Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System and Dexcom Pro Q Continuous Glucose Monitoring System

K191450 · Dexcom, Inc. · QBJ · Jun 28, 2019 · Clinical Chemistry

Device Facts

• Record ID: K191450
• Device Name: Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System and Dexcom Pro Q Continuous Glucose Monitoring System
• Applicant: Dexcom, Inc.
• Product Code: QBJ · Clinical Chemistry
• Decision Date: Jun 28, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1355
• Device Class: Class 2
• Attributes: 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, 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

System consists of subcutaneous sensor, BLE transmitter, and display device (receiver/mobile app). Sensor converts interstitial glucose to electrical current via glucose oxidase reaction; transmitter samples current, converts to glucose readings via onboard algorithm, and transmits data every 5 minutes. Used in home setting by patients or in clinic by healthcare professionals (Pro Q). Output includes real-time/retrospective glucose values, trends, and alerts. Enables therapy adjustments, AID system integration, and data sharing. Benefits include continuous monitoring, reduced fingersticks, and improved glycemic control.

Clinical Evidence

No clinical data provided. Substantial equivalence established via design control activities, risk analysis, and bench verification/validation of modifications.

Technological Characteristics

Integrated CGM system; subcutaneous sensor; transmitter; receiver/mobile app. Modifications: new adhesive patch (adhesive, release liner, ink); firmware updates (battery indicators, touchscreen); software updates (display, connectivity). Connectivity: Bluetooth/wireless to mobile apps/receiver.

Indications for Use

Indicated for patients requiring continuous glucose monitoring as part of an integrated continuous glucose monitoring system.

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 (CGM) System (K183206)
• Dexcom G6 Glucose Program Continuous Glucose Monitoring System (K182041)
• Dexcom Pro Q Continuous Glucose Monitoring System (K182405)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.

June 28, 2019

Dexcom, Inc. Emily Chung Senior Specialist, Regulatory Affairs 6310 Sequence Dr. San Diego, CA 92121

Re: K191450

Trade/Device Name: Dexcom G6 Glucose Program Continuous Glucose Monitoring System Dexcom G6 Glucose Program Continuous Glucose Monitoring System Dexcom Pro Q Continuous Glucose Monitoring System Regulation Number: 21 CFR 862.1355 Regulation Name: Integrated Continuous Glucose Monitoring System Regulatory Class: Class II Product Code: QBJ, QDK, QDL Dated: May 30, 2019 Received: May 31, 2019

Dear Emily Chung:

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.

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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 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 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,

Kellie B. Kelm, Ph.D. Acting 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) K191450

### 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 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.

**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)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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# Indications for Use

510(k) Number (if known) K191450

### Device Name

Dexcom G6 Glucose Program Continuous Glucose Monitoring 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 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 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></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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# Indications for Use

510(k) Number (if known) K191450

Device Name

Dexcom Pro Q Continuous Glucose Monitoring System

### Indications for Use (Describe)

The Dexcom Pro Q Continuous Glucose Monitoring System (Dexcom Pro Q System) is a factory calibrated continuous glucose recording device indicated for the retrospective discovery, and interpretation of glycemic variability in persons age 2 years and older under the supervision of a healthcare professional. The Dexcom Pro Q System collects and processes data for aiding in the management of a disease or condition related to glycemic control.

Interpretation of the data recorded by the Dexcom Pro Q System results should be made only by a qualified healthcare professional based on glucose trends and several sequential readings over time. The Dexcom Pro Q System aids in detecting glucose excursions facilitating care plan adjustments. The Dexcom Pro Q System is also interface with digitally connected devices.

| Type of Use ( <i>Select one or both, as applicable</i> ) |
|----------------------------------------------------------|
|----------------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

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

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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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:

#### 6.1 Submitter:

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

Contact: Emily Chung Senior Specialist, Regulatory Affairs Phone: [phone] Fax: [phone] [e-mail] Email:

## Secondary

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

Date Prepared:

