The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant desig
The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and thereby reduce lung volume. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) selfexpanding retainer that is covered with a silicone membrane. It is implanted in the target bronchus during a bronchoscopy procedure using the Zephyr Endobronchial Delivery Catheter (EDC) that is guided to the targeted bronchus by inserting it throughthe working channel of an adult bronchoscope. Successful lobar occlusion may require placement of multiple Zephyr Valves in bronchi of the target lobe. The Zephyr Valves permit air to vent out of the treated lobe during exhalation but do not permit refilling of this region during inhalation to reduce hyperinflation due to emphysema. Trapped air in the diseased lobe escapes through the Zephyr Valves until the lung volume of the treated lobe is reduced. The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary.
The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant desig
The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and thereby reduce lung volume. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) self-expanding retainer that is covered with a silicone membrane. It is implanted in the target bronchus during a bronchoscopy procedure using the Zephyr Endobronchial Delivery Catheter (EDC) that is guided to the targeted bronchus by inserting it through the working channel of an adult bronchoscope. Successful lobar occlusion may require placement of multiple Zephyr Valves in bronchi of the target lobe. The Zephyr Valves permit air to vent out of the treated lobe during exhalation but do not permit refilling of this region during inhalation to reduce hyperinflation due to emphysema. Trapped air in the diseased lobe escapes through the Zephyr Valves until the lung volume of the treated lobe is reduced. The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary.
The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant desig
The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and thereby reduce lung volume. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) self-expanding retainer that is covered with a silicone membrane. It is implanted in the target bronchus during a bronchoscopy procedure using the Zephyr Endobronchial Delivery Catheter (EDC) that is guided to the targeted bronchus by inserting it through the working channel of an adult bronchoscope. Successful lobar occlusion may require placement of multiple Zephyr Valves in bronchi of the target lobe. The Zephyr Valves permit air to vent out of the treated lobe during exhalation but do not permit refilling of this region during inhalation to reduce hyperinflation due to emphysema. Trapped air in the diseased lobe escapes through the Zephyr Valves until the lung volume of the treated lobe is reduced. The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary.
The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant desig
The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and thereby reduce lung volume. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) self-expanding retainer that is covered with a silicone membrane. It is implanted in the target bronchus during a bronchoscopy procedure using the Zephyr Endobronchial Delivery Catheter (EDC) that is guided to the targeted bronchus by inserting it through the working channel of an adult bronchoscope. Successful lobar occlusion may require placement of multiple Zephyr Valves in bronchi of the target lobe. The Zephyr Valves permit air to vent out of the treated lobe during exhalation but do not permit refilling of this region during inhalation to reduce hyperinflation due to emphysema. Trapped air in the diseased lobe escapes through the Zephyr Valves until the lung volume of the treated lobe is reduced. The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary.
The Lung Image Analysis (LIA) software is designed to aid in the interpretation
The Lung Image Analysis (LIA) software is designed to aid in the interpretation of Computed Tomography (CT) scans of the thorax that may contain pulmonary abnormalities. Lung Image Analysis has both a graphical user interface and command-line software which can be run as a Windows application or from a command-line interpreter. The LIA software is to be used by trained professionals who are responsible for the correct and accurate use of medical images. In a typical clinical environment, the results provided by the software are used together with other clinical information by a medical professional.The software may be installed on an off-the-shelf PC computer system and is intended to be used with uncompressed digital images that are saved in DICOM format.
The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant desig
The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and thereby reduce lung volume. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) self-expanding retainer that is covered with a silicone membrane. It is implanted in the target bronchus during a bronchoscopy procedure using the Zephyr Endobronchial Delivery Catheter (EDC) that is guided to the targeted bronchus by inserting it throughthe working channel of an adult bronchoscope. Successful lobar occlusion may require placement of multiple Zephyr Valves in bronchi of the target lobe. The Zephyr Valves permit air to vent out of the treated lobe during exhalation but do not permit refilling of this region during inhalation to reduce hyperinflation due to emphysema. Trapped air in the diseased lobe escapes through the Zephyr Valves until the lung volume of the treated lobe is reduced. The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary.
The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant desig
The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and thereby reduce lung volume. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) self-expanding retainer that is covered with a silicone membrane. It is implanted in the target bronchus during a bronchoscopy procedure using the Zephyr Endobronchial Delivery Catheter (EDC) that is guided to the targeted bronchus by inserting it through the working channel of an adult bronchoscope. Successful lobar occlusion may require placement of multiple Zephyr Valves in bronchi of the target lobe. The Zephyr Valves permit air to vent out of the treated lobe during exhalation but do not permit refilling of this region during inhalation to reduce hyperinflation due to emphysema. Trapped air in the diseased lobe escapes through the Zephyr Valves until the lung volume of the treated lobe is reduced. The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary.
