← Product Code [QJS](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/QJS) · K193483

# Basal-IQ Technology (K193483)

_Tandem Diabetes Care, Inc. · QJS · Feb 28, 2020 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/QJS/K193483

## Device Facts

- **Applicant:** Tandem Diabetes Care, Inc.
- **Product Code:** [QJS](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/QJS.md)
- **Decision Date:** Feb 28, 2020
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1356
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry
- **Attributes:** Therapeutic, Pediatric

## Indications for Use

Basal-IQ technology is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps to automatically suspend delivery of insulin based on iCGM readings and predicted glucose values. Basal-IQ technology is intended for the management of diabetes mellitus in persons six years of age and greater. Basal-IQ technology is intended for single patient use and requires a prescription. Basal-IQ technology is indicated for use with NovoLog or Humalog U-100 insulin. The bolus calculator is indicated for the management of diabetes by people with diabetes by calculating an insulin dose or carbohydrate intake based on user entered data.

## Device Story

Basal-IQ is a Predictive Low Glucose Suspend (PLGS) algorithm integrated into the Tandem t:slim X2 insulin pump. It receives interstitial glucose data from a paired iCGM via Bluetooth Low Energy. Every 5 minutes, the algorithm evaluates current glucose and 30-minute predicted values; it commands the pump to suspend insulin if glucose is <70 mg/dL or predicted to be <80 mg/dL. Insulin delivery resumes when glucose levels rise or predicted values exceed 80 mg/dL, subject to a 120-minute maximum suspension limit. The device also includes a bolus calculator for calculating insulin doses based on user-entered data. Used by patients with Type 1 diabetes in home settings. Healthcare providers program parameters; patients operate the device to manage insulin delivery. The system aims to reduce hypoglycemia by automating suspension, providing patients with improved glycemic control.

## Clinical Evidence

Multi-center, randomized, at-home crossover study of 107 subjects (102 completed) with Type 1 diabetes (age >6 years). Compared t:slim X2 with Basal-IQ vs. Sensor Augmented Pump (SAP) over two 3-week periods. Results demonstrate the system functions as intended to stop/resume insulin delivery based on glucose thresholds and is safe for use with iCGM sensors.

## Technological Characteristics

Software-based PLGS algorithm and bolus calculator integrated into Tandem t:slim X2 insulin pump. Connectivity via Bluetooth Low Energy (BLE) to iCGM. Operates on ACE pump hardware (21 CFR 880.5730). Rule-based algorithm logic for insulin suspension/resumption. No new materials; software-only modification to existing pump platform.

## 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))
- InPen Dose Calculator ([K192841](/device/K192841.md))

## Submission Summary (Full Text)

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>
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FDA

U.S. FOOD &amp; DRUG

ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

# INSTRUMENT ONLY

## I Background Information:

A 510(k) Number

K193483

B Applicant

Tandem Diabetes Care, Inc.

C Proprietary and Established Names

Basal-IQ Technology

D Regulatory Information

|  Product Code(s) | Classification | Regulation Section | Panel  |
| --- | --- | --- | --- |
|  QJS | Class II | 21 CFR 862.1356 - Interoperable Automated Glycemic Controller | CH - Clinical Chemistry  |
|  NDC | Class II | 21 CFR 868.1890 - Predictive pulmonary-function value calculator | CH - Clinical Chemistry  |

## II Submission/Device Overview:

A Purpose for Submission:

New Device

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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B Type of Test:

Not applicable

III Intended Use/Indications for Use:

A Intended Use(s):

See Indications for Use below.

B Indication(s) for Use:

Basal-IQ technology is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps to automatically suspend delivery of insulin based on iCGM readings and predicted glucose values.

Basal-IQ technology is intended for the management of diabetes mellitus in persons six years of age and greater.

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

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

The bolus calculator is indicated for the management of diabetes by people with diabetes by calculating an insulin dose or carbohydrate intake based on user entered data.

C Special Conditions for Use Statement(s):

Rx - For Prescription Use Only

The pump is not intended for anyone unable or unwilling to:

- Test blood glucose (BG) levels as recommended by a healthcare provider
- Maintain sufficient diabetes selfcare skills
- See a healthcare provider(s) regularly

The user must also have adequate vision and/or hearing in order to recognize pump alerts.

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.

