← Product Code [QJI](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/QJI) · K200467

# Control-IQ Technology (K200467)

_Tandem Diabetes Care, Inc. · QJI · Jun 16, 2020 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/QJI/K200467

## Device Facts

- **Applicant:** Tandem Diabetes Care, Inc.
- **Product Code:** [QJI](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/QJI.md)
- **Decision Date:** Jun 16, 2020
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1356
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry
- **Attributes:** Software as a Medical Device, Therapeutic, Pediatric

## 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 6 years of age and greater. Control-IQ technology is intended for single patient use and requires a prescription. Control-IQ technology is indicated for use with NovoLog or Humalog U-100 insulin.

## Device Story

Software-only device installed on compatible ACE insulin pumps; receives input from iCGM (Dexcom G6) and user (carbohydrate intake, exercise, sleep schedule). Operates in closed-loop mode to automatically adjust basal insulin delivery and deliver correction boluses based on predicted glucose values. Targets glucose range 112.5-160 mg/dL (adjustable for sleep/exercise). Used by patients at home; requires prescription. Healthcare providers establish weight and total daily insulin requirements for configuration. Output displayed on pump interface; assists patients in maintaining glycemic control. Benefits include automated glucose management and reduced hyperglycemia/hypoglycemia risk.

## Clinical Evidence

Prospective, multi-center, randomized controlled trial (iDCL trial) comparing Control-IQ (CLC) to sensor-augmented pump (SAP) in 101 pediatric subjects (ages 6-13). Primary endpoint: glycemic control over 4 months. Results: CLC group showed improved time in range (67% vs 55%) and lower mean glucose (162 vs 179 mg/dL) compared to SAP. No severe hypoglycemia or DKA reported. Extension phase (3 months) confirmed sustained performance. Postmarket surveillance (PS190006) expanded to include 6-13 age cohort to address long-term safety profile.

## Technological Characteristics

Software-only device; operates on compatible ACE insulin pumps. Integrates with iCGM (Dexcom G6). Connectivity via pump-CGM interface. Risk management per ISO 14971:2007. Requires minimum 10 units/day insulin and 55 lbs body weight for safe operation.

## Regulatory 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.

## Special Controls

*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.

## Predicate Devices

- Control-IQ technology ([DEN190034](/device/DEN190034.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

INSTRUMENT ONLY

## I Background Information:

A 510(k) Number

K200467

B Applicant

Tandem Diabetes Care, Inc.

C Proprietary and Established Names

Control-IQ Technology

D Regulatory Information

|  Product Code(s) | Classification | Regulation Section | Panel  |
| --- | --- | --- | --- |
|  QJI | Class II | 21 CFR 862.1356 - Interoperable Automated Glycemic Controller | CH - Clinical Chemistry  |

## II Submission/Device Overview:

A Purpose for Submission:

Modification to a cleared device to expand the age indication (from ≥14 years old to ≥6 years old).

B Type of Test:

Not applicable

## III Intended Use/Indications for Use:

A Intended Use(s):

See Indications for Use below.

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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B Indication(s) 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 6 years of age and greater.

Control-IQ technology is intended for single patient use and requires a prescription.

Control-IQ technology is indicated for use with NovoLog or Humalog U-100 insulin.

C Special Conditions for Use Statement(s):

Rx - For Prescription Use Only

Only use U-100 Humalog or U-100 NovoLog with your pump. Only U-100 Humalog and NovoLog have been tested and found to be compatible for use in the pump. Use of insulin with lesser or greater concentration can result in under delivery or over delivery of insulin. This can cause hypoglycemia (low BG) or hyperglycemia (high BG) events.

When the CGM reading is automatically populated into the bolus calculator, only the current CGM reading is used to calculate the correction bolus. The trend arrow is not used in the dose calculation. Speak with your healthcare provider for recommendations on how best to utilize the arrows for your correction bolus dosing.

Control-IQ technology should not be used in anyone under the age of six years old. Control-IQ technology should also not be used in patients who require less than a total daily insulin dose of 10 units per day or who weigh less than 55 pounds, as those are the required minimum values needed in order for Control-IQ technology to operate safely.

At the time of device authorization, compatible iCGMs include the following: Dexcom G6 iCGM

The t:slim X2 pump, transmitter, and sensor must be removed before Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or diathermy treatment. Exposure to MRI, CT, or diathermy treatment can damage the components.

