(26 days)
The Surflo Winged Infusion Set with Needle Protection (Surshield) is intended to access the peripheral vascular system, for intravenous administration of fluids and/or withdrawal of blood specimens using a syringe, luer adapter, or other compatible/appropriate devices. Additionally, after withdrawal of the needle from the patient's vein, the shield cover can be manually activated to cover the needle to minimize risk of accidental needle stick.
The 25 Gauge Terumo Surflo Winged Infusion Set with Needle Protection (Surshield) is a sterile, single use device consisting of a needle attached to a winged hub, tubing, adapter and adapter cap, and a hinged shield cover that attaches to the wing just below the needle-to-wing junction.
The shield cover can be turned 180 degrees on the hinge. As the needle is removed from the patient's vessel, the user's finger actively pushes the shield cover until it latches onto needle using a one- or twohanded technique. An audible click is noted upon activation. The shield cover is designed to allow the user's finger to remain behind the needle point so that the risk of needle stick injury is minimized. The shield cover is transparent for easy confirmation of the needle held in it.
The device possesses 350 mm length tubing.
The provided document is a 510(k) summary for a medical device, specifically an infusion set. It does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML powered device. The document primarily focuses on demonstrating substantial equivalence to a predicate device and outlining basic safety information as required for FDA clearance of a traditional medical device (like an infusion set), not an AI algorithm.
Therefore, I cannot provide the requested information from this document. The questions you've asked are typically relevant for the evaluation of AI/ML-powered medical devices, which this document does not describe.
§ 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.