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The Dideco ATS Autotransfusion Cardiotomy Reservoir is an accessory to an autotransfusion device and is intended for the sterile collection and filtration of recovered blood for subsequent processing for autotransfusion.

The Dideco ATS Autotransfusion Cardiotomy Reservoir (Dideco ATS) is a modification of the Dideco-Shiley ACR-40 Autotransfusion Reservoir (ACR-40) (K884872). The Dideco ATS is identical in intended use and fundamental technology to the previously cleared autotransfusion reservoir. Both the proposed and predicate devices consist of a reservoir with an internal filter system. The proposed device is available with two different means of removing fluids from the reservoir. The "draw tube configuration" has a draw tube attached to a fluid outlet port in the reservoir cover. Fluids may also be drained from this version of the reservoir via a piercable connector at the bottom of the reservoir housing. In the second form of the device, the "bottom outlet" version, the fluid outlet port is located on the bottom of the housing. In both configurations of the device, fluids enter the reservoir through an inlet port in the reservoir cover which is connected to the internal filter system. There is also a Luer lock connector on the reservoir cover which bypasses the filter system. Both versions of the reservoir also contain an overflow valve to prevent the volume of fluid in the reservoir from exceeding the maximum holding capacity.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance for Dideco ATS Autotransfusion Cardiotomy Reservoir

This 510(k) summary describes a device that is a modification of a previously cleared autotransfusion reservoir. The study presented aims to demonstrate substantial equivalence to the predicate device (Dideco-Shiley ACR-40) rather than establishing de novo performance targets. Therefore, the "acceptance criteria" are implicitly that the new device performs comparably or acceptably to the predicate device for key functional and safety aspects.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) summary for a modified device, the acceptance criteria are not explicitly stated as numerical thresholds but rather as maintaining comparable performance or successful completion of safety tests.

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