Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System
Device Facts
| Record ID | K200876 |
|---|---|
| Device Name | Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System |
| Applicant | Dexcom, Inc. |
| Product Code | QBJ · Clinical Chemistry |
| Decision Date | Dec 4, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1355 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The Dexcom G6 Continuous Glucose Monitoring System (Dexcom G6 System) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons age 2 years and older. The Dexcom G6 System is intended to replace fingerstick blood glucose testing for diabetes treatment decisions. Interpretation of the Dexcom G6 System results should be based on the glucose trends and sequential readings over time. The Dexcom G6 System also aids in the detection of evisodes 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/applicator, BLE transmitter, and display device (receiver/mobile app). Sensor converts interstitial glucose to electrical current via glucose oxidase reaction. Transmitter samples current, converts to estimated glucose values (EGV) via onboard algorithm, and transmits to display. Used in home setting by patients. Provides real-time glucose readings, trends, and alerts for out-of-range values. Supports connectivity to AID systems and data sharing. Modified firmware improves data availability by optimizing noise management and calibration handling; enhances detection of sensors nearing end-of-life. Output enables patient/clinician therapy adjustments.
Clinical Evidence
Clinical performance evaluated via reprocessing of raw data from previous clinical studies (DEN170088) using the updated algorithm. Study included 159 adults and 166 pediatric subjects. Primary endpoints included MARD, percent agreement within 15/15%, 20/20%, and 40/40% of laboratory comparator (YSI 2300 STAT Plus). Overall MARD and accuracy metrics across glucose ranges (e.g., <54, 54-69, 70-180, 181-250, >250 mg/dL) were reported, confirming performance consistency with the predicate.
Technological Characteristics
Amperometric sensing via glucose oxidase; interstitial fluid measurement. Components: sensor/applicator, BLE transmitter, receiver/mobile app. Factory calibrated with optional SMBG calibration. Software-based algorithm (JPA) for EGV calculation. Connectivity: BLE, Android/iOS. Wear time: 10 days.
Indications for Use
Indicated for management of diabetes in persons age 2 years and older. Not intended for pregnant women, people on dialysis, or critically ill patients.
Regulatory Classification
Identification
An integrated continuous glucose monitoring system (iCGM) is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time. iCGM systems are designed to reliably and securely transmit glucose measurement data to digitally connected devices, including automated insulin dosing systems, and are intended to be used alone or in conjunction with these digitally connected medical devices for the purpose of managing a disease or condition related to glycemic control.
Special Controls
*Classification.* Class II (special controls). The special controls for this device are:(1) Design verification and validation must include the following: (i) Robust clinical data demonstrating the accuracy of the device in the intended use population. (ii) The clinical data must include a comparison between iCGM values and blood glucose values in specimens collected in parallel that are measured on an FDA-accepted laboratory-based glucose measurement method that is precise and accurate, and that is traceable to a higher order ( *e.g.,* an internationally recognized reference material and/or method).(iii) The clinical data must be obtained from a clinical study designed to fully represent the performance of the device throughout the intended use population and throughout the measuring range of the device. (iv) Clinical study results must demonstrate consistent analytical and clinical performance throughout the sensor wear period. (v) Clinical study results in the adult population must meet the following performance requirements: (A) For all iCGM measurements less than 70 milligrams/deciliter (mg/dL), the percentage of iCGM measurements within ±15 mg/dL of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 85 percent. (B) For all iCGM measurements from 70 mg/dL to 180 mg/dL, the percentage of iCGM measurements within ±15 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 70 percent. (C) For all iCGM measurements greater than 180 mg/dL, the percentage of iCGM measurements within ±15 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 80 percent. (D) For all iCGM measurements less than 70 mg/dL, the percentage of iCGM measurements within ±40 mg/dL of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 98 percent. (E) For all iCGM measurements from 70 mg/dL to 180 mg/dL, the percentage of iCGM measurements within ±40 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 99 percent. (F) For all iCGM measurements greater than180 mg/dL, the percentage of iCGM measurements within ±40 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 99 percent. (G) Throughout the device measuring range, the percentage of iCGM measurements within ±20 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 87 percent. (H) When iCGM values are less than 70 mg/dL, no corresponding blood glucose value shall read above 180 mg/dL. (I) When iCGM values are greater than 180 mg/dL, no corresponding blood glucose value shall read less than 70 mg/dL. (J) There shall be no more than 1 percent of iCGM measurements that indicate a positive glucose rate of change greater than 1 mg/dL per minute (/min) when the corresponding true negative glucose rate of change is less than −2 mg/dL/min as determined by the corresponding blood glucose measurements. (K) There shall be no more than 1 percent of iCGM measurements that indicate a negative glucose rate of change less than −1 mg/dL/min when the corresponding true positive glucose rate of change is greater than 2 mg/dL/min as determined by the corresponding blood glucose measurements. (vi) Data demonstrating similar accuracy and rate of change performance of the iCGM in the pediatric population as compared to that in the adult population, or alternatively a clinical and/or technical justification for why pediatric data are not needed, must be provided and determined by FDA to be acceptable and appropriate. (vii) Data must demonstrate that throughout the claimed sensor life, the device does not allow clinically significant gaps in sensor data availability that would prevent any digitally connected devices from achieving their intended use. (2) Design verification and validation must include a detailed strategy to ensure secure and reliable means of iCGM data transmission to provide real-time glucose readings at clinically meaningful time intervals to devices intended to receive the iCGM glucose data. (3) Design verification and validation must include adequate controls established during manufacturing and at product release to ensure the released product meets the performance specifications as defined in paragraphs (b)(1) and (b)(2) of this section. (4) The device must demonstrate clinically acceptable performance in the presence of clinically relevant levels of potential interfering substances that are reasonably present in the intended use population, including but not limited to endogenous substances and metabolites, foods, dietary supplements, and medications. (5) The device must include appropriate measures to ensure that disposable sensors cannot be used beyond its claimed sensor wear period. (6) Design verification and validation must include results obtained through a usability study that demonstrates that the intended user can use the device safely and obtain the expected glucose measurement accuracy. (7) The labeling required under § 809.10(b) of this chapter must include a separate description of the following sensor performance data observed in the clinical study performed in conformance with paragraph (b)(1) of this section for each intended use population, in addition to separate sensor performance data for each different iCGM insertion or use sites ( *e.g.,* abdomen, arm, buttock):(i) A description of the accuracy in the following blood glucose concentration ranges: less than 54 mg/dL, 54 mg/dL to less than 70 mg/dL, 70 to 180 mg/dL, greater than 180 to 250 mg/dL, and greater than 250 mg/dL. (ii) A description of the accuracy of positive and negative rate of change data. (iii) A description of the frequency and duration of gaps in sensor data. (iv) A description of the true, false, missed, and correct alert rates and a description of the available glucose concentration alert settings, if applicable. (v) A description of the observed duration of iCGM life for the device.
Predicate Devices
- Dexcom G6 Continuous Glucose Monitoring System (K191450)
- Dexcom G6 Glucose Program Continuous Glucose Monitoring System (K193642)
Related Devices
- K223931 — Dexcom G6 Continuous Glucose Monitoring (CGM) System · Dexcom, Inc. · Jan 11, 2023
- DEN170088 — Dexcom G6 Continuous Glucose Monitoring System · Dexcom, Inc. · Mar 27, 2018
- K191450 — Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System and Dexcom Pro Q Continuous Glucose Monitoring System · Dexcom, Inc. · Jun 28, 2019
Submission Summary (Full Text)
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FDA
U.S. FOOD & DRUG
ADMINISTRATION
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
ASSAY AND INSTRUMENT
## I Background Information:
A 510(k) Number
K200876
B Applicant
Dexcom, Inc.
C Proprietary and Established Names
Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| QBJ | Class II | 21 CFR 862.1355 - Integrated Continuous Glucose Monitoring System | CH - Clinical Chemistry |
| QDK | Class II | 21 CFR 862.1355 - Integrated Continuous Glucose Monitoring System | CH - Clinical Chemistry |
## II Submission/Device Overview:
A Purpose for Submission:
Modification to the glucose algorithm and the G6 CGM App for Android to address the mobile device's setting for the Do Not Disturb feature.
