(308 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description of the device's algorithm is limited to converting electrical current to estimated glucose values. There is no mention of learning or adaptive capabilities.
Yes
The device is indicated for the management of diabetes, which involves monitoring glucose levels for treatment decisions and long-term therapy adjustments, falling under the scope of therapeutic intervention for a medical condition.
Yes
The "Intended Use / Indications for Use" section states: "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." It also states: "The Dexcom Glucose Program System also aids in the detection of episodes of hyperglycemia, facilitating long-term therapy adjustments." These statements indicate that the device measures and provides information about a physiological state (glucose levels) to manage a disease (diabetes), which falls under the definition of a diagnostic device.
No
The device description explicitly states the system consists of a sensor/applicator, a Bluetooth Low Energy (BLE) transmitter, and a BLE enabled mobile CGM display. While the submission focuses on changes to the mobile software, the overall system includes hardware components.
Based on the provided text, the Dexcom G6 Glucose Program Continuous Glucose Monitoring System is an IVD (In Vitro Diagnostic).
Here's why:
- It measures glucose: The core function of the device is to measure glucose values.
- It uses a sensor in subcutaneous tissue: While the sensor is inserted into the body, it is measuring a substance (glucose) in the interstitial fluid, which is a biological sample.
- It is used for the management of diabetes: This is a diagnostic purpose, aiding in understanding and managing a medical condition.
- It is intended to replace fingerstick blood glucose testing: Fingerstick blood glucose testing is a classic example of an in vitro diagnostic test. The fact that this device is intended to replace it strongly suggests it falls under the IVD category.
While the device has components that are worn on the body, the fundamental action of measuring glucose in a biological sample (interstitial fluid) for diagnostic purposes aligns with the definition of an In Vitro Diagnostic device.
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
QDK
Device Description
The Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System measures and displays glucose values and trends for patients with diabetes who are not at significant risk of severe hypoglycemia. The system is factory calibrated and provides continuous glucose readings at five-minute intervals for up to ten days of use. The system consists of a sensor/applicator, a Bluetooth Low Energy (BLE) transmitter, and a BLE enabled mobile CGM display.
The sensor is a small and flexible wire, which is inserted by the applicator into subcutaneous tissue where it converts glucose into electrical current. The transmitter is connected to the sensor and is worn on the body. The transmitter samples the electrical current produced by the sensor and converts these measurements into estimated glucose values (EGV) using an onboard algorithm. The transmitter sends glucose data to the mobile CGM displays the current glucose reading (updated every 5 minutes) and glucose trends. The mobile CGM display does not include any glucose related alarm or alerts but will alert the user when important system conditions occur.
The subject of this submission is a change to the primary display mobile device software. Compared to the predicate device which uses a standalone mobile CGM application, the proposed Glucose Program System uses a new mobile CGM software module (app module) that is embedded within a third party program provider's mobile app (host app).
This change is to help encourage CGM retention for those not at significant risk of severe hypoglycemia by providing Dexcom Glucose Program CGM functions and program provider's functions on a single unified mobile application. The app module is designed as a finished sovereign software that interacts directly with smart device hardware/operating system and maintains the same core CGM functionality as the predicate device, independent of the host app. The proposed Glucose Program System uses the same sensor/applicator and transmitter as the predicate device, with only changes to the mobile CGM software.
The change to the primary display mobile device software described in this submission does not impact the standalone G6 mobile application used in the G6 CGM System (last cleared K200876) and only affects the Glucose Program System which is designed for payor-sponsored, valuebased health programs.
