Dexcom G6 Continuous Glucose Monitoring System

K183206 · Dexcom, Inc. · QBJ · Feb 14, 2019 · Clinical Chemistry

Device Facts

• Record ID: K183206
• Device Name: Dexcom G6 Continuous Glucose Monitoring System
• Applicant: Dexcom, Inc.
• Product Code: QBJ · Clinical Chemistry
• Decision Date: Feb 14, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1355
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Dexcom G6 Continuous Glucose Monitoring System (Dexcom G6 System) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons age 2 years and older. The Dexcom G6 System is intended to replace fingerstick blood glucose testing for diabetes treatment decisions. Interpretation of the Dexcom G6 System results should be based on the glucose trends and several sequential readings over time. The Dexcom G6 System also aids in the detection of episodes of hyperglycemia, facilitating both acute and long-term therapy adjustments. The Dexcom G6 System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The Dexcom G6 System can be used alone or in conjunction with these digitally connected medical devices for the purpose of managing diabetes.

Device Story

Dexcom G6 is an integrated continuous glucose monitoring (iCGM) system; measures interstitial glucose via enzymatic electrochemical reaction (glucose oxidase). Sensor probe inserted subcutaneously; transmitter attaches to sensor; transmits data via Bluetooth Low Energy (BLE) every 5 minutes to receiver or mobile app. System provides real-time glucose readings, trends, and alerts for hypo/hyperglycemia. Used by patients for diabetes management; replaces fingerstick testing for treatment decisions. Interoperable with AID systems. Transmitter hardware modified in this submission (polyetherimide shell, silver oxide battery); firmware updated to support hardware; core sensing/algorithm unchanged. System worn on abdomen (adults) or abdomen/buttock (pediatric).

Clinical Evidence

No new clinical data provided. Analytical and clinical performance established in DEN170088. Current submission relies on bench testing, biocompatibility, and electrical/wireless safety testing to demonstrate that transmitter modifications do not impact system performance.

Technological Characteristics

Amperometric sensing via glucose oxidase reaction. Components: subcutaneous sensor, BLE transmitter, BLE-enabled receiver/mobile app. Connectivity: BLE. Data update interval: 5 minutes. Sensor wear time: up to 10 days. Factory calibrated.

Indications for Use

Indicated for management of diabetes in persons age 2 years and older. Not intended for pregnant women, people on dialysis, or critically ill patients.

Regulatory Classification

Identification

An integrated continuous glucose monitoring system (iCGM) is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time. iCGM systems are designed to reliably and securely transmit glucose measurement data to digitally connected devices, including automated insulin dosing systems, and are intended to be used alone or in conjunction with these digitally connected medical devices for the purpose of managing a disease or condition related to glycemic control.

