(68 days)
Not Found
Yes.
The device automatically adjusts insulin delivery based on predicted glucose values and can deliver correction boluses based on predicted glucose values, which is indicative of an AI model, specifically a predictive algorithm.
Yes
The device is described as "automatically increas[ing], decreas[ing], and suspend[ing] delivery of basal insulin" and delivering "correction boluses," and targeting specific glucose ranges, all of which are direct therapeutic interventions for diabetes management.
No
Explanation: The device is designed to automatically manage insulin delivery based on glucose readings and predicted values, as well as administer correction boluses. Its primary function is to control and regulate insulin for diabetes treatment, not to diagnose a condition. While it uses glucose data, it doesn't provide a diagnosis.
Yes
The device explicitly states in the "Device Description" that "The Subject Device, Control-IQ+ technology ("Control-IQ+") is a software-only device intended for the management of type 1 and type 2 diabetes mellitus." It also clarifies that it is "meant to be installed on a compatible ACE pump," indicating it functions as software on a host device rather than being a standalone piece of hardware itself.
No.
The device is a software-only diabetes management system that controls an insulin pump based on iCGM readings and user inputs, directly affecting patient therapy rather than analyzing specimens to provide diagnostic information.
Yes
The letter explicitly states, "This submission included a predetermined change control plan (PCCP) that was reviewed and authorized by FDA," indicating that the FDA has cleared the PCCP for this device.
Intended Use / Indications for Use
Control-IQ+ technology is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also deliver correction boluses when the glucose value is predicted to exceed a predefined threshold.
Control-IQ+ technology is intended for the management of Type 1 diabetes mellitus in persons 2 years of age and greater and of Type 2 diabetes mellitus in persons 18 years of age and greater.
Control-IQ+ technology is intended for single patient use and requires a prescription.
Product codes
QJI
Device Description
The Subject Device, Control-IQ+ technology ("Control-IQ+") is a software-only device intended for the management of type 1 and type 2 diabetes mellitus. The device controls insulin delivery from a compatible alternate controller enabled insulin pump (ACE pump) based on inputs provided by a compatible integrated continuous glucose monitor (iCGM) and inputs provided by the user (e.g., carbohydrate intake, exercise, and sleep schedule). Control-IQ+ technology is meant to be installed on a compatible ACE pump.
Control-IQ+ technology has three different modes: Normal, Sleep, and Exercise. The glucose targets are not individually customizable in these modes but can change based on the mode selected. During Normal mode, Control-IQ+ technology aims to control glucose within a target range of 112.5 – 160 mg/dL, during Sleep mode the target range is 112.5 – 120 mg/dL, and during Exercise mode the target range is 140 – 160 mg/dL.
Control-IQ+ technology includes an integrated feature whereby iCGM values are automatically populated into the glucose field of the integrated bolus calculator when Control-IQ+ technology is active (i.e., the device is operating in closed-loop mode). This feature is disabled when Control-IQ is turned off.
Control-IQ+ technology requires users to input their weight and their total daily insulin requirement, which should be established with the help of a health care provider before using the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Type 1 diabetes mellitus in persons 2 years of age and greater
Type 2 diabetes mellitus in persons 18 years of age and greater.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A pivotal study, "Safety Evaluation of an Advanced Hybrid Closed Loop System Using Lyumjev with the Tandem t:slim X2 with Control-IQ in Adults, Adolescents and Children with Type 1 Diabetes (TL1)", was conducted to evaluate the safety and effectiveness of using Lyumjev with Control-IQ+ technology. Tandem performed a single-arm prospective safety trial that included 179 participants with type 1 diabetes (70 in adult cohort, ranging in age from 18-75 years old, and 109 in pediatric cohort, ranging in age from 6-17 years old) who were experienced users of the Control-IQ AID system.
The protocol consisted of two periods: ~16-day Humalog Lead-in Period and 13-week Lyumjev Treatment Period. The primary trial endpoints were related to safety, comparing the frequency of severe hypoglycemia and DKA events to the reported frequencies from the T1D Exchange clinic registry.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Rates of severe hypoglycemia and DKA were lower than in the T1D Exchange clinic registry data, with the statistical comparison meeting the prespecified success criteria.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
This submission included a predetermined change control plan (PCCP) that was reviewed and authorized by FDA for implementation of the proposed labeling modifications upon clearance of a compatible ACE pump. The change to Control-IQ+ Technology labeling will not be implemented prior to clearance of a compatible ACE pump submission. The PCCP outlines that the labeling modifications will match the cleared compatible insulins for both the ACE Pump and the iAGC.
