K Number
K192787
Device Name
Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System
Manufacturer
Date Cleared
2019-10-25

(25 days)

Product Code
Regulation Number
862.1355
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
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 mobile application. The proposed Dexcom G6 Glucose Program System is based on the same physical principles and fundamental design as the predicate system but includes an alternative, ultrasonic-welded transmitter. The transmitter attaches to the sensor wearable which is adhered to the user's body. The Dexcom G6 Glucose Program System is designed to function as intended with either the proposed or predicate transmitter (K191450). The proposed transmitter has the same form, fit, and function as the predicate transmitter (K191450) and, from the users' perspective, functions identically.
More Information

Not Found

No
The summary describes an "onboard algorithm" for converting sensor measurements to glucose readings, but there is no mention of AI, ML, or related concepts like training or test sets for such algorithms. The focus is on the physical components and basic data processing.

Yes
The device is indicated for the management of diabetes, which involves making treatment decisions based on glucose trends, and it aids in the detection of hyperglycemia to facilitate therapy adjustments. This qualifies it as a therapeutic device.

Yes

The text explicitly states that the device is a "real time, continuous glucose monitoring device indicated for the management of diabetes," and that it "aids in the detection of episodes of hyperglycemia, facilitating long-term therapy adjustments," which are diagnostic purposes.

No

The device description clearly states that the system consists of three main components: a sensor/applicator delivery system, a transmitter, and a mobile application (app). The sensor and transmitter are physical hardware components worn on the body.

Based on the provided text, the Dexcom G6 Glucose Program Continuous Glucose Monitoring System is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use explicitly states it's for "management of diabetes" and "to replace fingerstick blood glucose testing for diabetes treatment decisions." This indicates it's used to obtain information about a physiological state (glucose levels) from a sample (interstitial fluid, which is related to blood glucose).
  • Device Description: The sensor is described as being inserted into "subcutaneous tissue where it converts glucose into electrical current." This process involves analyzing a biological sample (interstitial fluid containing glucose) outside of the body's direct observation, which is a key characteristic of an in vitro diagnostic.
  • Function: The system measures glucose levels from the interstitial fluid and provides these readings to the user for making treatment decisions. This is a diagnostic function.

While the system has components worn on the body, the core function of measuring glucose from a biological sample (interstitial fluid) places it within the realm of in vitro diagnostics.

N/A

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 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.

Product codes (comma separated list FDA assigned to the subject device)

QDK

Device Description

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 mobile application.

The proposed Dexcom G6 Glucose Program System is based on the same physical principles and fundamental design as the predicate system but includes an alternative, ultrasonic-welded transmitter. The transmitter attaches to the sensor wearable which is adhered to the user's body. The Dexcom G6 Glucose Program System is designed to function as intended with either the proposed or predicate transmitter (K191450). The proposed transmitter has the same form, fit, and function as the predicate transmitter (K191450) and, from the users' perspective, functions identically.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

subcutaneous tissue

Indicated Patient Age Range

2 years and older.

Intended User / Care Setting

Home use

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The proposed Dexcom G6 Glucose Program System was verified and validated according to Dexcom's internal design control process and in accordance with special controls for integrated continuous glucose monitors. Performance testing and software verification and validation testing was completed for the proposed transmitter. To validate the design of the proposed transmitter firmware with the predicate Glucose Program Mobile App, system integration testing was completed to ensure system level and display requirements remain fulfilled.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K191450

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 862.1355 Integrated continuous glucose monitoring system.

(a)
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.(b)
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.

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part is in blue, with the acronym in a square and the full name written out as "U.S. Food & Drug Administration".

October 25, 2019

Dexcom, Inc. Bryan Osborne Specialist, Regulatory Affairs 6340 Sequence Dr. San Diego, CA 92121

Re: K192787

Trade/Device Name: Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System Regulation Number: 21 CFR 862.1355 Regulation Name: Integrated continuous glucose monitoring system Regulatory Class: Class II Product Code: QDK Dated: September 26, 2019 Received: September 30, 2019

Dear Bryan Osborne:

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

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

1

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 Ouality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known)

K192787

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)
☑ 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 PRAStaff@fda.hhs.gov

"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."

