document states that the device is "substantially equivalent" to a predicate device based on its intended use, indications for use, technology, design, materials, physician or patient use, and energy source. It also mentions that "the testing described below demonstrates that the differences in the devices do not raise any unresolved issues of safety or efficacy." However, the actual testing details, acceptance criteria, and specific performance results are not provided in the extracted text.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide the requested information about sample sizes, ground truth establishment, or comparative effectiveness studies. The primary focus of this document is establishing substantial equivalence to a predicate device and adherence to general medical device standards.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).