#### 6.2 Device Names and Classification:

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

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| Review Panel | Clinical Chemistry |
|---------------------------|-------------------------------------------------------------------|
| Other Devices | |
| Proprietary Name | Dexcom G6 Glucose Program Continuous Glucose<br>Monitoring System |
| Class | II |
| Classification Regulation | 21 CFR 862.1355 |
| Product Code | QDK |
| Proprietary Name | Dexcom Pro Q Continuous Glucose Monitoring System |
| Class | II |
| Classification Regulation | 21 CFR 862.1355 |
| Product Code | QDL |

#### 6.3 Predicate Device:

Dexcom G6 Continuous Glucose Monitoring (CGM) System (K183206) Dexcom G6 Glucose Program Continuous Glucose Monitoring System (K182041) Dexcom Pro Q Continuous Glucose Monitoring System (K182405)

#### 6.4 Device Description:

## 6.4.1 Dexcom G6 Continuous Glucose Monitoring (CGM) System

The Dexcom G6 Continuous Glucose Monitoring System (Dexcom G6 System) consists of three main components: a sensor, a Bluetooth Low Energy (BLE) transmitter, and a BLE enabled display device (receiver and/or mobile app). The sensor is a small and flexible wire inserted into 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 the receiver and/or mobile app which displays the current glucose reading (updated every 5 minutes) and glucose trends (up to 12 hours) from the transmitter. The G6 System does not require calibrations using SMBG, and the sensor life has an expected wear time of up to 10 days. The receiver and/or mobile app 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.

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### 6.4.2 Dexcom G6 Glucose Program Continuous Glucose Monitoring System

The Dexcom G6 Glucose Program Continuous Glucose Monitoring System (Dexcom Glucose Program System) is a continuous glucose monitor (CGM) that offers an altered feature set versus the Dexcom G6 CGM System.

The Dexcom Glucose Program System consists of three main components: a sensor/applicator delivery system, a transmitter, and a mobile application (app). The sensor is a small and flexible wire inserted into 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 the app. The app displays the current glucose reading (updated every 5 minutes) and glucose trends (up to 12 hours) from the transmitter. The app alerts 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 Follow (DEN140016).

### 6.4.3 Dexcom Pro Q Continuous Glucose Monitoring System

The Dexcom Pro Q Continuous Glucose Monitoring System (Dexcom Pro Q System) is a continuous glucose monitor that offers an altered feature set versus the Dexcom G6 CGM System.

The Dexcom Pro Q System consists of two main components: a sensor/applicator delivery system and a transmitter. The sensor is a small and flexible wire inserted into 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 logs estimated glucose values every 5 minutes during the sensor wear period (up to 10 days).

The proposed Dexcom G6 System, Dexcom G6 Glucose Program System, and Dexcom Pro Q System are based on the same physical principles and fundamental design as the predicate for each respective System but includes an alternative adhesive patch. The adhesive patch adheres the transmitter wearable to the user's body. The Dexcom G6 System, Dexcom G6 Glucose Program System, and the Dexcom Pro Q System are designed to function as intended with either the proposed or current adhesive patch. The proposed adhesive patch has the same form, fit, and function as the commercial adhesive patch and, from the users' perspective, functions identically.

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#### 6.5 INDICATIONS FOR USE

## 6.5.1 Dexcom G6 Continuous Glucose Monitoring (CGM) System

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.

## 6.5.2 Dexcom G6 Glucose Program Continuous Glucose Monitoring System

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.

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## 6.5.3 Dexcom Pro Q Continuous Glucose Monitoring System

The Dexcom Pro Q Continuous Glucose Monitoring System (Dexcom Pro Q System) is a factory calibrated continuous glucose recording device indicated for the retrospective discovery, analysis, and interpretation of glycemic variability in persons age 2 years and older under the supervision of a healthcare professional. The Dexcom Pro Q System collects and processes data for aiding in the management of a disease or condition related to glycemic control.

Interpretation of the data recorded by the Dexcom Pro Q System results should be made only by a qualified healthcare professional based on glucose trends and several sequential readings over time. The Dexcom Pro Q System aids in detecting glucose excursions facilitating care plan adjustments. The Dexcom Pro Q System is also intended to interface with digitally connected devices.