B Measurand:
Glucose in interstitial fluid
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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C Type of Test:
Quantitative, amperometric assay (glucose oxidase)
III Intended Use/Indications for Use:
A Intended Use(s):
See Indications for Use below.
B Indication(s) for Use:
Dexcom G6 Continuous Glucose Monitoring 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.
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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C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only
For both the Dexcom G6 System and the Dexcom Glucose Program System:
- Remove the Dexcom G6 sensor, transmitter, and receiver before Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment. The magnetic fields and heat could damage the components of the Dexcom G6 System, which may cause it to display inaccurate blood glucose readings or may prevent alerts.
- When wearing the device, ask for hand-wanding or full-body pat-down and visual inspection instead of going through the Advanced Imaging Technology (AIT) body scanner. Also avoid putting any part of the device through baggage x-ray machine.
- This device is not intended for pregnant women, people on dialysis, or critically ill patients.
- The device should not be used to make diabetes treatment decisions when
- The user has not used the iCGM before or is unfamiliar with the Dexcom G6 System. (It may take days, weeks or months for a user to gain confidence in using the iCGM to make treatment decisions.)
- The user’s symptoms do not match the glucose values displayed by the device.
- The device does not show a glucose value or a trend arrow.
- During the first two hours of sensor warm-up period, the user should use a blood glucose meter to make treatment decisions.
- Although standard dosing of acetaminophen (1000 mg per every 6 hours) does not appear to cause significant bias, higher supra-therapeutic levels of acetaminophen have shown significant positive bias.
- Sensor glucose readings will be falsely higher if the user is taking hydroxyurea. Do not use your Dexcom CGM System for diabetes treatment decisions if you are taking hydroxyurea.
- Adult users should only use the abdomen and pediatric users should only use the buttock or abdomen. Sensor performance has not been evaluated in other insertion sites and may differ from expected iCGM performance.
- If a sensor wire breaks or detaches from the sensor, it could remain under the user’s skin. The user should contact their healthcare practitioner if this occurs.
- The transmitter should not be shared to avoid transmission of bloodborne illnesses.
- When using the smart device as a receiver, the user should follow the user manual instructions to ensure that all glucose values, important alarms and alerts can be seen and heard. Do not use headphones will using the smart device as a receiver. The app must always be running in the background of the smart device to ensure the user receives glucose values, alarms and alerts.
- Before updating the smart device hardware or operating system, verify the compatibility of the updated hardware/software with the device system.
For the Dexcom Glucose Program System Only:
- The Dexcom Glucose Program System does not alert or alarm the user when the glucose is low (below the target range), high (above the target range), or rapidly changing. Users should check readings often if they need to know their glucose level.
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D Special Instrument Requirements:
Not applicable.
IV Device/System Characteristics:
A Device Description:
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM (called the DEXCOM G6 SYSTEM hereafter)
The Dexcom G6 System in an integrated continuous glucose monitoring system (iCGM) that provides continuous glucose readings which are updated every 5 minutes providing glucose levels, trends, and alerts. The System consists of three main components: a sensor, a Bluetooth Low Energy (BLE) transmitter and a BLE enabled display device (receiver and/or mobile application). The user can view glucose data on the receiver or on the G6 CGM App (i.e., a mobile medical application) running on a compatible mobile device, or on both simultaneously.
The system provides alerts and alarms which warn the user of low or impending low and high or impending high glucose levels. The user may determine their treatment based on the glucose values provided by the system.
G6 CGM Sensor
The sensor component is a sterile device that consists of the sensor applicator, plastic base ("transmitter holder"), and sensor probe. The applicator is a single use, disposable unit that contains an introducer needle holding the sensor probe. The applicator deploys the needle and inserts the sensor under the skin. The needle is retracted back into the applicator after insertion. The sensor probe continuously measures glucose concentration in interstitial fluid and can be worn for up to 10 days.
The sensor may be worn in the abdomen for adults, and both the abdomen and buttock for children ages 2-17 years old. Sensor comes with a calibration code that the user enters into the system upon initializing a new sensor. Once the code is applied, the user does not need to calibrate the system throughout the entirety of the sensor lifetime, which is 10 days. However, the user has the option to manually calibrate the system using self-measurements from a blood glucose meter in addition to entering the calibration code. Alternatively, if the user chooses not to enter the calibration code, he or she must manually calibrate the sensor by entering two fingerstick blood glucose values during start up and every 24 hours thereafter.
G6 CGM Transmitter
The G6 CGM Transmitter is a miniature radio transmitter that incorporates data processing functionality. The transmitter contains a Bluetooth radio transceiver for communication with a compatible display device (i.e., receiver and/or smart device). The transmitter attaches to the sensor and can be re-used for multiple sensing sessions up to three months.
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G6 CGM Receiver
The G6 CGM Receiver is small hand-held device that wirelessly receives glucose information from the transmitter every five minutes and includes a touchscreen display. The receiver displays the current glucose reading and glucose trends to the user. It alerts the user when glucose levels are outside of a target zone and when other important system conditions occur.
## Dexcom G6 System Mobile App
The G6 CGM App for iOS and G6 CGM App for Android provides an alternative display device to the receiver for users with a compatible, BLE-enabled smart device and behaves similarly to the receiver. The G6 CGM App is compatible with certain iOS, Android and Smart Device watches. The G6 CGM App for Android now includes a mechanism to ensure that mobile device operating system settings for Do Not Disturb cannot prevent the user from receiving auditory Urgent Low Glucose Alarms; this safety risk was present in previous versions of the Dexcom G6 Android Mobile App. A link to a list of compatible devices is included in the instructions for use.
The Dexcom G6 System is an interoperable connected device that can communicate glucose readings and other information wirelessly and securely to and from interoperable electronic interfaces; including compatible AID systems. The G6 CGM system is designed to communicate with interoperable devices in several ways, such as described below:
- Wireless communication from the transmitter directly to an interoperable device communicating through the same protocol.
- The app communicates to another app on a single mobile platform.
- The app communicates through the cloud to another software device.
## DEXCOM G6 GLUCOSE PROGRAM CONTINUOUS GLUCOSE MONITORING SYSTEM (called the DEXCOM GLUCOSE PROGRAM SYSTEM hereafter)
The Dexcom G6 Glucose Program System is an integrated continuous glucose monitoring system (iCGM) that provides continuous glucose readings which are updated every 5 minutes providing glucose levels and trends. The System consists of three main components: a sensor, a Bluetooth Low Energy (BLE) transmitter and a BLE enabled display device (receiver and/or mobile application). A user must use the Dexcom G6 Glucose Program App (i.e., a mobile medical application) running on a compatible mobile device in order to view glucose data.
## G6 Glucose Program CGM Sensor
The sensor component is a sterile device that consists of the sensor applicator, plastic base ("transmitter holder"), and sensor probe. The applicator is a single use, disposable unit that contains an introducer needle holding the sensor probe. The applicator deploys the needle and inserts the sensor under the skin. The needle is retracted back into the applicator after insertion. The sensor probe continuously measures glucose concentration in interstitial fluid and can be worn for up to 10 days.
The sensor may be worn in the abdomen for adults, and both the abdomen and buttock for children ages 2-17 years old.
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G6 Glucose Program Transmitter
The transmitter component is a miniature radio transmitter that incorporates data processing functionality. The transmitter contains a Bluetooth radio transceiver for communication with a compatible display device (i.e., mobile device). The transmitter attaches to the sensor and can be re-used for multiple sensing sessions up to three months.
G6 Glucose Program Mobile App
The Dexcom G6 Glucose Program CGM App for Android is the primary display for the system. The Dexcom G6 Glucose Program CGM App is compatible with specific Android devices. A link to a list of compatible devices is included in the instructions for use.
The Dexcom G6 Glucose Program CGM System is an interoperable connected device that can communicate glucose readings and other information wirelessly and securely to and from interoperable electronic interfaces. The G6 Glucose Program CGM system is designed to communicate with interoperable devices in several ways, such as described below:
- Wireless communication from the transmitter directly to an interoperable device communicating through the same protocol.
- The app communicates to another app on a single mobile platform.
- The app communicates through the cloud to another software device.
