The Dexcom G7 Continuous Glucose Monitoring System (Dexcom G7 CGM System or G7) is a real time, continuous qlucose monitoring device indicated for the management of diabetes in persons 2 years and older.

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

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

Device Description

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

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

The proposed G7 CGM System is modified to allow users to display glucose data directly from the transmitter on compatible iOS smartwatches.

To achieve the intended functions and performance of the G7 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 displays glucose data and provides alerts and information signals to the user. The reportable glucose range for the G7 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 10 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 G7 is an interoperable connected device that can communicate glucose readings and other information wirelessy 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 o 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 System renain the same as prior generations of Dexcom CGM 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.

AI/ML Overview

I am sorry, but the provided text does not contain the specific information required to describe the acceptance criteria and the study that proves the device meets those criteria, especially regarding a table of acceptance criteria and reported device performance, sample size for test and training sets, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.

The document is a 510(k) premarket notification letter from the FDA to Dexcom Inc. for their G7 Continuous Glucose Monitoring System, confirming its substantial equivalence to a predicate device. It briefly mentions non-clinical testing performed to establish performance characteristics related to the "Direct to Watch (DTW) feature" (EMC, communication range, human factors, software V&V, cybersecurity) and states that these tests demonstrate the system meets "pre-defined acceptance criteria." However, it does not detail what those acceptance criteria are or present the performance results against them. It also explicitly states, "No clinical data was necessary to determine substantial equivalence."

Therefore, I cannot fulfill your request for the detailed information as the source text does not provide it.

Summary

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February 26, 2024

Dexcom Inc. Michelle Monroe Staff Regulatory Affairs Specialist 6340 Sequence Dr San Diego, California 92121

Re: K234133

Trade/Device Name: Dexcom G7 Continuous Glucose Monitoring System Regulation Number: 21 CFR 862.1355 Regulation Name: Integrated continuous glucose monitoring system Regulatory Class: Class II Product Code: QBJ Dated: December 28, 2023 Received: December 29, 2023

Dear Michelle Monroe:

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" (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).

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Your device is also subject to, among other requirements, the Quality System (OS) 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 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-safetyreporting-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.

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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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

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Indications for Use

Submission Number (if known)

Device Name

Dexcom G7 Continuous Glucose Monitoring System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) #:

510(k) Summary

Prepared on: 2023-12-28

Contact Details

21 CFR 807.92(a)(1)

Applicant Name	Dexcom Inc.
Applicant Address	6340 Sequence Dr San Diego CA 92121 United States
Applicant Contact Telephone	1(828) 203-6362
Applicant Contact	Mrs. Neeta Sharma
Applicant Contact Email	neeta.sharma@dexcom.com
Correspondent Name	Dexcom Inc.
Correspondent Address	6340 Sequence Dr San Diego CA 92121 United States
Correspondent Contact Telephone	1(714) 200-6922
Correspondent Contact	Michelle Monroe
Correspondent Contact Email	michelle.monroe@dexcom.com

21 CFR 807.92(a)(2)

Device Trade Name	Dexcom G7 Continuous Glucose Monitoring 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 (CLASS 1) - TAPE AND BANDAGE, ADHESIVE

21 CFR 807.92(a)(3)
Legally Marketed Predicate Devices

Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K231081	Dexcom G7 Continuous Glucose Monitoring System	QBJ

21 CFR 807.92(a)(4)
Device Description Summary
The Dexcom G7 Continuous Glucose Monitoring System (G7 System) is an interoperable continuous glucose monitoring (CGM) system intended to continuously measure the glucose in the interstitial fluid, calculate the glucose reading and make this available to the user.The G7 System is intended for single patient use at home and requires a prescription.

The proposed G7 CGM System is modified to allow users to display glucose data directly from the transmitter on compatible iOS smartwatches.

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· 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 o 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:

Intended Use/Indications for Use

The Dexcom G7 Continuous Glucose Monitoring System G7 CGM System or G7) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons 2 years and older.

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

The Dexcom G7 CGM System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AD) systems. The Dexcom G7 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 indications for use are the same as the predicate device.

Technological Comparison

The modified device has the same technological characteristics as the predicate device shares identical 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 & Conclusions 21 CFR 807.92(b)

The G7 GSS and RVS materials, hardware components, and packaging are identical to those of the predicate device.

The following performance characteristics were established through nonclinical testing performed on the subject G7 System with Direct to Watch (DTW) feature:

· EMC and Common Electromagnetic Emitters testing

o These testing demonstrate that the electromagnetic emissions and immunities of the G7 System are not impacted by the DTW feature.

· Communication Range testing

21 CFR 807.92(a)(5)

21 CFR 807.92(a)(6)

21 CFR 807.92(a)(5)

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o This testing demonstrates that the G7 Watch App with DTW feature has the same communication range as the G7 Mobile App.

· Human Factors testing
o This testing demonstrates that the representative users of the G7 System can safely use the DTW feature under representative conditions. The results of this testing are equivalent to the usability testing results for the predicate.
· Software Verification and Validation
o This testing demonstrates that the G7 iOS and Watch Apps with DTW feature meet their requirements.
· Cybersecurity testing
o This testing demonstrates that the cybersecurity of the G7 System (including DTW feature) has been evaluated, risk assessed, and mitigated appropriately.

Nonclinical testing results demonstrate that the proposed G7 Continuous Glucose Monitoring System meets pre-defined acceptance criteria, support that the device is acceptable for its intended use, and is as safe and effective as the predicate device.

No clinical data was necessary to determine substantial equivalence.

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.