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 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 G6 Glucose Program Continuous Glucose Monitoring (CGM) System measures and displays glucose values and trends for patients with diabetes who are not at significant risk of severe hypoglycemia. The system is factory calibrated and provides continuous glucose readings at five-minute intervals for up to ten days of use. The system consists of a sensor/applicator, a Bluetooth Low Energy (BLE) transmitter, and a BLE enabled mobile CGM display.

The sensor is a small and flexible wire, which is inserted by the applicator into subcutaneous tissue where it converts glucose into electrical current. The transmitter is connected to the sensor and is worn on the body. The transmitter samples the electrical current produced by the sensor and converts these measurements into estimated glucose values (EGV) using an onboard algorithm. The transmitter sends glucose data to the mobile CGM displays the current glucose reading (updated every 5 minutes) and glucose trends. The mobile CGM display does not include any glucose related alarm or alerts but will alert the user when important system conditions occur.

The subject of this submission is a change to the primary display mobile device software. Compared to the predicate device which uses a standalone mobile CGM application, the proposed Glucose Program System uses a new mobile CGM software module (app module) that is embedded within a third party program provider's mobile app (host app).

This change is to help encourage CGM retention for those not at significant risk of severe hypoglycemia by providing Dexcom Glucose Program CGM functions and program provider's functions on a single unified mobile application. The app module is designed as a finished sovereign software that interacts directly with smart device hardware/operating system and maintains the same core CGM functionality as the predicate device, independent of the host app. The proposed Glucose Program System uses the same sensor/applicator and transmitter as the predicate device, with only changes to the mobile CGM software.

The change to the primary display mobile device software described in this submission does not impact the standalone G6 mobile application used in the G6 CGM System (last cleared K200876) and only affects the Glucose Program System which is designed for payor-sponsored, valuebased health programs.

AI/ML Overview

The document describes the Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System and its comparison to a predicate device (K200876). The core of the information provided shows that the new device, referred to as the "subject device," is substantially equivalent to the predicate, with the primary change being a modification to the mobile display software.

Here's an analysis of the provided text in relation to the requested information:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with corresponding reported device performance values. Instead, it asserts "substantial equivalence" to a predicate device, implying that the subject device meets the same performance standards as the predicate. The description highlights that the subject device "has the same core CGM functionality and meets the same system requirements as the predicate G6 Glucose Program System."

2. Sample size used for the test set and the data provenance

The document does not specify a sample size for a test set that was used to prove the device meets acceptance criteria. It mentions that "All testing referenced in the predicate device (K200876) in accordance with special controls for integrated continuous glucose monitors remain applicable." This suggests that new clinical performance testing with human subjects was not conducted for this specific submission because the underlying hardware and core algorithms are the same as the predicate.

Regarding data provenance (country of origin, retrospective/prospective), this information is also not provided as new clinical trials were not detailed for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. As stated above, new clinical performance data from human subjects is not detailed for this submission, as the claim is based on substantial equivalence to a predicate device for which such testing would have been performed.

4. Adjudication method for the test set

This information is not provided in the document.

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

This type of study is not applicable to this device. The Dexcom G6 Glucose Program CGM System is a continuous glucose monitoring device, not an AI-assisted diagnostic imaging or interpretation tool that would involve "human readers" in the context of an MRMC study.

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

The device itself is a continuous glucose monitoring system with an onboard algorithm that converts sensor measurements into estimated glucose values. The document states, "The transmitter samples the electrical current produced by the sensor and converts these measurements into estimated glucose values (EGV) using an onboard algorithm." This confirms a standalone algorithm that processes raw sensor data. The claim of substantial equivalence implies that the performance of this standalone algorithm has been previously validated as part of the predicate device's clearance.

7. The type of ground truth used

For a glucose monitoring device, the typical "ground truth" for evaluating accuracy would be laboratory reference standard blood glucose measurements (e.g., from a YSI analyzer). While the document doesn't explicitly state the ground truth used for this specific submission, it relies on the predicate device's clearance, which would have established accuracy against such a standard. The section "Glucose Value Estimation Algorithm" mentions an "Optimized Joint Probability Algorithm with improved data availability," which would be evaluated against such ground truth.

8. The sample size for the training set

The document does not provide information regarding the sample size for the training set. This is likely because the core algorithm remains the same as the predicate device, and new training data for algorithm development is not part of this specific submission.

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

The document does not provide this information. It only states that the "Optimized Joint Probability Algorithm" is used, implying that any training and its associated ground truth establishment would have occurred during the development of this algorithm (likely for the predicate device).

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

August 17, 2021

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

Re: K203089

Trade/Device Name: Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System Regulation Number: 21 CFR 862.1355 Regulation Name: Integrated continuous glucose monitoring system Regulatory Class: Class II Product Code: QDK Dated: March 5, 2021 Received: March 8, 2021

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

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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 (QS) 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,

Marianela Perez-Torres, Ph.D. Deputy 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) K203089

Device Name

Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) 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.

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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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: K203089

5.1 Submitter:

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

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

Secondary Contact: Ginny Hu Senior Manager, Regulatory Affairs Phone: 858.203.6591 Fax: 858.332.0204 Email: ginny.hu@dexcom.com

Date Prepared: July 19, 2021

5.2 Device Names and Classification:

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

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Review Panel	Clinical Chemistry
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5.3 Predicate Device:

Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System (K200876)

5.4 Device Description:

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5.5 Indications for Use:

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.

