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.

Device Description

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 mobile application.

The proposed Dexcom G6 Glucose Program System is based on the same physical principles and fundamental design as the predicate system but includes an alternative, ultrasonic-welded transmitter. The transmitter attaches to the sensor wearable which is adhered to the user's body. The Dexcom G6 Glucose Program System is designed to function as intended with either the proposed or predicate transmitter (K191450). The proposed transmitter has the same form, fit, and function as the predicate transmitter (K191450) and, from the users' perspective, functions identically.

AI/ML Overview

This is a 510(k) premarket notification for the Dexcom G6 Glucose Program Continuous Glucose Monitoring System. The manufacturer, Dexcom, Inc., is seeking to market a device that is substantially equivalent to a legally marketed predicate device. The primary change in the new device is the inclusion of an alternative, ultrasonic-welded transmitter.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

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

The provided document does not explicitly present a table of acceptance criteria and reported device performance in the format of a clinical study summary with specific numerical endpoints and their corresponding achieved values. Instead, it states that:

"The proposed Dexcom G6 Glucose Program System was verified and validated according to Dexcom's internal design control process and in accordance with special controls for integrated continuous glucose monitors. Performance testing and software verification and validation testing was completed for the proposed transmitter. To validate the design of the proposed transmitter firmware with the predicate Glucose Program Mobile App, system integration testing was completed to ensure system level and display requirements remain fulfilled."

This implies that the acceptance criteria are met through verification and validation activities aligned with the stated standards and internal processes, but the specific performance metrics (e.g., MARD, accuracy at different glucose levels) are not detailed in this summary. The substantial equivalence argument relies on the fact that the hardware change (transmitter) does not impact the core performance.

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 specify the sample size used for the test set or the data provenance (country of origin, retrospective/prospective). The testing described focuses on "performance testing and software verification and validation testing" for the new transmitter and "system integration testing" with the existing mobile app. This suggests technical validation rather than a clinical trial with a patient test set for performance comparison.

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. Given the nature of a Continuous Glucose Monitoring (CGM) system, the "ground truth" for glucose measurements is typically established using a laboratory reference method (e.g., YSI analyzer for blood glucose), not expert consensus from medical professionals.

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

The document does not mention any adjudication method. This type of adjudication is typically used in clinical studies where expert review is required for endpoints, which is not directly applicable to the performance evaluation of a CGM system's glucose readings in the same way as, for example, image interpretation.

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 to this device. The Dexcom G6 is a Continuous Glucose Monitoring system that provides direct glucose readings and trends; it is not an AI-assisted diagnostic device that requires human interpretation in the same manner as a radiological imaging system. Therefore, the concept of "human readers improving with AI vs without AI assistance" does not apply here.

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

Yes, the core performance of the Dexcom G6 system, which includes the algorithm's ability to convert sensor signals into glucose readings, is fundamentally a standalone (algorithm only) performance evaluation. The document states: "The proposed Dexcom G6 Glucose Program System is used to measure glucose values via amperometric measurement of current proportional to glucose concentration in interstitial fluid via a glucose oxidase chemical reaction." and "The transmitter... converts these measurements into glucose readings using an onboard algorithm." The "performance testing" mentioned validates this standalone function.

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

While not explicitly stated in this summary, for Continuous Glucose Monitoring (CGM) systems, the ground truth for performance testing (e.g., accuracy against reference values) is typically established by laboratory reference methods for blood glucose, such as a YSI glucose analyzer, which measures glucose concentrations in blood samples.

8. The sample size for the training set

The document does not provide information on the sample size for the training set. This is a 510(k) submission for a modification (new transmitter) to an already cleared device, not an initial submission for a novel algorithm where training set details would be more prominently discussed. The original Dexcom G6 system would have undergone extensive training and validation.

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

The document does not provide details on how the ground truth for the training set was established. Similar to the test set, it would have involved laboratory reference methods for glucose measurement during the development of the original Dexcom G6 algorithm.

