(247 days)
Not Found
Unknown
The document mentions an "onboard algorithm" and a "Bayesian Joint probability algorithm (JPA)" for estimating glucose values. While Bayesian methods can be used in some ML contexts, the description is not detailed enough to definitively confirm the use of AI or ML. The document explicitly states "Not Found" for mentions of AI, DNN, or ML, and provides no information about training or test sets, which are typical for ML models.
Yes
The device aids in the detection of episodes of hyperglycemia, facilitating both acute and long-term therapy adjustments, and it can be used in conjunction with automated insulin dosing (AID) systems for managing diabetes.
Yes
The device is a continuous glucose monitoring device used for the "management of diabetes" and "aids in the detection of episodes of hyperglycemia," which indicates it is used to diagnose or monitor a medical condition.
No
The device description explicitly states that the system consists of a sensor/applicator, a transmitter, and a display device (receiver and/or mobile app), which are hardware components. The software is part of a larger system that includes hardware.
Based on the provided text, the Dexcom G6 Continuous Glucose Monitoring System and the Dexcom G6 Glucose Program Continuous Glucose Monitoring System are IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "management of diabetes" and is "intended to replace fingerstick blood glucose testing for diabetes treatment decisions." This indicates that the device is used to obtain information about a patient's health status (glucose levels) for the purpose of diagnosis, monitoring, or treatment decisions.
- Device Description: The device measures glucose in "subcutaneous tissue," which is a biological sample from the body.
- Function: The system converts glucose into an electrical current and then into estimated glucose values. This process of analyzing a biological sample to obtain diagnostic information is characteristic of an IVD.
While the device is worn on the body and involves a sensor inserted into tissue, the core function is the in vitro analysis of glucose in the interstitial fluid (which is in equilibrium with blood glucose) for diagnostic purposes related to diabetes management. The "in vitro" aspect refers to the analysis of a biological sample outside of the living organism, even though the sample is collected in vivo.
N/A
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.
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
OBJ, QDK
Device Description
The Dexcom G6 Continuous Glucose Monitoring (CGM) System consists of three main components: a sensor/applicator, a Bluetooth Low Energy (BLE) transmitter, and a BLE enabled display device (receiver and/or mobile app). The sensor is a small and flexible wire 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. It samples the electrical current produced by the sensor and converts these measurements into estimated glucose values (EGV) using an onboard algorithm. The transmitter sends glucose data to the receiver and/or mobile app which displays the current glucose reading (updated every 5 minutes) and glucose trends. The receiver and/or mobile app alerts the user when glucose levels are outside of a target zone and when other important system conditions occur. The G6 sensor life has an expected wear time of up to 10 days. Though the Dexcom G6 CGM System is factory calibrated and does not require user calibration, users of the Dexcom G6 CGM System have the option to calibrate the device (e.g., in situations where users do not have to use the sensor code). When operating in factory calibration mode (using sensor code, the primary mode of G6 CGM System), the G6 algorithm does not require SMBG calibration and instead uses sensor glucose sensitivity estimates determined during manufacturing for EGV calculation. When operating in manual calibration mode (no sensor code), the G6 algorithm relies on daily SMBG calibrations and timematched sensor counts (matched pairs) to estimate calibration parameters for EGV calculation. When a SMBG calibration is entered into the system (in either mode), this information may be used by the system for estimating the glucose using the Bayesian Joint probability algorithm (JPA).
The proposed G6 CGM System is based on the same physical principles and fundamental design as the commercially available G6 CGM System (K191450), but it includes a modified algorithm (onboard algorithm) in the welded version of the G6 Transmitter (also named "Firefly" Transmitter in Dexcom's internal documents). The proposed algorithm is modified to improve data availability by modifications to modules that handle noise events and calibrations when applicable. Additionally, the algorithm has been modified to improve detectability of sensors approaching end of life. Except the modified transmitter firmware, there have been no changes to other components of the G6 CGM System (sensor/applicator, transmitter hardware, receiver, and mobile app) introduced by the modified algorithm.
The Dexcom G6 Glucose Program CGM System consists of three main components: the sensor/applicator delivery system, transmitter, and 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. 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. The G6 sensor life has an expected wear time of up to 10 days. Though the Dexcom G6 Glucose Program CGM System is factory calibrated and does not require user calibration, users have the option to calibrate the device when operating in factory calibration mode (using sensor code, the only mode of System). When a SMBG calibration is entered into the system, this information may be used by the system for estimating the glucose using the Bayesian Joint probability algorithm (JPA).
