Dexcom G7 15 Day Continuous Glucose Monitoring System

K243214 · Dexcom, Inc. · QBJ · Apr 9, 2025 · Clinical Chemistry

Device Facts

• Record ID: K243214
• Device Name: Dexcom G7 15 Day Continuous Glucose Monitoring System
• Applicant: Dexcom, Inc.
• Product Code: QBJ · Clinical Chemistry
• Decision Date: Apr 9, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1355
• Device Class: Class 2

Indications for Use

The Dexcom G7 15 Day Continuous Glucose Monitoring System (Dexcom G7 15 Day CGM System or G7 15 Day) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons 18 years and older. The Dexcom G7 15 Day CGM System is intended to replace fingerstick BG testing for diabetes treatment decisions. Interpretation of the Dexcom G7 15 Day CGM System results should be based on the glucose trends and several sequential sensor readings over time. The Dexcom G7 15 Day CGM System also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. The Dexcom G7 15 Day CGM System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The Dexcom G7 15 Day CGM System can be used alone or in conjunction with these digitally connected medical devices for the purpose of managing diabetes.

Device Story

Wearable iCGM system measures interstitial fluid glucose via enzymatic electrochemical reaction (glucose oxidase). Sensor probe generates electrical current proportional to glucose concentration; transmitter converts signal via algorithm to glucose value (mg/dL). Data transmitted every 5 minutes to mobile app or receiver. Used at home by patients for diabetes management; replaces fingerstick testing for treatment decisions. Integrates with digitally connected devices, including automated insulin dosing (AID) systems. Provides real-time glucose trends, alerts for hypo/hyperglycemia, and facilitates therapy adjustments. Wearable sensor lasts up to 15 days. Healthcare providers use output to monitor glycemic control and adjust long-term therapy. Benefits include continuous monitoring, reduced fingersticks, and automated data sharing for improved diabetes management.

Clinical Evidence

Pivotal clinical study (N=130) evaluated accuracy against YSI 2300 comparator. Overall MARD was 8.2% (70-180 mg/dL range). Accuracy metrics: 93.7% of readings within 20% of comparator. Low glucose alert detection rate was 92.1% at 70 mg/dL; high glucose alert detection rate was 96.7% at 180 mg/dL. Sensor survival rate was 73.9% through 15 days. Data availability (capture rate) remained high (>96%) throughout the 15-day wear period.

Technological Characteristics

Wire-type interstitial glucose sensing; radio transmitter for wireless communication. Wearable form factor with 15-day wear life. Connectivity via secure wireless protocols to mobile apps, receivers, and cloud/partner APIs. Software verification per IEC 62304. Biocompatible materials; sterilization validated.

Indications for Use

Indicated for the management of diabetes in persons 18 years and older. Intended to replace fingerstick blood glucose testing for treatment decisions and aid in detection of hyperglycemia and hypoglycemia.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Dexcom G7 Continuous Glucose Monitoring System (K240902)

Reference Devices

• K234070

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT

## I Background Information:

A 510(k) Number

K243214

B Applicant

Dexcom, Inc.

C Proprietary and Established Names

Dexcom G7 15 Day Continuous Glucose Monitoring System

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| QBJ | Class II | 21 CFR 862.1355 - Integrated Continuous Glucose Monitoring System | CH - Clinical Chemistry |

## II Submission/Device Overview:

A Purpose for Submission:

Modifications to a cleared device to introduce a new glucose algorithm and to extend the wear period to 15 days for users 18 years and older.

B Measurand:

Glucose in Interstitial Fluid

C Type of Test:

Quantitative, amperometric assay (Glucose Oxidase)

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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III Intended Use/Indications for Use:

A Intended Use(s):

See Indications for Use below.

B Indication(s) for Use:

The Dexcom G7 15 Day Continuous Glucose Monitoring System (Dexcom G7 15 Day CGM System or G7 15 Day) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons 18 years and older.

The Dexcom G7 15 Day CGM System is intended to replace fingerstick BG testing for diabetes treatment decisions. Interpretation of the Dexcom G7 15 Day CGM System results should be based on the glucose trends and several sequential sensor readings over time. The Dexcom G7 15 Day CGM System also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments.

The Dexcom G7 15 Day CGM System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The Dexcom G7 15 Day CGM System can be used alone or in conjunction with these digitally connected medical devices for the purpose of managing diabetes.

