Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System

K193642 · Dexcom, Inc. · QDK · Jan 29, 2020 · Clinical Chemistry

Device Facts

• Record ID: K193642
• Device Name: Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System
• Applicant: Dexcom, Inc.
• Product Code: QDK · Clinical Chemistry
• Decision Date: Jan 29, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1355
• Device Class: Class 2
• Attributes: Pediatric

Intended 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 sequential sensor readings over time. The Dexcom Glucose Program System also aids in the detection of episodes of hyperglycemia, 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 consists of subcutaneous wire sensor, transmitter, and mobile app (iOS/Android). Sensor converts interstitial glucose to electrical current via glucose oxidase reaction; transmitter samples current, converts to glucose readings via onboard algorithm, and transmits data to app every 5 minutes. App displays current glucose, trends, and historical data; alerts users to system conditions or glucose thresholds. Used in home setting by patients for diabetes management. Output supports clinical decision-making by replacing fingerstick testing and facilitating therapy adjustments. System supports connectivity to Dexcom Share and Follow apps for remote monitoring.

Clinical Evidence

No new clinical data provided. Substantial equivalence supported by design control activities, risk analysis, and verification/validation of firmware and software modifications.

Technological Characteristics

Subcutaneous glucose sensor; Bluetooth-enabled transmitter; iOS mobile application; receiver. Firmware-based signal processing. System operates as an integrated CGM (iCGM).

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

• Dexcom G6 Glucose Program Continuous Glucose Monitoring System (K192787)

Submission Summary (Full Text)

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January 29, 2020

Dexcom, Inc. Linda Wang Staff Regulatory Affairs Specialist 6340 Sequence Drive San Diego, CA 92121

Re: K193642

Trade/Device Name: Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System Regulation Number: 21 CFR 862.1355 Regulation Name: Integrated continuous glucose monitoring system Regulatory Class: Class II Product Code: QDK Dated: December 27, 2019 Received: December 30, 2019

Dear Linda Wang:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Marianela Perez-Torres, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K193642

### Device Name

Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System

Indications for Use (Describe)

The Dexcom G6 Glucose Program Continuous Glucose Monitoring System 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 sequential sensor readings over time. The Dexcom Glucose Program System also aids in the detection of episodes of hyperglycemia, 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.

Type of Use (Select one or both, as applicable)

| <span style="font-family: Arial;"> <svg height="12" width="12"> <rect fill="white" height="12" stroke="black" width="12" x="0" y="0"></rect> <path d="M0 0 L12 12 M12 0 L0 12" stroke="black"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial;"> <svg height="12" width="12"> <rect fill="white" height="12" stroke="black" width="12" x="0" y="0"></rect> </svg> Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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#### 1. 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

The assigned 510(k) number is: K193642

#### SUBMITTER 1.1

| Sponsor | Dexcom<br>6340 Sequence Drive<br>San Diego, CA 92121 |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Linda Wang<br>Staff Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Alternative Contact | Bryan Osborne<br>Regulatory Affairs Specialist<br>Phone: [phone]<br>Email: [e-mail] |
| Date Prepared | December 27, 2019 |

#### DEVICE NAMES AND CLASSIFICATION 1.2

| Proprietary Name | Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM)<br>System |
|---------------------------|-------------------------------------------------------------------------|
| Common Name | Integrated Continuous Glucose Monitoring System, Factory Calibrated |
| Class | II |
| Classification Regulation | 21 CFR 862.1355 |
| Product Code | QDK |
| Review Panel | Clinical Chemistry |

#### PREDICATE DEVICE 1.3

Dexcom G6 Glucose Program Continuous Glucose Monitoring System (K192787, cleared October 25, 2019)

#### REFERENCE DEVICE 1.4

Dexcom G6 Glucose Program Continuous Glucose Monitoring System (K182041, cleared October 26, 2018)

#### DEVICE DESCRIPTION 1.5

The proposed Dexcom G6 Glucose Program Continuous Glucose Monitoring System consists of three main components: the sensor/applicator delivery system, transmitter, and mobile application (app). The sensor is a small and flexible wire inserted into

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subcutaneous tissue where it converts glucose into electrical current. The transmitter is connected to the sensor and is worn on the body. It samples the electrical current produced by the sensor and converts these measurements into glucose readings using an onboard algorithm. The transmitter sends glucose data to either the Android app (part of the predicate system) or iOS app (part of the proposed system). The app displays the current glucose reading (updated every 5 minutes) and glucose trends from the transmitter. The app alert users of important system conditions, when it enters an error state, or when it requires the user to enter information. The app also supports connectivity to Dexcom Share and the Follow mobile application.

