(357 days)
There are no Reference Devices listed in the provided text.
No
The document describes an "onboard algorithm" within the transmitter that converts measurements into estimated glucose values and calculates the rate of change. While this is an algorithm, the description does not explicitly mention or provide details suggesting the use of AI or ML techniques for this process. The focus is on the sensor technology, data transmission, and display of glucose values and trends.
Yes
The device is intended for the management of diabetes and facilitating therapy adjustments, which are therapeutic actions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended to replace fingerstick BG testing for diabetes treatment decisions" and "aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments." These functions clearly demonstrate its role in diagnosing and monitoring health conditions.
No
The device description explicitly states that the system consists of hardware components, including a sensor applicator, on-body wearable with a transmitter, adhesive patch, and sensor wire, in addition to the software components (Mobile Application Subsystem and Receiver Subsystem).
Based on the provided text, the Dexcom G7 Continuous Glucose Monitoring (CGM) System is an In Vitro Diagnostic (IVD) device.
Here's why:
- Measures a biological sample: The device measures glucose levels in the subcutaneous tissue, which is a biological sample from the body.
- Provides information for diagnosis or treatment: The intended use explicitly states it's "indicated for the management of diabetes" and "intended to replace fingerstick BG testing for diabetes treatment decisions." It also "aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments." This information is used to make decisions about a patient's health and treatment.
- Used outside the body: While the sensor is inserted into the body, the measurement and analysis of the glucose in the interstitial fluid occur via the sensor and transmitter, which are components of the system. The results are then displayed on external devices (MAS and RVS).
Therefore, the Dexcom G7 CGM System fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Dexcom G7 Continuous Glucose Monitoring (CGM) System 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 sequential sensor readings over time. The Dexcom G7 CGM System also aids in the detection of episodes of hyperglycemia and hypoglycemia, 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 purposes of managing diabetes.
Product codes
QBJ
Device Description
The Dexcom G7 Continuous Glucose Monitoring System (G7 System) is an interoperable connected device that measures and displays estimated glucose values for people with diabetes. The G7 System consists of the following components: the Glucose Sensing Subsystem (GSS), the Mobile Application Subsystem (MAS), the Receiver Subsystem (RVS). The GSS is comprised of the sensor applicator and on-body wearable, which includes a Bluetooth Low Energy (BLE) molded transmitter, adhesive patch and sensor. The sensor is a small and flexible wire, which is inserted by the applicator into subcutaneous tissue where it converts glucose into electrical current. The 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 molded transmitter is pre-connected to the sensor and is cradled into the applicator needle inside the applicator housing. The applicator external housing consists of a cap and shroud which utilize a threaded cap and seal to create the sterile barrier system. A deployment lock mechanism prevents insertion of the on-body wearable until the applicator is pressed against the insertion site. The insertion is a single button press vertical spring deployed mechanism which introduces the sensor via the needle into the subcutaneous tissue, while also placing the embedded wearable onto the body which adheres to the skin via an adhesive patch.
After deployment, the molded transmitter initiates automatic wakeup and session start. The sensor's small and flexible wire converts glucose to electrical current and the transmitter samples the electrical current produced by the sensor. The transmitter's onboard algorithm converts these measurements into estimated glucose values and calculates the glucose rate of change which are sent every 5 minutes to the MAS and/or the RVS. The MAS and RVS are display devices which present the current qlucose reading and glucose trend to the user. Both display devices alert the user when glucose levels are outside of a target zone and when specific system states occur. The G7 System is designed to communicate to one or both display devices simultaneously.
