Dexcom G6 Glucose Program Continuous Glucose Monitoring System

K182041 · Dexcom, Inc. · QDK · Oct 26, 2018 · Clinical Chemistry

Device Facts

• Record ID: K182041
• Device Name: Dexcom G6 Glucose Program Continuous Glucose Monitoring System
• Applicant: Dexcom, Inc.
• Product Code: QDK · Clinical Chemistry
• Decision Date: Oct 26, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1355
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Dexcom G6 Glucose Program Continuous Glucose Monitoring System (Dexcom Glucose Program System) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons age 2 years and older. The Dexcom Glucose Program System is intended to replace fingerstick blood glucose testing for diabetes treatment decisions for persons with diabetes who are not at significant risk of severe hypoglycemia. Interpretation of the Dexcom Glucose Program System results should be based on the glucose trends and several sequential sensor readings over time. The Dexcom Glucose Program System also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating long-term therapy adjustments. The Dexcom Glucose Program System is also intended to autonomously communicate with digitally connected devices. The Dexcom Glucose Program System can be used alone or in conjunction with these digitally connected devices or services for the purpose of managing diabetes.

Device Story

System provides real-time continuous glucose monitoring (CGM) via interstitial fluid analysis. Components include sterile sensor probe, BLE transmitter, and mobile application. Sensor uses glucose oxidase to catalyze glucose oxidation, producing hydrogen peroxide; current generated is proportional to glucose concentration. Transmitter processes signal via algorithm to calculate glucose values (mg/dL) and transmits data to mobile app every 5 minutes. Used by patients for diabetes management; replaces fingerstick testing for treatment decisions in low-risk populations. App displays current glucose, trends, and history. System is interoperable, communicating wirelessly with connected devices or cloud services. Benefits include long-term therapy adjustments through detection of hyper/hypoglycemic episodes. Device does not provide alerts/alarms for glucose levels or rapid changes.

Clinical Evidence

No clinical data; performance characteristics established in DEN170088. Analytical and clinical performance is identical to the predicate device due to unchanged sensor, transmitter, and algorithm design.

Technological Characteristics

Amperometric sensor; glucose oxidase chemical reaction; subcutaneous wire form factor; transmitter-based processing; mobile app interface; Bluetooth connectivity; factory calibrated.

Indications for Use

Indicated for management of diabetes in persons age 2 years and older. Intended to replace fingerstick blood glucose testing for treatment decisions in patients not at significant risk of severe hypoglycemia.

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 ASSAY AND INSTRUMENT COMBINATION TEMPLATE

A. 510(k) Number:
k182041

B. Purpose for Submission:
New Device

C. Measurand:
Glucose in Interstitial Fluid

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

E. Applicant:
Dexcom, Inc.

F. Proprietary and Established Names:
Dexcom G6 Glucose Program Continuous Glucose Monitoring System

G. Regulatory Information:
1. Regulation section: 21 CFR 862.1355
2. Classification: Class II
3. Product code: QDK (integrated continuous glucose monitoring system for non-intensive diabetes management)
4. Panel: Chemistry (75)

H. Intended Use:
1. Intended use(s):
See Indications for use below.

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2. Indication(s) for use:

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

The Dexcom Glucose Program System is intended to replace fingerstick blood glucose testing for diabetes treatment decisions for persons with diabetes who are not at significant risk of severe hypoglycemia. Interpretation of the Dexcom Glucose Program System results should be based on the glucose trends and several sequential sensor readings over time. The Dexcom Glucose Program System also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating long-term therapy adjustments. The Dexcom Glucose Program System is also intended to autonomously communicate with digitally connected devices. The Dexcom Glucose Program System can be used alone or in conjunction with these digitally connected devices or services for the purpose of managing diabetes.

