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The following ALARIS Medical Infusion Systems are intended for use in today's growing professional healthcare environment including healthcare facilities, home care, and medical transport that utilize infusion systems for the delivery of fluids, medications, blood and blood products:

• IVAC® Signature Edition® Infusion Pumps and Administration Sets. ●
• IVAC® MedSystem III® Multi-Channel Infusion Pump and IVAC MedSystem III® Multi-. Channel Infusion Pump with DLE and Administration Sets.
• IMED® Gemini Infusion Pumps/Controllers and Administration Sets. .
• ALARIS Medical Medication Safety System and Administration Sets. ●
• IVAC®, IMED®, and ALARIS® Gravity, Extension, Components, and Secondary . Administration Sets.

The following ALARIS Medical Infusion Systems are included in this Special 510(k):

• . IVAC Signature Edition Infusion Pumps & Administration Sets.
• IVAC MedSystem III Multi-Channel Infusion Pump & IVAC MedSystem III Multi-Channel Infusion Pump with DLE & Administration Sets.
• . IMED Gemini Infusion Pumps/Controllers & Administration Sets.
• ALARIS Medical Medication Management System & Administration Sets.
• IVAC, IMED, and ALARIS Medical Gravity, Extension, Components, & Secondary Administration Sets.

This document is a 510(k) premarket notification for ALARIS Medical Infusion System Administration Sets, not a study proving device performance against acceptance criteria. The submission is a "Special 510(k)" which affects only the labeling of the administration sets to improve consistency and customer satisfaction. It explicitly states that "The intended use, typical applications, and fundamental scientific technology for ALARIS Medical Infusion Systems have not changed with this Special 510(k) submission".

Therefore, the provided text does not contain any information regarding:

• Acceptance criteria for device performance.
• A study that demonstrates the device meets acceptance criteria.
• Sample sizes used for test sets or training sets.
• Data provenance.
• Number or qualifications of experts for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth used.
• How ground truth for a training set was established.

The document is a regulatory submission for a labeling change, asserting substantial equivalence to previously marketed devices, rather than a report on new performance testing.

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