The PCCP also defines the test methods and validation requirements to implement labeling changes per Tandem's Quality Management System. Following implementation new users will receive the physical Quick Start Guide upon receipt of their corresponding device and the new User Guide and Quick Start Guide will be available electronically or may be provided physically upon request. Existing users will be notified one of two ways. They will have the option to electronically download or request a printed version of the Quick Start Guide and User Guide, which will contain these labeling updates. Or be notified via email that an additional insulin has been approved for use with their device, and this communication will also include a link to download the Quick Start Guide and User Guide that contain the updated labeling.
§ 862.1356 Interoperable automated glycemic controller.
(a)
Identification. An interoperable automated glycemic controller is a device intended to automatically calculate drug doses based on inputs such as glucose and other relevant physiological parameters, and to command the delivery of such drug doses from a connected infusion pump. Interoperable automated glycemic controllers are designed to reliably and securely communicate with digitally connected devices to allow drug delivery commands to be sent, received, executed, and confirmed. Interoperable automated glycemic controllers are intended to be used in conjunction with digitally connected devices for the purpose of maintaining glycemic control.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include:
(i) An appropriate, as determined by FDA, clinical implementation strategy, including data demonstrating appropriate, as determined by FDA, clinical performance of the device for its intended use, including all of its indications for use.
(A) The clinical data must be representative of the performance of the device in the intended use population and in clinically relevant use scenarios and sufficient to demonstrate appropriate, as determined by FDA, clinical performance of the device for its intended use, including all of its indications for use.
(B) For devices indicated for use with multiple therapeutic agents for the same therapeutic effect (
e.g., more than one type of insulin), data demonstrating performance with each product or, alternatively, an appropriate, as determined by FDA, clinical justification for why such data are not needed.(C) When determined to be necessary by FDA, the strategy must include postmarket data collection to confirm safe real-world use and monitor for rare adverse events.
(ii) Results obtained through a human factors study that demonstrates that an intended user can safely use the device for its intended use.
(iii) A detailed and appropriate, as determined by FDA, strategy to ensure secure and reliable means of data transmission with other intended connected devices.
(iv) Specifications that are appropriate, as determined by FDA, for connected devices that shall be eligible to provide input to (
e.g., specification of glucose sensor performance) or accept commands from (e.g., specifications for drug infusion pump performance) the controller, and a detailed strategy for ensuring that connected devices meet these specifications.(v) Specifications for devices responsible for hosting the controller, and a detailed and appropriate, as determined by FDA, strategy for ensuring that the specifications are met by the hosting devices.
(vi) Documentation demonstrating that appropriate, as determined by FDA, measures are in place (
e.g., validated device design features) to ensure that safe therapy is maintained when communication with digitally connected devices is interrupted, lost, or re-established after an interruption. Validation testing results must demonstrate that critical events that occur during a loss of communications (e.g., commands, device malfunctions, occlusions, etc.) are handled and logged appropriately during and after the interruption to maintain patient safety.(vii) A detailed plan and procedure for assigning postmarket responsibilities including adverse event reporting, complaint handling, and investigations with the manufacturers of devices that are digitally connected to the controller.
(2) Design verification and validation documentation must include appropriate design inputs and design outputs that are essential for the proper functioning of the device that have been documented and include the following:
(i) Risk control measures to address device system hazards;
(ii) Design decisions related to how the risk control measures impact essential performance; and
(iii) A traceability analysis demonstrating that all hazards are adequately controlled and that all controls have been validated in the final device design.
(3) The device shall include appropriate, as determined by FDA, and validated interface specifications for digitally connected devices. These interface specifications shall, at a minimum, provide for the following:
(i) Secure authentication (pairing) to connected devices;
(ii) Secure, accurate, and reliable means of data transmission between the controller and connected devices;
(iii) Sharing of necessary state information between the controller and any connected devices (
e.g., battery level, reservoir level, sensor use life, pump status, error conditions);(iv) Ensuring that the controller continues to operate safely when data is received in a manner outside the bounds of the parameters specified;
(v) A detailed process and procedures for sharing the controller's interface specification with connected devices and for validating the correct implementation of that protocol; and
(vi) A mechanism for updating the controller software, including any software that is required for operation of the controller in a manner that ensures its safety and performance.
