(188 days)
No.
The document explicitly states "Not Found" for mentions of "AI, DNN, or ML" and describes the system's "Principle of Operation" as a "wire-type sensing mechanism" with a radio transmitter, which does not involve AI.
Yes.
The device is intended for the management of diabetes, aids in the detection of hyperglycemia and hypoglycemia, and facilitates both acute and long-term therapy adjustments, indicating a therapeutic purpose.
Yes
Explanation: The device is indicated for the "management of diabetes" and "aids in the detection of episodes of hyperglycemia and hypoglycemia," facilitating therapy adjustments. It replaces fingerstick BG testing for diabetes treatment decisions, indicating its role in providing information for diagnosis and monitoring of a medical condition.
No
The device description clearly states it consists of "a wearable, consisting of a sensor and transmitter worn on the body" in addition to the software applications (Mobile App and Receiver). This indicates the device includes significant hardware components, not just software.
No.
Reasoning: The device measures glucose levels in interstitial fluid using a sensor, not in vitro (outside the body) using a specimen directly for diagnostic purposes. It is a continuous glucose monitoring device.
N/A
Intended Use / Indications for Use
The Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) 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.
Product codes
QBJ, KGX
Device Description
The Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System (Dexcom G7 15 Day CGM System or G7 15 Day) is an interoperable continuous glucose monitoring system intended to continuously measure the glucose in the interstitial fluid, calculate the glucose reading and make this available to the user. The Dexcom G7 15 Day CGM System is intended for single patient use at home and requires a prescription.
The G7 15 Day 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 OS smart device or a G7 Receiver (Receiver).
To achieve the intended functions and performance of the G7 15 Day, 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 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 after the sensor session. The grace period allows additional time for the user to change the sensor at a convenient time.
The Dexcom G7 15 Day CGM System is an interoperable connected device that can communicate glucose readings and other information wirelessly and securely 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 secure and reliable 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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
18 years and older
Intended User / Care Setting
single patient use at home
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
A clinical study was conducted to evaluate the safety and effectiveness of the Dexcom G7 15 Day CGM System. The effectiveness of the device was evaluated with respect to reference venous plasma sample YSI measurements across the measuring range throughout a 15-day wear duration with a 12-hour grace period in adult (18 years and older) participants with diabetes.
A subsequent clinical study was performed to assess the impact of a new sensor patch intended to improve survival rate.
A separate clinical study was performed in adults with type 1 and type 2 diabetes to assess the data transmission reliability over the 15-day wear period.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Shelf-Life: Shelf-Life testing was performed to evaluate the stability of the G7 15 Day 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 met specifications.
- Human Factors: Human factors and usability testing of the Dexcom G7 15 Day CGM System was conducted to determine whether the changes, as compared to the predicate device, impact the usability of the device. Results of the human factors study support that the intended users can use the Dexcom G7 15 Day CGM System safely and effectively.
- Battery Life Analysis: An engineering analysis concluded that the G7 15 Day transmitter battery has sufficient capacity to meet the product performance specifications.
- Software Verification and Validation: Software verification and validation testing was conducted to confirm that the software used in the Dexcom 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 Dexcom G7 15 Day CGM System that includes analysis of confidentiality, integrity, and availability for data, information and software related to the G7 15 Day in accordance with the FDA Guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" (September 27, 2023). Appropriate risk mitigation controls have been implemented and tested.
- Clinical Study 1: A clinical study was conducted to evaluate the safety and effectiveness of the Dexcom G7 15 Day CGM System. Analysis of the results from the clinical study showed that the subject device meets the iCGM special controls for clinical performance set forth in 21 CFR 862.1355. The reported device-related AEs included local infection, skin irritation (edema), and pain or discomfort. The clinical study demonstrated that the Dexcom G7 15 Day CGM System is safe and effective for its intended use.
- Clinical Study 2: A subsequent clinical study was performed to assess the impact of a new sensor patch intended to improve survival rate.
- Clinical Study 3: A separate clinical study was performed in adults with type 1 and type 2 diabetes to assess the data transmission reliability over the 15-day wear period. The results from the study demonstrate the reliable data transmission rate to connected devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
FDA 510(k) Clearance Letter - Dexcom G7 15 Day CGM System
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
April 9, 2025
Dexcom, Inc.
Zachary Nelson
Sr. Manager, Regulatory Affairs
6340 Sequence Drive
San Diego, California 92121
Re: K243214
Trade/Device Name: Dexcom G7 15 Day Continuous Glucose Monitoring System
Regulation Number: 21 CFR 862.1355
Regulation Name: Integrated Continuous Glucose Monitoring System
Regulatory Class: Class II
Product Code: QBJ, KGX
Dated: February 21, 2025
Received: February 21, 2025
Dear Zachary Nelson:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
Page 2
K243214 - Zachary Nelson Page 2
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
Page 3
K243214 - Zachary Nelson Page 3
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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,
Joshua Balsam -S
Joshua M. Balsam, Ph.D.
