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510(k) Data Aggregation

    K Number
    K252440
    Manufacturer
    Date Cleared
    2025-10-02

    (59 days)

    Product Code
    Regulation Number
    870.2910
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    EasyTeleMed mobile applications (Home and Professional) connect with compatible physiological measurement devices intended to be used at home or healthcare-related environments to collect physiological parameters measurements and securely transmit them unaltered to the EasyTeleMed EMR Plus. The physiological parameters that can be acquired are:

    • Blood pressure (systolic/diastolic)
    • Heart rate (from ECG or auscultation)
    • Pulse rate (from finger or arm)
    • Body weight
    • ECG
    • Blood glucose
    • Pulse oximetry
    • Spirometry
    • Body temperature
    • Respiratory rate
    • Cardiac auscultation
    • Pulmonary auscultation

    EasyTeleMed serves as Software as a Medical Device and can be used only with specific FDA cleared or approved third-party measurement devices.

    EasyTeleMed securely stores the collected information and makes it available for viewing by remotely located clinicians using EasyTeleMed EMR Plus, accessible via a web browser. The clinician can analyze the data, prescribe medications, set up a care plan or contact the patient if needed (via message or video calls). Clinicians can set rules (activities and thresholds) individually for each patient and for any rule breach, notification is sent to the clinician, if desired.

    EasyTeleMed does not interpret, make diagnoses nor serve as a substitute for medical care. It is not intended to provide real-time data.

    EasyTeleMed is contraindicated for use in high-acuity environments, such as the ICU or operating rooms, and is not intended to use on acutely or critically ill patients or those requiring time-critical or emergency intervention. EasyTeleMed is not intended for use in settings and on patients where the nature of changes in vital parameters is such that they could create an immediate danger to the patient.

    EasyTeleMed is intended for patients who are willing and capable of managing its use or can be assisted by a caregiver. Clinical judgement and experience by a clinician are required to check and interpret the information delivered.

    Device Description

    EasyTeleMed is a flexible and highly configurable telemedicine/telemonitoring platform for data collection, transmission, storage, analysis, visualization and data sharing among medical personnel.

    EasyTeleMed is a software-only device, composed by:

    • a centralized module, the EMR Plus, an application to be installed on a server machine, exposing a web interface and performing electronic medical record functions;
    • two mobile modules:
      • Home: a mobile application for patient physiological parameters self-acquisition at home;
      • Professional: a mobile application (also available in Point of Care version) for patient physiological parameters acquisition by healthcare operators during visits or in facilities;

    The mobile modules are enabled to communicate with a predefined set of COTS measurement sensors to acquire physiological parameters values from patients and forward the data to the EMR Plus module.

    The device aims at automatically monitoring at distance physiological parameters and signals, lifestyle information and in general the clinical status of the enrolled patients, and to support the physician decision-making process with clinical evidence.

    The system introduces a very high optimization of the out-of-hospital patient management processes, reducing errors due to manual transcription, the delay of information sharing and enabling the healthcare personnel to remotely assign personalized care plans and monitor at distance patients' health status in a more continuous way with respect to domiciliary or in-hospital visits.

    The result is a greater effectiveness and proactivity of the healthcare service. The medical staff, through the device, is able to recognize a worsening situation in the health status of a monitored patient more readily than with periodic visits only, being able to nip worsening situations in the bud and prevent possible hospitalization of the patient.

    The device does not replace periodic visits, nor should it be used in place of existing emergency channels/systems.

    The high configurability of the system allows the healthcare team to tailor the service on the specific patient's needs and to make adjustment easily during the monitoring period. The health care professional is also enabled, via the EMR, to set thresholds on the physiological parameters values, so that the system can generate notification events if an entered measurement violates one of the set thresholds, thus bringing the patient to the attention of the physician.

    The device does not provide for automatic thresholds; thresholds setting is entirely up to the health care staff and each threshold is patient-specific.

    Moreover, the device allows for surveys administration, prescriptions, and implements a communication mechanism between patient and physicians via videocalls and messaging.

    The device was conceived to refer to a patient population typically with a chronic or postoperative condition with a low likelihood of complications, but does not preclude the device from being used for other situations as well, should the physician feel that the patient would gain benefits from device employment.

    AI/ML Overview

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