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The myAir app is indicated for patients: - prescribed with a compatible ResMed Air11 platform device to simulate therapy prior to using their device with their prescribed settings, and to configure their settings to support therapy. It is an optional software accessory to allow patients to acclimate to and operate their therapy device. - prescribed a NightOwl wearable device to provide the user interface to operate the connected device and aid in the home sleep testing process. The device is intended for home and hospital use for: - new and existing patients of ResMed Air10 and Air11 PAP therapy devices and - new users who are prescribed a compatible NightOwl home sleep test (HST).

myAir is a companion mobile medical application ("app") that serves as a patient self-monitoring, therapy usage tracking, and engagement platform for patients prescribed with compatible ResMed PAP therapy devices and the NightOwl home sleep test (HST) sensors. The app allows the patient to connect via Bluetooth to a compatible hardware device for control of their prescribed PAP or HST device and to allow self-tracking of device usage data. myAir can also be used as a communication pathway using the Bluetooth connection with the compatible device in order to send or receive data. Analysis of patient diagnostic data or display of diagnostic results are not in scope of myAir features. The myAir subject device for this premarket submission adds device software functions related to starting and stopping therapy, and control of comfort settings (collectively referred to as "device control"). The addition of these device software functions within the myAir subject device is a modification to the K241216 myAir predicate device, in addition to sustaining previously cleared medical device functions.

The Easy Care Tx 2 software is intended to be used with ResMed compatible therapy devices in a clinical environment. EasyCare Tx 2 provides therapy device setting changes and displays real-time data and treatment settings from compatible ResMed therapy devices when used together with the TxLink 2 module.

EasyCare Tx 2 is a personal computer application designed to allow clinicians to monitor real-time data from the ResMed compatible therapy device and adjust the therapy device settings from the control room of the sleep lab.

The myAir app is indicated for patients: • prescribed with a compatible ResMed Air11 platform device to simulate therapy prior to using their device with their prescribed settings. It is an optional software accessory to allow patients to acclimate to their therapy device. • prescribed a NightOwl wearable device to provide the user interface to operate the connected device and aid in the home sleep testing process. The device is intended for home and hospital use for: • new and existing patients of ResMed Air11 PAP therapy devices and • new users who are prescribed a compatible NightOwl home sleep test (HST).

myAir is a companion mobile medical application ("app") for self-monitoring use of the compatible devices that serve as a patient Home Sleep Test (HST), pre-therapy, and engagement platform for positive airway pressure (PAP) therapy. The app allows the patient to connect via Bluetooth to a compatible hardware device for temporary control of their prescribed HST or PAP device and to allow self-tracking of device usage data. myAir can also be used as a communication pathway using the Bluetooth connection with the compatible device in order to send or receive data. Analysis of patient diagnostic data or display of diagnostic results are not in scope of myAir features. The subject device modifies the predicate device by adding interoperability with the NightOwl HST (Stella functions) in addition to sustaining previously cleared medical device function of connecting to the Air 1 platform.

The Galapagos app is intended for patients who are prescribed a compatible ResMed S10 platform device to simulate therapy prior to using their device with their prescribed settings. It is an optional software accessory to allow patients to acclimate to their therapy device.

Galapagos is a mobile interface where the patient can control the device through pre-determined, scaled inspiratory pressures to help them adjust to pressure and mask fit prior to starting their prescribed therapy. In addition, Galapagos may also be used as a communication pathway using the mobile Bluetooth connection to the compatible flow generator in order to send and receive data.

The S9 Elouera self-adjusting device is indicated for the treatment of Obstructive Sleep Apnea (OSA) in patients (female patients with mild to moderate OSA when using AfH treatment mode) weighing more than 66 lb (30 kg). It is intended for home and hospital use.

The S9 Elouera retains all the same hardware and performance features of the predicate device(s). Key features include in-line power supply, fully integrated humidifier, tubing, colour LCD and simplified controls which provides improved usability. The S9 Elouera contains a Micro-processor controlled blower system that generates Continuous Positive Airway Pressure (CPAP) from 4-20 cmHzO as required to maintain an "air splint" for effective treatment of OSA. The system comprises the flow generator, patient tubing, mask (patient interface) and humidifier. The S9 Elouera flow generator includes three therapy modes. These include: - CPAP mode the device delivers a continuous positive airway pressure throughout the entire . therapy session - . AutoSet mode - the device automatically adjusts pressure in response to inspiratory flow limitation, snore and apnea. - t AutoSet for Her mode - the device automatically adjusts pressure in response to female-specific OSA characteristics. The functional characteristics of the S9 Elouera system includes all the clinician and user friendly features of the predicate device which have been verified during usability studies in accordance with IEC 62366 Medical devices - Application of usability engineering to medical devices.

The VPAP Adapt is indicated for the treatment of patients weighing more than 66 lb (30 kg) with obstructive sleep apnea (OSA), central and/or mixed apneas, or periodic breathing. It is intended for home and hospital use.