The proposed G6 Glucose Program CGM System is based on the same physical principles and fundamental design as the commercially available G6 Glucose Program CGM System, but it includes a modified algorithm (onboard algorithm) in the welded version of the G6 Transmitter (also named "Firefly" Transmitter in Dexcom's internal documents). The proposed algorithm is modified to improve data availability by modifications to modules that handle noise events and calibrations when applicable. Additionally, the algorithm has been modified to improve detectability of sensors approaching end of life. Except the modified transmitter firmware, the sensor/applicator, transmitter hardware, and mobile app remain unchanged.
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 CGM System and Dexcom G6 Glucose Program CGM System were verified and validated according to Dexcom's internal design control process and in accordance with special controls for integrated continuous glucose monitoring systems. This testing demonstrated that the proposed systems performed according to their respective specifications, and the proposed systems have met their respective technological and performance criteria, which have not changed from the predicate device (K191450).
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.
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). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 4, 2020
Dexcom, Inc. Maryam Amini Staff Regulatory Affairs Specialist 6310 Sequence Dr. San Diego, CA 92121
Re: K200876
Trade/Device Name: Dexcom G6 Continuous Glucose Monitoring System Dexcom G6 Glucose Program Continuous Glucose Monitoring System Regulation Number: 21 CFR 862.1355 Regulation Name: Integrated Continuous Glucose Monitoring System Regulatory Class: Class II Product Code: OBJ, ODK Dated: November 3, 2020 Received: November 5, 2020
Dear Maryam Amini:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Kellie B. Kelm, Ph.D. 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) K200876
Device Name
Dexcom G6 Continuous Glucose Monitoring System
Indications for Use (Describe)
The Dexcom G6 Continuous Glucose Monitoring System (Dexcom G6 System) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons age 2 years and older.
The Dexcom G6 System is intended to replace fingerstick blood glucose testing for diabetes treatment decisions. Interpretation of the Dexcom G6 System results should be based on the glucose trends and sequential readings over time. The Dexcom G6 System also aids in the detection of 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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff 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
Indications for Use
510(k) Number (if known) K200876
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 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 sequential sensor 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."
4
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: K200876
5.1 Submitter:
Dexcom, Inc. 6340 Sequence Dr. San Diego, CA 92121
Contact: Maryam Amini Staff Regulatory Affairs Specialist Phone: 858.203.6715 Fax: 858.332.0204 maryam.amini@dexcom.com Email:
Secondary Contact: Holly Drake Director, Regulatory Affairs Phone: 858.875.5326 Fax: 858.332.0204 Email: hdrake@dexcom.com
Date Prepared:
5.2 Device Names and Classification:
| Proprietary Name | Dexcom G6 Continuous Glucose Monitoring (CGM) System |
|---|---|
| Common Name | Integrated Continuous Glucose Monitoring System, Factory Calibrated |
| Class | II |
| Classification | |
| Regulation | 21 CFR 862.1355 |
| Product Code | QBJ |
| Review Panel | Clinical Chemistry |
5
| Proprietary Name | Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System |
|---|---|
| Class | II |
| Classification Regulation | 21 CFR 862.1355 |
| Product Code | QDK |
5.3 Predicate Device:
Dexcom G6 Continuous Glucose Monitoring (CGM) System (K191450)
Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System (K191450)
5.4 Device Description:
5.4.1 Dexcom G6 Continuous Glucose Monitoring (CGM) System
The Dexcom G6 Continuous Glucose Monitoring (CGM) System consists of three main components: a sensor/applicator, a Bluetooth Low Energy (BLE) transmitter, and a BLE enabled display device (receiver and/or mobile app). The sensor is a small and flexible wire 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. It samples the electrical current produced by the sensor and converts these measurements into estimated glucose values (EGV) using an onboard algorithm. The transmitter sends glucose data to the receiver and/or mobile app which displays the current glucose reading (updated every 5 minutes) and glucose trends. The receiver and/or mobile app alerts the user when glucose levels are outside of a target zone and when other important system conditions occur. The G6 sensor life has an expected wear time of up to 10 days. Though the Dexcom G6 CGM System is factory calibrated and does not require user calibration, users of the Dexcom G6 CGM System have the option to calibrate the device (e.g., in situations where users do not have to use the sensor code). When operating in factory calibration mode (using sensor code, the primary mode of G6 CGM System), the G6 algorithm does not require SMBG calibration and instead uses sensor glucose sensitivity estimates determined during manufacturing for EGV calculation. When operating in manual calibration mode (no sensor code), the G6 algorithm relies on daily SMBG calibrations and timematched sensor counts (matched pairs) to estimate calibration parameters for EGV calculation. When a SMBG calibration is entered into the system (in either mode), this information may be used by the system for estimating the glucose using the Bayesian Joint probability algorithm (JPA).
