(181 days)
The Model 7410 series CPAP system is a device that is intended to provide continuous positive airway pressure to adults who experience obstructive sleep apnea (OSA). The device will automatically adjust and maintain airway pressure based on the continuing needs of the patient. The device may be used in either the home or hospital environment.
Model 7410 Series CPAP System
I am sorry, but the provided text is a 510(k) clearance letter from the FDA to Healthdyne Technologies for their Model 7410 Voyager CPAP System. It states that the device is substantially equivalent to a legally marketed predicate device.
This document does not contain information about the acceptance criteria and the study details (like sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set details) that would prove the device meets specific performance criteria. It primarily focuses on regulatory clearance based on substantial equivalence.
§ 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).