C Special Conditions for Use Statement(s):

Rx - For Prescription Use Only

- Users of the Dexcom G7 15 Day Continuous Glucose Monitoring System can take a standard dose of acetaminophen (up to 1 gram every 6 hours in adults) and still use the Dexcom G7 15 Day CGM System readings. Sensor glucose readings will be falsely higher if the user is taking more than a standard acetaminophen dose.
- Sensor glucose readings will also be falsely higher if the user is taking hydroxyurea. Users should not use the Dexcom G7 15 Day CGM System for diabetes treatment decisions if they are taking hydroxyurea.
- Don't wear any Dexcom G7 15 Day CGM System component during magnetic resonance imaging (MRI) or high-frequency electrical heat (diathermy) treatment. However, it's safe to have a CT scan if you keep the sensor out of the scanned area and cover the sensor with a lead apron during the scan.
- Don't ignore low/high symptoms: Use BG meter to make treatment decisions when the sensor readings don't match the user's low/high symptoms. If needed, seek immediate medical attention.
- Use BG meter to make treatment decisions when the Dexcom G7 15 Day CGM System doesn't show both a number and trend arrow as well as during the sensor warmup period.
- Don't use if on dialysis or critically ill: The Dexcom G7 15 Day CGM System performance hasn't been evaluated in these populations and sensor readings may be inaccurate.
- Don't ignore broken or detached sensor wires. If this happens, contact 24/7 technical support.
- Before upgrading the smart device or its operating system, check dexcom.com/compatibility. Always update manually and verify correct device settings afterward.
- Let the date and time on the smart device automatically update when traveling across time zones or switch between standard and daylight saving times. Don't manually change the smart

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device time because the user may not get readings or alerts and it may make the time on the trend screen wrong.

- Not using supplied USB charger and cable may cause the receiver battery to not charge. Don't use if the supplied USB charger or cable is damaged.

## D Special Instrument Requirements:

None.

## IV Device/System Characteristics:

### A Device Description:

The Dexcom G7 15 Day Continuous Glucose Monitoring System (G7 15 Day System) is an integrated continuous glucose monitoring (iCGM) system intended to continuously measure the glucose in the interstitial fluid, calculate the glucose reading and make this available to the user. The G7 15 Day System is intended for single patient use at home and requires a prescription.

The G7 15 Day System consists of the following primary components: a wearable, consisting of a sensor and transmitter worn on the body and a display device, which can be a G7 Mobile Application (Mobile App) on an iOS or Android smart device or a G7 Receiver (Receiver).

To achieve the intended functions and performance of the G7 15 Day System, one sensor and at least one display device (App or Receiver) must be used together. The user must pair the display device(s) with each unique sensor to enable communication and start a sensor session. During an active session, the sensor reports new glucose data to the display device every 5-minutes. The display device then displays glucose data and provides alerts and information signals to the user. The reportable glucose range for the G7 15 Day System is 40 mg/dL to 400 mg/dL. Glucose values below this range are reported as 'LOW' and glucose values above this range are reported as 'HIGH'. The sensor has an expected wear period of up to 15 days with an extended 12-hour grace period. The grace period allows additional time for the user to change the sensor at a convenient time.

The G7 15 Day System is an interoperable connected device that can communicate glucose readings and other information wirelessly to and from compatible electronic interfaces via the following secure wireless connections:

- Wireless communication from the transmitter directly to an interoperable device communicating through the same protocol
- The Mobile App communicates to another app on a single mobile platform
- The Mobile App communicates through the cloud to another software device
- Dexcom Partner Web APIs: The Dexcom Partner Web APIs enable communication of CGM data to authorized client software intended to receive the data through the cloud. The Partner Web APIs is not intended to be used by automated insulin delivery systems (AID).

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## B Principle of Operation:

The Dexcom G7 Continuous Glucose Monitoring System detects glucose levels from the fluid just beneath the skin (interstitial fluid). The sensor probe continuously measures glucose concentration in the interstitial fluid via an enzymatic electrochemical reaction using glucose oxidase. The enzyme, glucose oxidase, catalyzes the oxidation of glucose and produces hydrogen peroxide. The production of hydrogen peroxide generates an electrical current that is proportionate to the interstitial glucose concentration. The transmitter converts the signal using an algorithm to a glucose value read in $\mathrm{mg/dL}$, which is then transmitted to the receiver/mobile application for the user to see and use accordingly.

## C Instrument Description Information:

1. Instrument Name:
Dexcom G7 15 Day Continuous Glucose Monitoring System

2. Specimen Identification:
Not applicable

3. Specimen Sampling and Handling:
Not applicable

4. Calibration:
The G7 Continuous Glucose Monitoring System is factory calibrated. User may enter optional calibration using fingerstick blood glucose values.