#### ୧.୧ Comparison with the Predicate Device:

| Device | Dexcom G6 CGM System (subject<br>device, K191450) | Dexcom G6 CGM System (K183206) |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Dexcom G6 Continuous Glucose<br>Monitoring (CGM) System | Dexcom G6 Continuous Glucose<br>Monitoring (CGM) System |
| Manufacturer | Dexcom, Inc. | Dexcom, Inc. |
| Intended Use | An integrated continuous glucose<br>monitoring system (iCGM) is intended<br>to automatically measure glucose in<br>bodily fluids continuously or frequently<br>for a specified period of time. iCGM<br>systems are designed to reliably and<br>securely transmit glucose<br>measurement data to digitally<br>connected devices, including<br>automated insulin dosing systems, and<br>are intended to be used alone or in<br>conjunction with these digitally<br>connected medical devices for the<br>purpose of managing a disease or<br>condition related to glycemic control. | An integrated continuous glucose<br>monitoring system (iCGM) is intended<br>to automatically measure glucose in<br>bodily fluids continuously or frequently<br>for a specified period of time. iCGM<br>systems are designed to reliably and<br>securely transmit glucose<br>measurement data to digitally<br>connected devices, including<br>automated insulin dosing systems, and<br>are intended to be used alone or in<br>conjunction with these digitally<br>connected medical devices for the<br>purpose of managing a disease or<br>condition related to glycemic control. |
| Indications for<br>Use | The Dexcom G6 Continuous Glucose<br>Monitoring System (Dexcom G6<br>System) is a real time, continuous<br>glucose monitoring device indicated | The Dexcom G6 Continuous Glucose<br>Monitoring System (Dexcom G6<br>System) is a real time, continuous<br>glucose monitoring device indicated |
| Device | Dexcom G6 CGM System (subject<br>device, K191450) | Dexcom G6 CGM System (K183206) |
| | for the management of diabetes in<br>persons age 2 years and older. | for the management of diabetes in<br>persons age 2 years and older. |
| | 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 the<br>detection of episodes of hyperglycemia<br>and hypoglycemia, facilitating both<br>acute and long-term therapy<br>adjustments. | 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 the<br>detection of episodes of hyperglycemia<br>and hypoglycemia, facilitating both<br>acute and long-term therapy<br>adjustments. |
| | 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. | 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. |
| Clinical<br>application | Management of diabetes mellitus | Management of diabetes mellitus |
| Clinical<br>setting/sites<br>of use | Home use | Home use |
| Principle of<br>Operation | Amperometric measurement of<br>current proportional to glucose<br>concentration in interstitial fluid via<br>glucose oxidase chemical reaction. | Amperometric measurement of<br>current proportional to glucose<br>concentration in interstitial fluid via<br>glucose oxidase chemical reaction. |
| Data<br>Presented | Estimated Glucose Value (EGV): The<br>EGV is the nominal glucose value<br>presented to the user. | Estimated Glucose Value (EGV): The<br>EGV is the nominal glucose value<br>presented to the user. |
| | Glucose Trend: Based off the glucose<br>rate of change, users are shown their<br>glucose trend with a corresponding<br>arrow. | Glucose Trend: Based off the glucose<br>rate of change, users are shown their<br>glucose trend with a corresponding<br>arrow. |
| | Historical Glucose Data: Users can<br>view their previous three, six, twelve,<br>or twenty-four hours of glucose data. | Historical Glucose Data: Users can<br>view their previous three, six, twelve,<br>or twenty-four hours of glucose data. |
| Features | Connect to Dexcom Share: Users can<br>share their glucose data with up to five<br>followers. | Connect to Dexcom Share: Users can<br>share their glucose data with up to five<br>followers. |
| Device | Dexcom G6 CGM System (subject<br>device, K191450) | Dexcom G6 CGM System (K183206) |
| Human<br>Factors | Easy to understand UI/UX.<br>Commonly understood navigation<br>tools and features.<br>Color-coded graphics. | Easy to understand UI/UX.<br>Commonly understood navigation<br>tools and features.<br>Color-coded graphics. |
| Compatibility<br>with intended<br>environments | iPhone 4S- iPhone X, Google Pixel,<br>Google Pixel 2, Samsung Galaxy Note<br>5, Samsung Galaxy Note 8, Samsung<br>Galaxy S6, Samsung Galaxy S6 Edge,<br>Samsung Galaxy S7, Samsung Galaxy<br>S7 Edge, Samsung Galaxy S8, Samsung<br>Galaxy S8 Plus, Samsung Galaxy S9,<br>Samsung Galaxy S9+, Samsung Galaxy<br>J3 [SM-J327 models only, including J3<br>Eclipse, J3 Emerge, J3 Prime, Express<br>Prime 2, Amp Prime 2], LG G5, LG G6<br>Compatible with Android OS version<br>7.0 and above, and iOS version 10.3.2<br>and above. | iPhone 4S- iPhone X, Google Pixel,<br>Google Pixel 2, Samsung Galaxy Note 5,<br>Samsung Galaxy Note 8, Samsung<br>Galaxy S6, Samsung Galaxy S6 Edge,<br>Samsung Galaxy S7, Samsung Galaxy<br>S7 Edge, Samsung Galaxy S8, Samsung<br>Galaxy S8 Plus, Samsung Galaxy S9,<br>Samsung Galaxy S9+, Samsung Galaxy<br>J3 [SM-J327 models only, including J3<br>Eclipse, J3 Emerge, J3 Prime, Express<br>Prime 2, Amp Prime 2], LG G5, LG G6<br>Compatible with Android OS version<br>7.0 and above, and iOS version 10.3.2<br>and above. |
| Adhesive<br>Patch | MA-91 patch | Dermamed patch |

