Search Results

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.

Ask a specific question about this device