5. Quality Control:
Not applicable

## V Substantial Equivalence Information:

### A Predicate Device Name(s):

Dexcom G7 Continuous Glucose Monitoring System

### B Predicate 510(k) Number(s):

K240902

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C Comparison with Predicate(s):

| Device & Predicate Device(s): | K243214 | K240902 |
| --- | --- | --- |
| Device Trade Name | Dexcom G7 15 Day CGM System | Dexcom G7 CGM System |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | 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. | Same |
| Principle of Operation | Amperometric measurement of current proportional to glucose concentration in interstitial fluid via glucose oxidase chemical reaction. | Same |
| Compatibility with connected devices | Compatible with digitally connected devices, including | Same |

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VI Standards/Guidance Documents Referenced:

1. ISO 14971:2007, Medical devices - Application of Risk Management to Medical Devices
2. ANSI 62304:2006/A1:2016, Medical Device Software – Software Life Cycle Processes
3. IEC 62366-1:2015, Medical Devices – Application of Usability Engineering to Medical Devices
4. ANSI HE75:2009/(R) 2018, Human Factors Engineering – Design of Medical Devices
5. Design considerations for Devices intended for Home Use, Guidance to FDA Staff and Industry, November 24, 2014
6. Applying Human Factors and Usability Engineering to Medical Devices, Guidance to FDA Staff and Industry, February 3, 2016
7. Guidance for the Content of Premarket Submissions for Device Software Functions, June 14, 2023
8. Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, September 27, 2023)

VII Performance Characteristics (if/when applicable):

A Analytical Performance:

1. Precision/Reproducibility:

iCGM performance was evaluated in clinical studies described below in section C(3). A subset of subjects wore two iCGM Systems at the same time (N=18). Precision was evaluated by comparing the glucose reading from the two Systems worn by the same subject on the backs of both upper arms.

| Coefficient of Variation (%) | Paired Absolute Difference (mg/dL) | Paired Absolute Relative Difference (%) | Number of Paired Readings | Number of Subjects |
| --- | --- | --- | --- | --- |
| 6.3 | 13.6 | 9.0 | 62,889 | 18 |

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2. Linearity:

The reportable range for the System is 40 to 400 mg/dL. Data supporting this claimed measurement range was generated in the clinical study described in Section C(3) below.

3. Analytical Specificity/Interference:

Previously established in K213919.

Users of the CGM System can take a standard or maximum dose of acetaminophen (up to 1 gram every 6 hours) and still use the System readings. Sensor glucose readings will be falsely higher if the user is taking more than a standard acetaminophen dose. Sensor glucose readings will also be falsely higher if the user is taking hydroxyurea. Clinicians should consider alternative glucose monitoring approaches for users taking hydroxyurea.

4. Assay Reportable Range:

See Linearity section above.

5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):

The Dexcom G7 sensor and transmitter have a storage shelf-life of up to 18 months. Shelf life was evaluated at 86°F. Sensors should be stored at 36°-86°F and 10-90% relative humidity.

6. Detection Limit:

If a glucose measurement is less than 40 mg/dL, the result is displayed by the system as LOW. If a glucose measurement exceeds 400 mg/dL, result is displayed as HIGH.

7. Assay Cut-Off:

Not applicable.

8. Accuracy (Instrument):

Not applicable.

9. Carry-Over:

Not applicable.

B Comparison Studies:

1. Method Comparison with Predicate Device:

Not applicable. Accuracy is determined by comparing device values to an FDA cleared laboratory grade glucose analyzer (Yellow Springs Instrument 2300 STAT Plus™ Glucose Analyzer) and referred to as the "comparator method" in Section C(3) below.

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2. **Matrix Comparison:**

Not applicable. Interstitial fluid is the only indicated matrix.

## C Clinical Studies:

1. **Clinical Sensitivity:**

Not applicable.

2. **Clinical Specificity:**

Not applicable.

3. **Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):**

In the pivotal study for the Dexcom G7 15 Day CGM System in subjects ages 18 years and older, the subject device was evaluated by comparing iCGM glucose values to glucose values from venous blood draws measured with an FDA-cleared laboratory grade comparator method (YSI 2300).

Glucose values were obtained from the system and from the comparator at the same or similar time. Absolute differences in mg/dL of values compared to the comparator method were calculated for all values below 70 mg/dL. For values of 70 mg/dL and above, percentage differences compared to the comparator method were calculated.

