(99 days)
The Transcend Auto provides positive airway pressure for treatment of obstructive sleep apnea (OSA) in adults weighing over 66 pounds (30 kg). The device is intended for home and hospital/institutional use.
The Transcend Auto is a microprocessor-controlled, blower-based system that generates positive airway pressure to support treatment of obstructive sleep apnea. It utilizes a differential pressure sensor connected to an internal pneumotach positioned in the airstream to determine flow levels. This flow signal, coupled with pressure sensing, is used to monitor breathing and adjust pressure. When interfaced with a mask, the system provides pressure from 4 to 20 cmHzO above the ambient atmospheric pressure to a patient's oral/nasal airway.
Here's a breakdown of the acceptance criteria and study information for the Transcend Auto device, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Criteria (Predicate Device) | Reported Device Performance (Transcend Auto) |
|---|---|---|
| Pneumatic Performance: | ||
| Therapy Pressure (cm H2O) | 4-20 | 4-20 |
| Pressure Regulation | Transcend CPAP: ±1 cm H2O or 10%, whichever is greater | |
| REMstar Auto CPAP: |
§ 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).