Search Filters

Search Results

Found 12 results

510(k) Data Aggregation

    K Number
    K153654
    Device Name
    Sentry WEB SmartInterp
    Manufacturer
    CareFusion Germany 234 GmbH
    Date Cleared
    2016-09-16

    (270 days)

    Product Code
    DQK, BZC
    Regulation Number
    870.1425
    Why did this record match?
    Applicant Name (Manufacturer) :

    CareFusion Germany 234 GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sentry WEB SmartInterp is a medical software which is intended to be used as an aid in the evaluation and diagnosis of already measured cardiopulmonary data. Access to data will be realized via network or internet with assigned access rights. Patient population is not assigned as it is defined by the measuring devices itself.
    Device Description
    Sentry Web SmartInterp is a web application providing support for execution of post-measurement related clinical tasks like re-evaluation, quality grading and interpretation of medical readings. Sentry WEB SmartInterp does not primarily rely on electronic document formats – PDF-like reports – but utilizes modern web technologies to create a rich web-based user experience. Due to its general approach Sentry WEB SmartInterp can serve in many environments as 'the post-measurement' solution - customer-owned or as cloud based software service. Hence, Sentry WEB SmartInterp on one hand extends stand-alone diagnostic systems by running on the measurement system as local post-measurement component. For small labs Sentry WEB SmartInterp enables the attending physician to supervise several measurement units from his office. In mid-sized cardiopulmonary labs Sentry SmartInterp introduces optimized post-measurement workflow WEB capabilities. Finally in sophisticated multi-site setups Sentry WEB SmartInterp supports the channeling of data and creates the throughput required for large clinical teams.
    Ask a Question
    K Number
    K150810
    Device Name
    Vyntus / SentrySuite Product Line
    Manufacturer
    CareFusion Germany 234 GmbH
    Date Cleared
    2015-08-14

    (141 days)

    Product Code
    BZC, DPS
    Regulation Number
    868.1880
    Why did this record match?
    Applicant Name (Manufacturer) :

    CareFusion Germany 234 GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vyntus/SentrySuite Product Line is intended to be used for measurements, data collection and analysis of lung function (PFT) and cardio-pulmonary (CPET) parameters, aiding in the diagnosis of related conditions. The results of the test can be viewed online with the help of a computer screen and can be printed after the test results can be saved for future reference or report generation purposes. The products can be utilized with patients age 4 years and older as long as they can cooperate in the performance - no special limit to patient's sex or height exists. Measurements will be performed under the direction of a physician in a hospital environment, physician's office or similar setting (professional healthcare facilities). A qualified physician has to reassess all Vyntus/SentrySuite measurements. An interpretation by Vyntus/SentrySuite is only significant if it is considered in connection with other clinical findings. Additional for Vyntus ECG: The Vyntus ECG is intended for measuring the surface electrocardiogram (ECG) of a patient. The acquired ECG can be recorded and displayed on the screen or printed on paper. 12-lead ECGs are analyzed automatically and suggestions for the interpretation of the resting ECG can be made by the software. ECG interpretation statements made by the Vyntus/ SentrySuite represent partial qualitative information on the patient's cardiovascular condition and no therapy or drugs can be administered based solely on the interpretation statements. The Vyntus ECG can be used for non-interpretive applications in patients age 4 years and older and a weight of 20 kg or higher. The Vyntus ECG is intended to be used for routine ECG collection, recording both under resting and stress conditions. The measurement is performed by trained healthcare professionals under the direction of a physician in healthcare facilities (e.g. the doctor's office or hospital). The Vyntus ECG is not intended for intracranial use. The Vyntus ECG is not intended for use in an EMS environment (Emergency Medical Services Environment). The Vyntus ECC is not intended for use in home healthcare environments. Automatic interpretation of the ECG is not possible for pediatric and adolescent patients below 16 years of age and for patients with pacemakers.
    Device Description
    The Vyntus ECG is the perfect 12-Lead PC-ECG extension for the Vyntus CPX via secure Bluetooth® communication. One integrated solution through the SentrySuite platform helps laboratories ease procedures and integration to reduce costs. The Vyntus ECG records the full 12-lead resting and stress ECG via its wireless, battery operated ECG amplifier. The evaluation and interpretation is using the proven Hannover ECG System (HES). Scientific Concept: The surface electrodes of the Vyntus ECG record the electrical signals that are mainly generated by the heart muscle activity and repolarization. The small voltages are amplified and A/D converted. A low frequency high-pass filter is applied and the recorded signals are transmitted to the PC for recording, storing, evaluation, interpretation, display and reporting. Significant performance characteristics: - Full 12 lead ECG - Small, low weight (<300 g) - Data transfer by blue-tooth - Single AA battery operation - Pacemaker detection with 4000 Hz sample rate - 500 Hz per channel transmission rate - Bandwidth: 0.05-150 Hz - Resolution: < 2.5 µV/bit - Classification applied parts; CF, defibrillator proof - Automatic analysis by HES stress/resting algorithm package - Online evaluation and display of HR, ST-values and ST-slope - Arrhythmia detection - Different views - Rhythm view - Trace view - Full disclosure view (result view) - Different filters selectable - 50/60 Hz - Baseline - Muscle (20, 40, 100 Hz) - Continuous storage of raw ECG data for stress application
    Ask a Question
    K Number
    K142959
    Device Name
    Vyntus Walk
    Manufacturer
    CAREFUSION GERMANY 234 GMBH
    Date Cleared
    2015-03-20