## 6.6.1 Dexcom G6 Continuous Glucose Monitoring (CGM) System

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# 6.6.2 Dexcom G6 Glucose Program Continuous Glucose Monitoring System

| Device | Dexcom G6 Glucose Program System<br>(subject device, K191450) | Dexcom G6 Glucose Program System<br>(K182041) |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Dexcom G6 Glucose Program<br>Continuous Glucose Monitoring (CGM)<br>System | Dexcom G6 Glucose Program<br>Continuous Glucose Monitoring (CGM)<br>System |
| Manufacturer | Dexcom, Inc. | Dexcom, Inc. |
| Intended Use | An integrated continuous glucose<br>monitoring system (iCGM) is intended<br>to automatically measure glucose in<br>bodily fluids continuously or frequently<br>for a specified period of time. iCGM<br>systems are designed to reliably and<br>securely transmit glucose<br>measurement data to digitally<br>connected devices, including | An integrated continuous glucose<br>monitoring system (iCGM) is intended<br>to automatically measure glucose in<br>bodily fluids continuously or frequently<br>for a specified period of time. iCGM<br>systems are designed to reliably and<br>securely transmit glucose<br>measurement data to digitally<br>connected devices, including |
| Device | Dexcom G6 Glucose Program System<br>(subject device, K191450) | Dexcom G6 Glucose Program System<br>(K182041) |
| | automated insulin dosing systems, and<br>are intended to be used alone or in<br>conjunction with these digitally<br>connected medical devices for the<br>purpose of managing a disease or<br>condition related to glycemic control. | automated insulin dosing systems, and<br>are intended to be used alone or in<br>conjunction with these digitally<br>connected medical devices for the<br>purpose of managing a disease or<br>condition related to glycemic control. |
| Indications for<br>Use | The Dexcom G6 Glucose Program<br>Continuous Glucose Monitoring<br>System (Dexcom Glucose Program<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. | The Dexcom G6 Glucose Program<br>Continuous Glucose Monitoring<br>System (Dexcom Glucose Program<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. |
| | The Dexcom Glucose Program System<br>is intended to replace fingerstick blood<br>glucose testing for diabetes treatment<br>decisions for persons with diabetes<br>who are not at significant risk of severe<br>hypoglycemia. Interpretation of the<br>Dexcom Glucose Program System<br>results should be based on the glucose<br>trends and several sequential sensor<br>readings over time. The Dexcom<br>Glucose Program System also aids in<br>the detection of episodes of<br>hyperglycemia and hypoglycemia,<br>facilitating long-term therapy<br>adjustments. | The Dexcom Glucose Program System<br>is intended to replace fingerstick blood<br>glucose testing for diabetes treatment<br>decisions for persons with diabetes<br>who are not at significant risk of severe<br>hypoglycemia. Interpretation of the<br>Dexcom Glucose Program System<br>results should be based on the glucose<br>trends and several sequential sensor<br>readings over time. The Dexcom<br>Glucose Program System also aids in<br>the detection of episodes of<br>hyperglycemia and hypoglycemia,<br>facilitating long-term therapy<br>adjustments. |