ONLY use U-100 Humalog or 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.

ALWAYS use cartridges manufactured by Tandem Diabetes Care. Use of any other cartridge brand may result in over delivery or under delivery of insulin. This can cause hypoglycemia (low BG) or hyperglycemia (high BG) events.

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DO NOT reuse cartridges. Reuse of cartridges may result in over delivery or under delivery of insulin. This can cause hypoglycemia (low BG) or hyperglycemia (high BG) events.

## IV Device/System Characteristics:

### A Device Description:

**Device Description**

Basal-IQ technology is a Predictive Low Glucose Suspend (PLGS) algorithm for the management of diabetes mellitus and is compatible with an Alternate Controller Enabled Infusion Pump (cleared under 21 CFR 880.5730)(ACE pump). Basal-IQ technology is only compatible with the Tandem t:slim X2 insulin pump (DEN180058). The Basal-IQ software and algorithm can receive interstitial sensor glucose values from a compatible iCGM system (cleared under 21 CFR 862.1355), via Bluetooth Low Energy (BLE) communication. Compatible iCGM systems are cleared and marketed separately from the Basal-IQ algorithm and are identified in device labeling.

Basal-IQ assesses glucose information provided by a paired iCGM and sends commands to a compatible ACE pump to temporarily suspend insulin delivery in cases of impending or detected low blood glucose. Every 5 minutes, the Basal-IQ feature assesses glucose information provided by the iCGM to predict whether glucose values will fall below 80 mg/dL in the next 30 minutes or detect if glucose levels are currently below 70 mg/dL. Under these conditions it will command the compatible pump to suspend insulin delivery; otherwise insulin delivery continues as normal. After insulin delivery is suspended, insulin delivery resumption is commended when the system detects glucose values begin to rise. A sustained suspension period when blood glucose is above the sensor suspend threshold is mitigated by a maximum suspend time where Basal-IQ will command resume insulin delivery after 120 minutes of suspension within a 150 minute window. The Basal-IQ technology uses CGM sensor readings to send commands to a compatible insulin pump to stop and resume insulin based on the current sensor value and a 30 minute future predicted value along with the following rules:

1. Insulin delivery is suspended if the current CGM sensor reading is less than 70 mg/dL
2. Insulin delivery is suspended if the glucose value is predicted to be less than 80 mg/dL in 30 minutes.
3. Basal insulin delivery is resumed once the current CGM sensor reading increases compared to the previous reading.
4. Basal insulin delivery will also be resumed if the 30 minute predicted CGM reading is above 80 mg/dL, even if the CGM reading has not increased compared to the previous reading.
5. Basal insulin delivery is resumed if insulin delivery has been suspended for 2 hours in a 2.5 hour window.

The software comprising the Basal-IQ algorithm also includes an insulin bolus dose calculator. This calculator is for assisting patients with Type 1 diabetes who use insulin pumps as their insulin delivery therapy. It is used to calculate insulin bolus doses of rapid acting U-100 insulin analogs (Humalog and Novolog). The bolus calculator is used with manually-inputted glucose values and pump insulin delivery data to generate bolus size recommendations.

K193483 - Page 3 of 7

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B Instrument Description Information:

|  Modes of Operation | Yes | No  |
| --- | --- | --- |
|  Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? | ☑ | ☐  |
|  Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? | ☐ | ☑  |
|  Software  |   |   |
|  FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types. | ☑ | ☐  |

V Substantial Equivalence Information:

A Predicate Device Name(s):

Control-IQ Technology, InPen Dose Calculator

B Predicate 510(k) Number(s):

DEN190034, K190487

C Comparison with Predicate(s):

|  Device & Predicate Device(s): | K193483 | DEN190034  |
| --- | --- | --- |
|  Device Trade Name | Basal-IQ Technology | Control-IQ Technology  |
|  General Device Characteristic Similarities |  |   |
|  Intended Use/Indications For Use | Intended to automatically command suspension and resumption of basal insulin delivery from a compatible ACE pump based on glucose values from a compatible iCGM. | Intended to automatically command basal and bolus insulin delivery from a compatible ACE pump based on glucose values from a compatible iCGM.  |
|  Commands insulin suspension when trending or found low CGM reading | Yes | Same  |
|  Intended Hardware Device | An Alternate Controller Enabled Infusion Pump (cleared under 21 CFR 880.5730) | Same  |

