(278 days)
The Silenzio Delta is intended for the treatment of Obstructive Sleep Apnea (OSA) in adult patients 30 kg and over.
Silenzio Delta has three modes of operation. In CPAP mode,treatment is carried out by applying a continuous positive airway pressure through a nasal mask. In the BPAP mode, the pressure during expiration is lower than during inspiration, as prescribed by the physician. In a third mode, a minimum breathing rate can be set between 0 to 25 BrPM. The operation is identical as in BPAP mode, but if the patient fails to make an inspiratory effort within the interval set by the minimum BrPM control, the device will cycle to the pressure support level to deliver the breath to the patient based on the minimum BrPM setting.
The Silenzio Delta can be used to administer oxygen by using external oxygen tank and bleeding oxygen into the patient circuit. This therapy is not metered or otherwise regulated. Patient monitoring must be performed to ensure effective administration of oxygen therapy.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding the Silenzio Delta Continuous Positive Airway Pressure System. It does not contain information about acceptance criteria, device performance studies, or details relevant to the specific questions posed.
The letter primarily:
- Confirms the device has been reviewed and determined to be "substantially equivalent" to legally marketed predicate devices.
- Outlines general regulatory requirements for the device.
- Provides contact information for further regulatory inquiries.
- Includes the "Indications For Use" for the device, describing its intended purpose and modes of operation.
Therefore, I cannot answer the questions regarding acceptance criteria and the study that proves the device meets them based on the provided text. The requested information would typically be found in a more detailed technical submission or clinical study report, which is not part of this FDA letter.
§ 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).