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The IV/Medical Line Stabilizer is non-sterile, single use, identified in 21 CFR 880.5440, as a medical device intended to be used by personnel who are most often in contact with pediatric patients that have intravenous lines or medical lines attached to them. The IV/Medical Line Stabilizer is made of latex-free food grade transparent plastic. The primary purpose of this device is to reduce the risk of intravenous and other medical line entanglement. The design of the IV Stabilizer helps prevent IV wraps or medical line(s) from entangling around itself and around the patient.

The IV/Medical Line Stabilizer is non-sterile, single use, identified in 21 CFR 880.5440, as a medical device intended to be used by personnel who are most often in contact with pediatric patients that have intravenous lines or medical lines attached to them. The IV/Medical Line Stabilizer is made of latex-free food grade transparent plastic. The primary purpose of this device is to reduce the risk of intravenous and other medical line entanglement. The design of the IV Stabilizer helps prevent IV wraps or medical line(s) from entangling around itself and around the patient.

I am sorry, but based on the provided text, I cannot provide the requested information. The document is a 510(k) premarket notification letter from the FDA regarding a medical device called "IVY Devices Incorporated IV/Medical Line Stabilizer."

This type of document typically does not contain information about acceptance criteria, detailed study designs, sample sizes, expert qualifications, adjudication methods, or specific performance metrics of the device. Instead, it is an FDA letter confirming that the device has been found substantially equivalent to a legally marketed predicate device, allowing it to be marketed.

The text focuses on regulatory compliance, product classification, and general information about the device's intended use (reducing entanglement of IV and medical lines in pediatric patients). It explicitly states that the device is "non-sterile, single use" and made of "latex-free food grade transparent plastic." It does not present any clinical study data or performance evaluations.

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