Branch Chief
Division of Chemistry and
Toxicology Devices
OHT7: Office of In Vitro Diagnostics
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Submission Number (if known)
K243214
Device Name
Dexcom G7 15 Day Continuous Glucose Monitoring System
Indications for Use (Describe)
The Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) 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.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Page 5
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: K243214
Prepared on: 2025-04-04
CONTACT DETAILS
| Field | Value |
|---|---|
| Applicant Name | Dexcom, Inc. |
| Applicant Address | 6340 Sequence Dr., San Diego, CA 92121 United States |
| Applicant Contact Telephone | 1(858) 875-5326 |
| Applicant Contact | Holly Drake |
| Applicant Contact Email | hdrake@dexcom.com |
| Correspondent Name | Dexcom, Inc. |
| Correspondent Address | 6340 Sequence Dr., San Diego, CA 92121 United States |
| Correspondent Contact Telephone | 1(814) 730-2518 |
| Correspondent Contact | Zachary Nelson |
| Correspondent Contact Email | zachary.nelson@dexcom.com |
DEVICE NAME AND CLASSIFICATION
| Field | Value |
|---|---|
| Device Trade Name | Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System |
| Common Name | Integrated Continuous Glucose Monitoring System |
| Classification Name | Integrated Continuous Glucose Monitoring System, Factory Calibrated |
| Regulation Number | 862.1355 |
| Product Code(s) | QBJ, KGX |
LEGALLY MARKETED PREDICATE DEVICES
| Field | Value |
|---|---|
| Predicate # | K240902 |
| Predicate Trade Name | Dexcom G7 Continuous Glucose Monitoring System |
| Product Code | QBJ |
Page 6
DEVICE DESCRIPTION SUMMARY
The Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System (Dexcom G7 15 Day CGM System or G7 15 Day) is an interoperable continuous glucose monitoring system intended to continuously measure the glucose in the interstitial fluid, calculate the glucose reading and make this available to the user. The Dexcom G7 15 Day CGM System is intended for single patient use at home and requires a prescription.
The G7 15 Day 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 OS smart device or a G7 Receiver (Receiver).
To achieve the intended functions and performance of the G7 15 Day, 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 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 after the sensor session. The grace period allows additional time for the user to change the sensor at a convenient time.
The Dexcom G7 15 Day CGM System is an interoperable connected device that can communicate glucose readings and other information wirelessly and securely 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 secure and reliable 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).
Principle of Operation:
The principles of operation for the Dexcom G7 15 Day CGM System remain the same as prior generations of Dexcom CGM Systems. The System uses a wire-type sensing mechanism that continuously measures interstitial glucose levels and uses a radio transmitter to wirelessly communicate glucose data to the display device for the user to see and use accordingly.
INTENDED USE/INDICATIONS FOR USE
The Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) 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.
Page 7
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.
INDICATIONS FOR USE COMPARISON
The differences between the indications for use of the predicate (Dexcom G7 CGM System) and subject (Dexcom G7 15 Day CGM System) devices are only related to the age of the patient population – the subject device is indicated for persons with diabetes age 18 years and older, whereas the predicate is indicated for persons with diabetes age 2 years and older. Both devices are real-time, continuous glucose monitoring devices indicated for the management of diabetes.
TECHNOLOGICAL COMPARISON
The subject device has the same fundamental technological characteristics as the predicate device. The subject device shares similar hardware, material, chemical composition, principle of operation and energy source with the predicate device. Design differences between the subject device and the predicate device do not constitute a new intended use. The subject device is as safe and effective as the predicate device and does not raise different questions of safety and effectiveness.
NON-CLINICAL AND/OR CLINICAL TESTS SUMMARY AND CONCLUSIONS
The following supportive performance characteristics were established through nonclinical testing of the predicate device and reference device (K234070) and are applicable to the Dexcom G7 15 Day CGM System in this 510(k):
- Mechanical Functional Testing
- Electrical Functional Testing (except for the battery life performance)
- Shelf-Life Testing
- Wireless Performance Testing
- Medical Electrical System Safety Testing (except for the standard compliance to IEC 62304)
- Medical Electrical System Electromagnetic Compatibility & Radio Approval Testing
- Biocompatibility
- Sterilization Validation
- Packaging Validation
- Substance Restrictions and Product Waste Regulations
Page 8
The following performance characteristics were verified or validated through studies conducted on the subject device, Dexcom G7 15 Day CGM System:
-
Shelf-Life:
Shelf-Life testing was performed to evaluate the stability of the G7 15 Day 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 met specifications. -
Human Factors:
Human factors and usability testing of the Dexcom 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:- 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
- 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 Dexcom 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 Dexcom 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 Dexcom G7 15 Day CGM System safely and effectively.
-
Battery Life Analysis:
An engineering analysis concluded that the G7 15 Day transmitter battery has sufficient capacity to meet the product performance specifications. -
Software Verification and Validation:
Software verification and validation testing was conducted to confirm that the software used in the Dexcom 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 Dexcom G7 15 Day CGM System that includes analysis of confidentiality, integrity, and availability for data, information and software related to the G7 15 Day in accordance with the FDA Guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" (September 27,
Page 9
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.
A clinical study was conducted to evaluate the safety and effectiveness of the Dexcom G7 15 Day CGM System. The effectiveness of the device was evaluated with respect to reference venous plasma sample YSI measurements across the measuring range throughout a 15-day wear duration with a 12-hour grace period in adult (18 years and older) participants with diabetes. Analysis of the results from the clinical study showed that the subject device meets the iCGM special controls for clinical performance set forth in 21 CFR 862.1355. The safety of the device was evaluated by the incidence of device-related adverse events (AEs) experienced by study subjects. The reported device-related AEs included local infection, skin irritation (edema), and pain or discomfort. The clinical study demonstrated that the Dexcom G7 15 Day CGM System is safe and effective for its intended use.
A subsequent clinical study was performed to assess the impact of a new sensor patch intended to improve survival rate.
A separate clinical study was performed in adults with type 1 and type 2 diabetes to assess the data transmission reliability over the 15-day wear period. The results from the study demonstrate the reliable data transmission rate to connected devices.
Nonclinical testing results demonstrate that the Dexcom G7 15 Day CGM System meets pre-defined acceptance criteria and support that the device is acceptable for its intended use. Clinical study results demonstrate that the Dexcom G7 15 Day CGM System meets the iCGM special controls for clinical performance set forth in 21 CFR 862.1355. The clinical data of the Dexcom G7 15 Day CGM System were also compared to that of the predicate device to support a substantial equivalence decision.