B Principle of Operation:
The Dexcom G6 System and Dexcom Glucose Program System detect glucose levels from the fluid just beneath the skin (interstitial fluid). The sensor probe continuously measures glucose concentration in the interstitial fluid via an enzymatic electrochemical reaction using glucose oxidase. The enzyme, glucose oxidase, catalyzes the oxidation of glucose and produces hydrogen peroxide. The production of hydrogen peroxide generates an electrical current that is proportionate to the interstitial glucose concentration. The transmitter converts the signal using an algorithm to a glucose value read in mg/dL, which is then transmitted to the receiver/mobile application for the user to see and use accordingly.
Instrument Description Information:
1. Instrument Name:
Dexcom G6 Continuous Glucose Monitoring System
Dexcom G6 Glucose Program Continuous Glucose Monitoring System
2. Specimen Identification:
Not applicable.
3. Specimen Sampling and Handling:
Not applicable.
4. Calibration:
Though the Dexcom G6 System and the Dexcom Glucose Program System do not require user calibration. Users have the option to calibrate the device manually (e.g., in situations where users do not have to use the calibration code). Therefore, a calibration stability evaluation was completed to demonstrate that the system could be calibrated manually without impact to system performance. Subjects were instructed to calibrate their CGM
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devices according to the explicit system requirements. Beginning two hours after sensor insertion, calibration prompts were provided on the receiver twice the first day and every 24 hours for the remainder of the study. To demonstrate the performance of the System over a calibration cycle, the CGM-laboratory comparator percentage agreement was evaluated in 4-hour increments after calibration. Results were similar to the results obtained using the factory calibration codes.
# 5. Quality Control:
Not applicable.
# V Substantial Equivalence Information:
# A Predicate Device Name(s):
Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System
# B Predicate 510(k) Number(s):
K191450
# C Comparison with Predicate(s):
| Device & Predicate Device(s): | K200876 | K191450 |
| --- | --- | --- |
| Device Trade Name | Dexcom G6 Continuous Glucose Monitoring System | Same |
| General Device Characteristic Similarities | | |
| Intended Use/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. | Same |
| Principle of Operations | Amperometric measurement of current proportional to glucose concentration in interstitial fluid via glucose oxidase chemical reaction | Same |
| Data Presentation | Estimated Glucose Value (EGV) | Same |
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| | Glucose Trend Historical Glucose Data | |
| --- | --- | --- |
| Factory Calibration | Yes | Same |
| Optional Calibration | Yes | Same |
| Features | Share application to share glucose data with followers | Same |
| Compatibility with Intended Environments | Android OS and Apple iOS | Same |
| General Device Characteristic Differences | | |
| Alarm Restrictions when using the Mobile App | G6 Android Mobile App requires users to provide the App with “Do-Not Disturb” (DND) override privileges to ensure that user receives the Urgent Low Glucose Auditory Alarm | Does not alarm when the Android device is set at the most restrictive “Do-Not Disturb” (DND) settings |
| Glucose Value Estimation Algorithm | Optimized Joint Probability Algorithm | Joint Probability Algorithm |
| Algorithm Self-Diagnostics | Optimized Noise Management Optimized Progressive Sensor Decline detection | Noise Management Progressive Sensor Decline (PSD) detection |
| Device & Predicate Device(s): | K200876 | K193642 |
| --- | --- | --- |
| Device Trade Name | Dexcom G6 Glucose Program Continuous Glucose Monitoring System | Same |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | The Dexcom G6 Glucose Program Continuous Glucose Monitoring System (Dexcom Glucose Program System) is a real time, continuous glucose monitoring device indicated for the | Same |
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| | management of diabetes in persons age 2 years and older. | |
| --- | --- | --- |
| Principle of Operations | Amperometric measurement of current proportional to glucose concentration in interstitial fluid via glucose oxidase chemical reaction | Same |
| Data Presentation | Estimated Glucose Value (EGV) Glucose Trend Historical Glucose Data Time in Range | Same |
| Factory Calibration | Yes | Same |
| Optional Calibration | Yes | Same |
| Features | Share application to share glucose data with followers Chat with Wellness Coach | Same |
| Compatibility with Intended Environments | Android OS and Apple iOS | Same |
| General Device Characteristic Differences | | |
| Glucose Value Estimation Algorithm | Optimized Joint Probability Algorithm | Joint Probability Algorithm |
| Algorithm Self-Diagnostics | Optimized Noise Management Optimized Progressive Sensor Decline detection | Noise Management Progressive Sensor Decline (PSD) detection |
VI Standards/Guidance Documents Referenced:
1. ISO 10993-1:2009/AC:2010; Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
2. ISO 10993-3:2009; Biological Evaluation of Medical Devices – Part 3: Tests For Genotoxicity, Carcinogenicity and Reproductive Toxicity
3. ISO 10993-5:2009; Biological Evaluation of Medical Devices – Part 5: Tests for in vitro Cytotoxicity
4. ISO 10993-6:2016; Biological Evaluation of Medical Devices – Part 6: Tests for Local Effects after Implantation
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5. ISO 10993-10:2013; Biological evaluation of Medical Devices – Part 10: Tests for Irritation and Skin Sensitization
6. ISO 10993-11; 2009; Biological Evaluation of Medical Devices – Part 11: Test for Systemic Toxicity
7. ISO 11137-1:2006/A1:2013; Sterilization of Health Care Products – Radiation – Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices
8. ISO 11607-1:2014; Packaging for Terminally Sterilized Medical Devices – Part 1: Requirements for Material, Sterile Barrier Systems, and Packaging Systems
9. ISO 11607-2:2006/A1:2014; Packaging for Terminally Sterilized Medical Devices – Part 2: Validation Requirements for Forming, Sealing and Assembly Processes
10. ISO 11737-1:2006/AC:2009; Sterilization of Medical Devices – Microbiological Methods – Part 1: Determination of a Population of Microorganisms on Products
11. ISO 11737-2:2009; Sterilization of Medical Devices – Microbiological Methods – Part 2: Tests of Sterility Performed in the Definition, Validation and Maintenance of a Sterilization Process
12. ISO 23908:2013; Sharps Injury Protection. Requirements and Test Methods. Sharps Protection Features for Single-Use Hypodermic Needles, Introducers for Catheters and Needles Used for Blood Sampling
13. ISO 14971:2012; Medical Devices – Application of Risk Management to Medical Devices
14. ISO 11137-3:2006; Sterilization of Health Care Products – Radiation – Part 3 – Guidance on Dosimetric Aspects
15. ISO 7010:2012; Graphical Symbols – Safety Colors and Safety Signs – Registered Safety Signs
16. ISO 15223-1:2012; Medical Devices – Symbols to be Used with Medical Device Labels, Labeling and Information to be Supplied – Part 1: General Requirements
17. EN 62304:2006/AC:2008; Medical device software – Software life cycle processes
18. EN 62304:2006/AC:2015; Medical device software – Software life cycle processes
19. BS EN 62366:2015; Medical devices – Application of usability engineering to medical devices
20. EN 60601-1:2006/A1:2013; Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
21. EN 60601-1-2:2014; Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests
22. IEC 60601-1-11:2015; Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in home healthcare environment
23. ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012; Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
24. ASTM F2096-11; Standard test method for detecting gross leaks in packaging by internal pressurization
25. ASTM F88/F88M-15; Standard test method for seal strength of flexible barrier materials
26. ANSI/AAMI/IEC 60601-1-8:2006 & A1:2012, IEC 60601-1:2006/A1:2013; MEDICAL ELECTRICAL EQUIPMENT – Part 1-8: General requirements for basic
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safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
27. IEC 60417-DB-12M:2002; Graphical symbols for use on equipment
28. IEC 60601-1-2:2014; Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic disturbances – Requirements and tests
29. IEC 60086-4:2014; Primary batteries – Part 4: Safety of lithium batteries
30. IEC 62133 Edition 2.0:2012; (Battery Cell) Secondary cells and batteries containing alkaline or other non-acid electrolytes – Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications
31. IEC 60601-1-11:2015; Medical electrical equipment, Part 1-11: General requirements for basic safety and essential performance – Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
32. USP Chapter <151>; Pyrogen Test
33. USP Chapter <161>; Transfusion and infusion assemblies and similar medical devices – Bacterial Endotoxin and Pyrogen Tests
34. FCC: Part 15 (2016); Radio Frequency Devices, Conducted Limits, Section 15.207 and Section 15.247
35. FAA AC No. 91.21-1C; Use of Portable Electronic Devices Aboard Aircraft
36. UL 1642 Fifth Edition, Revision, March 15, 2012; Standard for Safety, Lithium Batteries
## VII Performance Characteristics (if/when applicable):
### A Analytical Performance:
The optimized joint probability algorithm in the modified Dexcom G6 Continuous Glucose Monitoring System and the Dexcom G6 Glucose Program Continuous Glucose Monitoring System was developed independently from the clinical validation dataset. Because the two systems use the same modified glucose algorithm, the following sections represent the performance for both Systems. iCGM performance was previously evaluated in clinical studies described in DEN170088. The raw data was reprocessed using the updated algorithm in K200876.
