PARADIGM SILHOUETTE - 379

• • Terminated Z-0359-2017 FDA Class II ·initiated 7 Nov 2014

  Tubing detachment

• • Terminated Z-0524-2015 FDA Class II ·initiated 4 Nov 2014

  Tubing may detach at the connect/disconnect location on the MiniMed Silhouette and MiniMed Sure-T infusion sets. Detachment causes interrupted insulin delivery and the pump will not alarm to notify your patient. This can lead to hyperglycemia, and diabetic ketoacidosis (DKA).

510(k) Number

K002138 ↗

FDA Product Code

FPA

Models / Variants

Mmt-377

378

379

380

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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See all devices from Maersk Medical A/S →

• What is the Paradigm Silhouette designed for?

  The Paradigm Silhouette is an intravascular administration set designed for delivering fluids or medications directly into a patient’s bloodstream via intravenous routes. It includes infusion tubing and catheters tailored for general hospital use, ensuring compatibility with standard infusion protocols. The device’s modular design allows for flexibility in clinical applications, accommodating different patient needs through varied tubing lengths and connector sizes.

• How is the Paradigm Silhouette supplied and intended for use?

  The Paradigm Silhouette is supplied as a sterile, single-use device, meaning each set is intended for one-time clinical application only. This design minimizes infection risks and ensures patient safety by preventing reuse. The sterile packaging must be maintained until use, and proper disposal follows standard medical waste protocols to uphold infection control standards.

• What models and configurations are available for the Paradigm Silhouette?

  The Paradigm Silhouette comes in four models: MMT-377, 378, 379, and 380. These models differ primarily in tubing length and catheter gauge, such as the 23-inch tubing with a 17mm connector in some configurations. This variety allows clinicians to select the appropriate set based on specific patient requirements, ensuring optimal intravenous therapy delivery.

• Is the Paradigm Silhouette reusable, or is it meant for single-use?

  The Paradigm Silhouette is explicitly designed as a single-use device. Single-use medical devices like this one are engineered to be used once and then discarded to prevent contamination and ensure patient safety. Reusing this device could compromise sterility and increase infection risks, which is why adherence to single-use guidelines is critical.

• How should the Paradigm Silhouette be stored to maintain sterility?

  The Paradigm Silhouette must be stored in its original sterile packaging until ready for use. The packaging is designed to protect the device from contamination, so it should remain unopened and undamaged. Proper storage conditions—such as in a clean, dry environment away from direct sunlight or extreme temperatures—are essential to preserve sterility and functionality until clinical application.