Special Controls

*Classification.* Class II (special controls). The special controls for this device are:(1) Design verification and validation must include the following: (i) Robust clinical data demonstrating the accuracy of the device in the intended use population. (ii) The clinical data must include a comparison between iCGM values and blood glucose values in specimens collected in parallel that are measured on an FDA-accepted laboratory-based glucose measurement method that is precise and accurate, and that is traceable to a higher order ( *e.g.,* an internationally recognized reference material and/or method).(iii) The clinical data must be obtained from a clinical study designed to fully represent the performance of the device throughout the intended use population and throughout the measuring range of the device. (iv) Clinical study results must demonstrate consistent analytical and clinical performance throughout the sensor wear period. (v) Clinical study results in the adult population must meet the following performance requirements: (A) For all iCGM measurements less than 70 milligrams/deciliter (mg/dL), the percentage of iCGM measurements within ±15 mg/dL of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 85 percent. (B) For all iCGM measurements from 70 mg/dL to 180 mg/dL, the percentage of iCGM measurements within ±15 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 70 percent. (C) For all iCGM measurements greater than 180 mg/dL, the percentage of iCGM measurements within ±15 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 80 percent. (D) For all iCGM measurements less than 70 mg/dL, the percentage of iCGM measurements within ±40 mg/dL of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 98 percent. (E) For all iCGM measurements from 70 mg/dL to 180 mg/dL, the percentage of iCGM measurements within ±40 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 99 percent. (F) For all iCGM measurements greater than180 mg/dL, the percentage of iCGM measurements within ±40 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 99 percent. (G) Throughout the device measuring range, the percentage of iCGM measurements within ±20 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 87 percent. (H) When iCGM values are less than 70 mg/dL, no corresponding blood glucose value shall read above 180 mg/dL. (I) When iCGM values are greater than 180 mg/dL, no corresponding blood glucose value shall read less than 70 mg/dL. (J) There shall be no more than 1 percent of iCGM measurements that indicate a positive glucose rate of change greater than 1 mg/dL per minute (/min) when the corresponding true negative glucose rate of change is less than −2 mg/dL/min as determined by the corresponding blood glucose measurements. (K) There shall be no more than 1 percent of iCGM measurements that indicate a negative glucose rate of change less than −1 mg/dL/min when the corresponding true positive glucose rate of change is greater than 2 mg/dL/min as determined by the corresponding blood glucose measurements. (vi) Data demonstrating similar accuracy and rate of change performance of the iCGM in the pediatric population as compared to that in the adult population, or alternatively a clinical and/or technical justification for why pediatric data are not needed, must be provided and determined by FDA to be acceptable and appropriate. (vii) Data must demonstrate that throughout the claimed sensor life, the device does not allow clinically significant gaps in sensor data availability that would prevent any digitally connected devices from achieving their intended use. (2) Design verification and validation must include a detailed strategy to ensure secure and reliable means of iCGM data transmission to provide real-time glucose readings at clinically meaningful time intervals to devices intended to receive the iCGM glucose data. (3) Design verification and validation must include adequate controls established during manufacturing and at product release to ensure the released product meets the performance specifications as defined in paragraphs (b)(1) and (b)(2) of this section. (4) The device must demonstrate clinically acceptable performance in the presence of clinically relevant levels of potential interfering substances that are reasonably present in the intended use population, including but not limited to endogenous substances and metabolites, foods, dietary supplements, and medications. (5) The device must include appropriate measures to ensure that disposable sensors cannot be used beyond its claimed sensor wear period. (6) Design verification and validation must include results obtained through a usability study that demonstrates that the intended user can use the device safely and obtain the expected glucose measurement accuracy. (7) The labeling required under § 809.10(b) of this chapter must include a separate description of the following sensor performance data observed in the clinical study performed in conformance with paragraph (b)(1) of this section for each intended use population, in addition to separate sensor performance data for each different iCGM insertion or use sites ( *e.g.,* abdomen, arm, buttock):(i) A description of the accuracy in the following blood glucose concentration ranges: less than 54 mg/dL, 54 mg/dL to less than 70 mg/dL, 70 to 180 mg/dL, greater than 180 to 250 mg/dL, and greater than 250 mg/dL. (ii) A description of the accuracy of positive and negative rate of change data. (iii) A description of the frequency and duration of gaps in sensor data. (iv) A description of the true, false, missed, and correct alert rates and a description of the available glucose concentration alert settings, if applicable. (v) A description of the observed duration of iCGM life for the device.

Predicate Devices

• G6 Continuous Glucose Monitoring System (DEN170088)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY INSTRUMENT ONLY TEMPLATE

A. 510(k) Number:
k183206

B. Purpose for Submission:
Modification to the CGM Transmitter of the predicate device

C. Manufacturer and Instrument Name:
Dexcom, Inc., Dexcom G6 Continuous Glucose Monitoring System

D. Type of Test or Tests Performed:
Quantitative, amperometric assay (Glucose Oxidase)

E. System Descriptions:

1. Device Description:

The Dexcom G6 Continuous Glucose Monitoring System is an integrated continuous glucose monitoring system (iCGM) that provides continuous glucose readings which are updated every 5 minutes providing glucose levels, trends, and alerts. The System consists of three main components: a sensor, a Bluetooth Low Energy (BLE) transmitter and a BLE enabled display device (receiver and/or mobile application). The user can view glucose data on the receiver or on the G6 CGM App (i.e., a mobile medical application) running on a compatible mobile device, or on both simultaneously.

The system provides alerts and alarms which warn the user of low or impending low and high or impending high glucose levels. The user may determine their treatment based on the glucose values provided by the system.

G6 CGM SENSOR

The sensor component is a sterile device that consists of the sensor applicator, plastic base ("transmitter holder"), and sensor probe. The applicator is a single use, disposable unit that contains an introducer needle holding the sensor probe. The applicator deploys the needle and inserts the sensor under the skin. The needle is retracted back into the applicator after insertion. The sensor probe continuously measures glucose concentration in interstitial fluid and can be worn for up to 10 days.

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The sensor may be worn in the abdomen for adults, and both the abdomen and buttock for children ages 2-17 years old. The sensor comes with a calibration code that the user enters into the system upon initializing a new sensor. Once the code is applied, the user does not need to calibrate the system throughout the entirety of the sensor lifetime, which is 10 days. However, the user has the option to manually calibrate the system using self-measurements from a blood glucose meter in addition to entering the calibration code. Alternatively, if the user chooses not to enter the calibration code, he or she must manually calibrate the sensor by entering two fingerstick blood glucose values during start up and every 24 hours thereafter.

