Summary: The FDA has classified intravenous catheter force-activated separation devices as Class II, establishing special controls to ensure safety and effectiveness. This classification follows a request from Lineus Medical for their SafeBreak Vascular device. The device is designed to reduce IV catheter failures, enhancing patient access to innovative, beneficial technologies.

Key Takeaways:

  • Class II Classification: The FDA classified intravenous catheter force-activated separation devices as Class II with special controls for safety and effectiveness.
  • Device Purpose: The device, placed in-line with IV catheters, is designed to reduce the risk of catheter failures requiring replacement.
  • Regulatory Background: The classification follows a De Novo request from Lineus Medical, with the FDA finalizing the classification in August 2024.

The U.S. Food and Drug Administration (FDA), announced that it is classifying the intravenous catheter force-activated separation device into class II (special controls).

Special Controls for Safety and Effectiveness

The special controls that apply to the device type will be part of the codified language for the intravenous catheter force-activated separation device’s classification. The FDA stated that it took this action because it determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. The action is also expected to enhance patients’ access to beneficial innovative devices.

Criteria for Class II Classification

The FDA classifies devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use.

Background on the SafeBreak Vascular Device

On Sept. 18, 2019, FDA received a request from Lineus Medical for De Novo classification of the SafeBreak Vascular intravenous catheter force-activated separation device.

After review of the information submitted in the request, the agency determined that the device can be classified into class II with the establishment of special controls. FDA determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device.

Final Codification and Device Identification

The FDA issued an order in 2021 classifying the device as Class II and on Aug. 16, 2024, the agency officially codified the order. The FDA named the generic type of this device an intravenous catheter force-activated separation device and it is identified as a device placed in-line with an intravenous (IV) catheter and an intravascular administration set, including any administration set accessories. It separates into two parts when a specified force is applied. The device is intended to reduce the risk of IV catheter failure(s) requiring IV catheter replacement.