(83 days)
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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§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.