3. Special conditions for use statement(s):

- This device is for prescription use only.
- The Dexcom Glucose Program System, which is intended for use in persons with diabetes who do not have a significant risk of hypoglycemia, does not alert or alarm to tell you when your glucose is low (below your target range), high (above your target range), or rapidly changing. Users should check readings often if they need to know their glucose level.
- The components of the Dexcom Glucose Program System (sensor, transmitter, or smart device) must be removed prior to magnetic resonance imaging (MRI), computed tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment. The Dexcom Glucose Program System has not been tested in those situations.
- This device is not intended for pregnant women, people on dialysis, or patients receiving intensive medical intervention/therapy.
- Taking higher than the maximum dose of acetaminophen (e.g. >1 gram every 6 hours in adults) may affect the Dexcom Glucose Program System readings and make them look higher than they really are.
- Sensor placement is important to ensure system performance. Users should choose a site:
- At least 3 inches from insulin pump infusion set or injection site or previous CGM insertion site
- Away from waistband, scarring, tattoos, irritation, and bones
- Unlikely to be bumped, pushed, or laid on while sleeping
- Store your sensors only between 36° F and 86° F.

4. Special instrument requirements:

Not Applicable.

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I. Device Description:

The Dexcom G6 Glucose Program System in an integrated continuous glucose monitoring system (iCGM) that provides continuous glucose readings which are updated every 5 minutes providing glucose levels and trends. 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). A user must use the Dexcom G6 Glucose Program App (i.e., a mobile medical application) running on a compatible mobile device in order to view glucose data.

G6 GLUCOSE PROGRAM 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.

The sensor may be worn in the abdomen for adults, and both the abdomen and buttock for children ages 2-17 years old.

G6 GLUCOSE PROGRAM TRANSMITTER

The transmitter component 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., mobile device). The transmitter attaches to the sensor and can be re-used for multiple sensing sessions up to three months.

G6 GLUCOSE PROGRAM MOBILE APP

The Dexcom G6 Glucose Program CGM App for Android is the primary display for the system. The Dexcom G6 Glucose Program CGM App is compatible with specific Android devices. A link to a list of compatible devices is included in the instructions for use.

The Dexcom G6 Glucose Program CGM System is an interoperable connected device that can communicate glucose readings and other information wirelessly and securely to and from interoperable electronic interfaces. The G6 Glucose Program 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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J. Substantial Equivalence Information:

1. Predicate device name(s):

G6 Continuous Glucose Monitoring System

2. Predicate 510(k) number(s):

DEN170088

3. Comparison with predicate:

The Dexcom G6 Glucose Program System is identical to the predicate device with the exception of the user interface (e.g., a new mobile app and no dedicated hardware receiver), and the population that the device is intended for. The predicate device was intended for use by people with diabetes age 2 years and older, whereas the Dexcom G6 Glucose Program System is only intended for those people with diabetes who have a low risk of experiencing severe hypoglycemia.

| Similarities | | |
| --- | --- | --- |
| Item | Dexcom G6 Glucose Program Continuous Glucose Monitoring System (Candidate) | Dexcom G6 Continuous Glucose Monitoring System (Predicate) |
| Device Type | Interoperable CGM | Same |
| Detection Method | Amperometric electrochemical | Same |
| Sample Type | Interstitial fluid | Same |
| Sensor Calibration | Factory calibrated, with optional user calibration | Same |
| Test Range | 40-400 mg/dL | Same |
| Enzyme | Glucose oxidase | Same |
| Glucose reading update interval | Autonomously every 5 minutes | Same |
| Mobile App glucose reading storage | 30 days of glucose readings | Same |
| Wireless communications protocol | Bluetooth Core Specification v4.0 | Same |
| Glucose trend arrows | →, -1 to +1 mg/dL/min
↗, +1 to +2mg/dL/min
↘, -2 to -1 mg/dL/min
↑, +2 to +3 mg/dL/min
↓, -3 to -2 mg/dL/min
↑↑, > +3mg/dL/min
↓↓, < -3mg/dL/min | Same |

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| Similarities | | |
| --- | --- | --- |
| Item | Dexcom G6 Glucose Program Continuous Glucose Monitoring System (Candidate) | Dexcom G6 Continuous Glucose Monitoring System (Predicate) |
| 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 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 |
| Transmitter power supply | Lithium manganese dioxide battery (not replaceable or rechargeable) | Same |
| Communications range | 20 feet | Same |

