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 sequential sensor readings over time. The Dexcom Glucose Program System also aids in the detection of episodes of hyperglycemia, facilitating long-term therapy adjustments.

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

Device Description

The proposed Dexcom G6 Glucose Program Continuous Glucose Monitoring System consists of three main components: the sensor/applicator delivery system, transmitter, and mobile application (app). The sensor is a small and flexible wire inserted into subcutaneous tissue where it converts glucose into electrical current. The transmitter is connected to the sensor and is worn on the body. It samples the electrical current produced by the sensor and converts these measurements into glucose readings using an onboard algorithm. The transmitter sends glucose data to either the Android app (part of the predicate system) or iOS app (part of the proposed system). The app displays the current glucose reading (updated every 5 minutes) and glucose trends from the transmitter. The app alert 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 the Follow mobile application.

AI/ML Overview

This document describes a 510(k) premarket notification for the Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System. The submission, K193642, seeks to add an iOS mobile application to an existing Android-based system. As such, the performance data provided largely defers to the existing predicate and reference devices.

Here's an analysis of the provided information concerning acceptance criteria and study data:

Overall Assessment:
The document does not contain explicit acceptance criteria tables with numerical targets, nor does it present detailed performance study results from a new test set for K193642. This is because the core technology (sensor, transmitter, underlying algorithm) and the intended use remain unchanged from the predicate device (K192787) and reference device (K182041). The current submission is primarily for the addition of an iOS application that functions identically to the already cleared Android application. Therefore, performance claims and acceptance are based on the previously cleared devices.

The document states: "All testing performed on the predicate device and reference device in accordance with special controls for integrated continuous glucose monitors remain applicable." and "Therefore, performance testing and software verification and validation testing completed for the predicate device (K192787) remain applicable."

Given this, I will extract information related to what would be the basis for acceptance for such a device, and explicitly note where the information is not present in this specific submission document as a new study.

1. Table of Acceptance Criteria and Reported Device Performance

As noted, this document (K193642) does not present a new table of acceptance criteria with numerical targets and corresponding performance data from a new study specific to the iOS app's glucose measurement accuracy. Instead, it relies on the predicate (K192787) and reference (K182041) devices for performance.

For a CGM system, typical acceptance criteria and performance metrics would include:

Metric (Hypothetical for CGM)	Acceptance Criteria (Example)	Reported Device Performance (Likely from K192787/K182041)	Comments (Based on provided text)
Accuracy (MARD)	Overall MARD < 10%	Not explicitly reported in K193642	The document states that performance testing completed for the predicate device (K192787) remains applicable. The MARD (Mean Absolute Relative Difference) is the primary metric for CGM accuracy. The previous submissions would have detailed this.
Accuracy (Clark Error Grid)	>95% of points in Zones A+B	Not explicitly reported in K193642	Similar to MARD, this is a standard accuracy metric for CGM. Performance data for the predicate devices would have included this.
Hypoglycemic Detection Accuracy	Sensitivity/Specificity > X% for low glucose	Not explicitly reported in K193642	Critical for safety, especially given the "replace fingerstick" indication. Data from predicate submissions would cover this.
Hyperglycemic Detection Accuracy	Sensitivity/Specificity > Y% for high glucose	Not explicitly reported in K193642	Important for therapy adjustments. Data from predicate submissions would cover this.
Sensor Wear Time (Usability/Reliability)	Consistent performance over 10-day wear period	"updated every 5 minutes" (implied continuous)	The device's continuous monitoring and 10-day wear are fundamental, but specific metrics like sensor failures or premature removals are not detailed here for this specific submission. This would have been part of the original G6 clearance.
Software Functionality (iOS App)	All specified features (display, alerts, connectivity) function correctly and identically to Android app.	Software testing completed to ensure all requirements are fulfilled.	The core of this submission is validating the iOS app. The document confirms software testing was done to ensure the iOS app meets its requirements and functions similarly to the Android app. No specific detailed performance metrics for the iOS app's new software verification are presented beyond this general statement.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not explicitly stated for this specific submission (K193642) regarding new clinical performance data. The submission relies on the data from the predicate (K192787) and reference (K182041) devices. These previous submissions would have contained the sample sizes for their clinical studies.
Data Provenance: Not explicitly stated for this specific submission. Given Dexcom's nature, previous studies would likely be prospective clinical trials conducted with human subjects. The country of origin for previous studies is not specified in this document, but typically for a US FDA submission, significant clinical data would either be from the US or internationally recognized clinical trials. It implies that data is prospective as it's from clinical trials for performance verification.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This document does not describe the establishment of a "ground truth" using human experts for image or signal interpretation, as it's a CGM device, not an AI diagnostic imaging algorithm. For CGM devices, the ground truth is typically established by laboratory reference methods for blood glucose, not expert consensus. These methods are highly accurate and standardized (e.g., YSI instrument measurements).

