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The S.P.A.R.TM Sterile Ambulatory Reservoir is intended for use with the Pharmacia Deltec CADD® Model 5800 Ambulatory Infusion Pump, manufactured and distributed by Sims Deltec Inc. St. Paul, Minnesota. The S.P.A.R.™ Medication Reservoir is intended for use as an accessory to the Pharmacia Deltic CADD® infusion punip by replacing the Deltic Medication Cassette™, Model 2050 - 50 mL and 2100 - 100 mL with the S.P.A.R. Reservoir.

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This document is a 510(k) notification from the FDA regarding a Sterile Ambulatory Reservoir (S.P.A.R.™). It is a letter of substantial equivalence, which means the device is deemed equivalent to a legally marketed predicate device.

The document does not contain information about acceptance criteria, device performance, studies to prove performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.

Therefore, I cannot provide the requested information based on the provided text.

The document primarily focuses on:

• The FDA's decision regarding the 510(k) submission.
• The regulatory classification of the device (Class II).
• General controls and potential additional controls applicable to the device.
• Contact information for further regulatory inquiries.
• The intended use of the S.P.A.R.™ Sterile Ambulatory Reservoir as an accessory to specific infusion pumps.

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