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.

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.

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.

AI/ML Overview

This document is a 510(k) premarket notification for the Dexcom G6 Continuous Glucose Monitoring System and the Dexcom G6 Glucose Program Continuous Glucose Monitoring System. The notification aims to demonstrate the substantial equivalence of the modified device to its legally marketed predicate (K191450).

Key Takeaways:

Device: Dexcom G6 Continuous Glucose Monitoring System and Dexcom G6 Glucose Program Continuous Glucose Monitoring System.
Modification: Modified algorithm (onboard algorithm) in the transmitter to improve data availability by handling noise events and calibrations better, and to improve detectability of sensors approaching end of life. No changes to other components (sensor/applicator, transmitter hardware, receiver, mobile app).
Purpose: To demonstrate substantial equivalence to the predicate (K191450) despite the algorithm modification.

While the document highlights the device's intended use and compares it to a predicate device, it does not explicitly provide a table of acceptance criteria and reported device performance with specific metrics (e.g., MARD, accuracy at different glucose ranges). It states that performance testing was done but does not detail the results. Similarly, it doesn't provide information on sample sizes, ground truth establishment methods, or multi-reader studies in the format requested.

Therefore, many of the requested details cannot be extracted directly from this document. The document primarily focuses on demonstrating substantial equivalence based on the intended use and the technological characteristics remaining largely the same, with the algorithm modification being verified and validated internally.

Based on the provided text, here's what can be answered, and what cannot:

1. A table of acceptance criteria and the reported device performance:

Cannot be fully provided. The document states: "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)."
It also states regarding the algorithm modification: "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)."
However, the specific numerical acceptance criteria (e.g., a certain MARD %) and the actual reported device performance (e.g., the measured MARD) are not detailed in this summary.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Cannot be provided. The document mentions "Performance Testing - Clinical" but does not detail the sample size, data provenance, or whether the study was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable / Cannot be provided. This device is a Continuous Glucose Monitor (CGM). Its "ground truth" would typically refer to validated reference glucose measurements (e.g., YSI glucose analyzer, lab-derived plasma glucose). It does not involve human expert interpretation of images that would require multiple readers or their qualifications in the context of imaging.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable / Cannot be provided. As above, adjudication methods for expert interpretation are not relevant for a CGM's ground truth, which is based on objective glucose measurements.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is a standalone device that measures glucose, not an AI-assisted diagnostic tool that human readers would use to interpret medical images.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Yes, implicitly. The core of the device is the algorithm that converts sensor data into estimated glucose values. The document mentions "The proposed algorithm is modified to improve data availability by modifications to modules that handle noise events and calibrations when applicable." The "accuracy of the proposed G6 CGM System" was demonstrated to meet requirements. This refers to the algorithm's performance in generating glucose estimations. The device is intended to "replace fingerstick blood glucose testing for diabetes treatment decisions," implying a standalone measurement accuracy.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Implicitly, reference glucose measurements. For a CGM, the ground truth is established by highly accurate laboratory-grade glucose measurements, typically from venous blood samples analyzed by a calibrated reference method (e.g., YSI glucose analyzer). While not explicitly stated, this is the standard for CGM validation.

8. The sample size for the training set:

Cannot be provided. The document does not discuss the training set for the algorithm, only the performance testing of the final modified algorithm.

9. How the ground truth for the training set was established:

Cannot be provided. As with point 8, the document does not detail the training process or the establishment of ground truth for the training data.

Summary

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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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

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

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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.

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."

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Indications for Use

510(k) Number (if known) K200876

Device Name

Dexcom G6 Glucose Program Continuous Glucose Monitoring System

Indications for Use (Describe)

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.

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."

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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: 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
ClassificationRegulation	21 CFR 862.1355
Product Code	QBJ
Review Panel	Clinical Chemistry

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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

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5.4.2 Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System

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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.

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.

