Dexcom G6 Continuous Glucose Monitoring (CGM) System

K201328 · Dexcom, Inc. · QBJ · Jul 15, 2021 · Clinical Chemistry

Device Facts

• Record ID: K201328
• Device Name: Dexcom G6 Continuous Glucose Monitoring (CGM) System
• Applicant: Dexcom, Inc.
• Product Code: QBJ · Clinical Chemistry
• Decision Date: Jul 15, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1355
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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.

Device Story

Subcutaneous glucose sensor measures interstitial fluid glucose via glucose oxidase enzymatic reaction; generates electrical current proportional to glucose concentration. Transmitter processes signals using internal algorithm; transmits data via Bluetooth Low Energy (BLE) to receiver or mobile app. New Partner Web APIs enable cloud-based data sharing with authorized client software for non-medical applications, data analysis, secondary alarms, and patient monitoring. System provides real-time glucose readings, trend arrows, and alerts for hypo/hyperglycemia. Used by patients for diabetes management; replaces fingerstick testing for treatment decisions. Not intended for AID system integration via Partner Web APIs. Healthcare providers use output for therapy adjustments. Benefits include continuous monitoring, reduced fingersticks, and improved glycemic control.

Clinical Evidence

No new clinical data provided. Performance characteristics established in previous submissions (DEN170088, K200876) remain applicable. Bench testing and validation performed for software, interoperability, and cybersecurity.

Technological Characteristics

Subcutaneous enzymatic electrochemical sensor (glucose oxidase). BLE transmitter; receiver/mobile app display. Reportable range 40-400 mg/dL. Sterilization via radiation (ISO 11137). Biocompatibility per ISO 10993. Software lifecycle per IEC 62304. Cloud-based API connectivity added.

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 and aid in detection of hyperglycemia/hypoglycemia episodes.

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 Continuous Glucose Monitoring System (K200876)

Submission Summary (Full Text)

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July 15, 2021

Dexcom, Inc. Maryam Amini Staff Regulatory Affairs Specialist 6310 Sequence Dr. San Diego, California 92121

Re: K201328

Trade/Device Name: Dexcom G6 Continuous Glucose Monitoring (CGM) System Regulation Number: 21 CFR 862.1355 Regulation Name: Integrated continuous glucose monitoring system Regulatory Class: Class II Product Code: QBJ Dated: October 7, 2020 Received: October 8, 2020

Dear Maryam Amini:

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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 mediation-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. 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) K201328

Device Name

Dexcom G6 Continuous Glucose Monitoring System

Indications for Use (Describe)

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 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.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# 5 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K201328

## 5.1 Submitter:

Dexcom, Inc. 6340 Sequence Dr. San Diego, CA 92121

Contact: Maryam Amini Manager, Regulatory Affairs Phone: [phone] Fax: [phone] Email: [e-mail]

Secondary Contact: Holly Drake Director, Regulatory Affairs Phone: [phone] Fax: [phone] Email: [e-mail]

Date Prepared:

### 5.2 Device Names and Classification:

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

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#### 5.3 Predicate Device:

Dexcom G6 Continuous Glucose Monitoring (CGM) System (K200876)

#### 5.4 Device Description:

The Dexcom G6 Continuous Glucose Monitoring System (G6 System) is an interoperable connected device that measures and displays glucose values for patients with diabetes. The G6 System consists of three main components: a sensor/applicator, a Bluetooth Low Energy (BLE) transmitter, and a BLE enabled display device (receiver and/or mobile application). The sensor is a small and flexible wire, which is inserted by the applicator into subcutaneous tissue where it converts glucose into electrical current. The sensor has an expected wear time of up to 10 days. The transmitter is connected to the sensor and is worn on the body. The transmitter samples the electrical current produced by the sensor and converts these measurements into estimated glucose values (EGV) using an onboard algorithm. The transmitter sends glucose data to the receiver and/or mobile app, which displays the current glucose reading (updated every 5 minutes) and glucose trends. The receiver and/or mobile app also alerts the user when glucose levels are outside of a target zone and when other important system conditions occur. The G6 System is designed to be used alone or in conjunction with digitally connected devices. The G6 System can communicate Estimated Glucose Values (EGV) and other information wirelessly and securely to and from these digitally connected devices in several ways, such as described below:

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

The proposed G6 CGM System is based on the same physical principles and fundamental design as the commercially available G6 CGM System (K200876), but it includes an additional software component.

The added software component, which consists of cloud-based Application Programming Interfaces (APIs), is identified as Dexcom Partner Web APIs (Partner Web APIs). The Partner Web APIs enables communication of iCGM data to client software intended to receive the data through the cloud. The transmitted data can be used by authorized client software for specific and permitted use cases including non-medical device application, medical device data analysis, CGM secondary display alarm, active patient monitoring, and treatment decisions. The software application may not be used in environments not currently cleared for Dexcom G6 CGM System (e.g. hospital for inpatient care). The Partner Web APIs is not intended to be used by automated insulin delivery systems (AID).

Dexcom display devices (receiver and mobile app) continues to serve as a primary display device for the (iCGM) data, which directly receives the data from the transmitter. Identical

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to the G6 CGM System cleared in K200876, the mobile app includes a design mitigation that overrides Do Not Disturb settings on the smart device with the users' consent. With this app design mitigation, the G6 CGM system functions as intended to provide users with critical alarm and alerts (e.g. Urgent Low alarm) regardless of the user's smart device settings for Do Not Disturb. The current components of the Dexcom G6 System (sensor/applicator, transmitter, and display devices) have not been changed as a result of the added Partner Web APIs.

