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.

The Dexcom Pro Q Continuous Glucose Monitoring System (Dexcom Pro Q System) is a factory calibrated continuous glucose recording device indicated for the retrospective discovery, analysis, and interpretation of glycemic variability in persons age 2 years and older under the supervision of a healthcare professional. The Dexcom Pro Q System collects and processes data for aiding in the management of a disease or condition related to glycemic control. Interpretation of the data recorded by the Dexcom Pro Q System results should be made only by a qualified healthcare professional based on glucose trends and several sequential readings over time. The Dexcom Pro Q System aids in detecting glucose excursions facilitating care plan adjustments. The Dexcom Pro Q System is also intended to interface with digitally connected devices.

Device Description

The Dexcom G6 Continuous Glucose Monitoring System (Dexcom G6 System) consists of three main components: a sensor, 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 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 receiver and/or mobile app which displays the current glucose reading (updated every 5 minutes) and glucose trends (up to 12 hours) from the transmitter. The G6 System does not require calibrations using SMBG, and the sensor life has an expected wear time of up to 10 days. The receiver and/or mobile app displays the current glucose reading and glucose trends to the user. It alerts the user when glucose levels are outside of a target zone and when other important system conditions occur.

The Dexcom G6 Glucose Program Continuous Glucose Monitoring System (Dexcom Glucose Program System) is a continuous glucose monitor (CGM) that offers an altered feature set versus the Dexcom G6 CGM System. The Dexcom Glucose Program System consists of three main components: a sensor/applicator delivery system, a transmitter, and a mobile application (app). The sensor is a small and flexible wire inserted into subcutaneous tissue where it converts glucose into electrical current. The transmitter is connected to the sensor and is worn on the body. It samples the electrical current produced by the sensor and converts these measurements into glucose readings using an onboard algorithm. The transmitter sends glucose data to the app. The app displays the current glucose reading (updated every 5 minutes) and glucose trends (up to 12 hours) from the transmitter. The app alerts users of important system conditions, when it enters an error state, or when it requires the user to enter information. The app also supports connectivity to Dexcom Share and Follow (DEN140016).

The Dexcom Pro Q Continuous Glucose Monitoring System (Dexcom Pro Q System) is a continuous glucose monitor that offers an altered feature set versus the Dexcom G6 CGM System. The Dexcom Pro Q System consists of two main components: a sensor/applicator delivery system and a transmitter. 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 logs estimated glucose values every 5 minutes during the sensor wear period (up to 10 days).

The proposed Dexcom G6 System, Dexcom G6 Glucose Program System, and Dexcom Pro Q System are based on the same physical principles and fundamental design as the predicate for each respective System but includes an alternative adhesive patch. The adhesive patch adheres the transmitter wearable to the user's body. The Dexcom G6 System, Dexcom G6 Glucose Program System, and the Dexcom Pro Q System are designed to function as intended with either the proposed or current adhesive patch. The proposed adhesive patch has the same form, fit, and function as the commercial adhesive patch and, from the users' perspective, functions identically.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Dexcom G6 Glucose Program Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System (a repeated entry, likely an error in the original document format), and Dexcom Pro Q Continuous Glucose Monitoring System. The purpose of this submission is to demonstrate substantial equivalence to previously cleared predicate devices, specifically the Dexcom G6 Continuous Glucose Monitoring (CGM) System (K183206), Dexcom G6 Glucose Program Continuous Glucose Monitoring System (K182041), and Dexcom Pro Q Continuous Glucose Monitoring System (K182405).

The document states that the only modification in the proposed devices compared to their respective predicates is an alternative adhesive patch (MA-91 patch vs. Dermamed patch). It explicitly mentions that the proposed systems are based on the "same physical principles and fundamental design" and that their "technological and performance criteria have not changed from the predicate devices."

Therefore, the acceptance criteria and study information would predominantly refer to the performance of the predicate device (or the device with the original adhesive), focusing on the impact of the new adhesive. However, this document does not contain detailed primary performance data, acceptance criteria, or study specifics (like sample sizes, ground truth establishment, or expert qualifications) for the glucose monitoring functionality itself. It only states that the systems were "verified and validated according to Dexcom's internal design control process and in accordance with special controls for integrated continuous glucose monitors," and that "This testing demonstrated that the proposed systems performed according to their respective specifications."

