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510(k) Data Aggregation

    K Number
    K210844
    Device Name
    DreamWear Silicone Pillows Mask
    Manufacturer
    Respironics, Inc.
    Date Cleared
    2021-08-24

    (155 days)

    Product Code
    BZD
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    Respironics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dream Wear Silicone Pillows Mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single patient use in the home or multi-patient use in the hospital/institutional environment. The mask is to be used on patients (>66lbs/30kg) for whom CPAP or bi-level therapy has been prescribed.
    Device Description
    The DreamWear Silicone Pillows Mask consists of a nasal pillows cushion, a silicone mask frame, an elbow with swivel and exhalation ports, headgear with arm extenders, and optional fabric sleeves. The nasal pillows cushion tips seal at the entrance to the nillows cushion base sits under the nares, and comes in four sizes (small, medium, medium wide, large). Exhalation ports are incorporated into the mask. The built-in exhalation ports are molded into the front of the cushion as well as the top of the elbow. The mask exhalation ports for the DreamWear Silicone Pillows Mask were incorporated in both components, rather than only one of these components, to optimize diffusion, noise, comfort of breathing and CO2 inside the mask. The exhalation openings are used to flush exhaled CO2 out of the circuit. The fabric headgear is attached through the slots on the left and right headgear arms, which in turn are inserted into the slots on the sides of the frame to support the mask fit. The headgear can be adjusted with the hook and loop tabs. The elbow is inserted to the top of the frame. The fabric headgear goes over the mask frame and around the patient's head. The headgear comes in one size and includes adjustment sliders to allow for a large or small fitting on the patient's head. Fabric sleeves (optional) are also provided to provide additional comfort if desired. The mask design is intended to remove movement restrictions during sleep with the air inlet on the top of the head and air movement through both sides of the frame and cushion for therapy delivery to the patient's nose. The tubing frame is intentionally designed such that one side can collapse when the patient is lying on their side, while therapy is delivered to the cushion through the open side of the frame. The frame is available in three sizes (small, medium, and large) The mask was tested and verified to ensure performance is maintained according to its specifications. The mask elbow can rotate freely through 360 degrees and has a 22mm quick disconnect swivel that is used to connect the conventional air delivery hose between the mask and pressure source. The 22mm quick disconnect swivel can also rotate freely through 360 degrees and be easily removed from the elbow. The mask is designed in such a way that they can be easily disassembled for cleaning or replacement purposes. The mask components may be cleaned by the patient in the home (single patient use) or disinfected by the professional in the hospital/institutional environment (multi-patient use). The key benefits of this device to the patient are: - Ease of use ● - . Comfort - Fewer movement restrictions ● - Easy disassemblv .
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    K Number
    K210386
    Device Name
    Magneto Nasal Mask
    Manufacturer
    Respironics, Inc.
    Date Cleared
    2021-07-12

    (153 days)

    Product Code
    BZD
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    Respironics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single patient use in the home and multi-patient use in the hospital/institutional environment. The mask is to be used on patients > 7 years old (>40 lbs) for whom CPAP or bi-level therapy has been prescribed.
    Device Description
    The Magneto Nasal Mask includes two cushion type options: a nasal, cradle cushion and nasal, pillows cushion. The nasal cradle cushion seals around the bottom of the patient's nose, and comes in five sizes (extra small, medium wide, large). The nasal pillows cushion tips seal at the entrance to the nares. The pillows cushion base sits under the nares, and comes in five sizes (extra small, small, medium wide, large). Both of the cushion design options contain enclosed magnets. The mask frame also contains enclosed magnets, and connects to the mask cushion magnetically for easy and secure assembly by the user. The mask frame comes in one size and connects to the tubing with a snap fit, which allows the frame attached to the tubing. The fabric headqear goes over the top of the mask frame and around the patient's head. The headgear comes in one size and includes adjustment sliders to allow for a large or small fitting on the patient's head. The mask includes 10 mm tubing. The 10 mm tubing contains built-in exhalation at the top of the tube where the tubing connects to the mask frame. The tubing also includes an ISO 5356-1 compliant, 22 mm male conical swivel. The tubing swivel connects directly to ISO 5356-1 compliant, 22 mm female connections used on therapy device tubing. The tubing swivel detaches from the mask tubing, via a quick disconnect feature. The tubing connects to 12 mm connections when the tubing swivel is detached.
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    K Number
    K202142
    Device Name
    Sleepware G3
    Manufacturer
    Respironics, Inc.
    Date Cleared
    2020-10-29

    (90 days)