#### 1. Precision/Reproducibility:
iCGM performance was evaluated in clinical studies described in Section C(3) below. A subset of randomly selected subjects (n=67) wore two devices concurrently (blinded and unblinded iCGM Systems) at the same sensor insertion site (two in abdomen or two in buttock) to evaluate the device precision. A table of the sensor site distribution is provided below.
Another subset of randomly-selected pediatric subjects (n=28) wore one device in the abdomen and a second device in the buttock concurrently to evaluate agreement of device measurements between different sensor insertion sites.
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Precision by Insertion Site and Age
| | Adults (18+ YO) - Abdomen | Pediatrics (6-17 YO) - Abdomen | Pediatrics (6-17 YO) – Upper Buttocks | Pediatrics (2-5 YO) – Upper Buttocks |
| --- | --- | --- | --- | --- |
| CGM-CGM Matched pairs (n) | 23,466 | 1,262 | 12,593 | 2,637 |
| Number of Subjects | 34 | 3 | 25 | 5 |
| Paired Absolute Difference (mg/dL) | 14.2 | 14.4 | 16.7 | 9.2 |
| Paired Absolute Relative Difference (%) | 9.0 | 9.3 | 10.7 | 5.1 |
| Coefficient of Variation (%) | 8.2 | 7.6 | 8.9 | 4.6 |
2. **Linearity:**
The reportable range for the System is 40 to 400 mg/dL. Data supporting this claimed measurement range was generated in the clinical study described in Section C(3) below.
3. **Analytical Specificity/Interference:**
Interference was previously assessed in DEN170088 and was not impacted by the algorithm modifications.
4. **Assay Reportable Range:**
See Linearity section above.
5. **Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):**
The sensor has a storage shelf-life of 12 months. Shelf life was evaluated at 32°-86° F and 10-90% relative humidity. Sensors should be stored at 32°-86° F.
The Dexcom G6 CGM System and the Dexcom Glucose Program System transmitters have sufficient battery life to function for 3 months as intended following its maximum storage time of 8 months. Shelf life was evaluated at 32°-113° F and 10-95% relative humidity.
6. **Detection Limit:**
If a glucose measurement is less than 40 mg/dL, the result is displayed by the system as 'Lo'. If a glucose measurement exceeds 400 mg/dL, result is displayed as 'Hi'. Data supporting this claimed measurement range was generated in the clinical study described in Section C(3) below.
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7. Assay Cut-Off:
Not applicable.
8. Accuracy (Instrument):
Not applicable.
9. Carry-Over:
Not applicable.
## B Comparison Studies:
1. Method Comparison with Predicate Device:
Not applicable. Accuracy is determined by comparing device values to an FDA cleared laboratory grade glucose analyzer (Yellow Springs Instrument 2300 STAT Plus™ Glucose Analyzer) and referred to as the "comparator" in the tables below.
2. Matrix Comparison:
Not applicable. Interstitial fluid is the only indicated matrix.
## C Clinical Studies:
1. Clinical Sensitivity:
Not applicable.
2. Clinical Specificity:
Not applicable.
3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):
The following sections represent the performance for both the Dexcom G6 CGM System and the Dexcom G6 Glucose Program System:
Two clinical studies were previously conducted to support the accuracy performance of the predicate device; See DEN170088 for clinical study details. The clinical study raw data was reprocessed using the updated algorithm. The pediatric study included one additional subject following the data reprocessing as a result of the algorithm modifications; the sensor used in the additional pediatric subject was not declined by the updated algorithm, whereas the previous algorithm eliminated the sensor before the end-of-life (i.e., 10 days).
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The following tables present the data from the reprocessed study algorithm:
Percent and Point Accuracy by iCGM Glucose Range: Adults (N=159)
| iCGM Glucose Range | Matched Pairs (N) | Percent Within 15 mg/dL (95% LB) | Percent Within 40 mg/dL (95% LB) | Percent Within 15% (95% LB) | Percent Within 40% (95% LB) | Mean Bias (mg/dL) (95% UB) |
| --- | --- | --- | --- | --- | --- | --- |
| <70 mg/dL | 1,888 | 89.7 (87.1) | 99.5 (99.0) | --- | --- | -1.4 (-0.3) |
| 70-180 mg/dL | 9,433 | --- | --- | 74.1 (71.6) | 99.3 (99.1) | -2.7 (-1.0) |
| >180 mg/dL | 7,991 | --- | --- | 85.3 (82.7) | 99.9 (99.9) | -7.0 (-3.9) |
Percent and Point Accuracy by iCGM Glucose Range: Pediatrics (N=166)
| iCGM Glucose Range | Matched Pairs (N) | Percent Within 15 mg/dL (95% LB) | Percent Within 40 mg/dL (95% LB) | Percent Within 15% (95% LB) | Percent Within 40% (95% LB) | Mean Bias (mg/dL) (95% UB) |
| --- | --- | --- | --- | --- | --- | --- |
| <70 mg/dL | 350 | 76.9 (68.2) | 95.4 (91.6) | --- | --- | -8.4 (-5.2) |
| 70-180 mg/dL | 3,170 | --- | --- | 79.4 (76.1) | 99.3 (98.9) | -0.7 (1.0) |
| >180 mg/dL | 2,296 | --- | --- | 85.5 (81.4) | 99.9 (99.8) | 2.6 (6.3) |
Percent and Point Accuracy by Comparator Glucose Range: Adults (N=159)
| Comparator Glucose Range | Matched Pairs (N) | Percent Within 15 mg/dL (95% LB) | Percent Within 40 mg/dL (95% LB) | Percent Within 15% (95% LB) | Percent Within 40% (95% LB) | Mean Bias (mg/dL) (95% UB) |
| --- | --- | --- | --- | --- | --- | --- |
| <70 mg/dL | 2,252 | 88.9 (86.4) | 99.9 (99.6) | --- | --- | 4.5 (5.5) |
| 70-180 mg/dL | 8,675 | --- | --- | 77.2 (74.6) | 99.7 (99.5) | -0.7 (0.9) |
| >180 mg/dL | 8,385 | --- | --- | 83.1 (80.0) | 99.8 (99.6) | -10.5 (-7.6) |
Percent and Point Accuracy by Comparator Glucose Range: Pediatrics (N=166)
| Comparator Glucose Range | Matched Pairs (N) | Percent Within 15 mg/dL (95% LB) | Percent Within 40 mg/dL (95% LB) | Percent Within 15% (95% LB) | Percent Within 40% (95% LB) | Mean Bias (mg/dL) (95% UB) |
| --- | --- | --- | --- | --- | --- | --- |
| <70 mg/dL | 356 | 87.6 (82.8) | 100.0 (100.0) | --- | --- | 3.1 (4.8) |
| 70-180 mg/dL | 3,108 | --- | --- | 79.8 (76.5) | 98.9 (98.3) | 1.8 (3.4) |
| >180 mg/dL | 2,352 | --- | --- | 84.3 (79.8) | 99.7 (99.5) | -2.5 (1.4) |
Percent of values within 20% of comparator method were calculated across the measuring range overall, and for pediatric and adult populations.