Given the limited information in this document, I can only address some of your questions based on what is provided:

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

This document does not provide a table of acceptance criteria for glucose accuracy (e.g., MARD values, Clarke Error Grid analysis) or device performance metrics for the glucose monitoring function. It only states that the devices met their "respective specifications" and that "technological and performance criteria ... have not changed from the predicate devices."

The primary change being submitted for K191450 is a new adhesive patch. Therefore, the "acceptance criteria" for this specific submission would likely revolve around the safety and efficacy of the new adhesive patch (e.g., biocompatibility, adhesion strength, skin irritation). However, these specific criteria and their performance results are not detailed in this document.

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

The document does not explicitly state the sample size for any clinical or performance test set, nor does it specify the data provenance (country, retrospective/prospective). It generally refers to "performance testing" and "verification and validation" without providing these details.

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)

This information is not provided in the document. For glucose monitoring devices, ground truth is typically established using laboratory reference methods (e.g., YSI analyzer for blood glucose), not expert consensus.

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

This information is not applicable and not provided. Adjudication methods like 2+1 are typically used in imaging studies where human readers interpret medical images. Glucose monitoring accuracy studies compare device readings to a reference method.

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

MRMC studies and human reader improvement are not applicable to this type of device (continuous glucose monitor). The Dexcom G6 systems are medical devices that measure physiological parameters, not AI interpretation aids for human readers.

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

The Dexcom G6 systems are standalone in the sense that they continuously measure and report glucose values via an onboard algorithm. The document mentions the transmitter "samples the electrical current ... and converts these measurements into glucose readings using an onboard algorithm." This implies a standalone algorithmic performance for glucose measurement. However, specific details of this standalone performance (e.g., MARD values, accuracy metrics) are not provided in this document, as it mainly focuses on the change in adhesive and substantial equivalence to existing predicates.

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

For continuous glucose monitors, the ground truth for accuracy studies is typically established using a laboratory reference method for blood glucose, such as a YSI glucose analyzer, which provides highly accurate blood glucose measurements. This document does not explicitly state the ground truth method, but this is the standard for CGM validation.

8. The sample size for the training set

The document does not mention any training sets or their sample sizes for the glucose monitoring algorithm. This submission is for devices substantially equivalent to already cleared predicates, and the core algorithm's development and initial training information would have been part of previous submissions (K183206, K182041, K182405).

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

As above, this information is not provided in the document. If an algorithm training set were used for the underlying glucose measurement technology, the ground truth would typically be established using a laboratory reference method for blood glucose.

Summary of what the document does provide regarding acceptance/testing:

Change: The primary change for this 510(k) is the use of an "alternative adhesive patch" (MA-91 patch) instead of the previous "Dermamed patch."
Performance Claim: The document asserts that the proposed systems (with the new adhesive) "performed according to their respective specifications" and that "technological and performance criteria which have not changed from the predicate devices."
Validation: It states that validation was done "according to Dexcom's internal design control process and in accordance with special controls for integrated continuous glucose monitors."
Scope: The focus of this particular 510(k) is heavily on demonstrating that the new adhesive patch does not negatively impact the safety and effectiveness of the device, implying that the underlying glucose monitoring performance is unchanged from the predicates.

Summary

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June 28, 2019

Dexcom, Inc. Emily Chung Senior Specialist, Regulatory Affairs 6310 Sequence Dr. San Diego, CA 92121

Re: K191450

Trade/Device Name: Dexcom G6 Glucose Program Continuous Glucose Monitoring System Dexcom G6 Glucose Program Continuous Glucose Monitoring System Dexcom Pro Q Continuous Glucose Monitoring System Regulation Number: 21 CFR 862.1355 Regulation Name: Integrated Continuous Glucose Monitoring System Regulatory Class: Class II Product Code: QBJ, QDK, QDL Dated: May 30, 2019 Received: May 31, 2019

Dear Emily Chung:

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. Acting 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) K191450

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 several sequential readings over time. The Dexcom G6 System also aids in the detection of episodes 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)

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Indications for Use

510(k) Number (if known) K191450

Device Name

Dexcom G6 Glucose Program Continuous Glucose Monitoring System

Indications for Use (Describe)

The Dexcom G6 Glucose Program Continuous Glucose Monitoring System Glucose Program System) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons 2 years and older.

The Dexcom Glucose Program System is intended to replace fingerstick blood glucose testing for diabetes treatment decisions for persons with diabetes who are not at significant risk of severe hypoglycemia. Interpretation of the Dexcom Glucose Program System results should be based on the glucose trends and several sequential readings over time. The Dexcom Glucose Program System also aids in the detection of episodes of hyperglycemia, facilitating long-term therapy adjustments.