DO NOT use Control-IQ technology if you are taking hydroxyurea, a medication used in the treatment of diseases including cancer and sickle cell anemia. Your Dexcom G6 CGM readings may be falsely elevated and result in over-delivery of insulin that could result in severe hypoglycemia.

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## IV Device/System Characteristics:

### A Device Description:

Control-IQ technology (Control-IQ, the device) is a software-only device intended for use by people with diabetes. 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 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 works to control glucose towards a glucose target range of 112.5-160 mg/dL during normal use. Glucose targets are not customizable but can be changed by a user if sleep or exercise modes are set or announced. During sleep mode, this range is changed to 112.5-120 mg/dL, and it is changed to 140-160 mg/dL during exercise mode.

Control-IQ technology includes an integrated feature whereby iCGM values are automatically populated into the glucose field of the integrated bolus calculator when the 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.

Using Control-IQ technology requires that users 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.

### Instrument Description Information:

1. Instrument Name:
Control-IQ technology

2. Specimen Identification:
N/A

3. Specimen Sampling and Handling:
N/A

4. Calibration:
N/A

5. Quality Control:
N/A

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V Substantial Equivalence Information:

A Predicate Device Name(s): Control-IQ Technology

B Predicate 510(k) Number(s): DEN190034

C Comparison with Predicate(s):

|  Device & Predicate Device(s): | K200467 | DEN190034  |
| --- | --- | --- |
|  Device Trade Name | Control-IQ technology | Control-IQ technology  |
|  General Device Characteristic Similarities |  |   |
|  Intended Use/Indications For Use | Same | 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.  |
|  General Device Characteristic Differences |  |   |
|  Intended User Population | Persons age ≥6 years with Type 1 diabetes mellitus | Persons age ≥14 years with Type 1 diabetes mellitus  |

VI Standards/Guidance Documents Referenced:

Special controls established under 21 CFR 862.1356.

ISO 14971:2007: Medical Devices - Application of Risk Management to Medical Devices FDA Recognition No: 5-40

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VII Performance Characteristics (if/when applicable):

A Analytical Performance:

Control-IQ technology was previously granted marketing authorization under DEN190034. The version of Control-IQ technology described in this submission is identical to the predicate version, with the exception of an expanded intended use population. No modifications were made to the device in order to accommodate this change.

B Other Supportive Instrument Performance Characteristics Data:

Summary of Clinical Testing:

The sponsor conducted a prospective, multi-center, randomized controlled study to compare the use of Control-IQ technology (or Closed Loop Control, CLC) to the use of sensor-augmented pump (SAP). The randomized controlled phase (Primary Study) was 4 months in duration, followed by an Extension Phase of 3 months where all subjects were using the CLC.

A summary of the pivotal clinical study is provided in the following table (Control-IQ group abbreviated as CLC (closed-loop control)):

|  Study Feature | Description  |
| --- | --- |
|  Title | The International Diabetes Closed Loop (iDCL) Trial: Clinical Acceptance of the Artificial Pancreas in Pediatrics  |
|  Summary | A randomized controlled trial of 4 month at home closed loop control (CLC) system vs. sensor-augmented pump (SAP).  |
|  Investigational Device | Control-IQ Technology  |
|  Objectives | The objective of the study is to assess efficacy and safety of a closed loop system (Control-IQ Technology) in pediatrics in a randomized controlled trial.  |
|  Study Design | Randomized Clinical Trial with 3:1 randomization to intervention with the closed loop system vs. sensor-augmented pump for 3 months.  |
|  Number of Sites | Four US clinical sites  |

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|  Study Feature | Description  |
| --- | --- |
|  Population | There were 29 subjects ages ≥6 to ≤9 years old, and 72 subjects ages >9 to ≤13 years old. The average baseline HbA1c was 7.6% for the intervention arm and 7.9% for the control arm.

Key Inclusion Criteria
• Type 1 diabetes for at least 1 year
• Using insulin for at least 1 year
• Age ≥6 to ≤13 years old
• Weight 25-140 kg
• Total daily insulin dose of at least 10 U/day