    (157 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    CAREFUSION GERMANY 234 GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Vyntus Walk is a mobile medical application which is intended to be used on a mobile platform to collect and collate sequential pulse oximetry data during six minute walk tests (6MWT). Pulse oximetry data are collected from an external pulse oximeter, using Bluetooth connection. The mobile platform has access to a host computer with SQL database (SentrySuite) via a wireless network for further data evaluation and diagnosis. Patients as young as 4 years of age and older can be tested providing they can cooperate with the test instructions. Measurements are performed under the direction of a physician in a hospital environment, physician's office or similar setting (professional healthcare facilities).
    Device Description
    The Vyntus Walk is a tablet based software mobile application that collects and collates pulse oximeter data from an external pulse oximeter during a 6 Minute Walk Test and remotely transmits to the SentrySuite for access to physicians for diagnosis purposes. Vyntus WALK includes wearable, wireless sensors connected to a tablet PC running Android Operating System with a workflow driven 6MWT application. Vyntus WALK integrates seamlessly in today's mobile healthcare environment through the new Sentry CIS™ service landscape for central data management and reporting.
    Ask a Question
    K Number
    K141936
    Device Name
    MICROBLAB, MICROLOOP
    Manufacturer
    CAREFUSION GERMANY 234 GMBH
    Date Cleared
    2014-12-29

    (165 days)

    Product Code
    BZG, DQA
    Regulation Number
    868.1840
    Why did this record match?
    Applicant Name (Manufacturer) :

    CAREFUSION GERMANY 234 GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MicroLab / MicroLoop spirometer is intended, for prescription use only, to measure the maximal volume and flow of air that can be moved in and out of a patient's lungs and for pulse oximetry measurements. The system is intended for use with pediatric (4 to 17 years) and adult (18 to 99 years) patients in hospitals, physician offices, laboratories and occupational health testing environments. The optional Nonin IPOD® Integrated Pulse Oximetry Device is designed to measure pulse rate and oxygen saturation in adult patients. The sensor is designed for use on the fingers of patients weighing more than 30 kilograms, where the finger tissue is between 5 and 21 millimeters.
    Device Description
    The MicroLab / MicroLoop is a mains/battery operated desktop spirometer. It has context sensitive help screens, accessed at the touch of a button, that explain its features and navigational aides, making it easy to use. The results may be uploaded to a PC using the optional "Spirometry PC" software and patient details may be downloaded to the MicroLab / MicroLoop. Using spirometry PC software (SPCS) and the MicroLab / MicroLoop, live blows can be performed with the PC directly controlling the operation of the MicroLab / MicroLoop. The results and graphs produced are displayed directly on the PC screen. Stored data on the devices can be printed on an external printer using the USB cable supplied or uploaded to the PC. In addition the MicroLab is able to print the data on its integral thermal printer. Optional a Nonin Ipod® SpO2 sensor can be connected to the MicroLab / MicroLoop. The scientific concept which forms the basis of the MicroLab / MicroLoop is the CareFusion Digital Volume Transducer, a stable form of volume transducer, which measures expired air directly at B.T.P.S (Body Temperature and Pressure with Saturated water vapour) thus avoiding the inaccuracies of temperature corrections. The transducer is insensitive to the effects of condensation and temperature and avoids the need for individual calibration prior to performing a test.
    Ask a Question
    K Number
    K133925
    Device Name
    VYNTUS/ SENTRYSUITE PRODUCT LINE
    Manufacturer
    CAREFUSION GERMANY 234 GMBH
    Date Cleared
    2014-08-22

    (242 days)

    Product Code
    BZC
    Regulation Number
    868.1880
    Why did this record match?
    Applicant Name (Manufacturer) :