#### 5.5 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 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.

| Device | Dexcom G6 CGM System<br>(K200876, Predicate) | Dexcom G6 CGM System<br>(subject device) |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Dexcom G6 Continuous Glucose<br>Monitoring (CGM) System | Same |
| Manufacturer | Dexcom, Inc. | Same |
| Intended Use | An integrated continuous glucose<br>monitoring system (iCGM) is intended<br>to automatically measure glucose in<br>bodily fluids continuously or<br>frequently for a specified period of<br>time. iCGM systems are designed to<br>reliably and securely transmit glucose<br>measurement data to digitally<br>connected devices, including<br>automated insulin dosing systems,<br>and are intended to be used alone or<br>in conjunction with these digitally | Same |
| Device | Dexcom G6 CGM System<br>(K200876, Predicate) | Dexcom G6 CGM System<br>(subject device) |
| | connected medical devices for the<br>purpose of managing a disease or<br>condition related to glycemic control. | |
| Indications for Use | The Dexcom G6 Continuous Glucose<br>Monitoring System (Dexcom G6<br>System) is a real time, continuous<br>glucose monitoring device indicated<br>for the management of diabetes in<br>persons age 2 years and older.<br><br>The Dexcom G6 System is intended to<br>replace fingerstick blood glucose<br>testing for diabetes treatment<br>decisions. Interpretation of the<br>Dexcom G6 System results should be<br>based on the glucose trends and<br>several sequential readings over time.<br>The Dexcom G6 System also aids in<br>the detection of episodes of<br>hyperglycemia and hypoglycemia,<br>facilitating both acute and long-term<br>therapy adjustments.<br><br>The Dexcom G6 System is also<br>intended to autonomously<br>communicate with digitally connected<br>devices, including automated insulin<br>dosing (AID) systems. The Dexcom G6<br>System can be used alone or in<br>conjunction with these digitally<br>connected medical devices for the<br>purpose of managing diabetes. | Same |
| Clinical application | Management of diabetes mellitus | Same |
| Clinical setting/sites<br>of use | Home use | Same |
| Principle of<br>Operation | Amperometric measurement of<br>current proportional to glucose<br>concentration in interstitial fluid via<br>glucose oxidase chemical reaction | Same |
| Device | Dexcom G6 CGM System<br>(K200876, Predicate) | Dexcom G6 CGM System<br>(subject device) |
| Data Presented | Estimated Glucose Value (EGV): The<br>EGV is the nominal glucose value<br>presented to the user.<br><br>Glucose Trend: Based off the glucose<br>rate of change, users are shown their<br>glucose trend with a corresponding<br>arrow.<br><br>Historical Glucose Data: Users can<br>view their previous three, six, twelve,<br>or twenty-four hours of glucose data. | Same |
| Features | Connect to Dexcom Share: Users can<br>share their glucose data with<br>followers. | Substantially Equivalent with no<br>adverse impact on safety or<br>effectiveness.<br><br>Users can share their glucose data with<br>client software in addition to their<br>followers.<br><br>An interoperability communication plan<br>will be provided to potential<br>partners/developers. This<br>interoperability communication plan<br>specifies expectations, requirements<br>and interface specifications to ensure<br>the data is transmitted and received<br>securely and reliably by the digitally<br>connected devices.<br><br>Dexcom conducted software verification<br>to ensure predefined<br>requirements including but not limited<br>to data confidentiality, integrity, and<br>timely availability were fulfilled. |

## 5.6 Comparison with the Predicate Device:

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| Device | Dexcom G6 CGM System<br>(K200876, Predicate) | Dexcom G6 CGM System<br>(subject device) |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Interoperability | Designed to communicate with interoperable devices in several ways, such as described below:<br><br>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. | Substantially Equivalent with no adverse impact on safety or effectiveness.<br><br>The G6 System can now also communicate iCGM data wirelessly and securely to and from digitally connected devices (client software) through a cloud-based communication method, Partner Web APIs.<br><br>An interoperability communication plan will be provided to potential partners/developers. This interoperability communication plan specifies expectations, requirements and interface specifications to ensure the data is transmitted and received securely and reliably by the digitally connected devices.<br><br>Dexcom conducted software verification to ensure predefined requirements including but not limited to data confidentiality, integrity, and timely availability were fulfilled. |
| Human Factors | Easy to understand UI/UX.<br>Commonly understood navigation tools and features.<br>Color-coded graphics. | Same |
| Compatibility with<br>intended environments | Android OS and Apple iOS | Same |

## 5.7 Technology Characteristics

The proposed Dexcom G6 CGM System has the same technological characteristics as its predicate (K200876), which is used to measure glucose values via an amperometric measurement of current proportional to glucose concentration in interstitial fluid via a glucose oxidase chemical reaction. The proposed Dexcom G6 CGM System can communicate with authorized client software for specific and permitted use cases in the currently cleared intended use environments.

## 5.8 Summary of Performance Testing

The proposed Dexcom G6 CGM System was verified according to Dexcom's internal design control process and in accordance with special controls for integrated continuous glucose

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monitoring system. This testing demonstrated that the proposed system performed according to its specifications, and the proposed system have met its technological and performance criteria, which have not changed from the predicate device (K200876).

## 5.9 Conclusions

The information provided in this premarket notification support that the proposed Dexcom G6 CGM System is substantially equivalent to its predicate as they are identical with regard to intended use and indications for use and there are no differences in technological characteristics that raise different questions of safety and effectiveness.