**Percent and Point Accuracy by iCGM Glucose Range (N=130)**

| iCGM Glucose Range (mg/dL) | No. Pairs | Percent within 15 mg/dL (95% B) | Percent within 40 mg/dL (95% LB) | Percent within 15% (95% LB) | Percent within 40% (95% LB) | Mean Bias, mg/dL (95% CL) |
| --- | --- | --- | --- | --- | --- | --- |
| < 70 | 2,192 | 93.2 (89.3) | 99.5 (98.8) | --- | --- | -6.0 (-8.2, -3.7) |
| 70 - 180 | 10,488 | --- | --- | 85.4 (83.0) | 99.7 (99.4) | -5.0 (-7.2, -2.7) |
| >180 | 7,575 | --- | --- | 88.9 (85.4) | 99.9 (99.8) | -1.1 (-3.7, 1.5) |

**Percent and Point Accuracy by Comparator Glucose Range (N=130)**

| Comparator Glucose Range (mg/dL) | No. Pairs | Percent within 15 mg/dL (95% LCL) | Percent within 40 mg/dL (95% LCL) | Percent within 15% (95% LCL) | Percent within 40% (95% LCL) | Mean Bias, mg/dL (95% UCL) |
| --- | --- | --- | --- | --- | --- | --- |
| < 70 | 1,977 | 96.2 (94.1) | 99.9 (99.3) | --- | --- | -0.7 (-2.7, 1.4) |
| 70 - 180 | 10,447 | --- | --- | 86.3 (83.8) | 99.8 (99.6) | -3.1 (-5.2, -1.0) |
| >180 | 7,831 | --- | --- | 87.6 (84.0) | 99.8 (99.5) | -5.2 (-8.1, -2.3) |

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Percent of iCGM values within 20% of Comparator Glucose Values

| No. Pairs | No. Subjects | Percent within 20% Overall (95% LCL) | Percent Within ±20% / ±20 mg/dL on Day 1 |
| --- | --- | --- | --- |
| 20,255 | 130 | 93.7 (92.0) | 90.7* |

* N = 59 based on timing of clinic sessions.

Percent values within 15%/15 mg/dL, 20%/20 mg/dL and 40%/40 mg/dL stratified by glucose ranges of &lt;54, 54-69, 70-180. 181-250 and &gt;250 mg/dL for iCGM and comparator were also provided.

Accuracy to Comparator within iCGM Glucose Ranges (N=130)

| iCGM Glucose Level (mg/dL) | No. Pairs | Percent Within ±15 mg/dL | Percent Within ±20 mg/dL | Percent Within ±40 mg/dL | Percent Within ±15% | Percent Within ±20% | Percent Within ±40% | Mean bias (mg/dL) | MARD (%) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| <54 | 286 | 79.0 | 87.4 | 99.3 | --- | --- | --- | -8.3 | 14.9 |
| 54-69 | 1,906 | 91.5 | 96.0 | 99.7 | --- | --- | --- | -3.6 | 9.1 |
| 70-180 | 10,488 | --- | --- | --- | 85.9 | 93.7 | 99.7 | -2.8 | 8.2 |
| 181-250 | 2,969 | --- | --- | --- | 86.0 | 92.8 | 99.9 | -7.8 | 8.0 |
| >250 | 4,606 | --- | --- | --- | 92.2 | 97.3 | 100.0 | -2.3 | 6.6 |

Accuracy to Comparator within Comparator Glucose Ranges (N=130)

| Comparator Glucose Level (mg/dL) | No. Pairs | Percent Within ±15 mg/dL | Percent Within ±20 mg/dL | Percent Within ±40 mg/dL | Percent Within ±15% | Percent Within ±20% | Percent Within ±40% | Mean bias (mg/dL) | MARD (%) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| < 54 | 203 | 92.1 | 94.1 | 99.0 | --- | --- | --- | 5.0 | 12.5 |
| 54-69 | 1,774 | 97.0 | 99.0 | 100.0 | --- | --- | --- | 0.2 | 8.2 |
| 70-180 | 10,447 | --- | --- | --- | 85.8 | 93.5 | 99.8 | -2.0 | 8.2 |
| 181-250 | 2,983 | --- | --- | --- | 87.5 | 94.4 | 99.9 | -3.9 | 7.8 |
| >250 | 4,848 | --- | --- | --- | 88.8 | 94.3 | 99.8 | -8.5 | 7.4 |

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Concurrence of iCGM values compared to the comparator method across the entire measuring range was also evaluated. iCGM glucose ranges of &lt;40, 40-60, 61-80, 81-120, 121-160, 161-200, 201-250, 251-300, 351-400 and &gt;400 mg/dL were evaluated against the comparator glucose ranges and percent of iCGM values within those ranges were reported.

