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510(k) Data Aggregation

    K Number
    K082968
    Device Name
    APNEICARE CONNECTION CENTER/INTERNET ANALYSIS
    Manufacturer
    APNEICARE, LLC
    Date Cleared
    2009-01-02

    (88 days)

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

    APNEICARE, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ApneiCare Connection Center/Internet Analysis is a software device, intended to be used as an aid in the diagnosis of sleep and respiratory related sleep disorders. ApneiCare Connection Center/Internet Analysis is used for analysis (semi-automatic and manual rescoring), display, redisplay (retrieve), edit, summarize, to generate user defined reports, networking and managing of data received from devices that are typically used to evaluate sleep- and sleep related respiratory disorders. ApneiCare Connection Center/Internet Analysis software also provides scoring of desaturation events as they related to sleep breathing disorders. ApneiCare Connection Center/Internet Analysis is intended to be used as an information and decision management tool to import/record and transmit/transfer data typically captured to evaluate sleep and respiratory related sleep disorders. ApneiCare Connection Center/Internet Analysis itself is not a diagnostic tool. It is an information and decision management tool which allows medical personnel to upload, view, and score data related to a sleep study and provide output reports to a physician. The use of this software is to be under the supervision of a physician, sleep technologies, or clinician.
    Device Description
    ApneiCare Connection Center / Internet Analysis is composed of two components: The Connection Center and the Internet Analysis Application. The ApneiCare Connection Center and the ApneiCare Internet Analysis Application function in a client server relationship. The purpose of ApneiCare Connection Center is to download stored data from supported devices that are typically used to evaluate sleep and sleep related respiratory disorders. It allows users to export sleep data, and interact with the ApneiCare Internet Analysis to run analysis reports on sleep studies. ApneiCare Connection Center will operate under Windows XP and Windows Vista; but more importantly is built on Microsoft .NET Framework. The ApneiCare applications have been designed on Microsoft .NET Framework to take advantage of the latest laver of abstraction to allow for Operating System changes in the future while lowering the probability of the application being negatively impacted by operating system changes. "ApneiCare Connection Center is responsible for binding patient information to the study and downloading the data off of the source device. The ApneiCare Connection Center is a small program on the PC with functionality limited to that of general purpose data entry, storage and communication, it performs no data manipulation functions. The data is then communicated to ApneiCare Internet Analysis via an Internet connection, where the sleep analysis and reporting is performed. The ApneiCare Connection Center has built in features to insure that required patient information is entered and that internet connectivity is available. All Internet activity is encrypted and secure. Each transaction between ApneiCare Connection Center and ApneiCare Internet Analysis is conducted over at least 128-bit HTTPS using private and public encryption. Saved tests can be converted into ASCII format for importing to spreadsheets or databases. The patient information consists of the patient name and address, an ID number, patient insurance and other relevant information. The ApneiCare Internet Analysis Application provides information pertaining to the waveform patterns, such as those of the SpO2 and pulse recording, to aid physicians with the diagnosis of sleep and breathing disorders. Individual desaturation and respiratory events in series (cycles) are scored by algorithm. These patterns are identified using DPAR objects. In addition, to the Internet Analysis the ApneiCare Internet Analysis DPAR Case Viewer application module may also be used to manually score events and visually compare and analyze across multiple channels of data. The ApneiCare Internet Analysis Application is primarily a mathematical data processing function that reports cycling respiratory events across multiple channels of data. The functionality of the ApneiCare Internet Analysis Application is not time critical or real time. Therefore delays in internet transfer do not impact functionality. The ApneiCare Internet Analysis Application also performs a data management functions which allows the various authorized users of the system to access, view, report and analyze individual cases. The ApneiCare Connection Center is compiled for .NET 2.0, and dependent upon the .NET Framework as the OTS. .NET 2.0 is provided by Microsoft and contains the CLR (Common Language Runtime) which has abstracted ApneiCare Connection Center away from specific Microsoft Windows Operating System Versions. The ApneiCare Internet Analysis application is a server application, runs on Windows Server 2008 and SQL Server 2005, and .NET 3.5, it is managed in a centralized location by ApneiCare.
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