(77 days)
The HuberPRO ™ Safety Huber Infusion Set is intended to administer solutions and medications into vascular implant ports. In addition, to minimize the risk of accidental needle stick injury after use, the attached safety guard fully encapulates the needle when manually activated during withdrawal.
The device consists of a Protector cap, female Luer lock, PVC tubing, two each 4 inch, or one 8 inch tubing length and ( .3 mm) ID, a pinch clamp, with and without a needle free y- site, a butterfly wing, a safety needle guard, an AISI 304 (19ga., 20ga., 22ga.) stainless steel needle, and a needle sheath.
The provided text is a 510(k) premarket notification summary for a medical device, the "HuberPRO™ Safety Huber Infusion Set." This type of submission focuses on demonstrating substantial equivalence to pre-existing devices rather than detailing specific studies with acceptance criteria for device performance in a clinical or diagnostic setting. Therefore, the document does not describe acceptance criteria for device performance or a study proving the device meets those criteria in the way one might expect for an AI/machine learning medical device.
Instead, the document asserts: "Based on the fact that the HuberPRO™ Safety Huber Infusion Sets utilizes similar and equivalent designs, components, manufacturing Processes as currently legally marketed Products, the Safety Huber Infusion Set is safe and effective when used as intended." This statement serves as the justification for its safety and effectiveness, relying on the substantial equivalence principle rather than new performance data with discrete acceptance criteria.
Consequently, I cannot fill out the requested table and sections as they pertain to performance metrics and studies typical for AI/ML devices. The information simply isn't present in this 510(k) document.
§ 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.