## Concurrence Analysis by iCGM Glucose Level (N=130)

| iCGM (mg/dL) | Comparator (mg/dL) | | | | | | | | | | | N |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | <40 | 40-60 | 61-80 | 81-120 | 121-160 | 161-200 | 201-250 | 251-300 | 301-350 | 351-400 | >400 | |
| <40 | 2.0% | 55.1% | 40.8% | 2.0% | --- | --- | --- | --- | --- | --- | --- | 49 |
| 40-60 | --- | 53.6% | 42.4% | 4.0% | --- | --- | --- | --- | --- | --- | --- | 844 |
| 61-80 | --- | 8.0% | 74.2% | 17.7% | 0.2% | --- | --- | --- | --- | --- | --- | 2,893 |
| 81-120 | 0.0% | 0.1% | 7.4% | 78.1% | 13.9% | 0.3% | 0.0% | 0.0% | 0.0% | --- | --- | 4,269 |
| 121-160 | --- | --- | 0.0% | 11.8% | 73.6% | 13.6% | 0.8% | 0.1% | 0.0% | --- | --- | 3,394 |
| 161-200 | --- | --- | --- | 0.0% | 15.0% | 65.2% | 18.5% | 1.2% | 0.1% | --- | --- | 2,268 |
| 201-250 | --- | --- | --- | --- | 0.1% | 11.1% | 64.0% | 20.7% | 3.8% | 0.3% | --- | 1,981 |
| 251-300 | --- | --- | --- | --- | --- | --- | 12.9% | 58.1% | 25.9% | 3.0% | --- | 2,224 |
| 301-350 | --- | --- | --- | --- | --- | --- | --- | 19.7% | 67.9% | 12.2% | 0.2% | 1,896 |
| 351-400 | --- | --- | --- | --- | --- | --- | --- | --- | 39.5% | 56.4% | 4.1% | 486 |
| >400 | --- | --- | --- | --- | --- | --- | --- | --- | 1.2% | 65.9% | 32.9% | 82 |

## Concurrence Analysis by Comparator Glucose Level (N=130)

| Comparator (mg/dL) | iCGM (mg/dL) | | | | | | | | | | | N |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | <40 | 40-60 | 61-80 | 81-120 | 121-160 | 161-200 | 201-250 | 251-300 | 301-350 | 350-400 | >400 | |
| <40 | 50.0% | --- | --- | 50.0% | --- | --- | --- | --- | --- | --- | --- | 2 |
| 40-60 | 3.8% | 63.1% | 32.3% | 0.8% | --- | --- | --- | --- | --- | --- | --- | 716 |
| 61-80 | 0.7% | 12.6% | 75.5% | 11.2% | 0.0% | --- | --- | --- | --- | --- | --- | 2,842 |
| 81-120 | 0.0% | 0.8% | 11.9% | 77.9% | 9.4% | 0.0% | --- | --- | --- | --- | --- | 4,283 |
| 121-160 | --- | --- | 0.1% | 17.2% | 72.7% | 9.9% | 0.0% | --- | --- | --- | --- | 3,437 |
| 161-200 | --- | --- | --- | 0.6% | 21.3% | 68.0% | 10.1% | --- | --- | --- | --- | 2,173 |
| 201-250 | --- | --- | --- | 0.1% | 1.3% | 20.9% | 63.3% | 14.4% | --- | --- | --- | 2,003 |
| 251-300 | --- | --- | --- | 0.1% | 0.2% | 1.3% | 19.4% | 61.3% | 17.7% | --- | --- | 2,110 |
| 301-350 | --- | --- | --- | 0.0% | 0.0% | 0.1% | 3.6% | 27.0% | 60.3% | 9.0% | 0.0% | 2,136 |
| 351-400 | --- | --- | --- | --- | --- | --- | 0.9% | 10.6% | 36.7% | 43.3% | 8.5% | 633 |
| >400 | --- | --- | --- | --- | --- | --- | --- | --- | 7.8% | 39.2% | 52.9% | 51 |

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# Trend Accuracy

Trend accuracy describes the accuracy of the sensor during times of rapidly changing glucose and is characterized by slopes, such as from $&gt;2\mathrm{mg/dL/min}$ to $&lt;-2\mathrm{mg/dL/min}$ . Trend accuracy was assessed by the concurrence rate of the glucose rate of change from the iCGM and the corresponding comparator values for each iCGM-comparator measurement pair.

