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Kendall Monoject PreFill™ ADVANCED™ 0.9%Sodium Chloride Flush Syringes for Sterile Delivery is indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.

The proposed device is an extension to the Kendall Monoject PreFill™ ADVANCED™ Flush Syringe line is to include one or more PreFill syringe configurations equivalent to those already marketed by Tyco Healthcare with the syringe delivered to the customer in a package that will maintain the sterility of the syringe exterior surface.

The provided text is a 510(k) summary for a medical device: "Kendall Monoject PreFill™ ADVANCED™ 0.9%Sodium Chloride Flush Syringes for Sterile Delivery." This document describes the device, its intended use, and its substantial equivalence to a legally marketed predicate device.

However, the provided text does not contain any information about acceptance criteria or a study proving that a device meets those criteria in the context of an algorithm or AI performance. The document is for a physical medical device (pre-filled syringes) and a 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device, primarily through nonclinical testing (like biocompatibility) and comparison of technological characteristics.

Therefore, I cannot provide the requested information, such as:

• A table of acceptance criteria and reported device performance (for an algorithm).
• Sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, type of ground truth used, or training set details.

The nonclinical testing mentioned in the document is:

Nonclinical Testing:

• Biocompatibility testing against ISO Standard 10993, Part 1 and FDA modified matrix (G95-1).

This testing is relevant to the safety and compatibility of the physical syringe and its contents with the human body, not to the performance of any AI or algorithmic component.

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