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510(k) Data Aggregation

    K Number
    K142123
    Device Name
    REACH ACCESS TELEMEDICINE DOSE CALCULATOR
    Manufacturer
    Date Cleared
    2014-09-24

    (51 days)

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

    REACH HEALTH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The REACH Access Telemedicine Dose Calculator is designed for used by trained clinicians to calculate any individual patient's dose for a given agent based on a weight determined by the clinician. Drug dosing for a patient must be made only after careful consideration of the full clinical status of the patient by the ordering clinician and the software provides no validation as to the appropriateness of the entered weight-based dose. The REACH Access Telemedicine Dose Calculator is a convenience feature for trained clinicians based upon accurately entered data. No medical decision should be based solely upon the results provided by this software program. The REACH Access Telemedicine Dose Calculator is intended to be used as an aid in the consultative process and does not overrule or replace physician judgment or diagnosis.
    Device Description
    REACH Access is a highly integrated Telemedicine solution that combines workflow, video conferencing, electronic clinical documentation, and medical imaging into a comprehensive and secure internet-based service. It enables healthcare organizations to form virtual collaborative care teams which are created based on patient need rather than availability of specialists. With a flexible, template-based design tool, REACH Access can build template sets which support clinician workflow and documentation relevant to numerous protocols. REACH Access templates support a specific point-in-time consult. This means the workflow processes and clinical content is captured and coordinated with the integrated audio/video conference to allow a remote provider to collaborate with caregivers at a different location in the care of a patient. The normal process is the patient is assessed and treated in the Emergency Department (ED) by ED staff and the video conference support of a specialist consultant. After reviewing key patient data and assessing the patient, the remote consultant renders an impression, recommends the treatment order as indicated, and helps determine the appropriate disposition. This usually concludes the consultant's part in the session. The ED continues to render care by completing the recommended treatment order and monitoring patient vital signs and other assessments. The disposition commonly consists of transferring the originating hospital to the Hub with which the consultant is associated. However, if there is adequate local support, the decision may be made to admit the patient to the local facility. This process/workflow is similar to what may be required for other point-in-time consults needed to provide additional remote assistance to caregivers for other patient problems or conditions at the patient point of care. A protocol/template can be part of a coordinated collection of toolsets. The flexible template design process in REACH Access addresses the need for multiple protocols to support the various phases of care. The flexibility of the tool allows for the unique presentation of data for a specific condition; e.g., stroke, in the format most relevant to the patient's current need/condition. This flexibility can be replicated to address similar capability. This can be handled through a combination of both individual and a series of protocols arranged in clinically logical groups.
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