Key Exclusion Criteria
• Use of any non-insulin glucose-lowering agents other than metformin  |
|  Sample Size | 101 participants completed the 4-month randomized trial, with 78 in the intervention arm and 23 in the control arm.  |
|  Treatment Groups | Randomized Trial
• Intervention Group: t:slim X2 with Control-IQ Technology and Dexcom G6 iCGM.
• Control Group: Sensor-augmented pump (SAP) with no automated insulin delivery, and Dexcom G6 iCGM.  |
|  Study Duration | 4 months for primary study, and up to 7 months total with extension phase  |
|  Protocol Overview/Synopsis | Eligible participants not currently using an insulin pump and/or Dexcom G4, G5, or G6 CGM with minimum data requirements participated in a run-in phase of 2 to 8 weeks that was customized based on whether the participant was already a pump or CGM user. Participants who skip or successfully complete the run-in were randomly assigned 3:1 to the CLC group using t:slim X2 with Control-IQ Technology or the SAP group for 4 months.  |

## Primary Study Safety Results

No severe hypoglycemia or diabetic ketoacidosis (DKA) events occurred in either arm of the study.

Hyperglycemia / ketosis events not meeting the definition of DKA were reportable if they met one of the following criteria:

- evaluation or treatment was obtained at a health care provider facility for an acute event involving hyperglycemia or ketosis

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- blood ketone level ≥1.0 mmol/L and communication occurred with a health care provider at the time of the event
- blood ketone level ≥3.0 mmol/L, even if there was no communication with a health care provider

There were 7 hyperglycemia/ketosis events meeting the above reporting criteria in the CLC arm compared to 2 in the SAP arm.

Subjects in both study arms were provided with blood ketone meters for use at home. There were 10 recorded events of blood ketone levels >1.0 mmol/L in the CLC arm compared to 6 recorded events in the SAP arm.

A summary of all reportable adverse events observed during the study is provided in the following table:

Table 1: Adverse Events by Study Treatment Group
|   | CLC | SAP  |
| --- | --- | --- |
|  Hyperglycemia with or without ketosis | 7 | 2  |
|  Diabetic Ketoacidosis (DKA) | - | -  |
|  Ketosis due to illness | - | 1  |
|  Total: | 7 | 3  |

The sponsor performed an evaluation of the Control-IQ technology and determined that it may not be safe for use in children under the age of six because Control-IQ technology has lower limits of total daily insulin (≥10 units) and weight requirements (≥55 lbs.). Therefore, the sponsor has included a warning in the labeling for this device as follows:

“Tandem performed an evaluation of the Control-IQ technology and determined that it may not be safe for use in children under the age of six because Control-IQ technology has lower limits of total daily insulin and weight requirements. Therefore, Control-IQ technology should not be used in anyone under the age of six years old. Control-IQ technology should also not be used in patients who require less than a total daily insulin dose of 10 units per day or who weigh less than 55 pounds, as those are the required minimum values needed in order for Control-IQ technology to operate safely.”

## Primary Study Observed Results

The data below describe how the device performed during the primary study.

The table below provides a summary of selected metrics for the study run-in period (baseline), and the results after study completion (post randomization).

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Table 2: Available CGM readings, HbA1c, and mean glucose observed in the primary study

|   | Baseline |   | Post Randomization  |   |
| --- | --- | --- | --- | --- |
|   |  CLC (n=77*) | SAP (n=23) | CLC (n=78) | SAP (n=22*)  |
|  Hours of glucose readings, Mean ± SD | 306 ± 33 | 311 ± 23 | 2637 ± 134 | 2609 ± 128  |
|  HbA1c, Mean ± SD | 7.6 ± 1.0 | 7.9 ± 0.9 | 7.0 ± 0.8 | 7.6 ± 0.9  |
|  Mean CGM Glucose (mg/dL), Mean ± SD | 184 ± 33 | 189 ± 34 | 162 ± 18 | 179 ± 26  |

*One participant in the CLC group was missing baseline CGM data; one participant in the SAP group was missing follow-up data.

During the pivotal study, the amount of time subjects spent in different CGM glucose ranges was observed as described in the following tables:

Table 3: Time spent in different CGM glucose ranges as observed in the primary study

|   | Baseline |   | Post Randomization  |   |
| --- | --- | --- | --- | --- |
|   |  CLC (n=77*) | SAP (n=23) | CLC (n=78) | SAP (n=22*)  |
|  % time in range 70-180 mg/dL, Mean ± SD | 53 ± 17 | 51 ± 16 | 67 ± 10 | 55 ± 13  |
|  % time below 70 mg/dL, Mean ± SD | 1.92 ± 2.21 | 1.52 ± 1.52 | 1.80 ± 1.38 | 2.10 ± 1.18  |
|  % time below 54 mg/dL, Mean ± SD | 0.33 ± 0.54 | 0.19 ± 0.28 | 0.34 ± 0.35 | 0.38 ± 0.35  |

*One participant in the CLC group was missing baseline CGM data; one participant in the SAP group was missing follow-up data.