6
The proposed G6 CGM System is based on the same physical principles and fundamental design as the commercially available G6 CGM System (K191450), but it includes a modified algorithm (onboard algorithm) in the welded version of the G6 Transmitter (also named "Firefly" Transmitter in Dexcom's internal documents). The proposed algorithm is modified to improve data availability by modifications to modules that handle noise events and calibrations when applicable. Additionally, the algorithm has been modified to improve detectability of sensors approaching end of life. Except the modified transmitter firmware, there have been no changes to other components of the G6 CGM System (sensor/applicator, transmitter hardware, receiver, and mobile app) introduced by the modified algorithm.
5.4.2 Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System
The Dexcom G6 Glucose Program CGM System consists of three main components: the sensor/applicator delivery system, transmitter, and 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. 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. The G6 sensor life has an expected wear time of up to 10 days. Though the Dexcom G6 Glucose Program CGM System is factory calibrated and does not require user calibration, users have the option to calibrate the device when operating in factory calibration mode (using sensor code, the only mode of System). When a SMBG calibration is entered into the system, this information may be used by the system for estimating the glucose using the Bayesian Joint probability algorithm (JPA).
The proposed G6 Glucose Program CGM System is based on the same physical principles and fundamental design as the commercially available G6 Glucose Program CGM System, but it includes a modified algorithm (onboard algorithm) in the welded version of the G6 Transmitter (also named "Firefly" Transmitter in Dexcom's internal documents). The proposed algorithm is modified to improve data availability by modifications to modules that handle noise events and calibrations when applicable. Additionally, the algorithm has been modified to improve detectability of sensors approaching end of life. Except the modified transmitter firmware, the sensor/applicator, transmitter hardware, and mobile app remain unchanged.
7
5.5 Indications for Use:
5.5.1 Dexcom G6 Continuous Glucose Monitoring (CGM) System
The Dexcom G6 Continuous Glucose Monitoring System (Dexcom G6 System) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons age 2 years and older.
The Dexcom G6 System is intended to replace fingerstick blood glucose testing for diabetes treatment decisions. Interpretation of the Dexcom G6 System results should be based on the glucose trends and several sequential readings over time. The Dexcom G6 System also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments.
The Dexcom G6 System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The Dexcom G6 System can be used alone or in conjunction with these digitally connected medical devices for the purpose of managing diabetes.
5.5.2 Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) 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.
5.6 Comparison with the Predicate Device:
5.6.1 Dexcom G6 Continuous Glucose Monitoring (CGM) System
| Device | Dexcom G6 CGM System
(K191450, Predicate) | Dexcom G6 CGM System
(subject device) |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Dexcom G6 Continuous Glucose
Monitoring (CGM) System | Same |
| Device | Dexcom G6 CGM System
(K191450, Predicate) | Dexcom G6 CGM System
(subject device) |
| 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 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. | Same |
| Device | Dexcom G6 CGM System | Dexcom G6 CGM System |
| | (K191450, Predicate) | (subject device) |
| 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 |
| Data Presented | 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 three, six, twelve, or
twenty-four hours of glucose data. | Same |
| Glucose Value
Estimation
Algorithm | Joint Probability Algorithm (JPA) | Substantially Equivalent with no
adverse impact on safety or
effectiveness.
JPA was optimized to improve data
availability by better handling
calibrations when applicable.
The accuracy of the proposed G6 CGM
System was demonstrated to meet the
iCGM (21 CFR 862.1355) Special
Controls requirements (Section
20, Performance Testing - Clinical).
