(191 days)
The Z1 CPAP System is a single patient reusable device that provides continuous positive airway pressure (CPAP) to support treatment of adults weighing over 66 lbs (30 kg) with obstructive sleep apnea.
The Z1 CPAP System provides continuous positive pressure to support the treatment of adults over 66 lbs (30 kg) with obstructive sleep apnea. The device is a non-critical care, reusable, single patient device for use in the home setting, and it is intended to be a prescription use only device. The Z1 CPAP System is a modified version of the Z1 Blower cleared in K121374. The modifications include: addition of an optional battery, addition of an APAP mode, addition of Bluetooth and a mobile app, addition of new user settings, and changes to firmware.
The provided document describes the Z1 CPAP System and its substantial equivalence to predicate devices, focusing on performance testing rather than clinical studies with human subjects. Therefore, some of the requested information, such as sample sizes for test and training sets, number of experts for ground truth, adjudication methods, or MRMC studies, are not applicable in this context.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Z1 CPAP System are primarily based on equivalence to predicate devices and adherence to established performance standards.
| Acceptance Criteria Category (Derived from document) | Z1 CPAP System Performance/Compliance |
|---|---|
| General Performance Characteristics | |
| Max Temperature at patient connection 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).