(90 days)
Intended for use in removing solutes or fluid in renal supportive therapies in an acute setting. This filter can be used for intermittent and continuous therapies.
The RAC 100 Filter is intended for use in the following continuous veno-venous therapies:
- continuous veno-venous hemofiltration (CVVH)
- continuous veno-venous hemodialysis (CVVHD)
The RAC 100 Filter is intended for use in the following intermittent therapies, e.g. slow low efficiency dialysis (SLED) or other renal supportive therapies of less than 8 hours duration.
The Fresenius Renal Acute Care (RAC 100) Filter is substantially equivalent in construction, design, materials, and intended use to the commercially available Fresenius Optiflux F160NR, Gambro Hospal Multiflow 100 Hemofilter and the Gambro M100 Hemofilter.
The provided text is a 510(k) Summary for the Fresenius Renal Acute Care (RAC 100) Filter. It discusses the device's substantial equivalence to predicate devices but does not contain information about specific acceptance criteria, performance studies with detailed results, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence based on intended use, technological characteristics, and general safety/effectiveness, rather than presenting a detailed study with quantitative acceptance criteria and performance metrics.
§ 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.”