| | The Dexcom Glucose Program System<br>is also intended to autonomously<br>communicate with digitally connected<br>devices. The Dexcom Glucose Program<br>System can be used alone or in<br>conjunction with these digitally<br>connected devices or services for the<br>purpose of managing diabetes. | The Dexcom Glucose Program System<br>is also intended to autonomously<br>communicate with digitally connected<br>devices. The Dexcom Glucose Program<br>System can be used alone or in<br>conjunction with these digitally<br>connected devices or services for the<br>purpose of managing diabetes. |
| Clinical<br>application | Management of diabetes mellitus | Management of diabetes mellitus |
| Clinical<br>setting/sites<br>of use | Home use | Home use |
| Principle of<br>Operation | Amperometric measurement of<br>current proportional to glucose<br>concentration in interstitial fluid via<br>glucose oxidase chemical reaction | Amperometric measurement of<br>current proportional to glucose<br>concentration in interstitial fluid via<br>glucose oxidase chemical reaction |
| Device | Dexcom G6 Glucose Program System<br>(subject device, K191450) | Dexcom G6 Glucose Program System<br>(K182041) |
| Data<br>Presented | Estimated Glucose Value (EGV): The<br>EGV is the nominal glucose value<br>presented to the user. | Estimated Glucose Value (EGV): The<br>EGV is the nominal glucose value<br>presented to the user. |
| | Glucose Trend: Based off the glucose<br>rate of change, users are shown their<br>glucose trend with a corresponding<br>arrow. | Glucose Trend: Based off the glucose<br>rate of change, users are shown their<br>glucose trend with a corresponding<br>arrow. |
| | Historical Glucose Data: Users can<br>view their previous six, or twelve hours<br>of glucose data on a graph with<br>high/low glucose thresholds. | Historical Glucose Data: Users can<br>view their previous six, or twelve hours<br>of glucose data on a graph with<br>high/low glucose thresholds. |
| | Time in Range: Users can view the<br>percent of time they spend in their<br>target glucose range based on their<br>configured high/low glucose<br>thresholds. | Time in Range: Users can view the<br>percent of time they spend in their<br>target glucose range based on their<br>configured high/low glucose<br>thresholds. |
| Features | Connect to Dexcom Share: Users can<br>share their glucose data with up to<br>three followers. | Connect to Dexcom Share: Users can<br>share their glucose data with up to<br>three followers. |
| | Chat with Wellness Coach: Users can<br>chat with a third-party wellness coach<br>for encouragement, education, and<br>motivation regarding their diabetes<br>management. | Chat with Wellness Coach: Users can<br>chat with a third-party wellness coach<br>for encouragement, education, and<br>motivation regarding their diabetes<br>management. |
| Human<br>Factors | Easy to understand UI/UX. | Easy to understand UI/UX. |
| | Commonly understood navigation<br>tools and features. | Commonly understood navigation<br>tools and features. |
| | Color-coded graphics. | Color-coded graphics. |
| Compatibility<br>with intended<br>environments | Compatible with the Samsung J3 | Compatible with the Samsung J3 |
| | Compatible with Android OS version<br>7.0 and above | Compatible with Android OS version<br>7.0 and above |
| Adhesive<br>Patch | MA-91 patch | Dermamed patch |

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# 6.6.3 Dexcom Pro Q Continuous Glucose Monitoring System

| Device | Dexcom Pro Q System (subject device,<br>K191450) | Dexcom Pro Q System (K182405) |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------…