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Percent of iCGM values within 20% of Reference Blood Glucose
| iCGM Glucose Range | Matched Pairs (N) | Percent within 20% (95% LB) |
| --- | --- | --- |
| Overall (40-400 mg/dL) | 25,128 | 90.0 (88.8) |
| Adults (18 years and up) | 19,312 | 89.7 (88.4) |
| Pediatrics (6-17 years old) | 5,816 | 91.0 (88.6) |
| Pediatrics (2-5 years old)* | 82 | 90.2 (84.5) |
*Subjects 2-5 years old were compared to an SMBG reference
*95% LB is the lower bound of the confidence interval
Percent of values within 15%/15 mg/dL, 20%/20 mg/dL, and 40%/40 mg/dL stratified by glucose ranges of <54, 54-69, 70-180, 181-250, and >250 mg/dL for iCGM and laboratory comparator were also provided for abdominal insertion site in adult subjects, and both buttock and abdominal insertion site in pediatric populations. For pediatric subjects ages 6 and under, values were compared to SMBG.
System Accuracy to Comparator within iCGM Glucose Ranges (Adults N=159)
| iCGM Glucose Range^{1} (mg/dL) | Matched Pairs (N) | Percent Within 15 mg/dL | Percent Within 20 mg/dL | Percent Within 40 mg/dL | Percent Within 15% | Percent Within 20% | Percent Within 40% | Mean Bias (mg/dL) | MARD (%) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| <54 | 374 | 86.6 | 92.0 | 98.7 | --- | --- | --- | -6.4 | 13.3 |
| 54-69 | 1,514 | 90.5 | 95.8 | 99.7 | --- | --- | --- | -0.2 | 11.2 |
| 70-180 | 9,433 | --- | --- | --- | 74.1 | 86.8 | 99.3 | -2.7 | 10.9 |
| 181-250 | 4,106 | --- | --- | --- | 80.0 | 92.0 | 99.9 | -10.0 | 9.3 |
| >250 | 3,885 | --- | --- | --- | 91.0 | 97.7 | 100.0 | -3.8 | 7.1 |
System Accuracy to Comparator within iCGM Glucose Ranges (Pediatrics N=166)
| iCGM Glucose Range (mg/dL) | Matched Pairs (N) | Percent Within 15 mg/dL | Percent Within 20 mg/dL | Percent Within 40 mg/dL | Percent Within 15% | Percent Within 20% | Percent Within 40% | Mean Bias (mg/dL) | MARD (%) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| <54 | 86 | 51.2 | 66.3 | 90.7 | --- | --- | --- | -16.9 | 24.1 |
| 54-69 | 264 | 85.2 | 89.0 | 97.0 | --- | --- | --- | -5.7 | 13.1 |
| 70-180 | 3,170 | --- | --- | --- | 79.4 | 90.5 | 99.3 | -0.7 | 9.8 |
| 181-250 | 1,373 | --- | --- | --- | 83.3 | 93.5 | 99.9 | -1.6 | 8.9 |
| >250 | 923 | --- | --- | --- | 88.7 | 96.1 | 99.9 | 8.9 | 7.5 |
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System Accuracy to Comparator within iCGM Glucose Ranges (Pediatrics, Abdomen; N=99)
| iCGM Glucose Range (mg/dL) | Matched Pairs (N) | Percent Within 15 mg/dL | Percent Within 20 mg/dL | Percent Within 40 mg/dL | Percent Within 15% | Percent Within 20% | Percent Within 40% | Mean Bias (mg/dL) | MARD (%) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| <54 | 55 | 43.6 | 58.2 | 89.1 | --- | --- | --- | -18.9 | 25.8 |
| 54-69 | 175 | 88.0 | 89.7 | 96.6 | --- | --- | --- | -5.5 | 12.8 |
| 70-180 | 1,924 | --- | --- | --- | 80.1 | 90.7 | 99.2 | -1.6 | 9.8 |
| 181-250 | 788 | --- | --- | --- | 81.7 | 94.8 | 100.0 | -2.7 | 9.2 |
| >250 | 579 | --- | --- | --- | 88.6 | 96.9 | 99.8 | 7.5 | 7.5 |
System Accuracy to Comparator within iCGM Glucose Ranges (Pediatrics, Buttock; N=67)
| iCGM Glucose Range (mg/dL) | Matched Pairs (N) | Percent Within 15 mg/dL | Percent Within 20 mg/dL | Percent Within 40 mg/dL | Percent Within 15% | Percent Within 20% | Percent Within 40% | Mean Bias (mg/dL) | MARD (%) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| <54 | 31 | 64.5 | 80.6 | 93.5 | --- | --- | --- | -13.4 | 21.1 |
| 54-69 | 89 | 79.8 | 87.6 | 97.8 | --- | --- | --- | -6.0 | 13.7 |
| 70-180 | 1,246 | --- | --- | --- | 78.4 | 90.0 | 99.4 | 0.7 | 9.7 |
| 181-250 | 585 | --- | --- | --- | 85.5 | 91.8 | 99.8 | -0.1 | 8.5 |
| >250 | 344 | --- | --- | --- | 89.0 | 94.8 | 100.0 | 11.3 | 7.4 |
System Accuracy to Comparator within Comparator Glucose Ranges (Adults; N=159)
| Glucose Range (mg/dL) | Matched Pairs (N) | Percent Within 15 mg/dL | Percent Within 20 mg/dL | Percent Within 40 mg/dL | Percent Within 15% | Percent Within 20% | Percent Within 40% | Mean Bias (mg/dL) | MARD (%) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| <54 | 481 | 88.1 | 95.8 | 99.8 | --- | --- | --- | 6.0 | 15.8 |
| 54-69 | 1,771 | 89.0 | 96.2 | 99.9 | --- | --- | --- | 4.1 | 12.3 |
| 70-180 | 8,675 | --- | --- | --- | 77.2 | 89.4 | 99.7 | -0.7 | 10.2 |
| 181-250 | 3,949 | --- | --- | --- | 82.9 | 92.9 | 99.8 | -7.1 | 8.8 |
| >250 | 4,436 | --- | --- | --- | 83.3 | 93.2 | 99.8 | -13.6 | 8.6 |
System Accuracy to Comparator within Comparator Glucose Ranges (Pediatrics; N=166)
| Glucose Range (mg/dL) | Matched Pairs (N) | Percent Within 15 mg/dL | Percent Within 20 mg/dL | Percent Within 40 mg/dL | Percent Within 15% | Percent Within 20% | Percent Within 40% | Mean Bias (mg/dL) | MARD (%) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| <54 | 47 | 95.7 | 100.0 | 100.0 | --- | --- | --- | 4.9 | 11.6 |
| 54-69 | 309 | 86.4 | 95.8 | 100.0 | --- | --- | --- | 2.8 | 13.5 |
| 70-180 | 3,108 | --- | --- | --- | 79.8 | 90.6 | 98.9 | 1.8 | 9.8 |
| 181-250 | 1,424 | --- | --- | --- | 84.3 | 92.7 | 99.6 | -1.5 | 9.1 |
| >250 | 928 | --- | --- | --- | 84.3 | 93.9 | 99.9 | -4.0 | 8.2 |
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System Accuracy to Comparator within Comparator Glucose Ranges (Pediatrics, Abdomen; N=99)
| iCGM Glucose Range (mg/dL) | Matched Pairs (N) | Percent Within 15 mg/dL | Percent Within 20 mg/dL | Percent Within 40 mg/dL | Percent Within 15% | Percent Within 20% | Percent Within 40% | Mean Bias (mg/dL) | MARD (%) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| <54 | 28 | 100.0 | 100.0 | 100.0 | --- | --- | --- | 4.0 | 11.0 |
| 54-69 | 201 | 90.0 | 96.0 | 100.0 | --- | --- | --- | 3.0 | 12.8 |
| 70-180 | 1,898 | --- | --- | --- | 79.7 | 90.1 | 98.7 | 0.8 | 9.9 |
| 181-250 | 782 | --- | --- | --- | 83.8 | 93.7 | 99.2 | -2.6 | 9.4 |
| >250 | 612 | --- | --- | --- | 84.5 | 95.6 | 99.8 | -4.9 | 8.3 |
System Accuracy to Comparator within Comparator Glucose Ranges (Pediatrics, Buttocks; N=67)
| iCGM Glucose Range (mg/dL) | Matched Pairs (N) | Percent Within 15 mg/dL | Percent Within 20 mg/dL | Percent Within 40 mg/dL | Percent Within 15% | Percent Within 20% | Percent Within 40% | Mean Bias (mg/dL) | MARD (%) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| <54 | 19 | 89.5 | 100.0 | 100.0 | --- | --- | --- | 6.2 | 12.6 |
| 54-69 | 108 | 79.6 | 95.4 | 100.0 | --- | --- | --- | 2.5 | 14.8 |
| 70-180 | 1,210 | --- | --- | --- | 80.0 | 91.4 | 99.3 | 3.4 | 9.5 |
| 181-250 | 642 | --- | --- | --- | 85.0 | 91.4 | 100.0 | -0.1 | 8.8 |
| >250 | 316 | --- | --- | --- | 83.9 | 90.5 | 100.0 | -2.1 | 7.9 |
Concurrence of iCGM values compared to the comparator method across the entire measuring range was also evaluated. iCGM glucose ranges of <40, 40-60, 61-80, 81-120, 121-160, 161-200, 201-250, 251-300, 301-350, 351-400, and >400 mg/dL were evaluated against comparator glucose ranges and percent of iCGM values within those ranges were reported in the following tables.