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Table 4: Time spent in different CGM glucose ranges analyzed by time of day, post-randomization

|   | Daytime |   | Nighttime  |   |
| --- | --- | --- | --- | --- |
|   |  CLC (n=77*) | SAP (n=23) | CLC (n=78) | SAP (n=22*)  |
|  Mean CGM Glucose (mg/dL), Mean ± SD | 167 ± 21 | 179 ± 27 | 146 ± 16 | 180 ± 28  |
|  % time above 180 mg/dL, Mean ± SD | 35 ± 11 | 42 ± 15 | 19 ± 9 | 44 ± 16  |
|  % time 70-180 mg/dL, Mean ± SD | 63 ± 11 | 56 ± 14 | 80 ± 9 | 54 ± 16  |
|  % time below 70 mg/dL, Median (Q1, Q3)** | 1.55 (0.77, 2.76) | 1.78 (1.31, 3.34) | 0.91 (0.44, 1.82) | 1.33 (0.59, 2.68)  |

*One participant in the CLC group was missing baseline CGM data; one participant in the SAP group was missing follow-up data.
**Quartile 1, Quartile 3

## Extension Phase

The primary study was followed by a 3-month single-arm extension phase. Of the 101 subjects enrolled in the primary study, 100 subjects continued into the extension phase. During the extension phase, subjects who were originally randomized to the control (SAP) arm of the primary study were switched to use of the investigational Control-IQ device (CLC arm) such that all subjects were in the CLC study arm for the extension phase.

## Extension Phase Safety Results

There were an additional eight (8) device related hyperglycemia / ketosis events during the extension phase, and no episodes of DKA or severe hypoglycemia.

## Extension Phase Observed Results

Results observed in the extension phase were similar to results observed during the primary study. Those subjects originally randomized into the CLC arm maintained similar results during the extension phase. Results for subjects originally randomized in the SAP arm who switched to the CLC arm are summarized in the table below:

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Table 5: Available CGM readings, HbA1c, mean glucose, and time spent in different CGM glucose ranges observed in the study extension phase

|   | Extension Baseline* | Weeks 17-28  |
| --- | --- | --- |
|   |  SAP – CLC Group (n=22) | SAP – CLC Group (n=22)  |
|  Hours of glucose readings, Mean ± SD | 1885 ± 88 | 1981 ± 86  |
|  HbA1c, Mean ± SD | 7.6 ± 0.9 | 7.3 ± 0.6  |
|  Mean CGM Glucose (mg/dL), Mean ± SD | 179 ± 26 | 167 ± 18  |
|  % time in range 70-180 mg/dL, Mean ± SD | 55 ± 14 | 65 ± 10  |
|  % time above 180 mg/dL, Mean ± SD | 43 ± 14 | 34 ± 10  |
|  % time below 70 mg/dL, Median (Q1, Q3)** | 1.88 (1.12, 2.94) | 1.34 (0.92, 1.95)  |

*Extension baseline is defined as the last 12 weeks of the primary study.
**Quartile 1, Quartile 3

## Postmarket Surveillance Study:

There is uncertainty remaining regarding the risk/benefit profile of the device when used in the broader intended use population. While the premarket clinical study provided to support this premarket notification showed some benefits, the study included device users and their caregivers with relatively high levels of education relative to the general use population, and it was not adequately powered to assess differences in the rates of safety events (e.g., diabetic ketoacidosis and severe hypoglycemia). Furthermore, due to the nature of the study design, the apparent unfavorable difference in the rates of hyperglycemia/ketosis events (not rising to the level of severity of diabetic ketoacidosis) between the treatment and control arms may be due to reporting differences between users rather than a true difference from the device itself.

Accordingly, the existing postmarket surveillance study that was ordered for the Control-IQ device (PS190006, order dated December 13, 2019) will be expanded to include subjects ages 6-13 years old and to increase the total enrollment in the study to allow for inclusion of this additional cohort.

## Summary of Human Factors Testing for the Expanded Age Range:

As established in DEN190034. The summative human factors study conducted under DEN190034 included assessment of the 6-13 year pediatric age group, and the results were found to be acceptable.

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VIII Proposed Labeling:

The labeling supports the finding of substantial equivalence for this device.

IX Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/QJI/K200467](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/QJI/K200467)

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