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 Glucose Program System was verified and validated according to Dexcom's internal design control process. All testing referenced in the predicate device (K200876) in accordance with special controls for integrated continuous glucose monitors remain applicable. The proposed system uses the same transmitter hardware and software requirements/design specifications as the predicate device. Therefore, performance testing and software verification and validation testing for the transmitter referenced in the predicate device (K200876) remains applicable. Software testing was completed to ensure all requirements of the proposed iOS and Android app modules are fulfilled while operating in the final host-app configuration.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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August 17, 2021
Dexcom, Inc. Bryan Osborne Senior Regulatory Affairs Specialist 6340 Sequence Dr. San Diego, California 92121
Re: K203089
Trade/Device Name: Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System Regulation Number: 21 CFR 862.1355 Regulation Name: Integrated continuous glucose monitoring system Regulatory Class: Class II Product Code: QDK Dated: March 5, 2021 Received: March 8, 2021
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
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Marianela Perez-Torres, Ph.D. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203089
Device Name
Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System
Indications for Use (Describe)
The Dexcom G6 Glucose Program Continuous Glucose Monitoring System Glucose Program System) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons 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) |
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5 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K203089
5.1 Submitter:
Dexcom, Inc. 6340 Sequence Dr. San Diego, CA 92121
Contact: Bryan Osborne Senior Regulatory Affairs Specialist Phone: 858.875.9896 Fax: 858.332.0204 bosborne@dexcom.com Email:
Secondary Contact: Ginny Hu Senior Manager, Regulatory Affairs Phone: 858.203.6591 Fax: 858.332.0204 Email: ginny.hu@dexcom.com
Date Prepared: July 19, 2021
5.2 Device Names and Classification:
| Proprietary Name | Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM)
System |
|------------------------------|-------------------------------------------------------------------------|
| Common Name | Integrated Continuous Glucose Monitoring System, Factory Calibrated |
| Class | II |
| Classification
Regulation | 21 CFR 862.1355 |
| Product Code | QDK |
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| Review Panel | Clinical Chemistry |
|---|---|
| -------------- | -------------------- |
5.3 Predicate Device:
Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System (K200876)
5.4 Device Description:
The Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System measures and displays glucose values and trends for patients with diabetes who are not at significant risk of severe hypoglycemia. The system is factory calibrated and provides continuous glucose readings at five-minute intervals for up to ten days of use. The system consists of a sensor/applicator, a Bluetooth Low Energy (BLE) transmitter, and a BLE enabled mobile CGM display.
The sensor is a small and flexible wire, which is inserted by the applicator into subcutaneous tissue where it converts glucose into electrical current. The transmitter is connected to the sensor and is worn on the body. The transmitter samples the electrical current produced by the sensor and converts these measurements into estimated glucose values (EGV) using an onboard algorithm. The transmitter sends glucose data to the mobile CGM displays the current glucose reading (updated every 5 minutes) and glucose trends. The mobile CGM display does not include any glucose related alarm or alerts but will alert the user when important system conditions occur.
The subject of this submission is a change to the primary display mobile device software. Compared to the predicate device which uses a standalone mobile CGM application, the proposed Glucose Program System uses a new mobile CGM software module (app module) that is embedded within a third party program provider's mobile app (host app).
This change is to help encourage CGM retention for those not at significant risk of severe hypoglycemia by providing Dexcom Glucose Program CGM functions and program provider's functions on a single unified mobile application. The app module is designed as a finished sovereign software that interacts directly with smart device hardware/operating system and maintains the same core CGM functionality as the predicate device, independent of the host app. The proposed Glucose Program System uses the same sensor/applicator and transmitter as the predicate device, with only changes to the mobile CGM software.
The change to the primary display mobile device software described in this submission does not impact the standalone G6 mobile application used in the G6 CGM System (last cleared K200876) and only affects the Glucose Program System which is designed for payor-sponsored, valuebased health programs.
5
5.5 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 results should be based on the glucose trends and several sequential sensor readings over time. The Dexcom Glucose Program System also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating long-term therapy adjustments.
The Dexcom Glucose Program System is also intended to autonomously communicate with digitally connected devices. The Dexcom Glucose Program System can be used alone or in conjunction with these digitally connected devices or services for the purpose of managing diabetes.
| Device | Dexcom G6 Glucose Program System
(K200876, Predicate) | 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 | Same |
| Device | Dexcom G6 Glucose Program System
(K200876, Predicate) | Dexcom G6 Glucose Program System
(subject device) |
| | 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. | |
| 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 |
| Device | Dexcom G6 Glucose Program System
(K200876, Predicate) | Dexcom G6 Glucose Program System
(subject device) |
| System
Components | Sensor/Applicator, Transmitter, Display
Device (mobile app) | Substantially Equivalent with no
adverse impact on safety or
effectiveness. |
| | | The proposed Dexcom G6 Glucose
Program CGM System uses the same
Sensor/Applicator and Transmitter as
the predicate device while
introducing an alternative primary
display CGM software. The proposed
G6 Glucose Program System uses a
new mobile CGM software module
(app module) that is embedded
within a third-party program
provider's mobile app (host app) to
provide patients both CGM functions
and the program provider's functions
on a single unified mobile application.
