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A-Model The F&P Nova Nasal Mask is intended to be used by adults aged 22 years and older weighing ≥ 66 lb (30 ks) who have been prescribed non-invasive positive airway pressure therapy such as CPAP or Bi-Level by a physician. The Nova Nasal mask is intended for single-patient use in the home. SLA-Model The F&P Nova Nasal mask is intended to be used by adults aged 22 years and older weighing ≥ 66 lb (30 kg) who have been prescribed non-invasive positive airway pressure therapy such as CPAP or Bi-Level by a physician. The Nova Nasal mask is intended for single-patient use in the home and for multiple patient use in the hospital or other clinical setting where proper disinfection of the device can occur between patient uses.

The F&P Nova Nasal Mask is a non-invasive, Positive Airway Pressure (PAP) therapy nasal mask that features an over-the-nose cushion that seals the patient's nose, held in place by adjustable headgear straps. The mask is designed to aid in the delivery of PAP by providing an interface between the flow generator and tubing, and the patient. The F&P Nova Nasal Mask is a prescription-only device, provided in a non-sterile state. The Nova Nasal Mask range is available in three cushion sizes – Small, Medium, and Large. The mask has two models: A-Model and Sleeplab (SL) A-Model. Both models are identical except for their Indications for Use, Operating Environment, and Reusability. The A-Model is intended to be single-patient use in the home, while the SL A-Model is intended to be used on multiple patients in a hospital or other clinical setting where proper disinfection of the device can occur between patient uses.

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 Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. The Mask is intended for single-patient reuse in the home and multi-patient multi-use in the hospital environment. The Mask is to be used by adults weighing ≥ 30 kg whom positive airway pressure (CPAP or bi-level system) has been prescribed.

WiZARD 520 Full Face Mask's cushion and frame provide a secure interface between the mask and the patient's face and the flexible cushion improves seal. A series of vents on the elbow, serve as an exhalation vent to purge the exhaled carbon dioxide from the mask. The mask is designed to maintain a continuous airflow to minimize the amount of CO2 rebreathed by the patient. The mask features a wider visibility design that ensures a clear line of sight. It also includes a fabric frame equipped with 3D-shaped headgear for enhanced comfort and stability. WiZARD 520 Full Face Mask is intended for connection to a positive air pressure source such as CPAP or bi-level for the treatment of Obstructive Sleep Apnea. WiZARD 520 Full Face Mask can be linked to the CPAP or bi-level system's standard 22 mm breathing tube using a swivel hose, flexible tube, and tubing connector. Various sizes (small, medium, and large) are offered to ensure adequate fit over the extended patient population.

### AirFit F20 Mask System: The AirFit F20 mask has two product variants: - AirFit F20 mask is intended for single-patent reuse in the home environment. - AirFit F20 SLM (Sleep Lab Mask) variant is intended for multi-patient reuse in the hospital/institutional environment. Both masks are intended for patients weighing more than 66lb (30kg), who have been prescribed non-invasive CPAP or bi-level positive airway pressure (PAP) therapy. The Sleep Lab Mask is the only variant that is validated and intended for multi-patient reprocessing and must be reprocesssed if reused between patients. ### AirFit F20 NM Mask System: The AirFit F20 Non Magnetic mask has two product variants: - The AirFit F20 Non Magnetic variant is intended for single-patient reuse in the home environment. - The AirFit F20 Non Magnetic SLM (Sleep Lab Mask) variant is intended for multi-patient reuse in the hospital/institutional environment. This mask is for patients weighing more than 66 lb (30 kg), who have been prescribed non-invasive CPAP or bi-level positive airway pressure (PAP) therapy. The Sleep Lab Mask is the only variant that is validated and intended for multi-patient reprocessing and must be reprocessed if reused between patients.

The AirFit F20 and AirFit F20 NM Mask Systems are both full-face masks intended for use with Continuous Positive Airway Pressure (CPAP) and/or Bi-Level devices. CPAP & Bi-Level devices are used for the treatment of Obstructive Sleep Apnea (OSA) and/or ventilatory support. Both treatments deliver pressurized air from a flow generator to the patient. Such delivery of pressurized air relies on the Patient Interface; commonly known as the mask. Full face masks are a common type of Patient Interface (Mask) and are known to efficaciously support the delivery of pressurized air by providing a seal around the patient's nose and mouth. The AirFit F20 mask system has two product variants: - **AirFit F20 Mask:** This is the home use variant that is intended for single patient re-use. - **AirFit F20 SLM (sleep lab mask):** This is the variant that is intended for multi-patient re-use and must be reprocessed if reused between patients using the disinfection guide. AirFit F20 (K170924) had a "For Her" variant which was cleared with aesthetic colour pops, the AirFit F20 Mask and AirFit F20 SLM also have the same "For Her" variant. The AirFit F20 NM mask system has two product variants: - **AirFit F20 NM Mask:** This is the home use variant that is intended for single patient re-use. - **AirFit F20 NM SLM (sleep lab mask):** This is the variant that is intended for multi-patient re-use and must be reprocessed if reused between patients using the disinfection guide. The AirFit F20 and AirFit F20 NM Mask Systems share a common design architecture as the predicate AirFit F20 (K170924), except that the AirFit F20 NM Mask System has non-magnetic clips. The AirFit F20 and AirFit F20 NM mask systems are made up of the following four main component assemblies: cushion, elbow, frame, and headgear. The cushion and headgear are available in various sizes to allow for adequate mask fit over the intended patient population. The AirFit F20 and AirFit F20 NM mask systems are prescription devices supplied non-sterile.