Summary

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October 25, 2019

Dexcom, Inc. Bryan Osborne Specialist, Regulatory Affairs 6340 Sequence Dr. San Diego, CA 92121

Re: K192787

Trade/Device Name: Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System Regulation Number: 21 CFR 862.1355 Regulation Name: Integrated continuous glucose monitoring system Regulatory Class: Class II Product Code: QDK Dated: September 26, 2019 Received: September 30, 2019

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

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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 mediation-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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K192787

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)

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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: Bryan Osborne Specialist, Regulatory Affairs Phone: 858.875.9896 Fax: 858.332.0204 bosborne@dexcom.com Email:

Secondary

Contact: Kiley Hubert Sr. Manager, Regulatory Affairs Phone: Phone: Phone: 858.875.9770 Fax: 858.332.0204 Email: khubert@dexcom.com

Date Prepared: September 26, 2019

6.2 Device Names and Classification:

Predicate Device
Proprietary Name	Dexcom G6 Glucose Program Continuous GlucoseMonitoring (CGM) System
Common Name	Integrated Continuous Glucose Monitoring System,Factory Calibrated
Class	II
Classification Regulation	21 CFR 862.1355
Product Code	QDK

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Review Panel	Clinical Chemistry
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6.3 Predicate Device:

Dexcom G6 Glucose Program Continuous Glucose Monitoring System (K191450)

6.4 Device Description:

6.4.1 Dexcom G6 Glucose Program Continuous Glucose Monitoring System

6.5 Indications for Use

6.5.1 Dexcom G6 Glucose Program Continuous Glucose Monitoring 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.

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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.

6.6 Comparison with the Predicate Device:

Device	Dexcom G6 Glucose Program System(predicate device; K191450)	Dexcom G6 Glucose ProgramSystem (subject device)
Trade Name	Dexcom G6 Glucose ProgramContinuous Glucose Monitoring (CGM)System	Same
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 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.	Same
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 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 System	Same
Device	Dexcom G6 Glucose Program System(predicate device; K191450)	Dexcom G6 Glucose ProgramSystem (subject device)
	results 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.
Clinicalapplication	Management of diabetes mellitus	Same
Clinicalsetting/sitesof use	Home use	Same
Principle ofOperation	Amperometric measurement ofcurrent proportional to glucoseconcentration in interstitial fluid viaglucose oxidase chemical reaction.	Same
	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 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.	Same
DataPresented
Features	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.	Same
HumanFactors	Easy to understand UI/UX.	Same
Device	Dexcom G6 Glucose Program System (predicate device; K191450)	Dexcom G6 Glucose Program System (subject device)
	Commonly understood navigation tools and features.Color-coded graphics.
Compatibility with intended environments	Compatible with Android OS version 7.0 and above	Same
Transmitter	G6 (Epoxy) Transmitter only	G6 (Epoxy) Transmitter andG6 (Welded) Transmitter

6.6.1 Dexcom G6 Glucose Program Continuous Glucose Monitoring System

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6.7 Technological Characteristics

The proposed Dexcom G6 Glucose Program System is used to measure glucose values via amperometric measurement of current proportional to glucose concentration in interstitial fluid via a glucose oxidase chemical reaction. The proposed Dexcom G6 Glucose Program System shares the same technological characteristics as the predicate device (K191450).

6.8 Summary of Performance Testing

The proposed Dexcom G6 Glucose Program System was verified and validated according to Dexcom's internal design control process and in accordance with special controls for integrated continuous glucose monitors. Performance testing and software verification and validation testing was completed for the proposed transmitter. To validate the design of the proposed transmitter firmware with the predicate Glucose Program Mobile App, system integration testing was completed to ensure system level and display requirements remain fulfilled.

6.9 Conclusions

The proposed Dexcom G6 Glucose Program System is substantially equivalent to the predicate Dexcom G6 Glucose Program System as it shares the same intended use, indications for use, as well as technological characteristics. Further, the proposed change does not 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.