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For the delivery of I.V. solutions by or on the order of a physician or other licensed practitioner.

PROTOS® 100ml Burette Infusion Set/PROTOS® 150ml Burette Infusion

This document is a 510(k) summary for the PROTOS® 100ml and 150ml Burette Infusion Sets. It's a regulatory letter from the FDA to Globe Enterprises, Incorporated, dated December 17, 1997, indicating that the device has been found substantially equivalent to predicate devices.

This document does not contain information about acceptance criteria or a study proving that the device meets those criteria. It is a regulatory clearance letter, not a scientific study report. Therefore, I cannot extract the requested information such as:

• A table of acceptance criteria and reported device performance
• Sample size used for the test set and data provenance
• Number of experts and their qualifications
• Adjudication method
• MRMC comparative effectiveness study results
• Standalone performance
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

The document primarily focuses on:

• The FDA's determination of substantial equivalence (K972839) for the PROTOS® Burette Infusion Set.
• The regulatory classification (Class II, Product Code FPA).
• Indications for Use: "For the delivery of I.V. solutions by or on the order of a physician or other licensed practitioner."
• General regulatory requirements applicable to the device.

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