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The Antimicrobial CLAVE® Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to an intravascular administration set for the administration of fluids to a patient through a cannulae placed in the vein or artery.

The connector includes two antimicrobial agents. The first agent is compounded with liquid silicone rubber to provide a protective seal around the cannula. The second agent is compounded with the polycarbonate alloy and is intended to reduce microbial contamination in the device fluid path. The antimicrobial agents are not intended for treating existing patient infections.

The ICU Medical Ag CLA VE is created with two different and effective antimicrobial agents. The first antimicrobial agent, compounded with the liquid silicone rubber (LSR), then molded into the plug that seals around and protects the first line of defense. The second antimicrobial agent, compounded with the plastics used to mold the cannula protects the fluid path from bacteria growth. Both the plug material and the cannula material are identical to the traditional CLA VE Connector as described in K970855 before the antimicrobial agents are compounded with them. Both the submitted and predicate CLA VE device are made up of three components; an internal plastic cannula (spike) which incorporates the fluid path, a plastic housing which allows for standardized ISO 594-1/2 luer lock connections and a silicone septum (plug) which provides the sealing mechanism and swabbing surface.

The provided document is a 510(k) summary for a medical device called the "Antimicrobial CLAVE". It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria, study details, or performance results in the format requested.

It states that "Efficacy and functional testing of the device are included in this submission" and "ICU Medical has also performed testing recommended by the draft guidance 'Premarket Notification [5]0(k)] Submissions for Medical Devices that Include Antimicrobial Agents' and has included that testing as part of this submission." However, these tests and their results are simply referenced as being included in the submission, not detailed within this particular 510(k) summary document itself.

Therefore, I cannot provide the requested information from the given text. The document acts as a summary of the intent to market and the basis for substantial equivalence, rather than a detailed report of the device's technical acceptance criteria and accompanying study results.

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