Good news, another important step in the right direction, kudos to Tandem: FDA authorizes first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices
This is fantastic news!
This is huge!
Wounder if it will work with diy closed loop systems. Regardless this could be great.
Unless i read or understand this incorrectly, it should make it easier to get FDA approval on future products by using a “bolt on to existing approved item” type of mentality. So instead of needing to re-prove that a wheel turns every time an iteration of product is developed the mfrs can seek approval on the change as an add-on to the existing.
For example: Dexcom develops the G(x) and gets FDA approval. XQR pump mfr gets FDA approval for the XQR pump. Essentially if XQR pump wanted to integrate the technology from Dexcom G(x) it would streamline the process since both components individually are approved, so there is less to consider as an integrated whole. Sort of like approving Lego pieces individually and allowing you to build with the various Lego pieces to make something else and streamline the approval process for the new item.
@elver - Even more. The CGM cross compatibility was already established with the Dexcom iCGM designation. The Tandem X2 already received approval to work with iCGM when the Basal-IQ was approved.
This goes a step further and is more applicable to allowing approved algorithms to be swapped in and out of the pumps with this designation. Additionally, pumps which meet these special controls will not need clinical trial and PMA.
Near term benefit for Tandem is the t:sport (forecast launch 2020) will not require a clinical trial nor FDA PMA.
Quoted from FDA:
With the authorization of the interoperable t:Slim X2 insulin pump and the establishment of these special controls, the FDA’s action also created a new regulatory classification, which provides more efficient patient access for this type of device in the future, because future ACE insulin pumps that comply with the general and special controls can go through a more efficient premarket review known as [510(k) clearance]
The FDA granted marketing authorization of the t:Slim X2 insulin pump with interoperable technology to Tandem Diabetes Care Inc.
Diabetes therapy systems may be comprised of an ACE insulin pump and other compatible medical devices, including automated insulin dosing (AID) systems, continuous glucose monitors (CGMs), blood glucose meters or other electronic devices used for diabetes management.
One might assume the Control-IQ algorithm (Summer 2019) will be classified as an “automated insulin dosing (AID) system”. It certainly will be interesting to read the specific FDA approval on the Control-IQ.
= = = =
FDA Reclassification Order:
This order, therefore, classifies the t:Slim X2 insulin pump with interoperable technology, and substantially equivalent devices of this generic type, into Class II under the generic name Alternate controller enabled infusion pump.
= = = =
It is confusing about what Device Class an insulin pump is. Per current FDA:
Class 2 - 510(k) - Pump, Infusion, Insulin (LZG)
Class 2 - 510(k) - Pump, Infusion, Insulin Bolus (OPP)
Class 3 - PMA - Automated Insulin Dosing , Threshold Suspend (OZO)
Class 3 - PMA - Automated Insulin Dosing Device System, Single Hormonal Control (OZP)
Class 3 - PMA - Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor (OYC)
This FDA order now creates a new entry in the above list which might be similar to:
Class 2 - 510(k) - Pump, Infusion, Insulin, Alternate controller enabled (QFG)
aaack!! @Thomas the iCGM is EXACTLY what i was thinking of and was a bit too hillbilly to express eloquently (and yes I am a hillbilly)
I may have a different understanding of this, depending on what you mean. The t:sport will need a clinical trial and PMA. But after the t:sport gets ACE designation, it will be allowed to combine it with any iCGM and algorithm that is approved to control an ACE pump without having to run a clinical trial and submit a PMA for the combined system.
From the FDA document you linked at https://www.accessdata.fda.gov/cdrh_docs/pdf18/DEN180058.pdf we have
Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) of the FD&C Act, if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device type. FDA has determined premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of the device type and, therefore, the device is not exempt from the premarket notification requirements of the FD&C Act. Thus, persons who intend to market this device type must submit a premarket notification containing information on the Alternate controller enabled infusion pump they intend to market prior to marketing the device.
To me that says that although some class II devices can be exempt from PMA, this one is not exempt so it will need to go through the clinical study and PMA process.
What the ACE classification gets us is that there is no need to have a clinical study and PMA for any specific pairing of control algorithm with the pump. The algorithm can go to clinical studies to show it is safe and effective when used with an iCGM and ACE pump, without running separate studies for each combination of CGM and pump that will be used with the algorithm. Like elver said, it’s about having a “bolt on to existing approved item” approach, rather than having to run clinical studies on each different combination of CGM+algorithm+pump.
It will not.
You mean the t:sport can go through the 510(k) process, if it satifies the same controls—correct?
The Tandem t:sport will follow the FDA 510(k) process, will adhere to the special controls for the new ACE Pump designation, will not require a clinical trial and will not be required to follow the PMA process.
Sorry, too much FDA speak here for me. To be more simplistic, this is what I want to know.
Is this pump going to be controllable from an external bluetooth/rf device? Will it take commands to vary insulin delivery? If so it can immediately be embraced by OpenAPS/loop/etc. If not, then it is still being restricted to work only with FDA approved algorithms. I THINK the answer is “yes”, based on this: “The FDA also assessed the ability of the pump to communicate with external devices with appropriate reliability, cybersecurity and fail-safe modes.”
Can someone confirm this?
t:sport - Yes. 100% controllable from mobile app.
X2 - 100% definite it will be able to have information viewable on a mobile app.
Question remaining. Will Tandem allow the mobile app to control the X2. Not yet public info.
No. Key word “immediate”. Absolutely not immediate.
Hmm. No mention is made to the t:sport in this article. So the t:sport is some future product not being referenced in this article? Who knows when that will be available.
This article does refer only to the X2. And when you say it will be controllable from “the mobile app”, I hope you mean “any” mobile app, and not just the mobile app provided by Tandem? Or am I reading too much into that?
The Tandem Mobile App.
The launch of the first iteration of the Tandem Mobile app is close at hand.
I expect the first iteration will allow read only access to the X2.
The iteration with the t:sport will clearly allow full controllable access to the t:sport.
My question is whether or not Tandem will release a version of the app which will allow full control of the X2. That is the part which is not public information at this point.
Are the protocols standardized? I.e. are the communication channels betten pump, CGM and controller part of public (e.g. ISO) standards or are they some ad hoc proprietary standard?
I believe standardized protocols are the goal, but I don’t know that this has been achieved yet. I guess this may be part of the work of the Tidepool LOOP project.
Keep in mind that the companies involved don’t intend for this to become a mix-and-match at the patient’s option. They still want to control their customers and put roadblocks in the way of defection to other companies. The companies are pursuing iCGM, ACE pumps, and “iController” designations as a way to drastically reduce the uncertainty, cost, and delay of getting FDA approval for new products. I think it was at the last Tandem quarterly conference call we were told this, and that new combinations of components would require business agreements between the companies involved so there would be clear division of responsibility for patient support and adverse event reporting.