Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K050929
    Device Name
    THE HERMES SYSTEM
    Manufacturer
    PALAISTRA SYSTEMS INC.
    Date Cleared
    2005-05-20

    (36 days)

    Product Code
    DRG
    Regulation Number
    870.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    PALAISTRA SYSTEMS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hermes System is intended to be used by out-of-hospital patients as a means to collect and transmit medical measurements (such as blood glucose level, weight, and blood pressure) to their healthcare provider and to receive returned educational and motivational messages to help them better understand and manage their chronic condition. The Hermes System is to be used only upon prescription of a licensed physician or other authorized healthcare provider. The Hermes System is an accessory device that collects data from a range of supported monitoring devices. The data is collected and sent using standard wireless technologies and maintained on an associated database server located within the healthcare facility. Based on patient specific parameters set by the healthcare provider, educational and motivational messages are returned to the patient. The Hermes System is not intended for emergency calls or for transmission or indication of any real-time alarms or time-critical data. This device is not intended as a substitute for direct medical supervision or emergency intervention. Hermes is not intended to provide automated treatment decisions, nor to be used as a substitute for professional healthcare judgment. All patient medical diagnoses and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional.
    Device Description
    The Hermes System is an accessory device that collects data from a range of supported measurement devices. The data is collected and sent using standard wireless technologies and maintained on an associated database server located within the healthcare facility. Based on patient specific parameters set by the healthcare provider, educational and motivational messages are returned to the patient. Hermes is used by the patient to collect data from one or more off-the-shelf measurement devices. Hermes currently supports a glucometer, a noninvasive blood pressure cuff and a weight scale. Hermes is a software system composed of two components, a Collector module and a Server module. The Collector module is a software program that runs on a cell phone and provides the data collection, transmission and message display capabilities. The Server module is a software program that runs on standard web server hardware. The Server module receives the data sent to it by the Collector module and provides the set-up, data management, and message delivery capabilities. Hermes messages remind the user of good health habits such as taking all prescribed measurements and maintaining a healthy lifestyle. Hermes can send email to the patient's doctor and/or guardian if good habits are not maintained.
    Ask a Question

    Page 1 of 1