Concurrence Analysis by Glucose Rate of Change (N=130)

| iCGM Rate (mg/dL/min) | Comparator Rate (mg/dL/min) | | | | | | N |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | <-2 | [-2, -1) | [-1, 0) | [0, 1] | (1, 2] | >2 | |
| <-2 | 88 (33.0) | 108 (40.4) | 53 (19.9) | 15 (5.6) | 1 (0.4) | 2 (0.7) | 267 |
| -2 to -1 | 89 (6.1) | 651 (44.3) | 649 (44.1) | 73 (5.0) | 9 (0.6) | 0 (0.0) | 1,471 |
| -1 to 0 | 32 (0.4) | 544 (6.2) | 6,498 (73.6) | 1,658 (18.8) | 87 (1.0) | 11 (0.1) | 8,830 |
| 0 to 1 | 7 (0.1) | 76 (1.1) | 1,636 (24.4) | 4,266 (63.7) | 642 (9.6) | 73 (1.1) | 6,700 |
| 1 to 2 | 2 (0.1) | 6 (0.3) | 84 (4.9) | 630 (36.7) | 789 (46.0) | 205 (11.9) | 1,716 |
| >2 | 0 (0.0) | 1 (0.1) | 16 (2.1) | 101 (13.2) | 256 (33.4) | 392 (51.2) | 766 |

Note: iCGM rate of change was calculated using the slope of consecutive CGM readings compared to consecutive comparator data

# Agreement When iCGM Reads 'LOW' or 'HIGH'

The subject device reports glucose readings between 40 and $400\mathrm{mg / dL}$ . When the system determines that the glucose reading is below $40\mathrm{mg / dL}$ , it will display 'LOW' whenever the sensor is scanned. When the system determines that the glucose reading is above $400\mathrm{mg / dL}$ , it will display 'HIGH' whenever the sensor is scanned. Because the system does not display glucose values below $40\mathrm{mg / dL}$ or above $400\mathrm{mg / dL}$ , the comparisons to the actual blood glucose levels (as determined by the comparator) when the iCGM value is classified as 'LOW' or 'HIGH' are evaluated separately. The cumulative percentages of when the comparator values were less than certain glucose values (for 'LOW') and when comparator values were more that certain glucose values (for 'HIGH') are presented in the tables below.

Distribution of Comparator for iCGM Readings Below $40\mathrm{mg / dL}$ 'LOW'

| iCGM-Comparator Pairs | Comparator (mg/dL) | | | | | N |
| --- | --- | --- | --- | --- | --- | --- |
| | <50 | <60 | <70 | <80 | ≥80 | |
| n | 16 | 27 | 42 | 47 | 2 | 49 |
| Cumulative % | 33 | 55 | 86 | 96 | 4 | |

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Distribution of Comparator for iCGM Readings Above 400 mg/dL 'High'

| iCGM-Comparator Pairs | | Comparator (mg/dL) | | | | N |
| --- | --- | --- | --- | --- | --- | --- |
| | >340 | >320 | >280 | >250 | ≤250 | |
| n | 81 | 82 | 82 | 82 | 0 | 82 |
| Cumulative % | 99 | 100 | 100 | 100 | 0 | |

## Alert Performance

The tables in this section show the accuracy of the System's Low and High Glucose Alerts. The Alert Rate tells the user how often the alert is right or wrong. The Detection Rate tells the user how often the System is able to recognize and notify the user about a low or high glucose event (within 15 minutes before or after the event).

## Low Glucose Alert Performance

True Alert Rate: Percentage of time the alert issued, and blood glucose was below the alert level within 15 minutes before or after the alert.

False Alert Rate: Percentage of time the alert issued, and blood glucose was not below the alert level within 15 minutes before or after the alert.

Detection Rate: Percentage of time blood glucose was below the alert level and the alert issued within 15 minutes before or after the glucose event.

Missed Detection Rate: Percentage of time blood glucose was below the alert level and the alert didn't issue within 15 minutes before or after the glucose event.

Low Glucose Alert Performance (N=130)

| Low Glucose Alarm Level (mg/dL) | Alarm Rate | | | Detection Rate | | |
| --- | --- | --- | --- | --- | --- | --- |
| | Hypo Alerts (n) | True Alarm Rate (%) | False Alarm Rate (%) | Hypo Events (n) | Correct Detection Rate (%) | Missed Detection Rate (%) |
| 55 | 1,211 | 47.0 | 53.0 | 298 | 82.6 | 17.4 |
| 60 | 1,818 | 65.6 | 34.4 | 726 | 78.7 | 21.3 |
| 70 | 4,978 | 82.3 | 17.7 | 2,113 | 92.1 | 7.9 |
| 80 | 8,249 | 87.1 | 12.9 | 3,583 | 96.2 | 3.8 |
| 90 | 11,268 | 90.6 | 9.4 | 4,695 | 97.1 | 2.9 |

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High Glucose Alert Performance

True Alert Rate: Percentage of time the alert issued, and blood glucose was above the alert level within 15 minutes before or after the alert.

False Alert Rate: Percentage of time the alert issued, and blood glucose was not above the alert level within 15 minutes before or after the alert.

