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510(k) Data Aggregation

    K Number
    K180410
    Device Name
    Dosis SAM
    Manufacturer
    Dosis, Inc.
    Date Cleared
    2019-01-16

    (336 days)

    Product Code
    MQS
    Regulation Number
    876.5820
    Why did this record match?
    Applicant Name (Manufacturer) :

    Dosis, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SAM is a web application used to obtain, track and trend patient data pertaining to the management of anemia, and to provide a schedule of erythropoiesis-stimulating agent (ESA) dosage recommendations to help achieve and maintain target hemoglobin (Hgb) levels in hemodialysis patients. The device is intended to help clinicians manage chronic anemia. The device is not a substitute for, but rather intended to assist, clinical judgment. The ESA dosing regimen options calculated by this device are intended to inform the optimization of the dosage of ESAs in accordance with their approved labeling in conjunction with clinical history, symptoms, and other diagnostic measurements, as well as the clinicians' judgment. No medical decision should be based solely on the patient Hgb response to dosing regimen options calculated by this device.
    Device Description
    SAM is a web application used to obtain, track and trend patient data pertaining to the management of anemia, and to provide a schedule of erythropoiesis-stimulating agent (ESA) dosage recommendations to help achieve and maintain target hemoglobin (Hgb) levels in hemodialysis patients. The device is intended to help clinicians manage chronic anemia. Healthcare professionals access SAM using a web-enabled application (for example, a web browser or a web-enabled electronic health record system) communicating with the SAM web application server. Patient information is obtained by SAM from healthcare provider Electronic Medical Records. No components of SAM are required to be installed at end user or healthcare provider locations. SAM estimates individual patient's Hgb response to ESAs. The results of this estimation are used to generate new patient-specific ESA dose recommendation to achieve target Hgb level specified by the physician. The ESA dose recommendation is reviewed by the physician, who after considering any additional relevant information about patient's condition, decides whether to follow or override the presented ESA dose recommendation.
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