Dexcom conducted software
verification and validation to ensure
predefined requirements were met
(Section 16, Software Verification and
Validation Testing). |
| Device | Dexcom G6 CGM System | Dexcom G6 CGM System |
| | (K191450, Predicate) | (subject device) |
| Algorithm Self-
Diagnostics | Noise Management
Progressive Sensor Decline (PSD)
detection | Substantially Equivalent with no
adverse impact on safety or
effectiveness. |
| | | Noise Management was modified to
better handle noise events to improve
data availability while retaining the
accuracy. Additionally, progressive
sensor decline detection was
modified to improve detectability of
sensors that are approaching end of
life. |
| | | The accuracy of the proposed G6 CGM
System was demonstrated to meet the
iCGM (21 CFR 862.1355) Special
Controls requirements (Section
20, Performance Testing - Clinical).
Software verification and validation
demonstrated the proposed G6
firmware meets the predefined
requirements (Section
16, Software Verification and
Validation Testing). |
| Factory Calibration | Yes | Same |
| Optional
Calibration | Yes | Same |
| Features | Connect to Dexcom Share: Users can
share their glucose data with
followers. | Same |
| Human Factors | Easy to understand UI/UX.
Commonly understood navigation
tools and features.
Color-coded graphics. | Same |
| Compatibility with
intended
environments | Android OS and Apple iOS | Same |
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5.6.2 Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System
| Device | Dexcom G6 Glucose Program System
(K191450, Predicate) | Dexcom G6 Glucose Program System
(subject device) |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Dexcom G6 Glucose Program
Continuous Glucose Monitoring (CGM)
System | Same |
| Device | Dexcom G6 Glucose Program System
(K191450, Predicate) | Dexcom G6 Glucose Program System
(subject device) |
| 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
| 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
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 | Same |
| Device | Dexcom G6 Glucose Program System
(K191450, Predicate)
connected devices or services for the
purpose of managing diabetes. | Dexcom G6 Glucose Program System
(subject device) |
| 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 |
| Data Presented | 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 |
| Glucose Value
Estimation
Algorithm | Joint Probability Algorithm | Substantially Equivalent with no
adverse impact on safety or
effectiveness.
JPA was optimized to improve data
availability by better handling
calibrations when applicable.
The accuracy of the proposed G6 CGM
System was demonstrated to meet the
iCGM (21 CFR 862.1355) Special
Controls requirements (Section
20, Performance Testing - Clinical).
Dexcom conducted software
verification and validation to ensure
predefined requirements were met
(Section 16, Software Verification and
Validation Testing). |
| Device | Dexcom G6 Glucose Program System
(K191450, Predicate) | Dexcom G6 Glucose Program System
(subject device) |
| Algorithm Self-
Diagnostics | Noise Management
Progressive Sensor Decline (PSD)
detection | Substantially Equivalent with no
adverse impact on safety or
effectiveness.
Noise Management was modified to
better handle noise events to improve
data availability while retaining the
accuracy. Additionally, progressive
sensor decline was modified to
improve detectability of sensors
which are approaching end of life.
The accuracy of the proposed G6
CGM System was demonstrated to
meet the iCGM (21 CFR 862.1355)
Special Controls requirements
(Section 20, Performance Testing -
Clinical). Software verification and
validation demonstrated the
proposed G6 firmware meets the
predefined requirements (Section
16, Software Verification and
Validation Testing). |
| Factory Calibration | Yes | Same |
| Optional
Calibration | Yes | Same |
| Features | Connect to Dexcom Share: Users can
share their glucose data with
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.
Commonly understood navigation
tools and features.
Color-coded graphics. | Same |
| Compatibility with
intended
environments | Android OS and Apple iOS | Same |
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5.7 Technology Characteristics
The proposed Dexcom G6 CGM System and Dexcom G6 Glucose Program CGM System with modified algorithm are used to measure glucose values via an amperometric measurement of current proportional to glucose concentration in interstitial fluid via a glucose oxidase chemical reaction. The proposed Dexcom G6 CGM System and Dexcom G6 Glucose Program CGM System with modified algorithm share the same technological characteristics as the predicate device (K191450).
5.8 Summary of Performance Testing
The proposed Dexcom G6 CGM System and Dexcom G6 Glucose Program CGM System were verified and validated according to Dexcom's internal design control process and in accordance with special controls for integrated continuous glucose monitoring systems. This testing demonstrated that the proposed systems performed according to their respective specifications, and the proposed systems have met their respective technological and performance criteria, which have not changed from the predicate device (K191450).
5.9 Conclusions
The information provided in this premarket notification support that the proposed Dexcom G6 CGM System and Dexcom G6 Glucose Program CGM System are substantially equivalent to their respective predicates as they are identical with regard to intended use and indications for use and there are no differences in technological characteristics that raise different questions of safety and effectiveness.