VPAP Adapt System (VPAP Adapt with H5) is similar to the predicate device(s), using a blower based positive pressure system with an integrated heated humidfier and heater controller. The device platform is identical to the S9 VPAP Adapt (K102586) and contains a Micro-processor controlled blower system that generates controlled positive airway pressure between 3-25 cmHzO as required to maintain an "air splint" for effective treatment of OSA. The system comprises the flow generator, patient interface) and humidifier. The VPAP Adapt is a flow generator device designed to provide adaptive servo-ventilation therapy (ASV) to stabilize a patient's ventilation during sleep. The device continually measures the patient's instantaneous ventilation, and calculates a target ventilation based on to the patient's recent average. It then adjusts the degree of pressure support to servo-control the patient's ventilation to at least equal the target ventilation. Therapy modes contained in the VPAP Adapt are CPAP, ASV, and ASVAuto. CPAP and ASV therapy modes come from the S9 VPAP Adapt (K102586). The functional characteristics of the VPAP Adapt system includes all the clinician and user friendly features of the predicate device.

The Mirage Echo channels airflow noninvasively to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bilevel system. The Mirage Echo is: to be used by adult patients (> 66 lb/30 kg) for whom positive airway pressure has been prescribed intended for single-patient re-use in the home environment and multipatient re-use in the hospital/institutional environment.

The Mirage Echo provides an interface such that airflow from a positive pressure source is directed to the patient's nose. The mask is held in place with adjustable headgear that straps the mask to the face. Mirage Echo is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product. Mirage Echo is a prescription device supplied non-sterile.

The SomnoTraxx System is intended to augment the standard follow-up care of patients diagnosed with obstructive sleep apnea by providing wireless transmission and display of usage and therapeutic information. It is intended for home use only in conjunction with ResMed S7 Elite and AutoSet Spirit CPAP Systems Positive Airway Pressure flow generators. SomnoTraxx System is not intended to provide automated treatment decisions nor to be used as a substitute for a competent healthcare professional's judgment. All patients' medical diagnosis and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional. The S7 Elite and AutoSet Spirit CPAP Systems are indicated for the treatment of obstructive sleep apnea (OSA) in adult patients.

The S7™ Elite (K013909) and AutoSet® Spirit™ (K013843) CPAP Systems are microprocessor controlled blower-based systems that generate Continuous Positive Airway Pressure (CPAP) from 4-20 cmH2O as required to maintain an "air splint" for effective treatment of Obstructive Sleep Apnea (OSA). The system includes the flow generator, patient tubing and a mask (patient interface). For additional humidification, several humicifiers, including the integrated HuMDARE 2i, are designed to be compatible with the flow generators. AutoScan software allows viewing of flow-generator stored treatment data via a PC, transmitting the data using a direct connection or a modem. The SomnoTraxx™ System is designed to be used with ResMed's S7™ Elite and AutoSet Spirit™ CPAP The common raise " yetner retrieval and display of stored information from the flow generators to the clinician, via wireless transmission and web-based access. Access to the data is limited to subscribers of the system. There is no patient access to the system. The SomnoTraxx™ System is comprised of two distinct components, the ResTrax™ and the Server System. Data are extracted from the flow generator, transmitted via a wireless network, stored in a database, transmitted via the Internet and displayed for review by a healthcare provider. Both components must be present in order for the SomnoTraxx™ System to function. ResTrax™ ~ResTrax™ is an optional wireless module designed to attach to a ResMed S7™ Elite or AutoSet® Spirit™ flow generator using a docking mechanism allows the device to be electrically connected via the existing 15-pin expansion port located at the rear of the flow generator. When attached, the ResTrax™ can automatically collect usage and therapeutic information stored within the flow generator's memory. The ResTrax™ sends and receives information utilizing existing messaging networks providing wireless coverage to large portions of the US population. Server System – The Server System consists of several functional software modules that are designed to retrieve information from flow generators through the ResTrax™ and a wireless messaging network, store the information in a database and provide a secure interface into the system allowing users (not patients) to schedule information retrieval and view the results.

The AUTOSET SPIRIT CPAP System is indicated for the treatment of Obstructive Sleep Apnea (OSA) in adult patients. The optional integrated humidifier (HUMDAIRE® 2[™) is indicated for the humidification and warming of air from the AUTOSET SPIRIT flow generator device. The AUTOSET SPIRIT CPAP System and HUMIDAIRE 2i are for home and hospital use.

The AUTOSET SPIRIT CPAP System is a non-invasive Continuous Positive Airway Pressure (CPAP) system. It includes the following system components: - Flow generator device, - . Humidifier - Mask and air tubing. - . Clinical Interface (AutoScan) Software. The flow generator device incorporates a blower (motor/fan assembly), sensors and processing electronics. The blower supplies pressurized air to the patient via the air tubing and a mask. The AUTOSET SPIRIT flow generator has two (2) modes of operation: - (i) CPAP Mode In this mode the flow generator provides a single fixed-pressure as set by the clinician. - Auto-titrating (AutoSet) Mode (ii) In this mode the pressure is automatically set in response to the patient's breathing patterns. The AutoScan software allows adjustment of parameter settings and viewing of flow generator-stored treatment data via a PC.