    CAREFUSION GERMANY 234 GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vyntus/SentrySuite product line is intended to be used for measurements, data collection and analysis of lung function (PFT) and cardio-pulmonary (CPET) parameters, aiding in the diagnosis of related conditions. The results of the test can be viewed online with the help of a computer screen and can be printed after the test. The test results can be saved for future reference or report generation purposes. The products can be utilized with patients age 4 years and older as long as they can cooperate in the performance - no special limit to patient's sex or height exists. Measurements will be performed under the direction of a physician in a hospital environment, physician's office or similar setting (professional healthcare facilities).
    Device Description
    The Vyntus CPX system is an accurate and reliable system that allows the determination of a subjects' metabolic response while exercising. It is a stationary, mains powered ergospirometry system. The system records the data breath-by-breath. The breath-by-breath data is collected through a facemask or mouth-piece and is sent to a host computer system via cable connection. The digital volume transducer (DVT) measures the gas volume in- and expired. Gas samples are continuously drawn from a location very close to the mouth (between DVT and the face-mask or mouth-piece). The gas samples are dryed by Nafion tubes and analyzed for O2 and CO2 content. From the breathing volume and the differences between inspiratory and expiratory O2 and CO2 concentrations the oxygen uptake and the CO2 production (V'O2 and V'CO2) are calculated by the software. The workload protocol selected by the user will control the ergometer device accordingly and the changes in the above vital signs due to the change in workload are recorded. All data is stored together with the patient and test data in the database for later evaluation and printing.
    Ask a Question
    K Number
    K122699
    Device Name
    SENTRYSUITE PRODUCT LINE
    Manufacturer
    CAREFUSION GERMANY 234 GMBH
    Date Cleared
    2012-11-19

    (76 days)

    Product Code
    BTY, BZC, BZG, JEH
    Regulation Number
    868.1890
    Why did this record match?
    Applicant Name (Manufacturer) :

    CAREFUSION GERMANY 234 GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SentrySuite Product line is intended to be used for measurements, data collection and analysis of lung function (PFT) parameters, aiding in the diagnosis of related conditions. All the measurements are performed via a mouthpiece, a mask or nasal adapters. The results of the test can be viewed online with the help of a computer screen and can be printed after the test. The test results can be saved for further referral or report generation purposes. Use of the Option Bronchial Challenge requires the supervision of a physician familiar with emergency medicine. The products can be utilized for patients from 4 years on and older as long as they can cooperate in the performance - no special limit to patient's sex or height. Measurements will be performed under the direction of a physician in a hospital environment, physician's office or similar settings.
    Device Description
    The SentrySuite Product line when operating on the existing hardware for MasterScreen Pneumo, MasterScreen IOS, APS Pro and MasterScreen PFT will be as functional as the existing version of JLAB software for all the available measuring programs and options for these devices. - The SentrySuite software replaces the JLAB software and got a brand-new graphical surface. - Measurement can be accomplished under SentrySuite software equivalent as it was possible under the previously powerful JLAB software - The results of the tests can be viewed on-line on the computer screen during the test and can be saved on the computer hard disk for further referral or report generation purposes. - SentrySuite provides the functionality currently available on the MasterScreen devices using the JLAB software. - SentrySuite can be operated on workstations and on servers. Measurements: - Spiormetry - Flow Volume - Maximal Voluntary Ventilation (MVV) - Incentive Spirometry - R-Occlusion - Impulse oscillometry - Bronchial test - FRC Helium Rebreathing - Real Time Single Breath Diffusion - Intra Breath Diffusion - Bodyplethysmography - Respiratory Drive P0.1 - PI/PE Max (MIP/MEP) - Single Breath Diffusion CO/He
    Ask a Question
    K Number
    K113813
    Device Name
    SENTRYSUITE PRODUCT LINE
    Manufacturer
    CAREFUSION GERMANY 234 GMBH
    Date Cleared
    2012-05-10

    (139 days)

    Product Code
    BTY, BZC, BZG
    Regulation Number
    868.1890
    Why did this record match?
    Applicant Name (Manufacturer) :