Detection Rate: Percentage of time blood glucose was above the alert level and the alert issued within 15 minutes before or after the glucose event.

Missed Detection Rate: Percentage of time blood glucose was above the alert level and the alert didn't issue within 15 minutes before or after the glucose event.

High Glucose Alert Performance (N=130)

| High Glucose Alarm Level (mg/dL) | Alarm Rate | | | Detection Rate | | |
| --- | --- | --- | --- | --- | --- | --- |
| | Hyper Alerts (n) | True Alarm Rate (%) | False Alarm Rate (%) | Hyper Events (n) | Correct Detection Rate (%) | Missed Detection Rate (%) |
| 120 | 34,324 | 97.5 | 2.5 | 12,746 | 97.2 | 2.8 |
| 140 | 28,658 | 97.0 | 3.0 | 10,838 | 96.6 | 3.4 |
| 180 | 20,208 | 97.3 | 2.7 | 8,020 | 96.7 | 3.3 |
| 200 | 17,200 | 97.3 | 2.7 | 7,025 | 96.1 | 3.9 |
| 220 | 14,706 | 96.5 | 3.5 | 6,177 | 95.4 | 4.6 |
| 240 | 12,492 | 95.4 | 4.6 | 5,387 | 94.3 | 5.7 |
| 300 | 5,595 | 86.8 | 13.2 | 2,895 | 81.0 | 19.0 |

Sensor Stability

Sensor stability describes the performance of the sensor over the sensor lifetime. Sensors can be worn for up to 15 days. Performance was estimated by calculating the mean of the absolute relative differences between iCGM and comparator measurement and percentage of device readings within 15 mg/dL or 15 % (15/15%), 20 mg/dL or 20 % (20/20%) and 40 mg/dL or 40 % (40/40%) of the comparator values during the beginning, early middle, late middle, and end of the wear period. These times were defined as follows:

- Beginning (Days 1-3)
- Early Middle (Days 4-7),
- Late Middle (Days 9-12), and
- End (Days 13-15.5).

The mean absolute relative difference (MARD) and agreement rates with the comparator method were evaluated over 15 day life of the sensor.

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Sensor Accuracy Relative to Comparator Over the Wear Duration (N=130)

| Wear Period | No. Pairs | MARD (%) | Within ±15% / ±15mg/dL | Within ±20% / ±20mg/dL | Within ±40% / ±40mg/dL |
| --- | --- | --- | --- | --- | --- |
| Beginning | 5,653 | 8.6 | 84.5 | 93.0 | 99.8 |
| Early Middle | 5,507 | 7.4 | 90.4 | 95.8 | 99.9 |
| Late Middle | 5,175 | 7.3 | 90.7 | 96.2 | 99.9 |
| End | 3,920 | 8.9 | 85.3 | 91.6 | 99.5 |

## Sensor Life

A total of 131 sensors were evaluated to determine the percentage of sensors that lasted through the 15-day sensor life. Of the 131 Sensors, 73.9% of sensors lasted the full 15 days. Some sensors were excluded from this analysis if they were scheduled to be removed prior to Day 15. For example, on or before Day 15, 60 sensors were removed by the sponsor at the last scheduled clinic visit for the subject. 25 sensors (19.1%) had "early sensor shut-off" (ESS), which is when a sensor automatically ends a sensor session as a result of self-diagnostics. Survival rates were calculated using the Kaplan Meier method.

Sensor Survival Rate Over Wear Duration

| Day of Wear* | No. of Sensors | Survival Rate (%) |
| --- | --- | --- |
| 1 | 130 | 99.2 |
| 2 | 130 | 99.2 |
| 3 | 128 | 97.7 |
| 4 | 124 | 94.7 |
| 5 | 124 | 94.7 |
| 6 | 123 | 93.9 |
| 7 | 121 | 93.1 |
| 8 | 120 | 92.4 |
| 9 | 119 | 91.6 |
| 10 | 116 | 90.0 |
| 11 | 112 | 87.7 |
| 12 | 107 | 83.8 |
| 13 | 104 | 81.4 |

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| 14 | 75 | 79.7 |
| --- | --- | --- |
| 15 | 38 | 73.9 |

* Refers to the number of sensors that survived the full wear day

The pivotal clinical data was re-analyzed to censor devices where study staff assistance or supplemental adhesives were used during sensor insertion, as well as devices that were removed at a scheduled clinic visit prior to the full 15 days. The survival rate without these sensors included was 78.4% through day 15.

A separate survival study was conducted (Study 2) in which the survival rate through day 15 was 76.0% (N=95). The survival rate was re-analyzed to censor devices where application assistance or supplemental adhesives were used, as well as devices that were removed at a scheduled clinic visit prior to the full 15 days. The survival rate without these sensors included was 80.5% through day 15.