The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant desig
The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and thereby reduce lung volume. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) self-expanding retainer that is covered with a silicone membrane. It is implanted in the target bronchus during a bronchoscopy procedure using the Zephyr Endobronchial Delivery Catheter (EDC) that is guided to the targeted bronchus by inserting it through the working channel of an adult bronchoscope. Successful lobar occlusion may require placement of multiple Zephyr Valves in bronchi of the target lobe. The Zephyr Valves permit air to vent out of the treated lobe during exhalation but do not permit refilling of this region during inhalation to reduce hyperinflation due to emphysema. Trapped air in the diseased lobe escapes through the Zephyr Valves until the lung volume of the treated lobe is reduced. The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary.
The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant desig
The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and thereby reduce lung volume. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) self-expanding retainer that is covered with a silicone membrane. It is implanted in the target bronchus during a bronchoscopy procedure using the Zephyr Endobronchial Delivery Catheter (EDC) that is guided to the targeted bronchus by inserting it through the working channel of an adult bronchoscope. Successful lobar occlusion may require placement of multiple Zephyr Valves in bronchi of the target lobe. The Zephyr Valves permit air to vent out of the treated lobe during exhalation but do not permit refilling of this region during inhalation to reduce hyperinflation due to emphysema. Trapped air in the diseased lobe escapes through the Zephyr Valves until the lung volume of the treated lobe is reduced. The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary.
The Chartis Tablet Console is a two-part spirometry system comprised of a touchs
The Chartis Tablet Console is a two-part spirometry system comprised of a touchscreen computer and sensor enclosure designed for use in the bronchoscopy suite in conjunction with the Chartis Catheter. The Chartis Catheter is a previously cleared device (under K111522) and the subject 510(k) K180011 is solely for the Chartis Tablet Console. The proximal end of the Chartis Catheter is attached to a polymer tube with a filter whose opposite end is attached to an input fitting on the Chartis Console. Theballoon on the Chartis Catheter isolates the lung compartment of interest. The hardware components of the Tablet Console translate airflow and pressure detected through the Chartis Catheter into electrical signals. The Tablet Console analyzes and displays airflow and pressure from the isolated lung compartment in real time.
The Chartis Tablet Console is a two-part spirometry system comprised of a touchs
The Chartis Tablet Console is a two-part spirometry system comprised of a touchscreen computer and sensor enclosure designed for use in the bronchoscopy suite in conjunction with the Chartis Catheter. The Chartis Catheter is a previously cleared device (under K111522) and the subject 510(k) K180011 is solely for the Chartis Tablet Console. The proximal end of the Chartis Catheter is attached to a polymer tube with a filter whose opposite end is attached to an input fitting on the Chartis Console. The balloon on the Chartis Catheter isolates the lung compartment of interest. The hardware components of the Tablet Console translate airflow and pressure detected through the Chartis Catheter into electrical signals. The Tablet Console analyzes and displays airflow and pressure from the isolated lung compartment in real time.
The Chartis Catheter is a single use, sterile, disposable device designed to be
The Chartis Catheter is a single use, sterile, disposable device designed to be inserted into a 2.8mm working channel of a standard video bronchoscope during a diagnostic bronchoscopy procedure. The Chartis Catheter is a hollow catheter shaft made of medical-grade PEBAX. The Chartis Catheter is 169 cm in length with a working length of 72 cm and a 2.7 mm outer diameter. The distal end of the catheter employs an inflatable balloon made from a compliant elastomeric material. The catheter has two lumens: the main lumen allows air flow from the isolated lung compartment to the Console, and the second smaller lumen allows balloon inflation. The proximal end of the catheter has two ports, a balloon inflation port to inflate the distal balloon, and an obturator port with a luer fitting for connection to the Chartis Console via the Connector Set. A custom obturator inserted into the main lumen of the catheter is used for both pushability and to clear mucus that may obstruct the lumen during catheter manipulation in the airways. The only portion of the device that comes into bodily contact is the distal tip of the catheter, which is made from medical grade PEBAX (shaft) and a compliant elastomeric material (balloon). No medicinal substances are eluted from the catheter.