#### INDICATIONS FOR USE 1.6

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 | Predicate Device | Proposed Device |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| Trade Name | Dexcom G6 Glucose Program Continuous Glucose<br>Monitoring (CGM) System | Same |
| Manufacturer | Dexcom, Inc. | Same |
| Intended Use | An integrated continuous glucose monitoring system<br>(iCGM) is intended to automatically measure glucose in<br>bodily fluids continuously or frequently for a specified<br>period of time. iCGM systems are designed to reliably and<br>securely transmit glucose measurement data to digitally<br>connected devices, including automated insulin dosing<br>systems, and are intended to be used alone or in conjunction<br>with these digitally connected medical devices for the | Same |
| Device | Predicate Device | Proposed Device |
| | purpose of managing a disease or condition related to<br>glycemic control. | |
| Indications for<br>Use | The Dexcom G6 Glucose Program Continuous Glucose<br>Monitoring System (Dexcom Glucose Program System) is a<br>real time, continuous glucose monitoring device indicated<br>for the management of diabetes in persons age 2 years and<br>older.<br>The Dexcom Glucose Program System is intended to replace<br>fingerstick blood glucose testing for diabetes treatment<br>decisions for persons with diabetes who are not at significant<br>risk of severe hypoglycemia. Interpretation of the Dexcom<br>Glucose Program System results should be based on the<br>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,<br>facilitating long-term therapy adjustments.<br>The Dexcom Glucose Program System is also intended to<br>autonomously communicate with digitally connected<br>devices. The Dexcom Glucose Program System can be used<br>alone or in conjunction with these digitally connected<br>devices or services for the purpose of managing diabetes. | Same |
| Clinical<br>application | Management of diabetes mellitus | Same |
| Clinical<br>setting/sites of<br>use | Home use | Same |
| Principle of<br>Operation | Amperometric measurement of current proportional to<br>glucose concentration in interstitial fluid via glucose oxidase<br>chemical reaction. | Same |
| Data Presented | Estimated Glucose Value (EGV): The EGV is the nominal<br>glucose value presented to the user.<br>Glucose Trend: Based off the glucose rate of change, users<br>are shown their glucose trend with a corresponding arrow.<br>Historical Glucose Data: Users can view their previous six,<br>or twelve hours of glucose data on a graph with high/low<br>glucose thresholds.<br>Time in Range: Users can view the percent of time they<br>spend in their target glucose range based on their configured<br>high/low glucose thresholds. | Same |
| Features | Connect to Dexcom Share: Users can share their glucose<br>data with up to three followers.<br>Chat with Wellness Coach: Users can chat with a third-<br>party wellness coach for encouragement, education, and<br>motivation regarding their diabetes management. | Same |
| Human Factors | Easy to understand user interface and user experience.<br>Commonly understood navigation tools and features.<br>Color-coded graphics. | Same |
| Transmitter | G6 Epoxy Transmitter and G6 Welded Transmitter | Same |
| Compatibility<br>with intended<br>environments | Compatible with Android OS version 7.0 and above | Same for Android<br>Compatible with<br>iOS version 13.2<br>and above |

#### COMPARISON WITH THE PREDICATE DEVICE 1.7

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#### 1.8 TECHNOLOGICAL CHARACTERISTICS

The proposed Dexcom Glucose Program System is used to measure glucose values via amperometric measurement of current proportional to glucose concentration in interstitial fluid via a glucose oxidase chemical reaction. The proposed Dexcom Glucose Program System shares the same technological characteristics as the predicate device (K192787). The proposed Dexcom Glucose Program System adds an iOS-based app to the current/predicate CGM system's Android app capability.

#### 1.9 SUMMARY OF PERFORMANCE TESTING

The proposed Dexcom Glucose Program System was verified and validated according to Dexcom's internal design control process. All testing performed on the predicate device and reference device in accordance with special controls for integrated continuous glucose monitors remain applicable. The proposed system uses the same transmitter hardware and software requirements/design specifications as the predicate device. Therefore, performance testing and software verification and validation testing completed for the predicate device (K192787) remain applicable. Software testing was completed to ensure all requirements of the proposed iOS app are fulfilled.

# 1.10 CONCLUSION

The proposed Dexcom Glucose Program System is substantially equivalent to the predicate system as it shares the same intended use, indications for use, and technological characteristics. The difference between the proposed Dexcom Glucose Program System and the predicate device (cleared under K192787) is the addition of the iOS app, but the proposed app has the same functionality as the current Android app. Therefore, the proposed modification does not raise different questions of safety and effectiveness.