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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.

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