The Chartis Catheter is a single use, sterile, disposable device designed to be
The Chartis Catheter is a single use, sterile, disposable device designed to be inserted into a 2.8mm working channel of a standard video bronchoscope during a diagnostic bronchoscopy procedure. The Chartis Catheter is a hollow catheter shaft made of medical-grade PEBAX. The Chartis Catheter is 169 cm in length with a working length of 72 cm and a 2.7 mm outer diameter. The distal end of the catheter employs an inflatable balloon made from a compliant elastomeric material. The catheter has two lumens: the main lumen allows air flow from the isolated lung compartment to the Console, and the second smaller lumen allows balloon inflation. The proximal end of the catheter has two ports, a balloon inflation port to inflate the distal balloon, and an obturator port with a luer fitting for connection to the Chartis Console via the Connector Set. A custom obturator inserted into the main lumen of the catheter is used for both pushability and to clear mucus that may obstruct the lumen during catheter manipulation in the airways. The only portion of the device that comes into bodily contact is the distal tip of the catheter, which is made from medical grade PEBAX (shaft) and a compliant elastomeric material (balloon). No medicinal substances are eluted from the catheter.
Device Description:The GoSpiro® is intended to be used by adults and children ov
Device Description:The GoSpiro® is intended to be used by adults and children over 5 years old in physician’s offices, clinicsand home settings to conduct basic lung function and spirometry testing. It is a single-patient, use device.The GoSpiro spirometer transmits real-time lung function data to computers, tablets or smartphones over aBluetooth connection for tele-healthcare applications. The GoSpiro performs full flow-volume loopsincluding inspiratory and expiratory data. The internal program performs all of the calculations formeasurements to meet American Thoracic Society and European Respiratory Society requirements. It hasbuilt-in quality control measurements and transmits indices of measurement quality including time to peakflow, back-extrapolated volume, total expiratory time, and end-expiratory flow detection.It is used with the GoSpiro App display and communications software on a smartphone or tablet.The GoSpiro is powered by an internal rechargeable Lithium battery and is charged via its USB chargingstation connected to a USB power source. The device complies with ES 60601-1, IEC 60601-1-2, and IEC60601-1-11.The fundamental technology to measure flow is a vertical turbine volume sensor. The turbine transducermeasures expired air directly at B.T.P.S. (body temperature and pressure with saturated water vapor) thusavoiding the requirement for temperature correction on exhalation. An electronic temperature sensor on thedevice PCB measures atmospheric temperature, thus enabling correction of inspired volumes and flows. Thistransducer is insensitive to the effects of condensation and temperature and avoids the need for individualcalibration prior to performing a test.Indications for Use:The GoSpiro® is intended to be used by adults and children over 5 years old in physician’s offices, clinicsand home settings to conduct basic lung function and spirometry testing. It is a single-patient use device.
The Spiro PD personal spirometer is a hand held device that is used to test the
The Spiro PD personal spirometer is a hand held device that is used to test the user’s lung capacity. Measures of air flow and volume are indicators of lung health. By blowing into the tube of the Spiro PD the user can see a measure of his/her forced expiratory volume for one second (FEV1), forced vital capacity (FVC), FEV1/FVC ratio, peak expiratory flow (PEF), and forced expiratory flow from 25% to 75% (FEF 25/75). The SPIRO PD spirometer is intended to be used by a patient under the instruction of a physician or respiratory therapist to test lung function in child, adolescent and adult. It is intended to be used as a single-patient device only and can be used in any setting - home, factory, hospital or physician's office. The SPIRO PD spirometer is indicated for the following age groups: • 2-12 years - Child • 13-21 years - Adolescent • 22 and over- Adult.
Spirometry, Diffusion Capacity and Plethysmography Pulmonary Function Testing Sy
Spirometry, Diffusion Capacity and Plethysmography Pulmonary Function Testing System. Performs pre/post drug Spirometry (FVC, SVC & MVV), Bronchial Challenge, Diffusing Capacity (using ATS/ERS 10-second breath-hold or 3-Equation no breath hold methods), Single Breath Lung Volumes including SVC, Maldistribution of Ventilation, Whole Body Plethysmograph for Lung Volumes, Airways Resistance & Conductance and optional Maximum Pressures (MIP/MEP) tests.
Spirometry and Diffusion Capacity Pulmonary Function Testing System. Performs p
Spirometry and Diffusion Capacity Pulmonary Function Testing System. Performs pre/post drug Spirometry (FVC, SVC & MVV), Bronchial Challenge, Diffusing Capacity (using ATS/ERS 10-second breath-hold or 3-Equation no breath hold methods), Single Breath Lung Volumes including SVC, Maldistribution of Ventilation and optional Maximum Pressures (MIP/MEP) tests.