    Product Code
    OLZ
    Regulation Number
    882.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Respironics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sleepware G3 is a software application used for analysis (automatic and manual scoring), display, retrieval, summarization, report generation, and networking of data received from monitoring devices used to categorize sleep related events that help aid in the diagnosis of sleep-related disorders. It is indicated for use with adults (18 and older) and infant patients (one year old or less) in a clinical environment by or on the order of a physician. The optional Somnolyzer scoring algorithms are for use with adults (18 and older) to generate an output that is ready for review and interpretation by a physician. Cardio-Respiratory Sleep Staging (CReSS) is an additionality of Somnolyzer which uses standard Home Sleep Apnea Test HSAT signals (in the absence of EEG signals) to infer sleep stage.
    Device Description
    Sleepware G3 software is a polysomnography scoring application, used by trained clinical professionals, for managing data from sleep diagnostic devices using a personal computer. Sleepware G3 is able to configure sleep diagnostic device parameters, transfer data stored in sleep diagnostic device memory to the personal host computer, process and auto-score data to display graphical and statistical analyses, provide aid to clinical professionals for evaluating the physiological data waveforms relevant to sleep monitoring, and create unique patient reports. Sleepware G3 includes an optional Somnolyzer plug-in. The auto-scoring algorithms of the Somnolyzer Inside software can be used in addition to, or in the place of, the auto-scoring algorithms that are included in Sleepware G3. Sleepware G3, remains unchanged in function and fundamental scientific technology from Sleepware G3 which was cleared under K142988.
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    K Number
    K201439
    Device Name
    Ventilator, Non-continuous (Respirator)
    Manufacturer
    Respironics, Inc.
    Date Cleared
    2020-09-25

    (116 days)

    Product Code
    BZD, CAW, CBK, MNR, MNS, MNT, NOU, OLZ
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    Respironics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Care Orchestrator is intended to support clinicians by tracking data on patients who are prescribed compatible therapy devices in accordance with the intended use of those therapy devices. Care Orchestrator provides remote patient data collection & viewing and is intended to be used by healthcare representatives (e.g., Physicians, Clinicians, Durable Medical Equipment providers) in conjunction with compatible non-life support therapy devices to adjust prescription and/ or performance settings. In addition, Care Orchestrator can be used for analysis (automatic and manual scoring), display, retrieval, summarization, and report generation of data received from compatible monitoring devices used to categorize sleep-related events that help aid in the diagnosis of sleep-related disorders. The Home Sleep Testing function of Care Orchestrator is indicated for Adult use only. Care Orchestrator allows read-only access to patients. Care Orchestrator is intended to be used in hospital, institutional, provider, and home care settings.
    Device Description
    Care Orchestrator is a cloud-based software platform that allows entities including physicians, other professional home and clinical staff, and durable medical equipment providers in a patient's therapy lifecycle the ability to manage patients and referrals, control access to patient information and therapy data, enhance patient compliance management workflow, and gain efficiencies in the overall patient therapy workflow. Care Orchestrator also provides a method for sleep data acquired from a supported home sleep test (HST) devices to be imported, scored and reviewed by a qualified user. The HST function of Care Orchestrator is for adult use only. The intent of the Care Orchestrator sleep diagnostic functionality is to provide a capability that allows users to analyze, score, review and generate clinical reports for HST acquisitions (i.e. sleep studies) from within a web browser. Users can upload acquisitions to Care Orchestrator and perform these actions all from within the browserbased Care Orchestrator Client application. Care Orchestrator software has undergone no significant changes since in K181053. The addition of the Home Sleep Testing features, subject of this submission, add a sub-set of Home Sleep Testing functionality.
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    K Number
    K200480
    Device Name
    DreamStation 2 System, DreamStation 2 Advanced System
    Manufacturer
    Respironics, Inc.
    Date Cleared
    2020-07-10

    (134 days)

    Product Code
    BZD
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    Respironics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DreamStation 2 CPAP/DreamStation 2 Auto CPAP system delivers positive airway for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30 kg (66 lbs). It is for use in the home or hospital/institutional environment.
    Device Description
    The DreamStation 2 System uses a microprocessor-controlled blower to treat patients with Obstructive Sleep Apnea (OSA). There are 2 models: DreamStation 2 and DreamStation 2 Advanced. Both aforementioned models will be available in two therapy modes: CPAP only and Auto CPAP. With CPAP therapy, the device provides a continuous positive airway pressure throughout the entire therapy session. With Auto CPAP therapy, the device provides a positive airway pressure that automatically adjusts to the patient's needs as various breathing events are detected, such as apneas and hypopneas. In addition to the therapy modes, the DreamStation 2 System provides several optional features to aid with patient comfort. These patient comfort features include: Ramp Plus, adjustable pressure relief (FLEX), EZ-Start, Opti-Start, and humidification (adaptive and adaptive with heated tube). Note: some of the features are only available in the DreamStation 2 Advanced model. The DreamStation 2 device also features integrated Bluetooth and cellular technology for the transfer of patient management data between the therapy device and Respironics proprietary compliance software, Care Orchestrator.
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    K Number
    K183625
    Device Name
    SomnaPatch
    Manufacturer
    Respironics, Inc.
    Date Cleared
    2019-10-18