Clearo is indicated for use on adult or pediatric patients unable to cough or clear secretions effectively. It may be used either with a facemask or mouthpiece, or with an adapter to a patient's endotracheal or tracheostomy tube. The device is intended to be used in the hospital, institutional environment or in the home.

The Breas Medical Clearo is an airway clearance device that provides Mechanical Insufflation-Exsufflation (MI-E) therapy. Clearo is indicated for use on adult or pediatric patients who are unable to cough or clear secretions effectively. It may be used either with a facemask or mouthpiece, or with an adapter to a patient's endotracheal or tracheostomy tube. The device is intended to be used in the hospital, institutional environment or in the home. The Clearo device is not intended to be used in line with a ventilator. Clearo must be prescribed by a licensed physician and must be used only as directed by a physician or healthcare provider. Clearo must be used with a single-limb patient circuits fitted an anti-bacterial filter. Clearo functions by delivering ambient air at a defined positive pressure to the patient's airways (insufflation), followed by a rapid shift to negative pressure (exsufflation). This quick transition—known as "time through zero" – creates a high expiratory flow that stimulates or simulates a natural cough. Optional oscillatory vibrations may further aid in loosening and mobilizing secretions. The continued rapid transition to negative pressure helps generate sufficient expiratory flow from the central airways, supporting the clearance of respiratory secretions. Clearo achieves its intended use through a blower, which compresses air, a solenoid-controlled valve to manage air flow and pressure, and microcontroller electronics to control and monitor the operation. Clearo is powered from either a mains source or an internal battery. Clearo includes the following device modes to accommodate both clinical and patient use: - **Unlocked (Clinical) Mode:** Provides full access to all treatment settings and mode configurations, intended for use by healthcare professionals. Clinicians can enable specific modes for patient use and customize treatment protocols. - **Locked (Patient) Mode:** Restricts access to pre-selected modes as set by the clinician. Patients cannot modify treatment parameters but may view compliance data and alarm history. Clearo provides the following Treatment Modes: - **Manual Mode:** The user controls the cycling between insufflation and exsufflation via a manual switch. This mode supports "Insufflation Rise" to control pressure ramp-up. Sessions can be recorded and stored for repeated use using the Treat-Repeat feature. - **Basic Auto Mode:** Provides repeated, automatic cycling of insufflation, pause, and exsufflation, with configurable recruitment breaths, pause intervals, rise time, and optional patient-triggered breaths. Optional Stepped Insufflation Breaths gradually increases insufflation pressure across breaths for comfort. - **Program Auto Mode:** Similar to Basic Auto but with a customizable, repeatable sequence of multiple insufflations followed by one exsufflation. Includes all features of Basic Auto Mode.

Respiration Data Management Software is installed in a computer to perform patient management by treatment data viewing, treatment data reporting and remotely adjusting the prescribed compatible BMC CPAP and BPAP devices' settings. It is intended for healthcare professionals in healthcare facilities use only.

The Respiration Data Management Software is a softwareonly device, which allows physicians and other clinical staff to transmit, analyze and review respiration data from the compatible CPAP and BPAP devices (non-life support systems), thus to assist the users in patient management and follow-up work. This also includes remote modification of the treatment parameters of the compatible devices. It can also store patient data, upload data to the cloud platform, generate and print reports.

The Nasal Pillow Mask is intended for patients (> 30 kg) who have been prescribed CPAP/VPAP therapy in home, hospital, or institutional environments. This device is intended to be use under the direction of a physician.

The Nasal Pillow Mask is patient interface device intended for use with CPAP/VPAP therapy systems. The device provides non-invasive means of delivering positive airway pressure to the user by creating a sealed interface using nasal pillows that fit directly into the patients' nostrils. The Nasal Pillow Mask is made of silicone material and comes in 3 different sizes (S, M & L). The nasal mask comes with standard hose fitting intended to be used with standard CPAP/VPAP system. It is intended to be use on patients (> 30 kg) who have been prescribed CPAP/VPAP therapy at home, hospital, or institutional environments. The complete mask set incudes headgear, frame, tube, and nasal pillows (S, M, & L sizes).

The Sleepnet Mojo Full Face Vented Mask, Veraseal 2 Full Face Vented Mask, Innova Full Face Vented Mask and Ascend Full Face Vented Mask are intended to be used with positive airway pressure devices, such as CPAP or bilevel, operating at or above 3 cm H2O. The masks are to be used on adult patients (>30kg) for whom positive airway pressure therapy has been prescribed. Mojo is intended for Single patient, multi-use in the home or hospital/institutional environment. Veraseal 2 is intended for Short Term Single Patient use (maximum of 7 days) in the hospital institutional environment. Innova is intended for Single patient, multi-use in the home or hospital/institutional environment. Ascend is intended for Single patient, multi-use in the home or hospital/institutional environment.

The Sleepnet Mojo Vented Full Face Mask, Veraseal 2 Full Face Vented Mask, Innova Full Face Vented Mask and Ascend Full Face Vented Mask are used with positive pressure devices, such as CPAP and Bi-level. The modifications to the cleared Mojo Full Face mask (K120463) are: - Addition of contraindication and updated warning related to presence of magnets - Change to the headgear material - Addition of an XL size The modifications to the cleared Veraseal Full Face mask (K120463) are: - Modified design, now called the Veraseal 2 Full Face Vented Mask - . Addition of an XL size Other modifications include: - Addition of the Innova Full Face Vented Mask version - Addition of the Ascend Full Face Vented Mask version

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.