4. Adjudication Method for the Test Set

Not applicable in the context of a CGM device performing direct physiological measurements against a reference lab method. Adjudication (e.g., 2+1, 3+1) is typically used in studies where human readers are interpreting complex data (like medical images) and their opinions need to be reconciled to form a ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was it done? No, an MRMC study was not done. MRMC studies are relevant for evaluating the impact of AI on human reader performance for tasks involving interpretation (e.g., radiology). This is a continuous glucose monitor; its function is to measure glucose, not to assist human interpretation in the way an AI would.
Effect Size of Human Improvement: Not applicable, as no MRMC study was performed.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance

Was it done? Yes, the core performance of the Dexcom G6 system (sensor, transmitter, and onboard algorithm) is evaluated in a standalone manner against laboratory reference methods. The system autonomously measures and processes glucose data.
Details: While K193642 itself doesn't present new standalone performance data, it explicitly states that the previous standalone performance testing for the predicate (K192787) and reference (K182041) devices remains applicable. The device "samples the electrical current produced by the sensor and converts these measurements into glucose readings using an onboard algorithm." This "onboard algorithm" is the standalone component, and its accuracy is assessed by comparing its output directly to reference glucose values.

7. The Type of Ground Truth Used

The ground truth for CGM devices is established by laboratory reference blood glucose measurements. These are highly accurate measurements from a venipuncture blood sample, typically performed in a clinical setting using a YSI glucose analyzer or similar highly accurate laboratory method. This is a form of "outcomes data" or "pathology" in the sense of a gold standard for a physiological measurement.

8. The Sample Size for the Training Set

Not explicitly stated in K193642. The G6 system's core algorithm was likely developed and trained using extensive datasets from previous clinical studies and internal data. The training set size for the original G6 algorithm (from predicate/reference devices) would have been substantial, but this specific submission does not provide those details. Since the algorithm itself is not being fundamentally changed, new training is not the focus of this 510(k).

9. How the Ground Truth for the Training Set Was Established

Not explicitly stated in K193642. For the development and training of the original G6 algorithm (from predicate/reference devices), the ground truth for the training set would have also been established using laboratory reference blood glucose measurements, similar to the test set ground truth. These measurements would be collected concurrently with the sensor readings over a long period from a diverse group of individuals to train the algorithm to accurately translate interstitial fluid glucose signals into blood glucose estimates.

Summary

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January 29, 2020

Dexcom, Inc. Linda Wang Staff Regulatory Affairs Specialist 6340 Sequence Drive San Diego, CA 92121

Re: K193642

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: December 27, 2019 Received: December 30, 2019

Dear Linda Wang:

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/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. Acting 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) K193642

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 age 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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1. 510(K) SUMMARY

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: K193642

SUBMITTER 1.1

Sponsor	Dexcom6340 Sequence DriveSan Diego, CA 92121
Contact Person	Linda WangStaff Regulatory Affairs SpecialistPhone: (858) 203-6816Fax: (858) 332-0204Email: linda.wang@dexcom.com
Alternative Contact	Bryan OsborneRegulatory Affairs SpecialistPhone: (858) 875-9896Email: bosborne@dexcom.com
Date Prepared	December 27, 2019

DEVICE NAMES AND CLASSIFICATION 1.2

Proprietary Name	Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM)System
Common Name	Integrated Continuous Glucose Monitoring System, Factory Calibrated
Class	II
Classification Regulation	21 CFR 862.1355
Product Code	QDK
Review Panel	Clinical Chemistry

PREDICATE DEVICE 1.3

Dexcom G6 Glucose Program Continuous Glucose Monitoring System (K192787, cleared October 25, 2019)

REFERENCE DEVICE 1.4

Dexcom G6 Glucose Program Continuous Glucose Monitoring System (K182041, cleared October 26, 2018)

DEVICE DESCRIPTION 1.5

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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 either the Android app (part of the predicate system) or iOS app (part of the proposed system). The app displays the current glucose reading (updated every 5 minutes) and glucose trends from the transmitter. The app alert 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 the Follow mobile application.

