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Perfudrop® Air M-P with Needle is an intravascular administration set to administer IV fluids and pharmaceuticals from a container to a patient's vascular system through a needle inserted into a vein. The administration set is for use under gravity and pressure conditions. The set is not intended nor indicated for use with blood or blood products.

The Perfudrop® Air M-P intravascular administration set (model no. 48451606) is a disposable, single-use Intravascular administration set intended for use under gravity and pressure conditions as well. The intravascular administration set uses a needle attached to the set. The design of the intravascular administration set is according to the requirements of ISO 8536-4. The design of the sterile hypodermic needle is according to the requirements of ISO 7864. The device includes a drip chamber with a 15 μm filter and a spike to penetrate and connect the tubing to an I. V. bag or other infusion fluid container, tubing, flow regulator and a connector to connect the needle to the set.

This document is a 510(k) summary for the Perfudrop® Air M-P With Needle intravascular administration set. It describes a medical device and its intended use, but it does not contain information about acceptance criteria or a study proving the device meets those criteria.

The purpose of a 510(k) submission is to demonstrate that a device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing technological characteristics and intended use. The provided text confirms the device's substantial equivalence to the predicate "Gemini IV Administration Sets" (K022209) based on its design according to ISO 8536-4 and ISO 7864 for the needle.

Therefore, I cannot provide the requested information from the provided text for the following reasons:

• No acceptance criteria are mentioned. The document focuses on regulatory approval based on substantial equivalence, not performance criteria.
• No specific study is described. There is no mention of a performance study, clinical trial, or any other investigation designed to test the device against acceptance criteria.
• The document is a regulatory submission summary, not a study report. It outlines the device's characteristics and its comparison to a predicate device for 510(k) clearance.

To answer your request, a detailed performance study report with predefined acceptance criteria would be necessary.

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