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This device is intended solely for processing (e.g., in vitro rinsing) of hemodialyzers. Any subsequent clinical use of the dialyzer processed by this machine is the sole responsibility of the patient's physician.

The Seratronics DPS 4 Dialyzer Preparation System is an automatic four-station rinsing machine for removing formaldehyde, glutaraldehyde or peracetic acid from reused dialyzers. Dialyzers are stored filled with the germicide and with the venous and arterial blood ports connected by a filled tubing segment that includes a sample site. This provides a blood side circuit that can be recirculated while the germicide is removed by the process of diffusion across the membrane. The system removes the germicide from the dialyzer by delivering AAMI quality (RD5. 1992) water to the dialysate side of the dialyzer at a controlled temperature and flow rate while the blood side fluid is recirculated by a tubing pump. The germicide is diffused from the blood compartment of the dialyzer to a final concentration prescribed by the physician. The blood side of the dialysis circuit is never opened during the rinsing process on the DPS 4 rinse machine. At a predetermined time in the recirculation cycle (selected on the front panel), an alarm sounds, indicating that the rinse time has been completed. The blood and dialysate side flow continue when this end-of-cycle alarm occurs. A proprietary buffering agent, RINSE-QUICK concentrate, can be added to the rinse solution to reduce rinse out times with formaldehyde only.

The provided text describes the Seratronics DPS 4 Dialyzer Preparation System, an automatic four-station rinsing machine for removing germicides (formaldehyde, glutaraldehyde, or peracetic acid) from reused dialyzers. The core of the submission focuses on demonstrating the effectiveness of a proprietary buffering agent, RINSE-QUICK concentrate, in reducing formaldehyde rinse-out times.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" for the DPS 4 system itself in terms of numerical thresholds that must be met for device approval. Instead, the study aims to demonstrate the effectiveness of the Rinse-Quick concentrate in reducing rinse times to achieve physician-prescribed final germicide concentrations.

The "acceptance criteria" can be inferred as the ability to reduce germicide (specifically formaldehyde) to a safe level, which is then verified by a manual test by medical professionals prior to patient connection. The reported performance is the reduction in rinse time with the use of Rinse-Quick concentrate compared to rinsing with RO water alone.

Detailed Reported Device Performance for Formaldehyde Rinse-out Rate (with Rinse-Quick concentrate):

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