FDA's new ACE pump classification for the t:slim X2 insulin pump

Mar 20, 2019, 17:09 PM

On February 14, 2019, we announced that the t:slim X2™ insulin pump is the first toreceive approval in a new device category called alternate controller enabled infusion (ACE) pumps.

The FDA has now established special controls for ACE pumps; requirements for assuring the accuracy, reliability, cybersecurity and clinical relevance; as well as descriptions for the type of studies and data required to demonstrate acceptable pump performance. The recent ACE designation for the t:slim X2 pump states that it is capable of reliably and securely communicating with compatible external devices, and dosing software. We are very proud of this!

You may have heard people talk about iPumps … iPump was the assumed name for this category, but ACE pump is what the FDA ultimately named it. When the FDA named the interoperable CGM category “iCGM” last year, people began referring to the future interoperable pump category as “iPump.” ACE pump is the correct name of this new category.

What this REALLY means for our customers and the diabetes community:

This new designation does not represent a new product launch or any notable changes to the basic t:slim X2 insulin pump hardware. In-warranty t:slim X2 pump users will continue to have access to future software improvements and enhancements via remote software updates as they clear the necessary regulatory requirements.*

This new category of devices will make it easier for separate companies to integrate their products into advanced automated insulin delivery systems without having to resubmit each of the components and their associated clinical data every time. It’s a great move on the behalf of the FDA to make it easier for companies with leading-edge technologies to more quickly develop and deliver innovations for the diabetes community.

What this may mean for future uses:

It is too early for us to speculate on what this ACE designation means for future product development or integrations with non-Tandem-automated insulin delivery algorithms. We don’t currently have plans to make the t:slim X2 pump an open-platform device. At this time, our development resources are 100% dedicated to the products currently in late-stage development. Even with the new interoperable designation, integration with new algorithms would require some meaningful software development efforts and user interface adjustments. We will require that our business relationships allow us to provide Tandem pump users with adequate technical support and continue to meet regulatory reporting requirements for any integrated systems that include our technology. Because of this, we plan to be very purposeful and deliberate about how and when we partner on integrated system components to ensure our customers have the best possible experience.

The designation does not impact our current products in development. We have been working closely with the FDA on previous and ongoing submissions and have been incorporating their thoughts on interoperable device standards into our activities.

We have been getting a lot of questions about phone control for pumps, and what impact this new ACE pump designation could have for us on this front. Currently, no pumps on the market can be controlled by a smartphone, but it is high on the list of things all insulin pump companies would ultimately like to deliver. As you can imagine, given the variety of phones out there, the FDA has a number of security and safety questions that would have to be addressed before control of a pump using a smartphone could be approved. While the regulatory path has not yet been determined, it is of great interest to us and is something we are certainly looking into. This new ACE pump designation is a first step in that direction.

We believe this designation further establishes the role we have as a key innovator in the insulin pump industry, having launched the first touchscreen pump in the United States, the first pump capable of remote feature updates, the first pump approved as iCGM compatible, and now, the first in this new interoperable pump category.

Many thanks to everyone who is following this journey!

 

* A prescription and/or additional training may be required to access certain future software updates, and charges may apply. The determination regarding cost will be made individually for each software update.