INDICATIONS FOR USE 1.6

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	Predicate Device	Proposed Device
Trade Name	Dexcom G6 Glucose Program Continuous GlucoseMonitoring (CGM) System	Same
Manufacturer	Dexcom, Inc.	Same
Intended Use	An integrated continuous glucose monitoring system(iCGM) is intended to automatically measure glucose inbodily fluids continuously or frequently for a specifiedperiod of time. iCGM systems are designed to reliably andsecurely transmit glucose measurement data to digitallyconnected devices, including automated insulin dosingsystems, and are intended to be used alone or in conjunctionwith these digitally connected medical devices for the	Same
Device	Predicate Device	Proposed Device
	purpose of managing a disease or condition related toglycemic control.
Indications forUse	The Dexcom G6 Glucose Program Continuous GlucoseMonitoring System (Dexcom Glucose Program System) is areal time, continuous glucose monitoring device indicatedfor the management of diabetes in persons age 2 years andolder.The Dexcom Glucose Program System is intended to replacefingerstick blood glucose testing for diabetes treatmentdecisions for persons with diabetes who are not at significantrisk of severe hypoglycemia. Interpretation of the DexcomGlucose Program System results should be based on theglucose 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 toautonomously communicate with digitally connecteddevices. The Dexcom Glucose Program System can be usedalone or in conjunction with these digitally connecteddevices or services for the purpose of managing diabetes.	Same
Clinicalapplication	Management of diabetes mellitus	Same
Clinicalsetting/sites ofuse	Home use	Same
Principle ofOperation	Amperometric measurement of current proportional toglucose concentration in interstitial fluid via glucose oxidasechemical reaction.	Same
Data Presented	Estimated Glucose Value (EGV): The EGV is the nominalglucose value presented to the user.Glucose Trend: Based off the glucose rate of change, usersare shown their glucose trend with a corresponding arrow.Historical Glucose Data: Users can view their previous six,or twelve hours of glucose data on a graph with high/lowglucose thresholds.Time in Range: Users can view the percent of time theyspend in their target glucose range based on their configuredhigh/low glucose thresholds.	Same
Features	Connect to Dexcom Share: Users can share their glucosedata with up to three followers.Chat with Wellness Coach: Users can chat with a third-party wellness coach for encouragement, education, andmotivation regarding their diabetes management.	Same
Human Factors	Easy to understand user interface and user experience.Commonly understood navigation tools and features.Color-coded graphics.	Same
Transmitter	G6 Epoxy Transmitter and G6 Welded Transmitter	Same
Compatibilitywith intendedenvironments	Compatible with Android OS version 7.0 and above	Same for AndroidCompatible withiOS version 13.2and above

COMPARISON WITH THE PREDICATE DEVICE 1.7

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1.8 TECHNOLOGICAL 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 (K192787). The proposed Dexcom Glucose Program System adds an iOS-based app to the current/predicate CGM system's Android app capability.

1.9 SUMMARY OF PERFORMANCE TESTING

The proposed Dexcom Glucose Program System was verified and validated according to Dexcom's internal design control process. All testing performed on the predicate device and reference device 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 completed for the predicate device (K192787) remain applicable. Software testing was completed to ensure all requirements of the proposed iOS app are fulfilled.

1.10 CONCLUSION

The proposed Dexcom Glucose Program System is substantially equivalent to the predicate system as it shares the same intended use, indications for use, and technological characteristics. The difference between the proposed Dexcom Glucose Program System and the predicate device (cleared under K192787) is the addition of the iOS app, but the proposed app has the same functionality as the current Android app. Therefore, the proposed modification 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.