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Concurrence of System Readings and Comparator Values by iCGM Glucose Ranges (Adults; N=159)
| | Comparator Glucose Values (mg/dL) | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| iCGM Glucose Range (mg/dL) | <40 | 40-60 | 61-80 | 81-120 | 121-160 | 161-200 | 201-250 | 251-300 | 301-350 | 351-400 | >400 | Total |
| < 40 | 14
14.0% | 57
57.0% | 23
23.0% | 4
4.0% | 2
2.0% | | | | | | | 100 |
| 40-60 | 11
1.2% | 619
68.6% | 250
27.7% | 19
2.1% | 2
0.2% | 1
0.1% | | | | | | 902 |
| 61-80 | 2
0.1% | 479
21.3% | 1,392
61.8% | 374
16.6% | 5
0.2% | 2
0.1% | | | | | | 2,254 |
| 81-120 | | 15
0.4% | 510
13.6% | 2,653
70.5% | 561
14.9% | 21
0.6% | 1
0.0% | | | | | 3,761 |
| 121-160 | | | 1
0.0% | 428
14.1% | 1,950
64.4% | 607
20.1% | 38
1.3% | 1
0.0% | 1
0.0% | | | 3,026 |
| 161-200 | | | | 3
0.1% | 376
14.4% | 1,478
56.7% | 701
26.9% | 43
1.6% | 7
0.3% | 1
0.0% | | 2,609 |
| 201-250 | | | | | 5
0.2% | 349
12.1% | 1,707
59.4% | 733
25.5% | 80
2.8% | 1
0.0% | | 2,875 |
| 251-300 | | | | | | 2
0.1% | 312
13.7% | 1,345
59.0% | 577
25.3% | 43
1.9% | | 2,279 |
| 301-350 | | | | | | | 2
0.2% | 269
22.0% | 777
63.6% | 168
13.7% | 6
0.5% | 1,222 |
| 351-400 | | | | | | | | 3
0.8% | 170
44.3% | 200
52.1% | 11
2.9% | 384 |
| > 400 | | | | | | | | | 2
5.7% | 27
77.1% | 6
17.1% | 35 |
| Total | 27 | 1,170 | 2,176 | 3,481 | 2,901 | 2,460 | 2,761 | 2,394 | 1,614 | 440 | 23 | 19,447 |
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Concurrence of System Readings and Comparator Values by iCGM Glucose Ranges (Pediatrics; N=166)
| | Comparator Glucose Values (mg/dL) | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| iCGM Glucose Range (mg/dL) | <40 | 40-60 | 61-80 | 81-120 | 121-160 | 161-200 | 201-250 | 251-300 | 301-350 | 351-400 | >400 | Total |
| < 40 | 1
3.8% | 8
30.8% | 6
23.1% | 10
38.5% | 1
3.8% | | | | | | | 26 |
| 40-60 | 1
0.6% | 62
39.2% | 72
45.6% | 19
12.0% | 4
2.5% | | | | | | | 158 |
| 61-80 | | 55
11.3% | 320
65.7% | 101
20.7% | 11
2.3% | | | | | | | 487 |
| 81-120 | | 2
0.2% | 160
12.4% | 980
76.1% | 137
10.6% | 7
0.5% | 1
0.1% | | | | | 1,287 |
| 121-160 | | | | 137
13.3% | 733
71.2% | 141
13.7% | 17
1.7% | 1
0.1% | | | | 1,029 |
| 161-200 | | | | 2
0.2% | 203
18.5% | 653
59.6% | 221
20.2% | 17
1.6% | | | | 1,096 |
| 201-250 | | | | | 1
0.1% | 157
18.8% | 533
63.8% | 133
15.9% | 12
1.4% | | | 836 |
| 251-300 | | | | | | 1
0.2% | 154
28.0% | 325
59.1% | 68
12.4% | 2
0.4% | | 550 |
| 301-350 | | | | | | | 3
1.0% | 94
32.6% | 163
56.6% | 28
9.7% | | 288 |
| 351-400 | | | | | | | | 5
5.9% | 45
52.9% | 33
38.8% | 2
2.4% | 85 |
| > 400 | | | | | | | | | 1
5.0% | 11
55.0% | 8
40.0% | 20 |
| Total | 2 | 127 | 558 | 1,249 | 1,090 | 959 | 929 | 575 | 289 | 74 | 10 | 5,862 |
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Concurrence of System Readings and Comparator Values by Comparator Glucose Ranges (Adults; N=159)
| | Comparator Glucose Values (mg/dL) | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| iCGM Glucose Range (mg/dL) | <40 | 40-60 | 61-80 | 81-120 | 121-160 | 161-200 | 201-250 | 251-300 | 301-350 | 351-400 | >400 | Total |
| < 40 | 14
51.9% | 57
4.9% | 23
1.1% | 4
0.1% | 2
0.1% | | | | | | | 100 |
| 40-60 | 11
40.7% | 619
52.9% | 250
11.5% | 19
0.5% | 2
0.1% | 1
0.0% | | | | | | 902 |
| 61-80 | 2
7.4% | 479
40.9% | 1,392
64.0% | 374
10.7% | 5
0.2% | 2
0.1% | | | | | | 2,254 |
| 81-120 | | 15
1.3% | 510
23.4% | 2,653
76.2% | 561
19.3% | 21
0.9% | 1
0.0% | | | | | 3,761 |
| 121-160 | | | 1
0.0% | 428
12.3% | 1,950
67.2% | 607
24.7% | 38
1.4% | 1
0.0% | 1
0.1% | | | 3,026 |
| 161-200 | | | | 3
0.1% | 376
13.0% | 1,478
60.1% | 701
25.4% | 43
1.8% | 7
0.4% | 1
0.2% | | 2,609 |
| 201-250 | | | | | 5
0.2% | 349
14.2% | 1,707
61.8% | 733
30.6% | 80
5.0% | 1
0.2% | | 2,875 |
| 251-300 | | | | | | 2
0.1% | 312
11.3% | 1,345
56.2% | 577
35.7% | 43
9.8% | | 2,279 |
| 301-350 | | | | | | | 2
0.1% | 269
11.2% | 777
48.1% | 168
38.2% | 6
26.1% | 1,222 |
| 351-400 | | | | | | | | 3
0.1% | 170
10.5% | 200
45.5% | 11
47.8% | 384 |
| > 400 | | | | | | | | | 2
0.1% | 27
6.1% | 6
26.1% | 35 |
| Total | 27 | 1,170 | 2,176 | 3,481 | 2,901 | 2,460 | 2,761 | 2,394 | 1,614 | 440 | 23 | 19,447 |
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Concurrence of System Readings and Comparator Values by Comparator Glucose Ranges (Pediatrics; N=166)
| | Comparator Glucose Values (mg/dL) | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| iCGM Glucose Range (mg/dL) | <40 | 40-60 | 61-80 | 81-120 | 121-160 | 161-200 | 201-250 | 251-300 | 301-350 | 351-400 | >400 | Total |
| < 40 | 1
50.0% | 8
6.3% | 6
1.1% | 10
0.8% | 1
0.1% | | | | | | | 26 |
| 40-60 | 1
50.0% | 62
48.8% | 72
12.9% | 19
1.5% | 4
0.4% | | | | | | | 158 |
| 61-80 | | 55
43.3% | 320
57.3% | 101
8.1% | 11
1.0% | | | | | | | 487 |
| 81-120 | | 2
1.6% | 160
28.7% | 980
78.5% | 137
12.6% | 7
0.7% | 1
0.1% | | | | | 1,287 |
| 121-160 | | | | 137
11.0% | 733
67.2% | 141
14.7% | 17
1.8% | 1
0.2% | | | | 1,029 |
| 161-200 | | | | 2
0.2% | 203
18.6% | 653
68.1% | 221
23.8% | 17
3.0% | | | | 1,096 |
| 201-250 | | | | | 1
0.1% | 157
16.4% | 533
57.4% | 133
23.1% | 12
4.2% | | | 836 |
| 251-300 | | | | | | 1
0.1% | 154
16.6% | 325
56.5% | 68
23.5% | 2
2.7% | | 550 |
| 301-350 | | | | | | | 3
0.3% | 94
16.3% | 163
56.4% | 28
37.8% | | 288 |
| 351-400 | | | | | | | | 5
0.9% | 45
15.6% | 33
44.6% | 2
20.0% | 85 |
| > 400 | | | | | | | | | 1
0.3% | 11
14.9% | 8
80.0% | 20 |
| Total | 2 | 127 | 558 | 1,249 | 1,090 | 959 | 929 | 575 | 289 | 74 | 10 | 5,862 |
## Trend Accuracy
Trend accuracy describes the accuracy of the sensor during times of rapidly changing glucose and are characterized by slopes, such as from $>2\mathrm{mg/dL}$ to $<-2\mathrm{mg/dL}$. Trend accuracy was assessed by the concurrence rate of the glucose rate of change (changes in $\mathrm{mg/dL}$ of glucose per minute) determined by the iCGM values and the corresponding comparator values for each iCGM-comparator measured pairs (typically collected once every 15 minutes).
