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The Encore™ Neutral is intended for single patient use in intravenous and blood administrations and aspiration without the need for needles, thus eliminating the potential for needle-stick injuries during use.

The Encore™ Neutral may be used with low pressure power injectors having a maximum pressure of 325 psi and a maximum flow rate of 10 mL/sec. The subject device does not have to be changed subsequent to use with a low pressure power injector.

The Encore™ Neutral is a luer activated needleless IV Connector that is disposable and for single patient use. It includes the following features:

• . smooth swabbable surface
• . tight seal integrity with no gaps or openings
• straight-through fluid pathway resulting in zero dead space ●
• 100% effective blood clearing
• neutral fluid displacement ●
• . low priming volume
• saline-only flush option
• . no clamping sequence or positive pressure syringe technique required

The Encore™ Neutral is a sterile single-use device which is provided individually packaged. The Encore™ Neutral is also provided bulk non-sterile, to be further processed (packaged and sterilized) by another manufacturer.

The Encore™ Neutral is available with an optional protective end cap attached to the male luer of the device.

The Encore™ Neutral is compatible with ISO 594 compliant male luer slip devices and male luer lock devices.

The Encore™ Neutral is composed of medical grade materials that are not made with Bisphenol A (BPA), di-2-ethylhexyl phthalate, diethylhexyl phthalate (DEHP) or natural rubber latex. The materials used have been subjected to and have passed biocompatibility testing per the latest ISO 10993 standards.

The Encore™ Neutral is MR Safe as it does not contain metallic, magnetic or metal components.

The Encore™ Neutral may be used with low pressure power injectors having a maximum pressure of 325 psi and a maximum flow rate of 10 mL/sec. The device does not have to be changed subsequent to use with a low pressure power injector. When used with a low pressure power injector, the Encore™ Neutral must be secured with other devices rated for pressures up to 325 psi with a luer lock connection.

This document describes the Encore™ Neutral device, an intravenous (IV) connector, and its substantial equivalence to a predicate device. However, it does not contain a study that proves the device meets specific performance acceptance criteria in the manner you've requested (e.g., using a test set, ground truth, expert adjudication, etc.). The document focuses on regulatory approval (510(k)) based on substantial equivalence to an existing marketed device.

Here's an analysis based on the information provided, highlighting what is and is not present:

Summary of Acceptance Criteria and Device Performance (Limited Information)

The document states that "All testing met the predetermined acceptance criteria." However, the specific quantitative acceptance criteria and the corresponding reported device performance values are generally not provided in a detailed table format within this regulatory submission. For most items, it only lists the "performance test conducted" without numerical criteria or results.

Detailed Information as Requested:

1. A table of acceptance criteria and the reported device performance
   • As shown in the table above, the document lists performance tests and states that "All testing met the predetermined acceptance criteria." However, it does not provide the specific numerical acceptance criteria for each test (e.g., "activation force must be >X and

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