The Dexcom Glucose Program System is also intended to autonomously communicate with digitally connected devices. The Dexcom Glucose Program System can be used alone or in conjunction with these digitally connected devices or services for the purpose of managing diabetes.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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) K191450

Device Name

Dexcom Pro Q Continuous Glucose Monitoring System

Indications for Use (Describe)

Interpretation of the data recorded by the Dexcom Pro Q System results should be made only by a qualified healthcare professional based on glucose trends and several sequential readings over time. The Dexcom Pro Q System aids in detecting glucose excursions facilitating care plan adjustments. The Dexcom Pro Q System is also interface with digitally connected devices.

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.

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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This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

The assigned 510(k) number is:

6.1 Submitter:

Dexcom, Inc. 6340 Sequence Dr. San Diego, CA 92121

Contact: Emily Chung Senior Specialist, Regulatory Affairs Phone: 858.529.4737 Fax: 858.332.0204 echung@dexcom.com Email:

Secondary

Contact: Holly Drake Senior Manager, Regulatory Affairs Phone: Phone: Phone: 858.875.5326 Fax: 858.332.0204 Email: hdrake@dexcom.com

Date Prepared:

6.2 Device Names and Classification:

Predicate Device
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

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Review Panel	Clinical Chemistry
Other Devices
Proprietary Name	Dexcom G6 Glucose Program Continuous GlucoseMonitoring System
Class	II
Classification Regulation	21 CFR 862.1355
Product Code	QDK
Proprietary Name	Dexcom Pro Q Continuous Glucose Monitoring System
Class	II
Classification Regulation	21 CFR 862.1355
Product Code	QDL

6.3 Predicate Device:

Dexcom G6 Continuous Glucose Monitoring (CGM) System (K183206) Dexcom G6 Glucose Program Continuous Glucose Monitoring System (K182041) Dexcom Pro Q Continuous Glucose Monitoring System (K182405)

6.4 Device Description:

6.4.1 Dexcom G6 Continuous Glucose Monitoring (CGM) System

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6.4.2 Dexcom G6 Glucose Program Continuous Glucose Monitoring System

The Dexcom Glucose Program System consists of three main components: a sensor/applicator delivery system, a transmitter, and a mobile application (app). The sensor is a small and flexible wire inserted into subcutaneous tissue where it converts glucose into electrical current. The transmitter is connected to the sensor and is worn on the body. It samples the electrical current produced by the sensor and converts these measurements into glucose readings using an onboard algorithm. The transmitter sends glucose data to the app. The app displays the current glucose reading (updated every 5 minutes) and glucose trends (up to 12 hours) from the transmitter. The app alerts users of important system conditions, when it enters an error state, or when it requires the user to enter information. The app also supports connectivity to Dexcom Share and Follow (DEN140016).

6.4.3 Dexcom Pro Q Continuous Glucose Monitoring System

The Dexcom Pro Q Continuous Glucose Monitoring System (Dexcom Pro Q System) is a continuous glucose monitor that offers an altered feature set versus the Dexcom G6 CGM System.

The Dexcom Pro Q System consists of two main components: a sensor/applicator delivery system and a transmitter. 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 logs estimated glucose values every 5 minutes during the sensor wear period (up to 10 days).

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6.5 INDICATIONS FOR USE

6.5.1 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.

6.5.2 Dexcom G6 Glucose Program Continuous Glucose Monitoring System

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.

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6.5.3 Dexcom Pro Q Continuous Glucose Monitoring System

୧.୧ Comparison with the Predicate Device:

6.6.1 Dexcom G6 Continuous Glucose Monitoring (CGM) System

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6.6.2 Dexcom G6 Glucose Program Continuous Glucose Monitoring System

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6.6.3 Dexcom Pro Q Continuous Glucose Monitoring System

