Search Results

The single use dialyzer with pre-attached blood tubing set is indicated for use with the Fresenius 2008 Series Hemodialysis systems for the treatment of acute and chronic renal failure.

The proposed device provides for the treatment of acute or chronic renal failure when used with the commercially available Fresenius 2008 Series hemodialysis systems. The device is a single use high flux (permeability) hollow-fiber dialyzer pre-attached to a blood tubing set.

The provided text describes a 510(k) premarket notification for the NxStage® Streamline Express for Fresenius 2008 Series Hemodialysis Systems. This submission focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with a test set, expert ground truth, or a multi-reader, multi-case study. Therefore, many of the requested criteria cannot be directly extracted from the provided document.

Here's a breakdown of what can and cannot be answered:

1. A table of acceptance criteria and the reported device performance

The document provides a comparative table of technological characteristics and in-vitro performance between the proposed device and predicate devices. The acceptance criteria are implicitly that the proposed device should have "Same" or comparable performance to the predicate devices, as well as meeting general safety and performance standards for hemodialysis components.

Ask a specific question about this device