(291 days)
The ZI blower is a single patient reusable device that provides continuous positive airway pressure (CPAP) to support treatment of adults (over 30 kg) with obstructive sleep apnea.
The Z1 Blower provides the patient with a continuous positive airway pressure (CPAP) flow ranging from 4-20 cmH2O above ambient atmospheric pressure. The device consists of a flow generator and data interfaces. It is intended for home use, and for prescription use only. Treatment settings (e.g., air pressure, ramp) are directed by the physician and can be modified by the physician.
Here's an analysis of the provided 510(k) summary for the Z1 Blower, detailing its acceptance criteria and the study that proves it meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (If explicitly stated or inferred) | Reported Device Performance |
|---|---|---|
| Temperature at Patient Port |
§ 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).