Introduction
January 2023, Israeli company liberDi received FDA 510(k) clearance for its Intelligent Dialysis Assistant (IDA). The company’s Intelligent Dialysis Assistant allows patients to undergo dialysis outside a clinic while being remotely supervised by a healthcare professional. Device comes with an IDA cartridge with a medical supervision portal, and IDA smartphone app.
IDA gives a flexibility to patient to use the device at home. This allows patients to undergo peritoneal dialysis outside of a clinic while being remotely monitored by a medical professional via the device’s telemedicine capabilities. Peritoneal dialysis is one of the two methods of treating kidney failure and is typically performed at a dialysis center or in a hospital by trained healthcare professionals. The IDA device permits automatic single or multiple exchanges of dialysate solution for adults with renal failure. It comes with a single-use cartridge that interfaces with the Twin Bag Set (should that be the patient’s dialysis prescription) and the patient’s peritoneal catheter. The medical supervision portal is a physician-facing platform for healthcare professionals to oversee the patient’s dialysis treatment, and the IDA smartphone app allows patients to review their healthcare professional’s treatment recommendations. This system provides a cutting edge toolbox scaling up high-quality services to Health Care Professionals: existing and new dialysis organizations, as well as independent clinics and hospitals. Once registered on liberDi’s Digital Dialysis Clinic, Health Care Professionals can immediately provide personalized service through a secure cloud-based Digital Illness Management Portal
Device Name
Digital Dialysis Clinic – Intelligent Dialysis Assistant (IDA) & IDA Cartridge with Medical Supervision Portal and IDA Smartphone App
Device Details:
The liberDi portable PD system (PPDS™) is a portable automatic device for peritoneal dialysis (PD) exchange. It uses a small rechargeable battery-operated pump for injection/ejection mechanism to drain and fill the dialysate at a controlled rate, with automatic disinfection of the connectors which increases the safety of PD. The PPDS™ also enables monitoring the effluent stream speed, ultrafiltration and transmits the data to a PD centre to allow remote monitoring and detection of effluent characteristic changes that may indicate catheter malfunction or peritonitis.
Indications for 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 data to a central 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 create decisions or treatment pathways. The IDA Smartphone App is a software medical application intended for patients to review their treatment parameters 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 output without consultation of a qualified healthcare professional.
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