3

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: Bryan Osborne Specialist, Regulatory Affairs Phone: 858.875.9896 Fax: 858.332.0204 bosborne@dexcom.com Email:

Secondary

Contact: Kiley Hubert Sr. Manager, Regulatory Affairs Phone: Phone: Phone: 858.875.9770 Fax: 858.332.0204 Email: khubert@dexcom.com

Date Prepared: September 26, 2019

6.2 Device Names and Classification:

Predicate Device
Proprietary NameDexcom G6 Glucose Program Continuous Glucose
Monitoring (CGM) System
Common NameIntegrated Continuous Glucose Monitoring System,
Factory Calibrated
ClassII
Classification Regulation21 CFR 862.1355
Product CodeQDK

4

Review PanelClinical Chemistry
----------------------------------

6.3 Predicate Device:

Dexcom G6 Glucose Program Continuous Glucose Monitoring System (K191450)

6.4 Device Description:

6.4.1 Dexcom G6 Glucose Program Continuous Glucose Monitoring 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 mobile application.

The proposed Dexcom G6 Glucose Program System is based on the same physical principles and fundamental design as the predicate system but includes an alternative, ultrasonic-welded transmitter. The transmitter attaches to the sensor wearable which is adhered to the user's body. The Dexcom G6 Glucose Program System is designed to function as intended with either the proposed or predicate transmitter (K191450). The proposed transmitter has the same form, fit, and function as the predicate transmitter (K191450) and, from the users' perspective, functions identically.

6.5 Indications for Use

6.5.1 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

5

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.

6.6 Comparison with the Predicate Device:

| Device | Dexcom G6 Glucose Program System
(predicate device; K191450) | Dexcom G6 Glucose Program
System (subject device) |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| Trade Name | Dexcom G6 Glucose Program
Continuous Glucose Monitoring (CGM)
System | Same |
| Manufacturer | Dexcom, Inc. | Same |
| Intended Use | 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. | Same |
| Indications for
Use | The Dexcom G6 Glucose Program
Continuous Glucose Monitoring
System (Dexcom Glucose Program
System) is a real time, continuous
glucose monitoring device indicated
for the management of diabetes in
persons age 2 years and older.
The Dexcom Glucose Program System
is intended to replace fingerstick blood
glucose testing for diabetes treatment
decisions for persons with diabetes
who are not at significant risk of severe
hypoglycemia. Interpretation of the
Dexcom Glucose Program System | Same |
| Device | Dexcom G6 Glucose Program System
(predicate device; K191450) | Dexcom G6 Glucose Program
System (subject device) |
| | 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. | |
| Clinical
application | Management of diabetes mellitus | Same |
| Clinical
setting/sites
of use | Home use | Same |
| Principle of
Operation | Amperometric measurement of
current proportional to glucose
concentration in interstitial fluid via
glucose oxidase chemical reaction. | Same |
| | Estimated Glucose Value (EGV): The
EGV is the nominal glucose value
presented to the user.
Glucose Trend: Based off the glucose
rate of change, users are shown their
glucose trend with a corresponding
arrow.
Historical Glucose Data: Users can
view their previous six, or twelve hours
of glucose data on a graph with
high/low glucose thresholds.
Time in Range: Users can view the
percent of time they spend in their
target glucose range based on their
configured high/low glucose
thresholds. | Same |
| Data
Presented | | |
| Features | Connect to Dexcom Share: Users can
share their glucose data with up to
three followers.
Chat with Wellness Coach: Users can
chat with a third-party wellness coach
for encouragement, education, and
motivation regarding their diabetes
management. | Same |
| Human
Factors | Easy to understand UI/UX. | Same |
| Device | Dexcom G6 Glucose Program System (predicate device; K191450) | Dexcom G6 Glucose Program System (subject device) |
| | Commonly understood navigation tools and features.
Color-coded graphics. | |
| Compatibility with intended environments | Compatible with Android OS version 7.0 and above | Same |
| Transmitter | G6 (Epoxy) Transmitter only | G6 (Epoxy) Transmitter and
G6 (Welded) Transmitter |

6.6.1 Dexcom G6 Glucose Program Continuous Glucose Monitoring System

6

7

6.7 Technological Characteristics

The proposed Dexcom G6 Glucose Program System is used to measure glucose values via amperometric measurement of current proportional to glucose concentration in interstitial fluid via a glucose oxidase chemical reaction. The proposed Dexcom G6 Glucose Program System shares the same technological characteristics as the predicate device (K191450).

6.8 Summary of Performance Testing

The proposed Dexcom G6 Glucose Program System was verified and validated according to Dexcom's internal design control process and in accordance with special controls for integrated continuous glucose monitors. Performance testing and software verification and validation testing was completed for the proposed transmitter. To validate the design of the proposed transmitter firmware with the predicate Glucose Program Mobile App, system integration testing was completed to ensure system level and display requirements remain fulfilled.

6.9 Conclusions

The proposed Dexcom G6 Glucose Program System is substantially equivalent to the predicate Dexcom G6 Glucose Program System as it shares the same intended use, indications for use, as well as technological characteristics. Further, the proposed change does not raise different questions of safety and effectiveness.