(4) The device design must ensure that a record of critical events is stored and accessible for an adequate period to allow for auditing of communications between digitally connected devices, and to facilitate the sharing of pertinent information with the responsible parties for those connected devices. Critical events to be stored by the controller must, at a minimum, include:
(i) Commands issued by the controller, and associated confirmations the controller receives from digitally connected devices;
(ii) Malfunctions of the controller and malfunctions reported to the controller by digitally connected devices (
e.g., infusion pump occlusion, glucose sensor shut down);(iii) Alarms and alerts and associated acknowledgements from the controller as well as those reported to the controller by digitally connected devices; and
(iv) Connectivity events (
e.g., establishment or loss of communications).(5) The device must only receive glucose input from devices cleared under § 862.1355 (integrated continuous glucose monitoring system), unless FDA determines an alternate type of glucose input device is designed appropriately to allow the controller to meet the special controls contained within this section.
(6) The device must only command drug delivery from devices cleared under § 880.5730 of this chapter (alternate controller enabled infusion pump), unless FDA determines an alternate type of drug infusion pump device is designed appropriately to allow the controller to meet the special controls contained within this section.
(7) An appropriate, as determined by FDA, training plan must be established for users and healthcare providers to assure the safety and performance of the device when used. This may include, but not be limited to, training on device contraindications, situations in which the device should not be used, notable differences in device functionality or features compared to similar alternative therapies, and information to help prescribers identify suitable candidate patients, as applicable.
(8) The labeling required under § 809.10(b) of this chapter must include:
(i) A contraindication for use in pediatric populations except to the extent clinical performance data or other available information demonstrates that it can be safely used in pediatric populations in whole or in part.
(ii) A prominent statement identifying any populations for which use of this device has been determined to be unsafe.
(iii) A prominent statement identifying by name the therapeutic agents that are compatible with the controller, including their identity and concentration, as appropriate.
(iv) The identity of those digitally connected devices with which the controller can be used, including descriptions of the specific system configurations that can be used, per the detailed strategy submitted under paragraph (b)(1)(iii) of this section.
(v) A comprehensive description of representative clinical performance in the hands of the intended user, including information specific to use in the pediatric use population, as appropriate.
(vi) A comprehensive description of safety of the device, including, for example, the incidence of severe hypoglycemia, diabetic ketoacidosis, and other relevant adverse events observed in a study conducted to satisfy paragraph (b)(1)(i) of this section.
(vii) For wireless connection enabled devices, a description of the wireless quality of service required for proper use of the device.
(viii) For any controller with hardware components intended for multiple patient reuse, instructions for safely reprocessing the hardware components between uses.
FDA 510(k) Clearance Letter - Control-IQ+ Technology
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
May 21, 2025
Tandem Diabetes Care, Inc.
Miriam Chan
Principal Regulatory Affairs Specialist
12400 High Bluff Drive
San Diego, California 92130
Re: K250798
Trade/Device Name: Control-IQ+ technology
Regulation Number: 21 CFR 862.1356
Regulation Name: Interoperable Automated Glycemic Controller
Regulatory Class: Class II
Product Code: QJI
Dated: March 14, 2025
Received: March 14, 2025
Dear Miriam Chan:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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K250798 - Miriam Chan
Page 2
FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP). Under section 515C(b)(1) of the Act, a new premarket notification is not required for a change to a device cleared under section 510(k) of the Act, if such change is consistent with an established PCCP granted pursuant to section 515C(b)(2) of the Act. Under 21 CFR 807.81(a)(3), a new premarket notification is required if there is a major change or modification in the intended use of a device, or if there is a change or modification in a device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process. Accordingly, if deviations from the established PCCP result in a major change or modification in the intended use of the device, or result in a change or modification in the device that could significantly affect the safety or effectiveness of the device, then a new premarket notification would be required consistent with section 515C(b)(1) of the Act and 21 CFR 807.81(a)(3). Failure to submit such a premarket submission would constitute adulteration and misbranding under sections 501(f)(1)(B) and 502(o) of the Act, respectively.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these
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K250798 - Miriam Chan
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requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Joshua Balsam -S
Joshua M. Balsam, Ph.D.