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Trend Accuracy (Adults; n=159)
| iCGM Rate Range (mg/dL/min) | Comparator Rate Range (mg/dL/min) | | | | | | iCGM-Comparator Matched Pairs (n) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | <-2 | [-2,-1) | [-1,-0) | [0,1] | (1,2] | >2 | |
| <-2 | 250 (53.0%) | 163 (34.5%) | 49 (10.4%) | 8 (1.7%) | 1 (0.2%) | 1 (0.2%) | 472 |
| [-2,-1) | 153 (7.4%) | 1,179 (56.8%) | 677 (32.6%) | 62 (3.0%) | 5 (0.2%) | 1 (0.0%) | 2,077 |
| [-1,0) | 34 (0.4%) | 763 (9.6%) | 6,129 (76.8%) | 1,000 (12.5%) | 47 (0.6%) | 9 (0.1%) | 7,982 |
| [0,1] | 3 (0.1%) | 48 (0.9%) | 1,353 (26.1%) | 3,151 (60.8%) | 548 (10.6%) | 81 (1.6%) | 5,184 |
| (1,2] | 0 (0.0%) | 10 (0.6%) | 62 (3.6%) | 467 (26.8%) | 915 (52.5%) | 289 (16.6%) | 1,743 |
| >2 | 1 (0.1%) | 2 (0.1%) | 9 (0.7%) | 71 (5.2%) | 298 (21.9%) | 979 (72.0%) | 1,360 |
Trend Accuracy (Pediatrics; N=166)
| iCGM Rate Range (mg/dL/min) | Comparator Rate Range (mg/dL/min) | | | | | | iCGM-Comparator Matched Pairs (n) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | <-2 | [-2,-1) | [-1,-0) | [0,1] | (1,2] | >2 | |
| <-2 | 108 (48.6%) | 78 (35.1%) | 29 (13.1%) | 6 (2.7%) | 0 (0.0%) | 1 (0.5%) | 222 |
| [-2,-1) | 44 (6.4%) | 382 (55.4%) | 234 (34.0%) | 24 (3.5%) | 4 (0.6%) | 1 (0.1%) | 689 |
| [-1,0) | 10 (0.5%) | 186 (9.0%) | 1,514 (73.6%) | 328 (15.9%) | 19 (0.9%) | 1 (0.0%) | 2,058 |
| [0,1] | 1 (0.1%) | 14 (0.8%) | 430 (25.6%) | 1,053 (62.7%) | 166 (9.9%) | 16 (1.0%) | 1,680 |
| (1,2] | 0 (0.0%) | 5 (0.9%) | 23 (4.2%) | 193 (35.3%) | 261 (47.7%) | 65 (11.9%) | 547 |
| >2 | 1 (0.2%) | 1 (0.2%) | 11 (2.5%) | 32 (7.4%) | 103 (23.8%) | 284 (65.7%) | 432 |
Agreement When iCGM Reads "LOW" or "HIGH"
The Dexcom G6 System and the Dexcom Glucose Program System report glucose readings between 40 and 400 mg/dL. When the system determines the glucose reading is below 40 mg/dL, it displays "LOW" in the Receiver or Mobile Application Status Box. When the system determines that the glucose level is above 400 mg/dL, it displays "HIGH" in the Receiver or Mobile Application Status Box. Because the System does not display glucose values below 40 mg/dL or above 400 mg/dL, the comparisons to the actual blood glucose levels (as determined by the laboratory comparator analyzer) when the iCGM value is
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classified as "LOW" or "HIGH" is evaluated separately, and the cumulative percentages when laboratory comparator values were less than certain glucose levels (for "LOW"), and when laboratory comparator values were greater than certain glucose levels (for "HIGH") are presented in the table below.
Distribution of Reference Values when CGM readings are "Low" or "High"
| iCGM Readings (mg/dL) | iCGM-comparator Pairs | Comparator (mg/dL) | | | | | Total |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | < 55 | < 60 | < 70 | < 80 | ≥ 80 | |
| "LOW" | n | 65 | 78 | 92 | 109 | 17 | 126 |
| | Cumulative Percent | 52% | 62% | 73% | 87% | 13% | |
| | | | | | | | |
| iCGM Readings (mg/dL) | iCGM-comparator Pairs | Comparator (mg/dL) | | | | | Total |
| | | > 340 | > 320 | > 280 | > 250 | ≤ 250 | |
| "HIGH" | n | 54 | 54 | 55 | 55 | 0 | 55 |
| | Cumulative Percent | 98% | 98% | 100% | 100% | 0% | |
## Alert performance:
The Hypoglycemic Alert Rate shows how often the alert is right or wrong. The True Notification Rate is the % of time the device alarmed when the blood glucose level was at or below the alert setting within 15 minutes before or after the device alarmed (as confirmed by the comparator method). The False Notification Rate is the % of time the device alarmed when the blood glucose level was above the alert setting within 15 minutes before or after the device alarmed. The Correct Detection Rate is the % of time the device alarmed when the blood glucose level was at or below the alert setting within 15 minutes before or after the hypoglycemic event. The Missed Detection Rate is the % of time the device did not alarm when the blood glucose level was at or below the alert setting within 15 minutes before and after the hypoglycemic event.