    (296 days)

    Product Code
    MNR
    Regulation Number
    868.2375
    Why did this record match?
    Applicant Name (Manufacturer) :

    Respironics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SomnaPatch™ is a single use physiologic recorder intended to collect and record data for use by clinical software used in polysomnography and sleep disorder studies by providing the information required for calculation of the apnea-hypopnea index. It is intended for adult use and can be used in a hospital, clinic, or patient home.
    Device Description
    The SomnaPatch Home Sleep Test is a single-use disposable physiologic recorder used as an aid in the diagnosis of sleep related breathing disorders. The SomnaPatch device is affixed to the face of the user and is designed to continuously be worn overnight, up to approximately 10-hours. Once activated, the device records and stores patient data for the wear period. After the wear period, the device is returned to the healthcare professional, where the data is downloaded and processed by the SomnaPatch Data Processing Software. The processed data can be viewed by a healthcare professional and analyzed either manually or by third-party sleep data viewing and scoring software. The SomnaPatch device is not involved in the data management performed by the host or third-party data viewing or scoring software. The forehead patch contains three sensors (Pressure Sensor, Accelerometer, and Optical SpO2), wherein their outputs' are recorded to a secure MicroSD card. The SomnaPatch Data Processing Software installed on a PC downloads the recorded data from the secure MicroSD card to derive 4 channels (nasal pressure, oxygen saturation (SpO2), pulse rate, and head position) of data in EDF format.
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    K Number
    K161411
    Device Name
    Care Cycle Connect Application
    Manufacturer
    RESPIRONICS, INC.
    Date Cleared
    2017-02-17

    (273 days)

    Product Code
    MOD
    Regulation Number
    868.5895
    Why did this record match?
    Applicant Name (Manufacturer) :

    RESPIRONICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Care Cycle Connect software application is intended for use with Trilogy Series ventilators by both caregivers and clinicians. The application pairs with the Trilogy device via a Bluetooth connection. The application provides the caregiver remote patient monitoring, and alarm surveillance. Alarm surveillance consists of both an audible tone and a visible alert if an alarm condition exists. The application provides the clinician with the ability to view, collect and store patient ventilator usage data. Care Cycle Connect also provides educational information on ventilator use to both caregivers and clinicians. It is intended to be used in the home, and hospital/ institutional settings. The Care Cycle connect application is intended to supplement and not replace any part of the current device monitoring procedures.
    Device Description
    The Care Cycle Connect application is an accessory to a continuous ventilator (product code MOD). Care Cycle Connect is intended for use with the Trilogy Series of Ventilators cleared by the US FDA under K083526, K093416, K093905, and K111610. Care Cycle Connect (CCC) is a mobile software application designed to provide features and functions related to respiratory care in the home, hospital and institutional healthcare settings. The application provides the caregiver remote patient monitoring and alarm surveillance. The CCC application has been designed with two users in mind, the caregiver and the clinician. The functionality of the application is tailored to the different needs of these users and is configured when the application is installed. At the initial start-up of the application, users are asked to choose either careqiver (for patients and their in-home caregivers) or clinician mode. Functionality is based on the configuration selected. Once this choice is made, users cannot switch back and forth between the two configurations. The primary users expected to interact with Care Cycle Connect in the context of patient care in the home (the main use scenario) are caregivers and respiratory therapists (clinicians). CCC may also be used if the patient is in a hospital or institutional environment (sub-acute care facility). Caregivers are not expected to use CCC in a hospital or institutional setting. Care Cycle Connect provides constant feedback to the caregiver while the app is connected to the ventilator. This feedback is displayed via the Manometer Display feature within the application. This constant display provides data on the patient's use of the ventilator, ensuring that the ventilator is providing therapy. Care Cycle Connect will also provide educational information on the use of the ventilator to the caregiver or clinician, independent of being connected to the ventilator. The respiratory therapist will use the app when connected to a patient ventilator while on a home visit to gather ventilator data. It provides an interface for keeping patient information. When the app is not connected to the patient ventilator, the clinician can review stored data, such as appointments, journal, and vent check records. In the hospital or institutional environment. CCC may be used by clinicians to schedule and perform vent checks, which would be completed in the patient's room. Care Cycle Connect is an application that can be loaded onto an Apple device (iPad) that uses iOS 8.0 or more recent. The application relies on a Bluetooth Class 1 radio connection to a Trilogy ventilator. With the exception of low level communication protocol information (i.e., handshake connection), the Trilogy device does not accept any data, commands, or controls from the CCC Application. The Trilogy device functionality is not changed in any manner by connecting to the CCC Application. The Trilogy device simply sends information to the CCC Application on a periodic basis.
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    K Number
    K151120
    Device Name
    Simple T Pediatric Nasal Mask
    Manufacturer
    RESPIRONICS, INC.
    Date Cleared
    2016-04-15