Device	Dexcom G6 Glucose Program System(K200876, Predicate)	Dexcom G6 Glucose Program System(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 for Use	The Dexcom G6 Glucose ProgramContinuous Glucose MonitoringSystem (Dexcom Glucose ProgramSystem) is a real time, continuousglucose monitoring device indicated	Same
Device	Dexcom G6 Glucose Program System(K200876, Predicate)	Dexcom G6 Glucose Program System(subject device)
	for 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 glucose
	trends 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.
Clinical application	Management of diabetes mellitus	Same
Clinical setting/sitesof use	Home use	Same
Principle ofOperation	Amperometric measurement ofcurrent proportional to glucoseconcentration in interstitial fluid viaglucose oxidase chemical reaction	Same
Device	Dexcom G6 Glucose Program System(K200876, Predicate)	Dexcom G6 Glucose Program System(subject device)
SystemComponents	Sensor/Applicator, Transmitter, DisplayDevice (mobile app)	Substantially Equivalent with noadverse impact on safety oreffectiveness.
		The proposed Dexcom G6 GlucoseProgram CGM System uses the sameSensor/Applicator and Transmitter asthe predicate device whileintroducing an alternative primarydisplay CGM software. The proposedG6 Glucose Program System uses anew mobile CGM software module(app module) that is embeddedwithin a third-party programprovider's mobile app (host app) toprovide patients both CGM functionsand the program provider's functionson a single unified mobile application.The proposed G6 Glucose Programapp module has the same core CGMfunctionality and meets the samesystem requirements as the predicateG6 Glucose Program System.
Data Presented	Estimated Glucose Value (EGV): TheEGV is the nominal glucose valuepresented to the user.	Substantially equivalent with noadverse impact on safety oreffectiveness.
	Glucose Trend: Based off the glucoserate of change, users are shown theirglucose trend with a correspondingarrow.Historical Glucose Data: Users can viewtheir previous six, or twelve hours ofglucose data on a graph with high/lowglucose thresholds.Time in Range: Users can view thepercent of time they spend in theirtarget glucose range based on theirconfigured high/low glucosethresholds.	The proposed Glucose Program Systemmaintains the same key features as thepredicate device, including EGV,glucose trend, historical glucose data,and time in range of target glucose.The proposed system includesmodifications to the graphical userinterface trend graph layout, symbolsused to show glucose rate of change(i.e. trend arrows), and general applayout/navigation. There is no impactto rate of change based on providedtrend arrows. These changes do notsignificantly impact safety oreffectiveness of the Glucose ProgramSystem and its intended population.
Transmitter	G6 Welded (Nuevo) Transmitter	Same
Device	Dexcom G6 Glucose Program System	Dexcom G6 Glucose Program System
	(K200876, Predicate)	(subject device)
Glucose ValueEstimationAlgorithm	Optimized Joint Probability Algorithmwith improved data availability	Same
Factory Calibration	Yes	Same
OptionalCalibration	Yes	Substantially equivalent with noadverse impact on safety oreffectiveness.No impact to clinical validation. Theaccuracy of the Factory Calibrated G6CGM System was demonstrated tomeet the iCGM (21 CFR 862.1355)Special Controls requirements inDEN170088. The predicate andproposed Glucose Program Systemsuse the same sensor and transmitter asthe G6 CGM System. The OptionalSMBG Calibration feature wasremoved to simplify user experience.
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 diabetes.	Substantially equivalent with noadverse impact on safety oreffectiveness.Removed Share/Follow and third-partywellness coach chat features from theproposed device. Chat feature can stillbe accessed through the host app.Changes do not significantly impactsafety or effectiveness and its intendedpopulation.
Human Factors	Easy to understand user interface anduser experience. Commonlyunderstood navigation tools andfeatures. Color-coded graphics.	Substantially equivalent with noadverse impact on safety oreffectiveness.Changes to the primary display mobiledevice software user interface andworkflow do not contribute to anysafety-critical risks or impact anypreviously validated mitigations for theG6 Glucose Program CGM System.
Alerts	Autonomous Detection andNotification:Signal Loss (not configurable)Sensor Failure (not configurable)Transmitter Failure (not configurable)	Same
Device	Dexcom G6 Glucose Program System(K200876, Predicate)	Dexcom G6 Glucose Program System(subject device)
Compatibility withintendedenvironments	Compatible with Android OS version7.0 and above and iOS version 13.2and above.	Substantially equivalent with noadverse impact on safety oreffectiveness.
		Dexcom qualifies mobile deviceoperating systems using the sameperformance/ acceptance criteria asthe predicate device.

5.6 Comparison with the Predicate Device:

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5.7 Technology Characteristics

The proposed Dexcom 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 Glucose Program System shares the same technological characteristics as the predicate device (K200876). The proposed Dexcom Glucose Program System adds a modified CGM app software solution that is embedded in a third party's iOS and Android 'host-app' for an improved single-app patient experience.

5.8 Summary of Performance Testing

The proposed Dexcom Glucose Program System was verified and validated according to Dexcom's internal design control process. All testing referenced in the predicate device (K200876) in accordance with special controls for integrated continuous glucose monitors remain applicable. The proposed system uses the same transmitter hardware and software requirements/design specifications as the predicate device. Therefore, performance testing and software verification and validation testing for the transmitter referenced in the predicate device (K200876) remains applicable. Software testing was completed to ensure all requirements of the proposed iOS and Android app modules are fulfilled while operating in the final host-app configuration.

5.9 Conclusions

The proposed Dexcom G6 Glucose Program CGM System and predicate Dexcom G6 Glucose Program CGM System (K200876) are identical with regard to intended use, indications for use, fundamental scientific technology, and principle of operation. The proposed system is substantially equivalent to the predicate device with regard to mobile software functionality, graphical user interface, and feature set. The proposed Glucose Program System CGM display is substantially equivalent to the predicate device as the proposed change does not raise any new questions of safety or 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.