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Hypoglycemic Alert and Detection Rate Evaluations (Adults; n=159)
| Alert Setting | Hypo Events (n) | Correct Detection Rate (%) | Missed Detection Rate (%) | Hypo Alerts (n) | True Notification Rate (%) | False Notification Rate (%) |
| --- | --- | --- | --- | --- | --- | --- |
| 55 mg/dL | 639 | 64.2 | 35.8 | 1,362 | 68.9 | 31.1 |
| 60 mg/dL | 1,149 | 74.2 | 25.8 | 2,313 | 75.9 | 24.1 |
| 70 mg/dL | 2,348 | 85.9 | 14.1 | 4,986 | 86.3 | 13.7 |
| 80 mg/dL | 3,346 | 92.7 | 7.3 | 8,078 | 89.5 | 10.5 |
| 90 mg/dL | 4,255 | 94.5 | 5.5 | 11,022 | 89.6 | 10.4 |
Hypoglycemic Alert and Detection Rate Evaluations (Pediatrics; n=166)
| Alert Setting | Hypo Events (n) | Correct Detection Rate (%) | Missed Detection Rate (%) | Hypo Alerts (n) | True Notification Rate (%) | False Notification Rate (%) |
| --- | --- | --- | --- | --- | --- | --- |
| 55 mg/dL | 66 | 68.2 | 31.8 | 326 | 35.0 | 65.0 |
| 60 mg/dL | 119 | 73.1 | 26.9 | 486 | 47.5 | 52.5 |
| 70 mg/dL | 369 | 81.6 | 18.4 | 1,030 | 70.0 | 30.0 |
| 80 mg/dL | 669 | 88.0 | 12.0 | 1,766 | 81.7 | 18.3 |
| 90 mg/dL | 1,030 | 92.8 | 7.2 | 2,722 | 87.3 | 12.7 |
The Hyperglycemic Alert Rate shows how often the alert is right or wrong. The True Notification Rate is the % of time the device alarmed when the blood glucose level was at or above the alert setting within 15 minutes before or after the device alarmed. The False Notification Rate is the % of time the device alarmed when the blood glucose level was below the alert setting within 15 minutes before or after the device alarmed. The Correct Detection Rate is the % of time the device alarmed when the blood glucose level was at or above the alert setting within 15 minutes before or after the hyperglycemic event. The Missed Detection Rate is the % of time the device did not alarm when the blood glucose level was at or above the alert setting within 15 minutes before and after the hyperglycemic event.
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Hyperglycemic Alert and Detection Rate Evaluations (Adults; n=159)
| Alert Setting | Hyper Events (n) | Correct Detection Rate (%) | Missed Detection Rate (%) | Hyper Alerts (n) | True Notification Rate (%) | False Notification Rate (%) |
| --- | --- | --- | --- | --- | --- | --- |
| 120 mg/dL | 12,676 | 97.7 | 2.3 | 37,167 | 97.5 | 2.5 |
| 140 mg/dL | 11,194 | 96.9 | 3.1 | 32,263 | 97.2 | 2.8 |
| 180 mg/dL | 8,484 | 95.3 | 4.7 | 23,521 | 96.6 | 3.4 |
| 200 mg/dL | 7,296 | 93.7 | 6.3 | 19,664 | 96.0 | 4.0 |
| 220 mg/dL | 6,179 | 91.3 | 8.7 | 15,763 | 95.7 | 4.3 |
| 240 mg/dL | 5,040 | 88.7 | 11.3 | 12,337 | 94.6 | 5.4 |
| 300 mg/dL | 2,120 | 75.0 | 25.0 | 4,243 | 86.0 | 14.0 |
Hyperglycemic Alert and Detection Rate Evaluations (Pediatric; n=166)
| Alert Setting | Hyper Events (n) | Correct Detection Rate (%) | Missed Detection Rate (%) | Hyper Alerts (n) | True Notification Rate (%) | False Notification Rate (%) |
| --- | --- | --- | --- | --- | --- | --- |
| 120 mg/dL | 3,962 | 98.0 | 2.0 | 11,800 | 97.3 | 2.7 |
| 140 mg/dL | 3,419 | 97.5 | 2.5 | 10,200 | 96.2 | 3.8 |
| 180 mg/dL | 2,390 | 94.5 | 5.5 | 6,872 | 93.5 | 6.5 |
| 200 mg/dL | 1,895 | 91.2 | 8.8 | 5,233 | 93.4 | 6.6 |
| 220 mg/dL | 1,470 | 91.8 | 8.2 | 4,128 | 90.4 | 9.6 |
| 240 mg/dL | 1,108 | 90.0 | 10.0 | 3,091 | 86.9 | 13.1 |
| 300 mg/dL | 382 | 83.8 | 16.2 | 1,012 | 77.2 | 22.8 |
**Sensor Stability:**
Sensor stability describes the performance over the sensor lifetime. Sensors can be worn for up to 10 days. Performance was estimated by calculating the percentage of iCGM readings within 15 mg/dL or 15% (15/15%), 20 mg/dL or 20% (20/20%), and 40 mg/dL or 40% (40/40%) of the laboratory comparator values at the beginning (Day 1, 2), middle (Day 4, 5), and end (Day 7, 10) of the System lifecycle. The mean of the absolute relative differences were evaluated over the 10-day life of the sensor within the measuring range.
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Sensor Stability Relative to Comparator (Accuracy Over Time)
| Wear Period | Matched Pairs (N) | MARD (%) | Percent within %15/15 (%) | Percent within %20/20 (%) | Percent within %40/40 (%) |
| --- | --- | --- | --- | --- | --- |
| Beginning | 8,864 | 10.7 | 77.6 | 89.1 | 99.6 |
| Middle | 7,755 | 9.2 | 84.2 | 94.5 | 99.8 |
| End | 8,509 | 9.5 | 82.7 | 92.2 | 99.6 |
**Sensor Life:**
A total of 374 sensors were evaluated to determine the percentage of sensors that lasted through the 10 day sensor life. Eighty-four percent (84%) of the sensors lasted through the end of the entire wear period (e.g., Day 10) (see Figure 1). Among the 374 sensors evaluated, 36 sensors (9.6%) had "early sensor shut-off" where the sensor algorithm would have detected sensors that did not function as intended and shut them off.
Sensor Survival Rate by Wear Day (Adults; n=164)
| Wear Day | Number of Sensors | Survival Rate (%) |
| --- | --- | --- |
| 1 | 162 | 99.4% |
| 2 | 160 | 98.8% |
| 3 | 158 | 98.8% |
| 4 | 155 | 98.8% |
| 5 | 155 | 98.8% |
| 6 | 154 | 98.1% |
| 7 | 150 | 96.8% |
| 8 | 145 | 96.2% |
| 9 | 143 | 94.9% |
| 10 | 138 | 93.5% |
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Sensor Survival Rate by Wear Day (Pediatrics; n=210)
| Wear Day | Number of Sensors | Survival Rate (%) |
| --- | --- | --- |
| 1 | 206 | 99.0% |
| 2 | 204 | 99.0% |
| 3 | 196 | 97.1% |
| 4 | 193 | 95.6% |
| 5 | 187 | 92.6% |
| 6 | 176 | 89.6% |
| 7 | 165 | 86.5% |
| 8 | 158 | 82.8% |
| 9 | 148 | 79.7% |
| 10 | 142 | 75.7% |
The capture rate characterizes the reliability of the communication between components of the system. The System provides a sensor glucose reading every 5 minutes, or up to 288 readings per day. The percentage of readings expected to be received from the system over the sensor life was evaluated from 374 sensors and is 98.6%. More than 97% of the sensors captured readings at least 90% of the time. The table below describes the percent of readings received throughout the life span of the sensor (capture rate).
Reading Capture Rate by Wear Day (n=374)
| Wear Day | Number of Sensors | Capture Rate (%) |
| --- | --- | --- |
| 1 | 374 | 97.9 |
| 2 | 368 | 98.8 |
| 3 | 364 | 98.9 |
| 4 | 354 | 99.0 |
| 5 | 348 | 98.8 |
| 6 | 342 | 98.2 |
| 7 | 330 | 99.0 |
| 8 | 315 | 99.0 |
| 9 | 303 | 98.6 |
| 10 | 291 | 98.4 |
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D Clinical Cut-Off:
Not applicable.
E Expected Values/Reference Range:
Not applicable.
F Other Supportive Instrument Performance Characteristics Data:
The following supportive instrument performance characteristics were established in the respective predicate for the Dexcom G6 System (k191450) and the Dexcom Glucose Program System (k193642), and are not affected by the modifications in glucose algorithm in the current 510(k):
- Human Factors
- Sterility
- Biocompatibility
- Mechanical Engineering
- Electromagnetic Compatibility
- Wireless
- Electrical Safety
- Environmental Testing
- Shelf-Life Stability
- Packaging Integrity/Shipping Integrity
- Interoperability
- Cybersecurity
- Contact Resistance
- G6 Android Mobile App has been updated to include “Do-Not Disturb” (DND) override privileges to ensure that users receive auditory Urgent Low Glucose Alarms which were not being generated in previous versions of the Dexcom G6 Mobile App and presented a safety risk to users who did not have the dedicated CGM Receiver.
VIII Proposed Labeling:
The labeling supports the finding of substantial equivalence for this device.
IX Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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