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| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended use population | Persons with diabetes age 2+ years without significant risk of severe hypoglycemia | Persons with diabetes age 2+ years |
| Alerts and Alarms | Signal loss, sensor failure, transmitter failure | Urgent low glucose (55 mg/dL), predictable low glucose, threshold low glucose, threshold high glucose, rising rate of glucose, falling rate of glucose, signal loss, sensor failure, transmitter failure. |
| Primary Display Device | Mobile app installed on compatible smart device | Hardware receiver or mobile app installed on compatible smart device |
| Compatible Smart Devices | Samsung J3 | iPhone 5S through iPhone X, and several Samsung phones |
| Trend Graph Glucose History | 6 and 12 hours | 1, 3, 6, 12, and 24 hours |
| Data displayed | Current glucose value, current glucose trend, time in range (user defined ranges) | Current glucose value, current glucose trend, user entered events |

## K. Standard/Guidance Document Referenced (if applicable):

ISO 14971:2012; Medical Devices – Application of Risk Management to Medical Devices

ISO 15223-1:2012; Medical Devices – Symbols to be Used with Medical Device Labels, Labeling and Information to be Supplied – Part 1: General Requirements

EN 62304:2006/AC:2015; Medical device software – Software life cycle processes

IEC 62366:2014; Medical devices – Application of usability engineering to medical devices

IEC 60601-1:2005 (Ed.3); Medical Electrical Equipment – Part 1: Requirements for basic safety and essential performance

## L. Test Principle:

The Dexcom G6 Glucose Program CGM 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

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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 mg/dL, which is then transmitted to the receiver for the user to see and use accordingly.

## M. Performance Characteristics (if/when applicable):

As established in DEN170088.

The components of the Dexcom G6 Glucose Program System are identical to those of the predicate device except for a new user interface (mobile app) that is specific for the new device.

The analytical and clinical performance of this device is primarily determined by the design of the sensor and transmitter system components, the glucose determination algorithm, and the method of calibration. All of these aspects of the predicate device are unchanged in the candidate device. Therefore the performance characteristics of the candidate device are referenced from the predicate device.

### 1. Analytical performance:

a. Precision/Reproducibility:
As established in DEN170088.

b. Linearity/assay reportable range:
As established in DEN170088.

c. Traceability, Stability, Expected values (controls, calibrators, or methods):
As established in DEN170088.

d. Detection limit:
As established in DEN170088.

e. Analytical specificity:
As established in DEN170088.

f. Assay cut-off:
Not Applicable.

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2. Comparison studies:

a. Method comparison with predicate device:
Not Applicable.

b. Matrix comparison:
Not applicable. Interstitial fluid is the only indicated matrix.

3. Clinical studies:

a. Clinical Sensitivity:
Not Applicable.

b. Clinical specificity:
Not Applicable.

c. Other clinical supportive data (when a. and b. are not applicable):
As established in DEN170088.

The Dexcom G6 Glucose Program System has a new user interface (mobile app) compared to the predicate device. The new user interface presents similar information to the user (e.g., glucose values and glucose trend information), and users must perform the same critical tasks when using the interface (e.g., entering sensor calibration codes, pairing the transmitter to the app using Bluetooth, and optionally entering blood glucose calibration values). The information provided was adequate to support the substantial equivalence of the new user interface.

4. Clinical cut-off:
Not applicable.

5. Expected values/Reference range:
Not applicable.

N. Instrument Name:
Dexcom G6 Glucose Program Continuous Glucose Monitoring System

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O. System Descriptions:

1. 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 ☐

2. Software:
FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types:
Yes ☐ X or No ☐

3. Specimen Identification:
Not Applicable

4. Specimen Sampling and Handling:
Not Applicable

5. Calibration:
Though the Dexcom G6 Glucose Program Continuous Glucose Monitoring System does not require user calibration, users have the option to calibrate the device manually (e.g., in situations where users do not have to use the calibration code). Calibration stability was established in DEN170088.

6. Quality Control:
Not Applicable

P. Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above:

The following supportive instrument performance characteristics were established in DEN170088:
- Biocompatibility
- Sterility

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- Human Factors
- Mechanical Engineering
- Electromagnetic Compatibility and Wireless
- Electrical Safety
- Environmental Testing
- Shelf Life Stability
- Packaging Integrity / Shipping Integrity
- Interoperability
- Contact Resistance

## Cyber Security:

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 provided reviewed. Cyber security parameters were identified for each asset and included the transmitter, receiver, and smart device applications. Traceability was provided and was adequate. 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.

## Q. 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.

## R. Conclusion:

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

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