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510(k) Data Aggregation

    K Number
    K211822
    Device Name
    LifePath Remote Patient Monitoring Platform
    Date Cleared
    2022-02-03

    (234 days)

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

    Elastic Care Incorporated

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The LifePath Remote Patient Monitoring Platform connects with compatible physiological measurement devices (blood pressure meters, pulse oximeters, thermometers, glucometers) to collect vital sign using a Patient App and securely transmit them, unaltered, to LifePath servers. The LifePath Platform is intended to be used at home or in healthcare-related environments such as long-term care facilities or clinics, nursing homes and hospitals. The LifePath Remote Patient Monitoring Platform serves as Software as a Medical Device and can be used only with specific FDA cleared third-party measurement devices. The LifePath Remote Patient Monitoring Platform securely stores the collected information on LifePath servers and make it available for viewing by remotely located clinicians using a Clinician App installed on their smartphones. The clinician can analyze the data, prescribe medications or contact the patient if needed. Clinicians can set thresholds individually for each patient; notifications are sent to the clinician for threshold breaches. The LifePath Platform does not interpret, make diagnoses or serve as a substitute for medical care. It is not intended to provide real time data. The LifePath Platform is contraindicated for use in high-acuity environments, such as the ICU or operating rooms, and is not intended for use on acutely or critically ill patients or those requiring time-critical or emergency intervention. It is intended for patients who are willing and capable of managing its use or where its operations can be performed by a caregiver. Clinical judgment and experience of a Clinician are required to check and interpret the information delivered.
    Device Description
    The LifePath Remote Patient Monitoring Platform (the "LifePath RPM Platform") is a software application. It is used in conjunction only with FDA cleared Commercial, Off-The-Shelf (COTS) Third-Party Medical Devices (TPDs). These TPDs are with Bluetooth functionality to collect, aggregate, and present, without modification, vital signs and symptoms required by clinicians to assess a patient's health. The device is intended for patients who have non-critical conditions and are located either in their own homes or in professional healthcare facilities such as hospitals, skilled nursing facilities, nursing homes, or long-term care facilities. The LifePath RPM Platform constitutes a telemedicine system for remote monitoring of patients with the connected Clinician. Both the Patient App and Clinician App are accessed via authentication using a one-time security code by the respective users. The LifePath Patient App connects through a short-range radio system using Bluetooth to FDA 510(k) cleared devices (listed in Table 1 below) to measure physiological parameters of adult patients and securely transmit unmodified data to the LifePath Processing Software residing on the LifePath Server (or central server) for storage, formatting, remote display, and download. The information is available for secure viewing by remotely-located healthcare professionals (eg. Clinicians). The data may be retrieved and viewed via the Clinician App and Patient App on smartphones through internet access using local Wi-Fi 802.11 or a 3G/4G/LTE cellular network. By using the Clinician App a Clinician can view the vital signs of the connected patient, analyze the data, and prescribe medications. Clinicians will also be able to set thresholds for each patient such that notifications will be sent to the Clinician in the event of any threshold breach. The LifePath RPM Platform will be prescribed by the Clinician to the patient as per the need to remotely monitor the patient. The patient, using the Patient App, can book appointments with the Clinician. The Patient App also has the provision for the patient to respond to the Clinician's questions on their prior health conditions, medical conditions, any allergic conditions, etc., that will enable Clinicians to get a clear medical status of the patient. The patient and the Clinician can interact through chats and video calls using their respective apps. The LifePath RPM Platform is not intended for use in high-acuity environments, such as the ICU or operating rooms, and is not intended for use on acutely or critically ill patients or those requiring time-critical or emergency intervention.
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