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The EMED Tetra Micro Infusion System is intended for subcutaneous infusion for prescription liquid medicines for use in the home and hospital environment by adults and children (2 years and older), when administered according to the approved biologic or drug product labeling. The Tetra Micro Infusion System is indicated for use with:

• Hizentra Immune Globulin Subcutaneous (Human) 20%, manufactured by CSL Behring.

The Tetra Micro Infuser is a reusable multi-patient use device, battery powered, prescription-only, designed to be used as a system for subcutaneous infusion using compatible syringes through EMED patient administration sets.

The syringe connects to the Tetra Micro Infuser, and the patient administration sets connects to the syringe. Patient administration sets are sterile and single use only.

There are 2 model options for the Tetra Micro Infuser: TM-20 (designed to connect to a 20mL syringe); and TM-50 (designed to connect a 50mL syringe). The TM-50 model can be used with 5 mL, 10 mL, and 20 mL syringe sizes when used with the optional Syringe Adapter (single-use, non-sterile; sold separately). Once attached to the syringe, the Syringe Adapter is not intended to be removed.

The patient administration sets are commercially available, previously marketed devices (K140131) and support the subject device without modification.

The Tetra Micro Infuser is designed for use in home and healthcare facility environments.

The Tetra Micro Infuser functions by applying controlled pressure to the syringe stopper (gasket) to deliver medication through the connected patient administration sets.

The user interface consists of two buttons used to power the device on/off and to select discrete delivery settings. The resulting flow rate depends on the selected setting and system factors such as syringe size, medication viscosity, and downstream resistance.

The device provides visual and audible notifications for status and certain conditions. The device battery is charged through a USB-C port, and infusion is disabled during charging. There is no user-accessible wireless or networking connectivity, and USB communication is restricted to factory/service access.

The Tetra Micro Infuser does not require calibration. Periodic cleaning of external surfaces is recommended between uses, and the infuser should be disinfected by healthcare or facility personnel between each patient when transferring to a new user.

Each Tetra Micro model is packaged in a labeled box containing: one infuser (either Tetra Micro TM-20 or TM-50); one USB-C to USB-A charging cable; one Instructions for Use document; and one Quick Reference Guide document.

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