The proposed G6 Glucose Program
app module has the same core CGM
functionality and meets the same
system requirements as the predicate
G6 Glucose Program System. |
| Data Presented | Estimated Glucose Value (EGV): The
EGV is the nominal glucose value
presented to the user. | Substantially equivalent with no
adverse impact on safety or
effectiveness. |
| | 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. | The proposed Glucose Program System
maintains the same key features as the
predicate device, including EGV,
glucose trend, historical glucose data,
and time in range of target glucose.
The proposed system includes
modifications to the graphical user
interface trend graph layout, symbols
used to show glucose rate of change
(i.e. trend arrows), and general app
layout/navigation. There is no impact
to rate of change based on provided
trend arrows. These changes do not
significantly impact safety or
effectiveness of the Glucose Program
System and its intended population. |
| Transmitter | G6 Welded (Nuevo) Transmitter | Same |
| Device | Dexcom G6 Glucose Program System | Dexcom G6 Glucose Program System |
| | (K200876, Predicate) | (subject device) |
| Glucose Value
Estimation
Algorithm | Optimized Joint Probability Algorithm
with improved data availability | Same |
| Factory Calibration | Yes | Same |
| Optional
Calibration | Yes | Substantially equivalent with no
adverse impact on safety or
effectiveness.
No impact to clinical validation. The
accuracy of the Factory Calibrated G6
CGM System was demonstrated to
meet the iCGM (21 CFR 862.1355)
Special Controls requirements in
DEN170088. The predicate and
proposed Glucose Program Systems
use the same sensor and transmitter as
the G6 CGM System. The Optional
SMBG Calibration feature was
removed to simplify user experience. |
| 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. | Substantially equivalent with no
adverse impact on safety or
effectiveness.
Removed Share/Follow and third-party
wellness coach chat features from the
proposed device. Chat feature can still
be accessed through the host app.
Changes do not significantly impact
safety or effectiveness and its intended
population. |
| Human Factors | Easy to understand user interface and
user experience. Commonly
understood navigation tools and
features. Color-coded graphics. | Substantially equivalent with no
adverse impact on safety or
effectiveness.
Changes to the primary display mobile
device software user interface and
workflow do not contribute to any
safety-critical risks or impact any
previously validated mitigations for the
G6 Glucose Program CGM System. |
| Alerts | Autonomous Detection and
Notification:
Signal Loss (not configurable)
Sensor Failure (not configurable)
Transmitter Failure (not configurable) | Same |
| Device | Dexcom G6 Glucose Program System
(K200876, Predicate) | Dexcom G6 Glucose Program System
(subject device) |
| Compatibility with
intended
environments | Compatible with Android OS version
7.0 and above and iOS version 13.2
and above. | Substantially equivalent with no
adverse impact on safety or
effectiveness. |
| | | Dexcom qualifies mobile device
operating systems using the same
performance/ acceptance criteria as
the predicate device. |
5.6 Comparison with the Predicate Device:
6
7
8
9
5.7 Technology Characteristics
The proposed Dexcom Glucose Program System is used to measure glucose values via amperometric measurement of current proportional to glucose concentration in interstitial fluid via a glucose oxidase chemical reaction. The proposed Dexcom Glucose Program System shares the same technological characteristics as the predicate device (K200876). The proposed Dexcom Glucose Program System adds a modified CGM app software solution that is embedded in a third party's iOS and Android 'host-app' for an improved single-app patient experience.
5.8 Summary of Performance Testing
The proposed Dexcom Glucose Program System was verified and validated according to Dexcom's internal design control process. All testing referenced in the predicate device (K200876) in accordance with special controls for integrated continuous glucose monitors remain applicable. The proposed system uses the same transmitter hardware and software requirements/design specifications as the predicate device. Therefore, performance testing and software verification and validation testing for the transmitter referenced in the predicate device (K200876) remains applicable. Software testing was completed to ensure all requirements of the proposed iOS and Android app modules are fulfilled while operating in the final host-app configuration.
5.9 Conclusions
The proposed Dexcom G6 Glucose Program CGM System and predicate Dexcom G6 Glucose Program CGM System (K200876) are identical with regard to intended use, indications for use, fundamental scientific technology, and principle of operation. The proposed system is substantially equivalent to the predicate device with regard to mobile software functionality, graphical user interface, and feature set. The proposed Glucose Program System CGM display is substantially equivalent to the predicate device as the proposed change does not raise any new questions of safety or effectiveness.