Device	Dexcom Pro Q System (subject device,K191450)	Dexcom Pro Q System (K182405)
Trade Name	Dexcom Pro Q Continuous GlucoseMonitoring System	Dexcom Pro Q Continuous GlucoseMonitoring System
Manufacturer	Dexcom, Inc.	Dexcom, Inc.
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 glucosemeasurement data to digitallyconnected devices, includingautomated insulin dosing systems, andare intended to be used alone or inconjunction with these digitallyconnected medical devices for thepurpose of managing a disease orcondition related to glycemic control.	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 glucosemeasurement data to digitallyconnected devices, includingautomated insulin dosing systems, andare intended to be used alone or inconjunction with these digitallyconnected medical devices for thepurpose of managing a disease orcondition related to glycemic control.
Indications forUse	The Dexcom Pro Q Continuous GlucoseMonitoring System (Dexcom Pro QSystem) is a factory calibratedcontinuous glucose recording deviceindicated for the retrospectivediscovery, analysis, and interpretationof glycemic variability in persons age 2years and older under the supervisionof a healthcare professional. TheDexcom Pro Q System collects andprocesses data for aiding in themanagement of a disease or conditionrelated to glycemic control.Interpretation of the data recorded bythe Dexcom Pro Q System resultsshould be made only by a qualifiedhealthcare professional based onglucose trends and several sequentialreadings over time. The Dexcom Pro QSystem aids in detecting glucoseexcursions facilitating care planadjustments. The Dexcom Pro QSystem is also intended to interfacewith digitally connected devices.	The Dexcom Pro Q Continuous GlucoseMonitoring System (Dexcom Pro QSystem) is a factory calibratedcontinuous glucose recording deviceindicated for the retrospectivediscovery, analysis, and interpretationof glycemic variability in persons age 2years and older under the supervisionof a healthcare professional. TheDexcom Pro Q System collects andprocesses data for aiding in themanagement of a disease or conditionrelated to glycemic control.Interpretation of the data recorded bythe Dexcom Pro Q System resultsshould be made only by a qualifiedhealthcare professional based onglucose trends and several sequentialreadings over time. The Dexcom Pro QSystem aids in detecting glucoseexcursions facilitating care planadjustments. The Dexcom Pro QSystem is also intended to interfacewith digitally connected devices.
Clinicalapplication	Management of a disease or conditionrelated to glycemic control	Management of a disease or conditionrelated to glycemic control
Device	Dexcom Pro Q System (subject device,K191450)	Dexcom Pro Q System (K182405)
Clinicalsetting/sitesof use	Home use (sensor insertion andinterpretation of retrospective glucosedata occurs in clinic with a healthcareprofessional)	Home use (sensor insertion andinterpretation of retrospective glucosedata occurs in clinic with a healthcareprofessional)
Principle ofOperation	Amperometric measurement of currentproportional to glucose concentrationin interstitial fluid via glucose oxidasechemical reaction.	Amperometric measurement of currentproportional to glucose concentrationin interstitial fluid via glucose oxidasechemical reaction
DataPresented	Estimated Glucose Value (EGV): TheEGV is the nominal glucose valuepresented to the user and healthcareprofessional after the sensor session.Historical Glucose Data: The glucosedata collected throughout the entirewear-period is presented to the userand healthcare professional after thesensor session.	Estimated Glucose Value (EGV): TheEGV is the nominal glucose valuepresented to the user and healthcareprofessional after the sensor session.Historical Glucose Data: The glucosedata collected throughout the entirewear-period is presented to the userand healthcare professional after thesensor session.
Features	Analysis with a healthcareprofessional: Healthcare professionalscan view the user's glucose datacollected across the entire sensorsession I to aid in the management of adisease or condition related to glycemiccontrol.	Analysis with a healthcareprofessional: Healthcare professionalscan view the user's glucose datacollected across the entire sensorsession I to aid in the management of adisease or condition related to glycemiccontrol.
Compatibilitywith intendedenvironments	Compatible authorized extractiondevice.	Compatible authorized extractiondevice.
AdhesivePatch	MA-91 patch	Dermamed patch

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Technological Characteristics 6.7

The proposed Dexcom G6 System, Dexcom G6 Glucose Program System, and Dexcom Pro Q System are used to measure glucose values via amperometric measurement of current proportional to glucose concentration in interstitial fluid via glucose oxidase chemical reaction. The proposed Dexcom G6 System, Dexcom G6 Glucose Program System, and Dexcom Pro Q System share the same technological characteristics as their respective predicates (K183206, K182041, K182405).

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6.8 Summary of Performance Testing

The proposed Dexcom G6 System, Dexcom G6 Glucose Program System, and Dexcom Pro Q System were verified and validated according to Dexcom's internal design control process and in accordance with special controls for integrated continuous glucose monitors. 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 devices.

6.9 Conclusions

The proposed Dexcom G6 System, Dexcom G6 Glucose Program System, and Dexcom Pro Q 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.