## G6 CGM TRANSMITTER

The G6 CGM Transmitter is a miniature radio transmitter that incorporates data processing functionality. The transmitter contains a Bluetooth radio transceiver for communication with a compatible display device (i.e., receiver and/or smart device). The transmitter attaches to the sensor and can be re-used for multiple sensing sessions up to three months.

## G6 CGM RECEIVER

The G6 CGM Receiver is small hand-held device that wirelessly receives glucose information from the transmitter every five minutes and includes a touchscreen display. The 5 receiver displays the current glucose reading and glucose trends to the user. It alerts the user when glucose levels are outside of a target zone and when other important system conditions occur.

## DEXCOM G6 System MOBILE APP

The G6 CGM App for iOS and G6 CGM App for Android provides an alternative display device to the receiver for users with a compatible, BLE-enabled smart device and behaves similarly to the receiver. The G6 CGM App is compatible with certain iOS, Android and Smart Device watches. A link to a list of compatible devices is included in the instructions for use.

The Dexcom G6 System is an interoperable connected device that can communicate glucose readings and other information wirelessly and securely to and from interoperable electronic interfaces; including compatible AID systems. The G6 CGM system is designed to communicate with interoperable devices in several ways, such as described below:

- Wireless communication from the transmitter directly to an interoperable device communicating through the same protocol.
- The app communicates to another app on a single mobile platform.
- The app communicates through the cloud to another software device.

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2. Principles of Operation:

The Dexcom G6 System detects glucose levels from the fluid just beneath the skin (interstitial fluid). The sensor probe continuously measures glucose concentration in the interstitial fluid via an enzymatic electrochemical reaction using glucose oxidase. The enzyme, glucose oxidase, catalyzes the oxidation of glucose and produces hydrogen peroxide. The production of hydrogen peroxide generates an electrical current that is proportionate to the interstitial glucose concentration. The transmitter converts the signal using an algorithm to a glucose value read in $\mathrm{mg/dL}$, which is then transmitted to the receiver for the user to see and use accordingly.

3. Modes of Operation:

Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device?

Yes ☐ X or No ☐

Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission?

Yes ☐ X or No ☐

4. Specimen Identification:

Not applicable.

5. Specimen Sampling and Handling:

Not applicable.

6. Calibration:

Though the Dexcom G6 System does not require user calibration, users of the Dexcom G6 System have the option to calibrate the device manually (e.g., in situations where users do not have to use the calibration code). An evaluation of calibration stability in DEN170088 demonstrated that the system could be calibrated manually without impacting system performance.

7. Quality Control:

Not applicable.

8. Software:

FDA has reviewed applicant’s Hazard Analysis and Software Development processes for

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this line of product types:

Yes ☐ X or No ☐

## F. Regulatory Information:

1. Regulation section:
21 CFR 862.1355

2. Classification:
Class II

3. Product code:
QBJ

4. Panel:
Chemistry (75)

## G. Intended Use:

1. Indication(s) for Use:

The Dexcom G6 Continuous Glucose Monitoring System (Dexcom G6 System) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons age 2 years and older.

The Dexcom G6 System is intended to replace fingerstick blood glucose testing for diabetes treatment decisions. Interpretation of the Dexcom G6 System results should be based on the glucose trends and several sequential readings over time. The Dexcom G6 System also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments.

The Dexcom G6 System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The Dexcom G6 System can be used alone or in conjunction with these digitally connected medical devices for the purpose of managing diabetes.

2. Special Conditions for Use Statement(s):

- This device is for prescription use only.
- Remove the Dexcom G6 sensor, transmitter, and receiver before Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment. The magnetic fields and heat could damage the components of

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the Dexcom G6 System, which may cause it to display inaccurate blood glucose readings or may prevent alerts.

- This device is not intended for pregnant women, people on dialysis, or critically ill patients.
- Although standard dosing of acetaminophen (1000 mg per every 6 hours) does not appear to cause significant bias, higher supra-therapeutic levels of acetaminophen have shown significant positive bias.
- Users should adhere to the instructions for sensor insertion site; Adult users should only use the abdomen and pediatric users should only use the buttock or abdomen. Sensor performance has not been evaluated in other insertion sites and may differ from expected iCGM performance.
- Change your insertion site so it is at least 3 inches from the previous insertion site. Using the same site too often may cause irritation or scarring.
- Do not insert your sensor over irritated skin, tattoos, near waistband, bones, or scarring and near places that are easily bumped, pushed or laid on while sleeping.
- Store your sensors only between 36° F and 86° F. Do not store sensors in the freezer.

