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510(k) Data Aggregation

    K Number
    K220935
    Device Name
    Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App
    Manufacturer
    iRen-Medical, Ltd
    Date Cleared
    2022-12-29

    (273 days)

    Product Code
    FKX
    Regulation Number
    876.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    iRen-Medical, Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intelligent Dialysis Assistant (IDA) is intended for automatic single exchange of dialysate solution exchanges in the treatment of adult renal failure patients undergoing peritoneal dialysis. All therapies using the Intelligent Dialysis Assistant (IDA) must be prescribed and performed under the responsibility of a physician who is familiar and well informed about peritoneal dialysis. The patient prescription may include single or multiple exchanges, depending on the patient's need. The IDA Cartridge is a single-use, sterile cartridge exclusively for use with the IDA. It is intended to interface the IDA with the Twin Bag Set (patient dialysis prescription) and the patient's peritoneal catheter. The Medical Supervision Portal is intended for use by healthcare professionals to remotely communicate new or modified treatment parameters with compatible dialysis instruments and transfer completed treatment database to aid in the review, analysis, and evaluation of patients' historical treatment results. This Medical Supervision Portal is not intended to be a substitute for good clinical management practices, nor does its operation creatment pathways. The IDA Smartphone App is a software medical application intended for patients to review their treatment and review and approve their dialysis prescription provided by the healthcare professional through the Medical Supervision Portal. The user is not intended to take clinical action based on the application of a qualified healthcare professional.
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