Branch Chief
Division of Chemistry and Toxicology Devices
OHT7: Office of In Vitro Diagnostics
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
Submission Number (if known)
K250798
Device Name
Control-IQ+ technology
Indications for Use (Describe)
Control-IQ+ technology is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also deliver correction boluses when the glucose value is predicted to exceed a predefined threshold.
Control-IQ+ technology is intended for the management of Type 1 diabetes mellitus in persons 2 years of age and greater and of Type 2 diabetes mellitus in persons 18 years of age and greater.
Control-IQ+ technology is intended for single patient use and requires a prescription.
Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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Page 5
510(k) Summary
Company: Tandem Diabetes Care, Inc
12400 High Bluff Drive
San Diego, CA 92130
Prepared: March 07, 2025
Contact: Miriam Chan
Principal Regulatory Affairs Specialist
mchan@tandemdiabetes.com
+1(858)202-6553
Trade Name: Control-IQ+ technology
Common Name: Interoperable Automated Glycemic Controller
Classification Product Code: QJI
Classification Name: Interoperable Automated Glycemic Controller
Regulation Number: 21 CFR 862.1356
Device Class: Class II
Predicate Device: K243823, Control-IQ+ technology
I. Device Under Review
The Subject Device, Control-IQ+ technology ("Control-IQ+") is a software-only device intended for the management of type 1 and type 2 diabetes mellitus. The device controls insulin delivery from a compatible alternate controller enabled insulin pump (ACE pump) based on inputs provided by a compatible integrated continuous glucose monitor (iCGM) and inputs provided by the user (e.g., carbohydrate intake, exercise, and sleep schedule). Control-IQ+ technology is meant to be installed on a compatible ACE pump.
Control-IQ+ technology has three different modes: Normal, Sleep, and Exercise. The glucose targets are not individually customizable in these modes but can change based on the mode selected. During Normal mode, Control-IQ+ technology aims to control glucose within a target range of 112.5 – 160 mg/dL, during Sleep mode the target range is 112.5 – 120 mg/dL, and during Exercise mode the target range is 140 – 160 mg/dL.
Control-IQ+ technology includes an integrated feature whereby iCGM values are automatically populated into the glucose field of the integrated bolus calculator when Control-IQ+ technology is active (i.e., the device is
Page 6
operating in closed-loop mode). This feature is disabled when Control-IQ is turned off.
Control-IQ+ technology requires users to input their weight and their total daily insulin requirement, which should be established with the help of a health care provider before using the device.
II. Intended Use/ Indications for Use
Control-IQ+ technology is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also deliver correction boluses when the glucose value is predicted to exceed a predefined threshold.
Control-IQ+ technology is intended for the management of Type 1 diabetes mellitus in persons 2 years of age and greater and of Type 2 diabetes mellitus in persons 18 years of age and greater.
Control-IQ+ technology is intended for single patient use and requires a prescription.
III. Technological Characteristics Compared to Predicate Device K243823
| Indications for Use/ Intended Use | Predicate Device K243823 | Subject Device |
|---|---|---|
| Control-IQ technology is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also deliver correction boluses when the glucose value is predicted to exceed a predefined threshold. Control-IQ technology is intended for the management of Type 1 diabetes mellitus in persons 2 years of age and greater Type 2 diabetes mellitus in persons 18 years of age and greater. Control-IQ technology is intended for single patient use and requires a prescription. | Identical |
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| Characteristic | Predicate Device K243823 | Subject Device |
|---|---|---|
| Pump Type | Alternate controller enabled insulin pump | Identical |
| Classification | 21 CFR 862.1356 | Identical |
| Product Code | QJI | Identical |
| Compatible Insulins | Type 1 diabetes mellitus in persons 2 years of age and greater Type 2 diabetes mellitus in persons 18 years of age and greater: NovoLog U-100 Insulin, Humalog U-100 Insulin | Type 1 diabetes mellitus in persons 2 years of age and greater Type 2 diabetes mellitus in persons 18 years of age and greater: NovoLog U-100 Insulin, Humalog U-100 Insulin, Lyumjev U-100 Insulin |
| Profile Delivery | When the predicted CGM value is within the target range, the pump will deliver insulin at the rate determined by the active Personal Profile settings. The user's profile basal rate may be set as high as 15 units/hr when Control-IQ is off and when Control-IQ is enabled same basal rate is applied. | Identical |
| Basal Rate Range | The Personal Profile correction factor is used to determine the predicted basal rate limits of 10 to 600 mg/dL per unit insulin. | Identical |
| Basal Attenuation | When Control-IQ technology predicts that the sensor glucose value will be at or below the target range 30 minutes in the future, the rate of insulin delivered will begin to decrease to attempt to keep glucose within the target range. | Identical |
| Automatic Correction Bolus | The upper limit for the automatic correction bolus is 600 mg/dL per unit insulin. | Identical |
| Body Weight Setting Range | 20 lbs (9 kg) – 440 lbs (200 kg) | Identical |
| Total Daily Insulin Setting Range | User setting of 5 units/day - 200 units/day | Identical |
| Extended Bolus | Up to 8-hour duration while Control-IQ is enabled or disabled and extended boluses are uninterrupted when enabling Control-IQ. | Identical |
| Temporary Basal Rate | Temp Rates can be enabled without turning Control-IQ technology off | Identical |
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IV. Overview of Non-Clinical and Clinical Performance Tests
Appropriate testing was performed to confirm the Subject Device met specified requirements and performed as intended. See summaries below.