    (354 days)

    Product Code
    BZD
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    RESPIRONICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This mask is intended to provide an interface for application of non-invasive ventilation to patients. The mask is for single patient use in the home and multi-patient use in the hospital/institutional environment. The mask is to be used on patients greater than 10 kg/22 lbs (>10 kg/22 lbs) for whom non-invasive ventilation has been prescribed. Use of this mask is limited by the indications for use of the compatible therapy device with respect to patient weight.
    Device Description
    The Simple T Pediatric Nasal Mask is intended to be used with positive airway pressure devices. For use of this mask with a CPAP therapy device, the patient population is limited by the intended use of the device (e.g. > 30 kg). In other words, this mask can be used with a variety of therapy devices which may have their own limitations on patient population. If the therapy device itself is limited to patients greater than 10 kg (e.g. 30 kg), then the use of this mask does not expand the intended use of that therapy device. The mask provides a seal such that positive pressure from the positive pressure source is directed into the patient's nose. It is held in place with a fabric frame and an adjustable headgear. The cushion contains an adjustment dial that can be engaged to reduce minor leaks around the nose. The mask may be cleaned in the home (single-patient use) or reprocessed by the professional in the hospital/institutional environment through high-level disinfection processes (multi-patient use).
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    K Number
    K150638
    Device Name
    AF541 SE Full Face Mask
    Manufacturer
    Respironics, Inc.
    Date Cleared
    2015-09-18

    (191 days)

    Product Code
    CBK
    Regulation Number
    868.5895
    Why did this record match?
    Applicant Name (Manufacturer) :

    Respironics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alams and safety systems for ventilation failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory insufficiency or obstructive sleep apnea. The mask is for single use in the hospital/institutional environment only. The mask is to be used on patients (>40lbs/20kg) who are appropriate candidates for noninvasive ventilation.
    Device Description
    The AF541 SE Full Face Mask is an oral-nasal full face mask that is available in two cushion configurations. The AF541 SE Full Face has two cushion configurations, an Over the Nose (OTN) cushion and an Under the Nose (UTN) cushion. The AF541 SE Full Face Mask will have interchangeable cushions that attach to a common frame. There will be four sizes available for the over the nose option (S, M, L, XL). The UTN option will have three sizes available (A, B, C). The AF541 SE will include a 4 point headgear and capstrap to allow for oral access with either headgear option.
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    K Number
    K150639
    Device Name
    AF541 EE Full Face Mask
    Manufacturer
    RESPIRONICS, INC.
    Date Cleared
    2015-09-18

    (191 days)

    Product Code
    BZD
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    RESPIRONICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AF541 EE Leak 1 Mask This Mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single use in the hospital/institutional environment only. The mask is to be used on patients (>40lbs/20kg) for whom CPAP or bi-level therapy has been prescribed. AF541 EE Leak 2 Mask This Mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single use in the hospital/institutional environment and single patient use in the home. The mask is to be used on patients (>40lbs/20kg) for whom CPAP or bi-level therapy has been prescribed.
    Device Description
    The AF541 EE Full Face Mask is an oral-nasal full face mask that is available in various configurations (cushions and elbows). The AF541 EE Full Face has two cushion configurations, an Over the Nose (OTN) cushion and an Under the Nose (UTN) cushion. The following elbow configurations are available: EE Leak 1 and EE Leak 2. The Leak 1 and Leak 2 elbows have an anti-asphyxia valve. In addition, the Leak 2 elbow has built in exhalation to provide intentional leak when needed. The AF541 EE Full Face Mask will have interchangeable cushions that attach to a common frame. There will be four sizes available for the nose option (S, M, L, XL). The UTN option will have three sizes available (A, B, C). The AF541 mask will include a 4-point headgear and capstrap to allow for oral access with either headgear option. There will be 22 mm female mask frame. The AF541 OTN and UTN will be compatible with the EE Leak 1 and EE Leak 2 elbow.
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