## Glucose Reading Availability

The capture rate characterizes the reliability of the communication between components of the system throughout the 15-day life span of the sensor life based on information collected in the pivotal study.

Data Availability Rate by Wear Period

| Day of Wear* | No. of Sensors | Capture Rate (%) |
| --- | --- | --- |
| 1 | 130 | 99.2 |
| 2 | 130 | 99.8 |
| 3 | 130 | 99.6 |
| 4 | 128 | 99.6 |
| 5 | 124 | 99.7 |
| 6 | 124 | 99.6 |
| 7 | 123 | 99.7 |
| 8 | 121 | 99.6 |
| 9 | 120 | 99.5 |
| 10 | 119 | 99.2 |
| 11 | 116 | 98.8 |
| 12 | 112 | 98.6 |
| 13 | 107 | 99.0 |
| 14 | 104 | 98.0 |
| 15 | 75 | 96.9 |

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* Refers to the number of sensors that provided glucose data during the wear day

# D Clinical Cut-Off:

Not applicable.

# E Expected Values/Reference Range:

Not applicable.

# F Other Supportive Instrument Performance Characteristics Data:

The following supportive performance characteristics were established through nonclinical testing of the predicate device and reference device (K234070) and are applicable to the G7 15 Day Continuous Glucose Monitoring System in this $510(\mathrm{k})$ :

Mechanical Functional Testing
- Electrical Functional Testing (except for the battery life performance)
- Wireless Performance Testing
Medical Electrical System Safety Testing (except for the standard compliance to IEC 62304)
Medical Electrical System Electromagnetic Compatibility &amp; Radio Approval Testing
Biocompatibility
- Sterilization Validation
- Packaging Validation
- Substance Restrictions and Product Waste Regulations

The following performance characteristics were verified or validated through studies conducted on the subject device, G7 15 Day CGM System:

# Shelf-Life:

Shelf-Life testing was performed to evaluate the stability of the G7 15 Day CGM System under real time anticipated storage conditions and supported its useful life to be up to 18 months. The test results for the G7 15 Day Continuous Glucose Monitoring System met specifications.

# Human Factors:

Human factors and usability testing of the G7 15 Day CGM System was conducted to determine whether the changes, as compared to the predicate device, impact the usability of the device. Human Factors testing was conducted in accordance with the following FDA guidance documents and recognized consensus standards:

- Design considerations for Devices intended for Home Use, Guidance to FDA Staff and Industry, November 24, 2014
- Applying Human Factors and Usability Engineering to Medical Devices, Guidance to FDA Staff and Industry, February 3, 2016
- IEC 62366-1:2015/AMD 1:2020: Medical devices - Part 1: Application of Usability Engineering to Medical Devices

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- ANSI/AAMI HE75:2009/(R) 2018 – Human Factors Engineer, Design of Medical Devices

The critical, essential and frequently performed tasks were evaluated to demonstrate safe and effective use of the G7 15 Day CGM System and were identified through a use-related risk analysis (URRA), which identified critical tasks solely based on the Severity of harm and included tasks resulting from known-use problems and hazards analysis. An analysis of hazards and risks was conducted on the G7 15 Day CGM System to determine safety risks associated with use of the system. Results of the human factors study support that the intended users can use the G7 15 Day CGM System safely and effectively.

**Software Verification and Validation:**

Software verification and validation testing was conducted to confirm that the software used in the G7 15 Day CGM System performed in accordance with established specifications, IEC 62304 and FDA Guidance document “Guidance for the Content of Premarket Submissions for Device Software Functions,” June 14, 2023. Evaluation activities included code review, unit, software verification, system integration, and system level testing which verified functionality of the device against established software requirements.

**Cybersecurity:**

Dexcom provided cybersecurity risk management documentation for the G7 15 Day CGM System that includes analysis of confidentiality, integrity, and availability for data, information and software related to the G7 15 Day System in accordance with the FDA Guidance “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (September 27, 2023). For each identified threat and vulnerability risk event scenario, risk assessment of impact to confidentiality, integrity, and availability was performed and documented within the cybersecurity risk management documentation. Appropriate risk mitigation controls have been implemented and tested. In addition, Dexcom has controls and processes in place to ensure continued support for keeping the device secure and to ensure that the device firmware, software and components are malware-free. Additional controls are also in place in manufacturing through distribution to ensure that the medical device firmware and software are malware free from point of origin to the hands of the end user.

**VIII** **Proposed Labeling:**

The labeling supports the finding of substantial equivalence for this device.

**IX** **Conclusion:**

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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