## H. Substantial Equivalence Information:

1. Predicate Device Name(s) and 510(k) numbers:

G6 Continuous Glucose Monitoring System (DEN170088)

2. Comparison with Predicate Device:

This submission is for modifications to the transmitter of the predicate Dexcom G6 Continuous Glucose Monitoring System. The candidate transmitter has the same overall form, fit, and function as the predicate transmitter. The sensor, algorithm, receiver, and mobile App (iOS and Android) remain unchanged.

| Similarities | | |
| --- | --- | --- |
| Item | Candidate Device: Dexcom G6 Continuous Glucose Monitoring System | Predicate Device: Dexcom G6 Continuous Glucose Monitoring System (DEN170088) |
| Intended use | Real time, continuous glucose monitoring device for the management of diabetes in persons age 2 years and older. Intended to replace fingerstick blood glucose testing for diabetes treatment decisions. | Same |
| Detection Method | Amperometric electrochemical | Same |
| Enzyme | Glucose oxidase | Same |

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| Similarities | | |
| --- | --- | --- |
| Item | Candidate Device: Dexcom G6 Continuous Glucose Monitoring System | Predicate Device: Dexcom G6 Continuous Glucose Monitoring System (DEN170088) |
| Sample Type | Interstitial fluid | Same |
| Test Range | 40-400 mg/dL | Same |
| Glucose reading update interval | Autonomously every 5 minutes | Same |
| Anatomical sensor wear locations | Abdomen (age 2+ years) or upper buttocks (age 2-17 years) | Same |
| Sensor dimensions | 45° insertion angle, 8mm depth, 0.2mm diameter | Same |
| Sensor calibration | Factory calibrated, with optional user calibration | Same |
| Sensor warm up time | 2 hours | Same |
| Sensor life | Up to 10 days (automatic sensor shutoff) | Same |
| Operational conditions | Ambient Temperature: 50°F – 107.6°F
Humidity: 10%-95% RH
Altitude: -1300 feet to 13,800 feet | Same |
| Wireless communications protocol | Bluetooth Core Specification v4.0 | Same |
| Communications range | 20 feet | Same |
| Transmitter dimensions | Length: 1.8 inches
Width: 1.2 inches
Thickness: 0.6 inches | Same |
| Transmitter life | Up to 3 months | Same |
| Differences | | |
| --- | --- | --- |
| Item | Candidate Device: Dexcom G6 Continuous Glucose Monitoring System | Predicate Device: Dexcom G6 Continuous Glucose Monitoring System (DEN170088) |
| Transmitter exterior design | Hardware is encapsulated by two plastic (polyetherimide) shells, which are ultrasonically welded together | Hardware is encapsulated by epoxy, which is formed in a mold |
| Transmitter weight | 0.29 ounces | 0.30 ounces |

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| Differences | | |
| --- | --- | --- |
| Item | Candidate Device: Dexcom G6 Continuous Glucose Monitoring System | Predicate Device: Dexcom G6 Continuous Glucose Monitoring System (DEN170088) |
| Transmitter power supply | Silver oxide 1.55V, 80 mAh battery (not replaceable or rechargeable) | Lithium manganese 3.0V, 140mAh dioxide battery (not replaceable or rechargeable) |

I. Special Control/Guidance Document Referenced (if applicable):

Standards referenced

- IEC 62304, Ed 1.1:2015. Medical Device Software – Software Life Cycle Processes.
- IEEE/ANSI C63.27-2017. American National Standard for Evaluation of Wireless Coexistence.
- IEC 60601-1:2012 (Third Edition). Medical Electrical Equipment – Part 1: Requirements for basic safety and essential performance.
- ISO 10993-1:2009. Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process.
- ISO 10993-5: 2009. Biological Evaluation of Medical Devices – Part 5: Tests for in Vitro Cytotoxicity.
- ISO 10993-10: 2010. Biological Evaluation of Medical Devices – Part 10: Tests for Irritation and Skin Sensitization.
- ISO 10993-12: 2012. Biological Evaluation of Medical Devices – Part 12: Sample preparation and reference materials.