Device	Dexcom G6 CGM System (subjectdevice, K191450)	Dexcom G6 CGM System (K183206)
Trade Name	Dexcom G6 Continuous GlucoseMonitoring (CGM) System	Dexcom G6 Continuous GlucoseMonitoring (CGM) System
Manufacturer	Dexcom, Inc.	Dexcom, Inc.
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 glucosemeasurement data to digitallyconnected devices, includingautomated insulin dosing systems, andare intended to be used alone or inconjunction with these digitallyconnected medical devices for thepurpose of managing a disease orcondition related to glycemic control.	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 glucosemeasurement data to digitallyconnected devices, includingautomated insulin dosing systems, andare intended to be used alone or inconjunction with these digitallyconnected medical devices for thepurpose of managing a disease orcondition related to glycemic control.
Indications forUse	The Dexcom G6 Continuous GlucoseMonitoring System (Dexcom G6System) is a real time, continuousglucose monitoring device indicated	The Dexcom G6 Continuous GlucoseMonitoring System (Dexcom G6System) is a real time, continuousglucose monitoring device indicated
Device	Dexcom G6 CGM System (subjectdevice, K191450)	Dexcom G6 CGM System (K183206)
	for the management of diabetes inpersons age 2 years and older.	for the management of diabetes inpersons age 2 years and older.
	The Dexcom G6 System is intended toreplace fingerstick blood glucosetesting for diabetes treatmentdecisions. Interpretation of theDexcom G6 System results should bebased on the glucose trends andseveral sequential readings over time.The Dexcom G6 System also aids in thedetection of episodes of hyperglycemiaand hypoglycemia, facilitating bothacute and long-term therapyadjustments.	The Dexcom G6 System is intended toreplace fingerstick blood glucosetesting for diabetes treatmentdecisions. Interpretation of theDexcom G6 System results should bebased on the glucose trends andseveral sequential readings over time.The Dexcom G6 System also aids in thedetection of episodes of hyperglycemiaand hypoglycemia, facilitating bothacute and long-term therapyadjustments.
	The Dexcom G6 System is alsointended to autonomouslycommunicate with digitally connecteddevices, including automated insulindosing (AID) systems. The Dexcom G6System can be used alone or inconjunction with these digitallyconnected medical devices for thepurpose of managing diabetes.	The Dexcom G6 System is alsointended to autonomouslycommunicate with digitally connecteddevices, including automated insulindosing (AID) systems. The Dexcom G6System can be used alone or inconjunction with these digitallyconnected medical devices for thepurpose of managing diabetes.
Clinicalapplication	Management of diabetes mellitus	Management of diabetes mellitus
Clinicalsetting/sitesof use	Home use	Home use
Principle ofOperation	Amperometric measurement ofcurrent proportional to glucoseconcentration in interstitial fluid viaglucose oxidase chemical reaction.	Amperometric measurement ofcurrent proportional to glucoseconcentration in interstitial fluid viaglucose oxidase chemical reaction.
DataPresented	Estimated Glucose Value (EGV): TheEGV is the nominal glucose valuepresented to the user.	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.	Glucose Trend: Based off the glucoserate of change, users are shown theirglucose trend with a correspondingarrow.
	Historical Glucose Data: Users canview their previous three, six, twelve,or twenty-four hours of glucose data.	Historical Glucose Data: Users canview their previous three, six, twelve,or twenty-four hours of glucose data.
Features	Connect to Dexcom Share: Users canshare their glucose data with up to fivefollowers.	Connect to Dexcom Share: Users canshare their glucose data with up to fivefollowers.
Device	Dexcom G6 CGM System (subjectdevice, K191450)	Dexcom G6 CGM System (K183206)
HumanFactors	Easy to understand UI/UX.Commonly understood navigationtools and features.Color-coded graphics.	Easy to understand UI/UX.Commonly understood navigationtools and features.Color-coded graphics.
Compatibilitywith intendedenvironments	iPhone 4S- iPhone X, Google Pixel,Google Pixel 2, Samsung Galaxy Note5, Samsung Galaxy Note 8, SamsungGalaxy S6, Samsung Galaxy S6 Edge,Samsung Galaxy S7, Samsung GalaxyS7 Edge, Samsung Galaxy S8, SamsungGalaxy S8 Plus, Samsung Galaxy S9,Samsung Galaxy S9+, Samsung GalaxyJ3 [SM-J327 models only, including J3Eclipse, J3 Emerge, J3 Prime, ExpressPrime 2, Amp Prime 2], LG G5, LG G6Compatible with Android OS version7.0 and above, and iOS version 10.3.2and above.	iPhone 4S- iPhone X, Google Pixel,Google Pixel 2, Samsung Galaxy Note 5,Samsung Galaxy Note 8, SamsungGalaxy S6, Samsung Galaxy S6 Edge,Samsung Galaxy S7, Samsung GalaxyS7 Edge, Samsung Galaxy S8, SamsungGalaxy S8 Plus, Samsung Galaxy S9,Samsung Galaxy S9+, Samsung GalaxyJ3 [SM-J327 models only, including J3Eclipse, J3 Emerge, J3 Prime, ExpressPrime 2, Amp Prime 2], LG G5, LG G6Compatible with Android OS version7.0 and above, and iOS version 10.3.2and above.
AdhesivePatch	MA-91 patch	Dermamed patch