K193483 - Page 4 of 7

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|  General Device Characteristic Differences |  |   |
| --- | --- | --- |
|  Auto-populates the Bolus Calculator with CGM values | No | Yes  |
|  Commands modified basal insulin delivery (beyond suspend) based on CGM readings | No | Yes  |
|  Commands adjusted basal or bolus insulin based on high CGM readings | No | Yes  |
|   | Predicate Device (K190487, InPen Dose Calculator) | Subject Device (K193483)  |
| --- | --- | --- |
|  Intended Use/Indications For Use | For calculating an insulin dose based on user entered data. | For calculating an insulin dose based on user entered data.  |
|  Prescription Use | Yes | Yes  |
|  User Group | Diabetes patients treated with multiple daily insulin injection (MDI) therapy | Diabetes patients treated with the insulin pump into which the calculator is integrated  |
|  Communication with insulin pumps | No | Yes, the insulin pump into which the calculator is integrated  |
|  Wireless Connectivity | Bluetooth Low Energy (BLE) | No  |
|  Control or effect blood glucose measurements | No | No  |
|  Control or effect insulin delivery | No | No  |
|  Carbohydrate Calculator | Calculation based either on user entered glucose and carbohydrates, meal size estimation, or fixed meal doses. | Calculations based on user entered carbohydrate and glucose data  |
|  Manual data entry | Yes | Yes  |
|  Operating platform | Android | Compatible insulin pump  |

K193483 - Page 5 of 7

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VI Standards/Guidance Documents Referenced:

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

ANSI/AAMI/IEC 62366-1:2015 Medical Devices – Application of usability engineering to medical devices

ANSI/AAMI HE75:2009 Human factors engineering, Design of medical devices

VII Performance Characteristics (if/when applicable):

A Analytical Performance:

Basal-IQ technology algorithm was previously approved as part of the T-slim X2 Insulin Pump with Basal-IQ Technology under P180008. Basal-IQ technology described in this submission consists of an identical insulin delivery algorithm and capacity for compatibility with an ACE pump and iCGM. No new non-clinical laboratory studies were conducted to validate the Basal-IQ technology separately from the system approved in P180008, in order to enable compatibility with and Alternate Controller Enabled (ACE) Infusion Pump (cleared under 21 CFR 880.5730) or integrated continuous glucose monitoring system (iCGM, under 21CFR 862.1355). The Basal-IQ technology is the same algorithm as reviewed in P180008, therefore no additional testing was conducted.

Software modifications were made to the Tandem insulin pump to add the Basal-IQ technology algorithm. Comprehensive verification and validation testing was conducted to confirm that the software used in the pump with Basal-IQ technology met all specified requirements and performed as intended.

B Other Supportive Instrument Performance Characteristics Data:

Summary of Clinical Testing:

A total of 107 subjects with Type 1 Diabetes were enrolled at 4 sites in the United States (US). The study was a multi-center, randomized, at home, crossover design evaluation of subjects with type 1 diabetes. Study subjects enrolled were either insulin pump users, multiple daily injection of insulin (MDI) users, CGM naïve users (may be pump or MDI users), or experienced CGM users (may be pump or MDI users). Of the 107 subjects enrolled (over the age of 6 years old) five subjects did not complete the study.

The 102 study subjects participated in a crossover design study, consisting of two 3- week periods with the t:slim X2 Insulin Pump with Basal-IQ (Basal-IQ enabled) used during one period and Sensor Augmented Pump (SAP) used during the other period. The crossover design study was preceded by a run-in phase in which participants received training using the study devices.

The performance data presented demonstrates that the Basal-IQ technology of the already approved t:slim X2 Insulin Pump paired with the Dexcom G5 CGM (P140015/S020) can be used safely and that it functions as intended. The analysis of input specifications is adequate to assure

K193483 - Page 6 of 7

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reasonable safety and effectiveness when iCGM sensors are used with the system as well. Additionally, the performance data demonstrates that the Basal-IQ technology functions as intended to stop and resume insulin delivery in response to low and high glucose levels, respectively.

## VIII Proposed Labeling:

The labeling supports the finding of substantial equivalence for this device and met the special controls for 21 CFR 862.1356.

## IX Conclusion:

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

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