Guidance documents referenced

1. Guidance for Industry and FDA Staff, Format for Traditional and Abbreviated 510(k)s (issued August 12, 2005).
2. eCopy Program for Medical Device Submissions, Guidance for Industry and Food and Drug Administration Staff (issued December 3, 2015).
3. Refuse to Accept Policy for 510(k)s, Guidance for Industry and Food and Drug Administration Staff (issued January 30, 2018).
4. Guidance for Industry and FDA Staff, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (issued May 11, 2005).
5. Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, Guidance for Industry and Food and Drug Administration Staff (issued dated October 2, 2014).
6. Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process,” Guidance for Industry and Food and Drug Administration Staff (issued June 16, 2016).

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7. Guidance for Industry and FDA Staff, Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices (issued September 14, 2018).
8. Guidance for Industry and FDA Staff, Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use (issued November 30, 2004).
9. General Principles of Software Validation; Final Guidance for Industry and FDA Staff (issued January 11, 2002).

## J. Performance Characteristics:

The analytical and clinical performance of this device was established in DEN170088. The candidate transmitter has the same overall form, fit, and function as the predicate transmitter, which would not be expected to impact the performance of the device. Transmitter firmware was modified to support the new transmitter hardware with the predicate G6 Algorithm. The sensor, algorithm, receiver, and mobile App (iOS and Android) remain unchanged.

### 1. Analytical Performance:

a. Accuracy:
As established in DEN170088.

b. Precision/Reproducibility:
As established in DEN170088.

c. Linearity:
As established in DEN170088.

d. Carryover:
Not applicable.

e. Interfering Substances:
As established in DEN170088.

### 2. Other Supportive Instrument Performance Data Not Covered Above:

#### Clinical performance

The clinical accuracy performance of the device was established in DEN170088.

#### Stability

Sensor shelf-life stability was established in DEN170088.

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The G6 Transmitter has sufficient battery life to function for 3 months as intended following its maximum storage time of 12 months. Battery life testing protocols were reviewed and found to be acceptable.

## Biocompatibility

Biocompatibility testing was conducted in accordance with ISO 10993-1:2009, ISO 10993-5: 2009, ISO 10993-10: 2010, and ISO 10993-12: 2012. Cytotoxicity, sensitization, and irritation testing of the G6 Transmitter was performed and the results were found to be acceptable.

Biocompatibility testing of other patient-contacting components of the G6 System was conducted in DEN170088 and found acceptable.

## Mechanical Engineering

Transmitter hardware testing provided to support sound mechanical function of the device was reviewed and found acceptable.

Mechanical hardware testing of other components of the G6 System was conducted in DEN170088 and found acceptable.

## Electromagnetic Compatibility and Wireless

Electromagnetic Compatibility testing for radio frequency (RF) emissions and electromagnetic immunity was conducted for the G6 Transmitter and demonstrated compliance to IEC 60601-1-2:2014.

Electromagnetic Compatibility testing for the G6 Receiver was established in DEN170088.

Wireless testing for the subject G6 System demonstrated compliance to Federal Communication Commission (FCC), Bluetooth Low Energy (BLE), and Federal Aviation Administration (FAA) requirements. Additionally, testing demonstrated that the subject G6 Transmitter meets all required performance specifications, which include radiofrequency (RF) communication range, wireless coexistence, RF interference, and compatibility with security and logistical systems.

## Electrical Safety

The basic safety and essential performance of the subject G6 Transmitter was evaluated and demonstrated compliance to IEC-60601-1:2012 and IEC 60601-1-11:2015.

The basic safety and essential performance of the G6 Receiver was established in DEN170088.

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# Packaging Integrity/Shipping Integrity

Packaging and shipping validation studies were performed for the subject G6 Transmitter kit and demonstrated that the packaging and distribution packaging configuration(s) withstand the hazards and rigors of the distribution and shipping environment and provide physical protection to the contained product.

Packaging and shipping validation for the G6 Receiver kits and G6 Sensor kits was established in DEN170088.

# Cybersecurity

The following information was provided for the device:

- Risk Management
- A model describing the assets, threats, vulnerabilities, and controls related to the device system was reviewed. Cybersecurity parameters were identified for each asset and included the transmitter, receiver, and smart device applications. The traceability provided was adequate and the risk management was acceptable.
- Planning for Continuing Support
- A plan for continuing to keep the device secure was provided and found to be complete and adequate.
- Plan for Malware-Free Shipping
- A plan to ensure the device is shipped without Malware was provided and found to be complete and adequate.

The following supportive instrument performance characteristics were established in DEN170088:

- Detection limit
- Sterility
- Human Factors
- Environmental testing
- Interoperability

# K. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Parts 801 and 809, as applicable, and the special controls for this device type under 21 CFR 862.1355.

# L. Conclusion:

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