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The Nipro SafeTouch LOCKTAIL™ is intended for use as a blood access device for blood purification and for other treatments requiring extracorporeal circuit. The Nipro SafeTouch LOCKTAIL ™ aids in the prevention of accidental needle stick injuries. The compatibility of available configurations is the responsibility of the physician in charge.

The NIPRO SafeTouch LockTail™ Safety Fistula Needle is a sterile, single use, safety AVF needle. It consists of an arterial and venous adapter, flexible tube and needle with an active sharps safety feature (non-implanted blood access device) as described in 21 CFR 876.5540.

The NIPRO SafeTouch LockTail "" includes 2 basic types of designs; fixed wing type (stationary) and turnable wing type (rotating). These two designs are offered in 80 configurations with options that include needle gauge (14-18G), needle length (1" and 1 ¼"), type of needle (with or without backeye), clamp color (white, red/blue), and tubing length (150 and 300 mm).

The integrated sharps injury prevention feature requires physical action by the clinician to activate and is designed to cover the needle tip after treatment. Correct use of this anti-stick feature will eliminate accidental needlesticks.

These devices operate on the principles of a blood access device. They are sterile, single use only, non-toxic and non-pyrogenic.

I am sorry, but based on the provided text, there is no detailed information about specific acceptance criteria or the study that proves the device meets those criteria in the format you described.

The document is a 510(k) summary for a medical device (NIPRO SafeTouch LockTail™ Safety Fistula Needle), which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed report of performance against specific, quantifiable acceptance criteria.

Here's what the document does state regarding testing:

• Non-clinical tests submitted: "The results of biocompatibility data support the equivalence of the predicate device and include sterility, bacterial endotoxin, systemic injection, intracutaneous reactivity, hemolysis and implantation testing. Performance testing was also conducted and is included in this submission."
• Conclusions drawn from non-clinical and clinical tests: "The results of the performance testing and the comparison of technological characteristics with the predicate device demonstrate that the NIPRO SafeTouch LockTail™ Safety Fistula Needle performs equivalent to the predicate device and is safe and effective when used as intended."

However, it does not provide:

1. A table of specific acceptance criteria (e.g., "sharps injury rate

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