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The function of the VanishPoint® Tube Holder is to provide a safe and reliable method for facilitating blood withdrawal from a patient into evacuated blood collection tubes without exposing the phlebotomist to an accidental needlestick injury. The VanishPoint® Tube Holder works like a conventional tube holder except for its ability to retract the contaminated needle inside of the tube holder immediately after blood collection. Regular size collection tubes are inserted into the tube holder blood through the blood collection needle. Regular size collection tubes are 13mm and 16mm diameter. After the last evacuated tube is removed and the tube holder endcap is pressed onto the back-end of the needle retraction mechanism is automatically activated and the contaminated needle is withdrawn from the patient's vein and carried into the tube holder. This automatic needle retraction protects the phlebotomist from an accidental needlestick. The tube holder cannot be reused. Accidental needlesticks typically occur between removing the needle from the patient, removing the needle from a reusable tube holder and disposing of the needle into a sharps disposal container.

The function of the VanishPoint®Small Tube Adapter is to permit the phlebotomist to use the VanishPoint® Tube Holder with small volume blood collection tubes. Small volume collection tubes are 10.25mm in diameter. The tube adapter is inserted into the tube holder and the small collection tube is inserted into the tube adapter. After the evacuated tube is filled with blood, the tube adapter is removed from the tube is removed from the tube adapter. The tube adapter can be reused.

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I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a medical device (Blood Collection Tube Holder Vanishpoint™) and an "Indications For Use" statement.

It details the substantial equivalence determination for the device, its intended use, and regulatory information. However, it does not include:

• A table of acceptance criteria and reported device performance.
• Information about specific studies, sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods.
• Details on multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.

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