(80 days)
Optiflux dialyzers are intended for hemodialysis, hemodiafiltration, hemofiltration, and isolated ultrafiltration in patients with acute kidney injury or chronic kidney disease when conservative therapy is judged to be inadequate.
The Optiflux dialyzers are part of the FMCRTG family of single use dialyzers which allow for the transfer of water and solutes between blood and the dialysate through a semi-permeable membrane. The Optiflux dialyzers are available in three (3) sizes. The sizes are differentiated by housing size, fiber count per bundle, and effective membrane surface area.
Optiflux dialyzers are high-flux, sterile devices designed for single use hemodialysis and hemodiafiltration for the treatment of acute kidney injury or chronic kidney disease. The dialyzer is configured to connect to a bloodline set which connects to a patient's vascular access system when used with a dialysis machine equipped with ultrafiltration control. During treatment, blood is pumped from the patient's body through an extracorporeal circuit, one component of which is the dialyzer contains a semi-permeable membrane that allows for diffusion and/or convection to transport toxins and excess fluid from the blood compartment (fiber lumen) to the dialysate or filtrate compartment. Dialyzers utilize a counter-current flow in which dialysate and blood flow in opposite directions in the dialyzer during hemodialysis. The counter-current flow maintains the concentration gradient across the membrane for waste and fluid removal.
The provided text does not contain information about an AI/algorithm-based device. The device described, Optiflux® Series of Dialyzers, is a medical device for hemodialysis, hemodiafiltration, hemofiltration, and isolated ultrafiltration. Therefore, this document cannot fulfill the request to provide details about acceptance criteria and study proving device meets acceptance criteria for an AI/algorithm-based device.
§ 876.5860 High permeability hemodialysis system.
(a)
Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K
uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.).
(3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).
(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ”
(2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,”
(3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,”
(4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and
(5) “Guidance for Hemodialyzer Reuse Labeling.”