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The 'Transcend 365 miniCPAP Auto System' provides positive airway pressure to support treatment of adults over 66 pounds (30 kg) with Obstructive Sleep Apnea (OSA). The device is intended for home and hospital/institutional use. The integrated humidifier provides humidification of air delivered from the Transcend 365 devices. The use of the humidifier is optional.

The Transcend 365 miniCPAP Auto System (Transcend 365) is a new member of Somnetics' family of devices used to treat obstructive sleep apnea which includes the Transcend Auto and Transcend Heated Humidifier devices and accessories cleared via K132127 and K131388. The Transcend 365 utilizes the same blower and the same algorithm as the Transcend Auto for respiratory event detection and therapy for sleep disordered breathing events. The Transcend 365 includes the following main modifications: - Integrated CPAP and humidification system . - . Modifications from predicate Transcend Auto device - Graphic LCD interface vs LED in predicate o - Housing design O - Updated air inlet filter o - Use of a standard 22-mm connection port for air hose attachment O - Integrated heated humidifier with water reservoir attached with magnets o - Integrated humidifier uses Capillary Force Vaporization™ (Vapore) technology ● - o Wick to a ceramic heater vaporizes water (instead of continuous heating with a heater plate) - Similar to PARI Hydrate V (K072982); same supplier (Vapore) o - Allows for a smaller water reservoir and footprint o The Transcend 365 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. When interfaced with a mask though use of a 22 mm breathing hose, this flow signal, coupled with pressure sensing, is used to monitor breathing and adjust pressure. The system provides fixed or auto-adjust pressure from 4 to 20 cmH20 above the ambient atmospheric pressure to a patient's oral/nasal airway. The humidifier uses Capillary Force Vaporization technology similar to that used in the PARI Hydrate V (Humidifier, Respiratory Gas (Direct Patient Interface); 868.5450, Product Code BTT) cleared under K072982. Water is drawn from a reservoir by a wick to a ceramic heater, which vaporizes the water resulting in comparable humidification output to the predicate devices. There is no heater plate and the water reservoir is not heated. Several humidification levels are available, with higher settings increasing the amount of water vapor. The humidifier is attached to the lower portion of the PAP through the use of magnets. It includes the following components and accessories, which are all single patient reusable: - . Filter Media - P10 Battery ● - Transcend 365 miniCPAP Unit . - USB cable* ● - Heater Cartridge . - Wick - Reservoir . - Power supply PSA3 ● - US 2-prong power cord

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.

The Transcend Heated Humidifier is indicated for the humidification of the air delivered from a compatible Transcend positive airway pressure therapy device. The Humidifier is intended for single patient re-use in the home environment and in a hospital/institutional environment. The Humidifier is for use only as recommended by a physician.

The Transcend Heated Humidifier is a humidifier that is designed to humidify the air delivered to the airway during positive airway pressure (PAP) therapy with a compatible Transcend PAP device.