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 GlucoseMonitoring (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/sitesof use	Home use	Same
Principle ofOperation	Amperometric measurement ofcurrent proportional to glucoseconcentration in interstitial fluid viaglucose oxidase chemical reaction	Same
Data Presented	Estimated Glucose Value (EGV): TheEGV is the nominal glucose valuepresented to the user.Glucose Trend: Based off the glucoserate of change, users are shown theirglucose trend with a correspondingarrow.Historical Glucose Data: Users can viewtheir previous three, six, twelve, ortwenty-four hours of glucose data.	Same
Glucose ValueEstimationAlgorithm	Joint Probability Algorithm (JPA)	Substantially Equivalent with noadverse impact on safety oreffectiveness.JPA was optimized to improve dataavailability by better handlingcalibrations when applicable.The accuracy of the proposed G6 CGMSystem was demonstrated to meet theiCGM (21 CFR 862.1355) SpecialControls requirements (Section20, Performance Testing - Clinical).Dexcom conducted softwareverification and validation to ensurepredefined requirements were met(Section 16, Software Verification andValidation Testing).
Device	Dexcom G6 CGM System	Dexcom G6 CGM System
	(K191450, Predicate)	(subject device)
Algorithm Self-Diagnostics	Noise ManagementProgressive Sensor Decline (PSD)detection	Substantially Equivalent with noadverse impact on safety oreffectiveness.
		Noise Management was modified tobetter handle noise events to improvedata availability while retaining theaccuracy. Additionally, progressivesensor decline detection wasmodified to improve detectability ofsensors that are approaching end oflife.
		The accuracy of the proposed G6 CGMSystem was demonstrated to meet theiCGM (21 CFR 862.1355) SpecialControls requirements (Section20, Performance Testing - Clinical).Software verification and validationdemonstrated the proposed G6firmware meets the predefinedrequirements (Section16, Software Verification andValidation Testing).
Factory Calibration	Yes	Same
OptionalCalibration	Yes	Same
Features	Connect to Dexcom Share: Users canshare their glucose data withfollowers.	Same
Human Factors	Easy to understand UI/UX.Commonly understood navigationtools and features.Color-coded graphics.	Same
Compatibility withintendedenvironments	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 ProgramContinuous 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 glucosemonitoring system (iCGM) is intendedto automatically measure glucose inbodily fluids continuously or frequentlyfor a specified period of time. iCGMsystems are designed to reliably andsecurely transmit glucose	Same
Indications for Use	The Dexcom G6 Glucose ProgramContinuous Glucose MonitoringSystem (Dexcom Glucose ProgramSystem) is a real time, continuousglucose monitoring device indicatedfor the management of diabetes inpersons age 2 years and older.The Dexcom Glucose Program Systemis intended to replace fingerstick bloodglucose testing for diabetes treatmentdecisions for persons with diabeteswho are not at significant risk of severehypoglycemia. Interpretation of theDexcom Glucose Program Systemresults should be based on the glucosetrends and several sequential sensorreadings over time. The DexcomGlucose Program System also aids inthe detection of episodes ofhyperglycemia and hypoglycemia,facilitating long-term therapyadjustments.The Dexcom Glucose Program Systemis also intended to autonomouslycommunicate with digitally connecteddevices. The Dexcom Glucose ProgramSystem can be used alone or inconjunction with these digitally	Same
Device	Dexcom G6 Glucose Program System(K191450, Predicate)connected devices or services for thepurpose of managing diabetes.	Dexcom G6 Glucose Program System(subject device)
Clinical application	Management of diabetes mellitus	Same
Clinical setting/sitesof use	Home use	Same
Principle ofOperation	Amperometric measurement ofcurrent proportional to glucoseconcentration in interstitial fluid viaglucose oxidase chemical reaction	Same
Data Presented	Estimated Glucose Value (EGV): TheEGV is the nominal glucose valuepresented to the user.Glucose Trend: Based off the glucoserate of change, users are shown theirglucose trend with a correspondingarrow.Historical Glucose Data: Users can viewtheir previous six, or twelve hours ofglucose data on a graph with high/lowglucose thresholds.Time in Range: Users can view thepercent of time they spend in theirtarget glucose range based on theirconfigured high/low glucosethresholds.	Same
Glucose ValueEstimationAlgorithm	Joint Probability Algorithm	Substantially Equivalent with noadverse impact on safety oreffectiveness.JPA was optimized to improve dataavailability by better handlingcalibrations when applicable.The accuracy of the proposed G6 CGMSystem was demonstrated to meet theiCGM (21 CFR 862.1355) SpecialControls requirements (Section20, Performance Testing - Clinical).Dexcom conducted softwareverification and validation to ensurepredefined requirements were met(Section 16, Software Verification andValidation Testing).
Device	Dexcom G6 Glucose Program System(K191450, Predicate)	Dexcom G6 Glucose Program System(subject device)
Algorithm Self-Diagnostics	Noise ManagementProgressive Sensor Decline (PSD)detection	Substantially Equivalent with noadverse impact on safety oreffectiveness.Noise Management was modified tobetter handle noise events to improvedata availability while retaining theaccuracy. Additionally, progressivesensor decline was modified toimprove detectability of sensorswhich are approaching end of life.The accuracy of the proposed G6CGM System was demonstrated tomeet the iCGM (21 CFR 862.1355)Special Controls requirements(Section 20, Performance Testing -Clinical). Software verification andvalidation demonstrated theproposed G6 firmware meets thepredefined requirements (Section16, Software Verification andValidation Testing).
Factory Calibration	Yes	Same
OptionalCalibration	Yes	Same
Features	Connect to Dexcom Share: Users canshare their glucose data withfollowers.Chat with Wellness Coach: Users canchat with a third-party wellness coachfor encouragement, education, andmotivation regarding their diabetesmanagement.	Same
Human Factors	Easy to understand UI/UX.Commonly understood navigationtools and features.Color-coded graphics.	Same
Compatibility withintendedenvironments	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.

Regulation Number and Section

§ 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.