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Improve Blood Collection Set and Improsafe Blood Collection Set are winged blood collection needles with flexible tubing and a female luer adapter intended for venipuncture to obtain blood samples from patients. Some reorder numbers are provided with a male luer adapter. The male luer adapter contains a non- patient needle end for puncturing the stopper of an evacuated blood collection tube. Those without a male luer adapter are provided with a protective cap on the end of the female luer adapter.

The Improsafe Blood Collection Set is provided with an attached safety shield for covering the used needle prior to disposal. After withdrawal of the needle from the patient's vein, the attached safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle stick.

The Improve Blood Collection Set and Improsafe Blood Collection Set is also indicated for short-term (up to 2 hours) intravenous administration of fluids and may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused and duration of therapy. For devices that include the male luer adapter: after removing the attached male luer adapter from the blood collection set, connect the female luer adapter to a syringe or other compatible/appropriate device.

Improve Blood Collection Set and Improsafe Blood Collection Set are winged blood collection needles with flexible tubing and a female luer adapter. The Improsafe Blood Collection Set includes an attached safety shield.

I am sorry, but the provided text does not contain information about the acceptance criteria for a device, nor does it describe a study that proves a device meets such criteria. The document is an FDA 510(k) clearance letter for the "Improve Blood Collection Set and Improsafe Blood Collection Set," specifically an administrative change letter and the original clearance letter with indications for use. It confirms that the device is substantially equivalent to a predicate device and outlines general regulatory information but does not detail performance acceptance criteria or a study proving their achievement.

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