    CAREFUSION GERMANY 234 GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SentrySuite Product line is intended to be used for measurements, data collection and analysis of lung function (PFT) parameters, aiding in the diagnosis of related conditions. All the measurements are performed via a mouthpiece, a mask or nasal adapters. The results of the test can be viewed on-line with the help of a computer screen and can be printed after the test. The test results can be saved for further referral or report generation purposes. Use of the Option Bronchial Challenge requires the supervision of a physician familiar with emergency medicine. The products can be utilized for patients from 4 years on and older as long as they can cooperate in the performance – no special limit to patient's sex or height. Measurements will be performed under the direction of a physician in a hospital environment, physician's office or similar settings.
    Device Description
    The SentrySuite Product line when operating on the existing hardware for MasterScreen Pneumo, MasterScreen IOS, APS Pro and MasterScreen PFT will be as functional as the existing version of JLAB software for all the available measuring programs and options for these devices. - The SentrySuite software replaces the JLAB software and got a brand-new graphical surface. - Measurement can be accomplished under SentrySuite software equivalent as it was possible under the previously powerful JLAB software - The results of the tests can be viewed on-line on the computer screen during the test and can be saved on the computer hard disk for further referral or report generation purposes. - SentrySuite provides the functionality currently available on the MasterScreen devices using the JLAB software. - SentrySuite can be operated on workstations and on servers. Measurements: - Spiormetry - Flow Volume - Maximal Voluntary Ventilation (MVV) - Incentive Spirometry - R-Occlusion - Impulse oscillometry - Bronchial test - FRC Helium Rebreathing - Real Time Single Breath Diffusion - Intra Breath Diffusion
    Ask a Question
    K Number
    K113096
    Device Name
    MICRO I
    Manufacturer
    CAREFUSION GERMANY 234 GMBH
    Date Cleared
    2012-04-13

    (177 days)

    Product Code
    BZG
    Regulation Number
    868.1840
    Why did this record match?
    Applicant Name (Manufacturer) :

    CAREFUSION GERMANY 234 GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Micro I spirometer is intended to measure the maximal volume and flow of air that can be moved out of a patient's lungs. The system is intended for use with pediatic and addlt patients over the age of 3 years in hospitals, physician offices, laboratories and occupational health testing environments.
    Device Description
    The Micro I spirometer is a hand held portable microprocessor based device designed to measure expiratory flows and volumes. To perform a spirometry test the user first inserts a mouthpiece into the mouthpiece holder of the spirometer, which aligns it with the volume transducer. The unit is then turned on and displays instructions and prompts according to the device type. When prompted to do so by the operator, the patient inhales as deeply as possible, seals his/her lips around the mouthpiece and exhales as hard and as fast as possible until no more air can be exhaled. The device converts the airflow to an electrical signal, and the onboard software calculates the required values.
    Ask a Question
    K Number
    K111408
    Device Name
    MICROGARD II
    Manufacturer
    CAREFUSION GERMANY 234 GMBH
    Date Cleared
    2011-10-17

    (151 days)

    Product Code
    CAH
    Regulation Number
    868.5260
    Why did this record match?
    Applicant Name (Manufacturer) :

    CAREFUSION GERMANY 234 GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CareFusion MicroGard® II filter series is indicated for use in prevention of contamination of pulmonary function testing equipment and associated valves and hoses by aerosols and particulates which may be present in a patient's exhaled gas volumes. The MicroGard® II filter should be used only on patients with a minimum body weight of 27.5 kg.
    Device Description
    The CareFusion MicroGard II filter is a disposable barrier type filter intended to protect both, patient and instrument, by preventing the transmission of pathogens by droplets and aerosolized particles between the patient and the spirometer, or pulmonary function testing instrument.
    Ask a Question
    K Number
    K111053
    Device Name
    SENTRYSUITE PRODUCT LINE
    Manufacturer
    CAREFUSION GERMANY 234 GMBH
    Date Cleared
    2011-08-12

    (119 days)

    Product Code
    BTY, BZC, BZG
    Regulation Number
    868.1890
    Why did this record match?
    Applicant Name (Manufacturer) :

    CAREFUSION GERMANY 234 GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SentrySuite Product line is intended to be used for measurements, data collection and analysis of lung function (PFT) parameters, aiding in the diagnosis of related conditions. All the measurements are performed via a mouthpiece, a mask or nasal adapters. The results of the test can be viewed online with the help of a computer screen and can be printed after the test. The test results can be saved for further referral or report generation purposes. Use of the Option Bronchial Challenge requires the supervision of a physician familiar with emergency medicine. The products can be utilized for patients from 4 years on and older as long as they can cooperate in the performance - no special limit to patient's sex or height. Measurements will be performed under the direction of a physician in a hospital environment, physician's office or similar settings.
    Device Description
    The SentrySuite Product line when operating on the existing hardware for MasterScreen Pneumo, MasterScreen IOS and APS Pro will be as functional as the existing version of JLAB software for all the available measuring programs and options for these devices. The SentrySuite software replaces the JLAB software and got a brand-new graphical surface. Measurement can be accomplished under SentrySuite software equivalent as it was possible under the previously powerful JLAB software. The results of the tests can be viewed on-line on the computer screen during the test and can be saved on the computer hard disk for further referral or report generation purposes. SentrySuite provides the functionality currently available on the MasterScreen devices using the JLAB software. SentrySuite can be operated on workstations and on servers. Measurements: Spiormetry Flow Volume Maximal Voluntary Ventilation (MVV) Incentive Spirometry R-Occlusion Impulse oscillometry Bronchial test
    Ask a Question

    Page 1 of 2