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For use in venous blood collection with attached butterfly needle or luer needle.

The Greiner Vacuette® Multiple Sample Luer Adapter is a device of which one end is a plastic male luer adapter and the other end is a sharpened stainless steel needle. The needle end of the luer adapter is epoxy bonded to the plastic upper end (hub) and is covered by a rubber sheath. The luer adapter is threaded into a needle holder for the purposes of attaching a butterfly needle for use in venous blood collection. The luer adapter is a sterile, single-use disposable device.

This is a 510(k) premarket notification for a Class II medical device, the Greiner Vacuette® Multiple Sample Luer Adapter. The submission claims substantial equivalence to a predicate device, the Greiner Medical's SURESHARP® Luer Adapter (K950159).

Therefore, the submission does not contain information on acceptance criteria, device performance studies, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.

The basis for claiming substantial equivalence is that both luer adapters "have the same intended use and contain the same material," and "are the same and purchased from the same supplier in Japan." This suggests that the substantial equivalence is being claimed primarily on the basis of material and design similarity to an already approved device, rather than through new performance studies.

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