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FOR USE TO MAINTAIN PATENCY OF IN-DWELLING INTRAVENOUS ACCESS DEVICES (IVAD)

The Normal Saline Flush Syringe (the DEVICE) is a single dose, disposable, sterile, plastic pre-filled syringe. The DEVICE consists of a hypodermic syringe with a hypodermic barrel, stopper plunger, plunger rod, tip cap and 0.9% Sodium Chloride Iniection, USP. Two different sizes (6 mL, 12 mL) of hypodermic syringes will be utilized in manufacturing. The DEVICE will be marketed in the following dosage forms:

1 mL fill in 6 mL Syringe LL
2 mL fill in 6 mL Syringe LL
2.5 mL fill in 6 mL Syringe LL
3 mL fill in 6 mL Syringe LL
3 mL fill in 12 mL Syringe LL
5 mL fill in 6 mL Syringe LL
5 mL fill in 12 mL Syringe LL
10 mL fill in 12 mL Syringe LL

The barrel of the syringe is the reservoir for the product. It shall be overfilled during repackaging as per Pharmacopoeial Forum, Volume 26, Number 2: page 471. Plunger and plunger rod are the two moving parts of the DEVICE. The solution is delivered by pressing down on the plunger rod, resulting in the expulsion of the fluid from the luer tip.

The DEVICE will be filled using aseptic technique utilizing pre-sterilized components in a Class 100 environment. The sterile components of the DEVICE (hypodermic syringe, tip cap and 0.9% Sodium Chloride Injection, USP) will be purchased from qualified vendors.

The DEVICE is used to maintain patency of in-dwelling intravenous access devices (IVAD). The solution is delivered by pressing down on the plunger rod, resulting in the expulsion of the fluid from the luer tip.

The provided text describes a 510(k) summary for Medefil's Normal Saline Flush Syringe, focusing on its substantial equivalence to a predicate device. It does not contain information about acceptance criteria, specific studies proving the device meets those criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to the request. The document describes the device, its intended use, and how it differs from a predicate device.

Therefore, I cannot provide the requested information based on the given text.

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