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.

Device Description

The Dexcom G6 Continuous Glucose Monitoring 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 Dexcom 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 sensor, algorithm, receiver, and app remain unchanged, with modifications to the design of the transmitter. The proposed Dexcom G6 System is based on the same physical principles and fundamental design as the commercially-available Dexcom G6 System (DEN170088), but has modifications to physical design, software, and hardware of the transmitter. The Dexcom G6 System is designed to function as intended with either the proposed, or current G6 transmitter. The proposed G6 transmitter has the same form, fit, and function as the commercial G6 transmitter and, from the users' perspective, functions identically.

AI/ML Overview

This document is an FDA 510(k) premarket notification for the Dexcom G6 Continuous Glucose Monitoring System, focusing on a modification to the transmitter. It does not contain the detailed study information typically found in a clinical trial report or a comprehensive technical performance study. Therefore, some of the requested information, particularly quantitative results and specific methodologies for establishing ground truth, cannot be extracted from this document.

However, based on the provided text, here's what can be gathered:

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

The document states that the proposed Dexcom G6 System meets all required performance criteria for the predicate Dexcom G6 System. However, the specific acceptance criteria and the quantitative performance metrics (e.g., MARD, accuracy at different glucose ranges) are not detailed in this summary.

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

This information is not provided in the summary. The document only states that the device was "verified and validated" through performance testing.

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 summary. For continuous glucose monitoring systems, ground truth is typically established by laboratory reference methods (e.g., YSI analyzer) measuring blood glucose, not by expert review in the same way it would be for imaging diagnostics.

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

This information is not provided in the summary. Adjudication is not typically applicable in the same way for CGM performance testing where objective measurements are compared against a reference.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable here. This device is a continuous glucose monitoring system, not an AI-assisted diagnostic imaging tool that involves human readers.

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

Yes, the performance testing for a CGM system fundamentally assesses the standalone algorithm and hardware performance in measuring and reporting glucose levels. The document states: "The proposed Dexcom G6 System was 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 system performed according to its specifications and that the technological and performance criteria are comparable to the predicate device." While human users interact with the device, the core performance evaluation concerns the accuracy of the glucose readings generated by the system itself.

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

For continuous glucose monitoring systems, the ground truth is typically established by laboratory reference methods to measure blood glucose concentrations. The document does not explicitly state the method, but this is the standard for CGM validation.

8. The sample size for the training set

This information is not provided in the summary. The document describes modifications to an existing device (Dexcom G6, DEN170088) that already had its algorithm developed and validated. The current submission focuses on a new transmitter design, implying that the core algorithm trained on previous data remains largely unchanged ("The Dexcom G6 sensor, algorithm, receiver, and app remain unchanged, with modifications to the design of the transmitter").

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

This information is not provided in the summary, as the training set details for the original Dexcom G6 algorithm are not within the scope of this particular submission for a transmitter modification. However, as with point 7, it would typically involve laboratory reference methods for blood glucose determination.

Summary

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February 14, 2019

Dexcom, Inc. Bryan Osborne Specialist II. Regulatory Affairs 6310 Sequence Dr. San Diego, CA 92121

Re: K183206

Trade/Device Name: Dexcom G6 Continuous Glucose Monitoring System Regulation Number: 21 CFR 862.1355 Regulation Name: Integrated continuous glucose monitoring system Regulatory Class: Class II Product Code: QBJ Dated: November 16, 2018 Received: November 19, 2018

Dear Bryan Osborne:

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

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 -S

for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K183206

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.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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5 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: __ K183206

5.1 Submitter:

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

Contact: Bryan Osborne

Specialist, Regulatory Affairs

Phone: 858.875.9896

Fax: 858.332.0204

Email: bosborne@dexcom.com

Date Prepared:

5.2 Device Names and Classification:

Proprietary Name	Dexcom G6 Continuous Glucose Monitoring 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

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5.3 Predicate Device:

Dexcom G6 Continuous Glucose Monitoring System (DEN170088)

5.4 Device Description:

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5.5 Comparison with the Predicate Device:

Device	Dexcom G6 CGM System (subjectdevice)	Dexcom G6 CGM System (DEN170088)
Trade Name	Dexcom G6 ContinuousGlucose Monitoring System	Dexcom G6 ContinuousGlucose Monitoring System
Manufacturer	Dexcom, Inc.	Dexcom, Inc.
Indications for Use	The Dexcom G6 Continuous GlucoseMonitoring System (Dexcom G6System) is a real time, continuousglucose monitoring device indicatedfor 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 alsointended to autonomously	The Dexcom G6 Continuous GlucoseMonitoring System (Dexcom G6System) is a real time, continuousglucose monitoring device indicatedfor 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 alsointended to autonomously
	communicate 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.	communicate 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.
Clinical application	Management of diabetes mellitus	Management of diabetes mellitus
Clinical setting/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 CGM System (subjectdevice)	Dexcom G6 CGM System (DEN170088)
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 canview their previous three, six, twelve,or twenty-four hours of glucose data.	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 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.
Human Factors	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.
Compatibility withintendedenvironments	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

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5.6 Summary of Performance Testing

The proposed Dexcom G6 System was 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 system performed according to its specifications and that the technological and performance criteria are comparable to the predicate device.

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5.7 Conclusions Drawn from Performance Testing

The proposed Dexcom G6 Continuous Glucose Monitoring System is substantially equivalent to the predicate Dexcom G6 System as they are identical with regard to intended use, indications for use, and there are no differences in technological characteristics that raise different questions of safety and effectiveness. The proposed Dexcom G6 Continuous Glucose Monitoring System provides an alternative transmitter for the manufacture (Dexcom, Inc.) that meets all required performance criteria for the predicate Dexcom G6 System.

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.