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The Safety-Multifly® is a winged blood collection needle set with flexible tubing, an adapter for the S-Monovette® system, and an integral needle protector. The Safety-Multifly® is intended for blood collection via venipuncture. The Safety-Multifly® needle protector, when activated after removal from the patient, covers the used needle until it can be properly disposed; therefore, aiding in the prevention of needle stick injuries.

The Safety-Multifly® is individually packaged. sterile, single-use and non-pyrogenic.

The Safety-Multifly® is intended to be used in all hospitals and/or practices where S-Monovettes are used.

The Safety-Multifly® is a winged blood collection needle set with flexible tubing, an adapter for the S-Monovette® system, and an integral needle protector.

This document is a 510(k) premarket notification acceptance letter for a medical device (Safety-Multifly®), not a study report. Therefore, it does not contain the detailed clinical trial or performance study information requested about acceptance criteria, device performance, sample sizes, ground truth establishment, or expert involvement.

Here's a breakdown of why the requested information cannot be extracted from the provided text:

• Type of Document: This is a regulatory approval letter from the FDA, confirming that the Safety-Multifly® device is "substantially equivalent" to legally marketed predicate devices. It is not a clinical study report or a detailed technical performance report.
• Focus of 510(k): The 510(k) process primarily focuses on demonstrating substantial equivalence to a predicate device, meaning it has the same intended use and technological characteristics, or different characteristics that do not raise new questions of safety and effectiveness. It often relies on comparisons to existing devices and bench testing rather than extensive new clinical trials, especially for Class II devices like this one.

Because the document only states that the device is "substantially equivalent" to predicate devices, it does not provide the specific data requested in your prompt. The FDA's determination of substantial equivalence implies that the device meets the safety and effectiveness standards comparable to the predicate device, but the details of how that was demonstrated (e.g., through specific acceptance criteria and a study) are not included in this letter.

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