Device	Dexcom G6 Glucose Program System(subject device, K191450)	Dexcom G6 Glucose Program System(K182041)
Trade Name	Dexcom G6 Glucose ProgramContinuous Glucose Monitoring (CGM)System	Dexcom G6 Glucose ProgramContinuous Glucose Monitoring (CGM)System
Manufacturer	Dexcom, Inc.	Dexcom, Inc.
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 glucosemeasurement data to digitallyconnected devices, including	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 glucosemeasurement data to digitallyconnected devices, including
Device	Dexcom G6 Glucose Program System(subject device, K191450)	Dexcom G6 Glucose Program System(K182041)
	automated insulin dosing systems, andare intended to be used alone or inconjunction with these digitallyconnected medical devices for thepurpose of managing a disease orcondition related to glycemic control.	automated insulin dosing systems, andare intended to be used alone or inconjunction with these digitallyconnected medical devices for thepurpose of managing a disease orcondition related to glycemic control.
Indications forUse	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 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 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 digitallyconnected devices or services for thepurpose of managing diabetes.	The Dexcom Glucose Program Systemis also intended to autonomouslycommunicate with digitally connecteddevices. The Dexcom Glucose ProgramSystem can be used alone or inconjunction with these digitallyconnected devices or services for thepurpose of managing diabetes.
Clinicalapplication	Management of diabetes mellitus	Management of diabetes mellitus
Clinicalsetting/sitesof use	Home use	Home use
Principle ofOperation	Amperometric measurement ofcurrent proportional to glucoseconcentration in interstitial fluid viaglucose oxidase chemical reaction	Amperometric measurement ofcurrent proportional to glucoseconcentration in interstitial fluid viaglucose oxidase chemical reaction
Device	Dexcom G6 Glucose Program System(subject device, K191450)	Dexcom G6 Glucose Program System(K182041)
DataPresented	Estimated Glucose Value (EGV): TheEGV is the nominal glucose valuepresented to the user.	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.	Glucose Trend: Based off the glucoserate of change, users are shown theirglucose trend with a correspondingarrow.
	Historical Glucose Data: Users canview their previous six, or twelve hoursof glucose data on a graph withhigh/low glucose thresholds.	Historical Glucose Data: Users canview their previous six, or twelve hoursof glucose data on a graph withhigh/low glucose thresholds.
	Time in Range: Users can view thepercent of time they spend in theirtarget glucose range based on theirconfigured high/low glucosethresholds.	Time in Range: Users can view thepercent of time they spend in theirtarget glucose range based on theirconfigured high/low glucosethresholds.
Features	Connect to Dexcom Share: Users canshare their glucose data with up tothree followers.	Connect to Dexcom Share: Users canshare their glucose data with up tothree followers.
	Chat with Wellness Coach: Users canchat with a third-party wellness coachfor encouragement, education, andmotivation regarding their diabetesmanagement.	Chat with Wellness Coach: Users canchat with a third-party wellness coachfor encouragement, education, andmotivation regarding their diabetesmanagement.
HumanFactors	Easy to understand UI/UX.	Easy to understand UI/UX.
	Commonly understood navigationtools and features.	Commonly understood navigationtools and features.
	Color-coded graphics.	Color-coded graphics.
Compatibilitywith intendedenvironments	Compatible with the Samsung J3	Compatible with the Samsung J3
	Compatible with Android OS version7.0 and above	Compatible with Android OS version7.0 and above
AdhesivePatch	MA-91 patch	Dermamed patch