Usability/Human Factors:
No new Usability/Human Factors testing was performed to support this 510(k) Notification.
Software Verification and Validation:
No new software testing was performed to support this 510(k) Notification.
Special Controls:
Evaluation and adherence to the Special Controls of the Predicate Device (K243823) demonstrates continued assurance of the safety and effectiveness of the Subject Device.
Clinical Testing:
A pivotal study, "Safety Evaluation of an Advanced Hybrid Closed Loop System Using Lyumjev with the Tandem t:slim X2 with Control-IQ in Adults, Adolescents and Children with Type 1 Diabetes (TL1)", was conducted to evaluate the safety and effectiveness of using Lyumjev with Control-IQ+ technology. Tandem performed a single-arm prospective safety trial that included 179 participants with type 1 diabetes (70 in adult cohort, ranging in age from 18-75 years old, and 109 in pediatric cohort, ranging in age from 6-17 years old) who were experienced users of the Control-IQ AID system.
The protocol consisted of two periods: ~16-day Humalog Lead-in Period and 13-week Lyumjev Treatment Period. The primary trial endpoints were related to safety, comparing the frequency of severe hypoglycemia and DKA events to the reported frequencies from the T1D Exchange clinic registry.
Conclusion:
The Subject Device has the same intended use and indications as the Predicate Device. The clinical study demonstrated that the use of Lyumjev with t:slim X2 insulin pump with Control-IQ technology was well tolerated with few adverse effects and no increase in hypoglycemia. Rates of severe hypoglycemia and DKA were lower
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than in the T1D Exchange clinic registry data, with the statistical comparison meeting the prespecified success criteria. Therefore, the trial data demonstrates that Lyumjev with the t:slim X2 insulin pump with Control-IQ technology is safe and effective in patients with Type 1 diabetes 6 years of age and greater. The required technical documentation provided in this 510(k) demonstrates the Subject Device is as safe and as effective as the Predicate Device. Therefore, the Subject Device has been evaluated to be substantially equivalent to the Predicate Device and does not raise new or different questions of safety or effectiveness.
V. Predetermined Change Control Plan
This submission included a predetermined change control plan (PCCP) that was reviewed and authorized by FDA for implementation of the proposed labeling modifications upon clearance of a compatible ACE pump. The change to Control-IQ+ Technology labeling will not be implemented prior to clearance of a compatible ACE pump submission. The PCCP outlines that the labeling modifications will match the cleared compatible insulins for both the ACE Pump and the iAGC.
The PCCP also defines the test methods and validation requirements to implement labeling changes per Tandem's Quality Management System. Following implementation new users will receive the physical Quick Start Guide upon receipt of their corresponding device and the new User Guide and Quick Start Guide will be available electronically or may be provided physically upon request. Existing users will be notified one of two ways. They will have the option to electronically download or request a printed version of the Quick Start Guide and User Guide, which will contain these labeling updates. Or be notified via email that an additional insulin has been approved for use with their device, and this communication will also include a link to download the Quick Start Guide and User Guide that contain the updated labeling.