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The Luth-All Safety Sub-Q Needle Set is a device intended to administer drugs to a patient from a container by infusion subcutaneously. It operates as a standard safety needle with the addition of a built in active safety feature which when activated the device is designed to aid in reducing the possibility of accidental needle sticks.

The Luth-All Safety Sub-Q Needle Set is a needle and administration set with a needlestick prevention feature, designed for use with a vascular access infusion system. It is manufactured with conventional medical grade, biocompatible materials. It operates as a standard safety needle with the addition of a built in active safety feature, which when activated the device is designed to aid in reducing the possibility of accidental needle sticks. It is supplied sterile for single use only.

The provided text is a 510(k) summary for the "Luth-All Safety Sub-Q Needle Set". This document describes a medical device for drug administration and its substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study proving that the device meets specific performance metrics.

The 510(k) process is primarily a premarket notification to demonstrate that a device is at least as safe and effective as a legally marketed predicate device. It typically relies on comparing the new device's characteristics (e.g., design, materials, intended use, technological features) to those of existing, cleared devices. While testing data might be included for comparison, this particular summary does not detail a specific performance study with acceptance criteria.

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