Spirometry, Diffusion Capacity, and Plethysmography Pulmonary Function Testing S
Spirometry, Diffusion Capacity, and Plethysmography Pulmonary Function Testing System. Performs pre/post drug Spirometry (FVC, SVC & MVV), Bronchial Challenge, Diffusing Capacity (using ATS/ERS 10-second breath-hold or 3-Equation no breath hold methods), Single Breath Lung Volumes including SVC, Maldistribution of Ventilation, Delta N2 & Closing Volume, Whole Body Plethysmograph for Lung Volumes, Airways Resistance & Conductance, and optional Maximum Pressures (MIP/MEP) tests.
Spirometry and Diffusion Capacity Pulmonary Function Testing System. Performs pr
Spirometry and Diffusion Capacity Pulmonary Function Testing System. Performs pre/post drug Spirometry (FVC, SVC & MVV), Bronchial Challenge, Diffusing Capacity (using ATS/ERS 10-second breath-hold or 3-Equation no breath hold methods), Single Breath Lung Volumes including SVC, Maldistribution of Ventilation, Delta N2 & Closing Volume, and optional Maximum Pressures (MIP/MEP) tests.
KoKo Sx 1000 spirometer and software package, fully compatible with Iris server
KoKo Sx 1000 spirometer and software package, fully compatible with Iris server to allow support for networked data access, patient questionnaires, workflow, and HL7 connectivity.
KoKo Sx 1000 Diagnostic Spirometer Standalone Edition
313120
KoKo Sx 1000 spirometer and software package. The Standalone Edition is configur
KoKo Sx 1000 spirometer and software package. The Standalone Edition is configured to operate on a single computer without access to an Iris central database.
The Midmark Digital Spirometer is intended for prescription-use only by physicia
The Midmark Digital Spirometer is intended for prescription-use only by physicians and professional medical personnel to conduct diagnostic spirometry testing of adults and pediatric patients, 5 years and older, in hospitals and physician/clinician offices. Kit contains: digital spirometer, 10 single mouthpieces, one (1) ten pack of nose clips, calibration syringe.
The Midmark Digital Spirometer is intended for prescription-use only by physicia
The Midmark Digital Spirometer is intended for prescription-use only by physicians and professional medical personnel to conduct diagnostic spirometry testing of adults and pediatric patients, 5 years and older, in hospitals and physician/clinician offices. Kit contains: digital spirometer, 10 single mouthpieces, one (1) ten pack of nose clips.
The Midmark Digital Spirometer is intended for prescription-use only by physicia
The Midmark Digital Spirometer is intended for prescription-use only by physicians and professional medical personnel to conduct diagnostic spirometry testing of adults and pediatric patients, 5 years and older, in hospitals and physician/clinician offices.
The IQspiro® Digital Spirometer is intended for use as a prescription-use-only c
The IQspiro® Digital Spirometer is intended for use as a prescription-use-only clinical diagnostic spirometer for pulmonary function evaluation and data management. The IQspiro® is for use in hospitals and physician/clinician offices by individuals that have received instruction or training in the administration of spirometry tests. The IQspiro® operates with a Windows-compatible computer using a USB port connection and the Midmark software.
The IQspiro Digital Spirometer is intended for use as a prescription-use-only cl
The IQspiro Digital Spirometer is intended for use as a prescription-use-only clinical diagnostic spirometer for pulmonary function evaluation and data management. The IQspiro is for use in hospitals and physician/clinician offices by individuals that have received instruction or training in the administration of spirometry tests. The IQspiro operates with a Windows-compatible computer using a USB port connection and the Midmark software. Kit includes: Midmark IQspiro Digital Spirometer, 10 Disposable Spirometer Mouthpieces, 10 Disposable Nose clips, and Carrying Case.
The IQspiro® Digital Spirometer is intended for use as a prescription-use-only c
The IQspiro® Digital Spirometer is intended for use as a prescription-use-only clinical diagnostic spirometer for pulmonary function evaluation and data management. The IQspiro® is for use in hospitals and physician/clinician offices by individuals that have received instruction or training in the administration of spirometry tests. The IQspiro® operates with a Windows-compatible computer using a USB port connection and the Midmark software. This Kit contains the IQcal® 3-Litre Calibration Syringe.
Midmark IQspiro® Digital Spirometer with Calibration Syringe