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The intended use of the MedSystem III Infusion Pump is to deliver a wide variety of drugs and fluids (e.g., bloods, lipids, saline, dextrose) over a broad range of infusion rates, at high levels of accuracy. IVAC's policy is to not indicate specific drugs and/or fluids. Specific intended uses include enteral, intravenous, and epidural deliveries.

The Drug Editing Software Kit (DESK) allows the user to customize the resident drug list for the Dose Rate Calculator (DRC) feature that is available in the legally marketed MedSystem III Infusion Pump. The current system allows custom changes on a one by one basis. The DESK system allows users to make permanent custom changes to the resident drug list.

The DESK is a PC-based software tool operated under Microsoft Windows. This software tool will be used to customize the drug list for the Dose Rate Calculator (DRC) feature that is already available in the legally marketed MedSystem III Infusion Pump. The DESK allows the user to access the factory default druq list in the infusion pump via the Field Maintenance Software (FMS). After access the user can add, modify, or delete drug names and dosing parameters. The modified list can then be downloaded into the MedSystem III Infusion Pump via the FMS. The FMS is already available as a legally marketed accessory to the MedSystem III Infusion Pump.

The provided text is related to a 510(k) submission for the IVAC MedSystem III™ Infusion Pump with Drug Editing Software Kit (DESK). However, it is a regulatory document and does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested.

The document primarily focuses on:

• Device Description: The DESK is PC-based software to customize the drug list for the Dose Rate Calculator (DRC) feature of the MedSystem III Infusion Pump.
• Intended Use: To allow users to add, modify, or delete drug names and dosing parameters. The pump itself delivers fluids at high accuracy.
• Technological Characteristics: States that the MedSystem III Infusion Pump has not changed and the DESK has the same technological characteristics as an existing software accessory (FMS). It highlights that a similar feature allowing single drug list customization already exists, and DESK enables permanent customization. Crucially, it states: "The technological characteristics of the devices are the same and raise no new questions of safety and effectiveness."
• Substantial Equivalence: The primary conclusion is that the device is substantially equivalent to existing legally marketed devices, and no new questions of safety and effectiveness are raised.

Because the submission claims substantial equivalence and states no new questions of safety and effectiveness are raised by the DESK software, no new performance studies are presented or required within this document. Therefore, I cannot provide the requested information regarding acceptance criteria and performance study details.

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