The G7 System is also designed to communicate estimated glucose values, trend and system information to other 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 app communicates to another app on a single mobile platform
- . The app communicates through the cloud to another software device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Arm (age 2+ years); Upper buttocks (age 2-6 years)
Indicated Patient Age Range
2 years and older
Intended User / Care Setting
Home use
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
Not Found
Summary of Performance Studies
The Dexcom G7 CGM System was verified and validated according to Dexcom's internal design control processes and in accordance with special controls for integrated continuous qlucose monitors. This testing demonstrated that the System performed accordingly to its specifications and that the technological and performance criteria are comparable to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 7, 2022
Dexcom. Inc. Holly Drake Director, Regulatory Affairs 6340 Sequence Dr. San Diego, California 92121
Re: K213919
Trade/Device Name: Dexcom G7 Continuous Glucose Monitoring (CGM) System Regulation Number: 21 CFR 862.1355 Regulation Name: Integrated continuous glucose monitoring system Regulatory Class: Class II Product Code: QBJ Dated: September 14, 2022 Received: September 15, 2022
Dear Holly Drake:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Marianela Perez-torres -S
Marianela Perez-Torres, Ph.D. Acting Director 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
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Indications for Use
510(k) Number (if known) K213919
Device Name
Dexcom G7 Continuous Glucose Monitoring (CGM) System
Indications for Use (Describe)
The Dexcom G7 Continuous Glucose Monitoring (CGM) System 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 sequential sensor readings over time. The Dexcom G7 CGM System also aids in the detection of episodes of hyperglycemia and hypoglycemia, 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 purposes 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) |
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5 510(K) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
The assigned 510(k) number is: K213919
5.1 Submitter:
Dexcom, Inc. 6340 Sequence Dr. San Diego, CA 92121
Primary Contact: Holly Drake Position/Title: Director, Regulatory Affairs Phone: 858.875.5326 Fax: 858.332.0204 Email: hdrake@dexcom.com
Alternate Contact: Neeta Sharma Position/Title: VP, Regulatory Affairs Phone: 858.203.6362 Fax: 858.332.0204 Email: neeta.sharma@dexcom.com
Date Prepared: November 29, 2022
5.2 DEVICE NAMES AND CLASSIFICATION:
| Proprietary Name | Dexcom G7 Continuous Glucose Monitoring (CGM) System |
|---|---|
| Common Name | Integrated Continuous Glucose Monitoring System, Factory |
| Calibrated | |
| Class | II |
| Classification | |
| Regulation | 21 CFR 862.1355 |
| Product Code | QBJ |
| Review Panel | Clinical Chemistry |
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5.3 PREDICATE DEVICE:
Dexcom G6 Continuous Glucose Monitoring (CGM) System (K201328)
5.4 Device Description:
The Dexcom G7 Continuous Glucose Monitoring System (G7 System) is an interoperable connected device that measures and displays estimated glucose values for people with diabetes. The G7 System consists of the following components: the Glucose Sensing Subsystem (GSS), the Mobile Application Subsystem (MAS), the Receiver Subsystem (RVS). The GSS is comprised of the sensor applicator and on-body wearable, which includes a Bluetooth Low Energy (BLE) molded transmitter, adhesive patch and sensor. The sensor is a small and flexible wire, which is inserted by the applicator into subcutaneous tissue where it converts glucose into electrical current. The 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 molded transmitter is pre-connected to the sensor and is cradled into the applicator needle inside the applicator housing. The applicator external housing consists of a cap and shroud which utilize a threaded cap and seal to create the sterile barrier system. A deployment lock mechanism prevents insertion of the on-body wearable until the applicator is pressed against the insertion site. The insertion is a single button press vertical spring deployed mechanism which introduces the sensor via the needle into the subcutaneous tissue, while also placing the embedded wearable onto the body which adheres to the skin via an adhesive patch.
After deployment, the molded transmitter initiates automatic wakeup and session start. The sensor's small and flexible wire converts glucose to electrical current and the transmitter samples the electrical current produced by the sensor. The transmitter's onboard algorithm converts these measurements into estimated glucose values and calculates the glucose rate of change which are sent every 5 minutes to the MAS and/or the RVS. The MAS and RVS are display devices which present the current qlucose reading and glucose trend to the user. Both display devices alert the user when glucose levels are outside of a target zone and when specific system states occur. The G7 System is designed to communicate to one or both display devices simultaneously.
The G7 System is also designed to communicate estimated glucose values, trend and system information to other 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 app communicates to another app on a single mobile platform
- . The app communicates through the cloud to another software device.
5
- Dexcom Partner Web APIs: The Dexcom Partner Web APIs enable o 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).
The proposed G7 CGM System is based on the same mode of operation and mechanism of reaction as the predicate G6 CGM System (K201328), which uses a wiretype sensing mechanism that continuously measures interstitial fluid glucose levels and a BLE enabled radio transmitter to wirelessly communicate CGM data to compatible display devices at regular 5-minute intervals. These data are also able to be reliably and securely transmitted to other digitally connected devices, including automated insulin dosing systems, for the purpose of managing diabetes. The Dexcom Partner Web APIs also enable secure and reliable communication of CGM data to authorized client software as another compatible electronic interface.
The G7 CGM System primarily improves upon the user experience of the predicate G6 CGM System by providing a fully enclosed miniaturized wearable with pre-connected sensor that is applied to the body in a single button press. The MAS and RVS include redesigned user interfaces which simplify the use of CGM while including retrospective summary reports for quick access by the user.
5.5 Indications for Use
The Dexcom G7 Continuous Glucose Monitoring System (Dexcom 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 and hypoglycemia, 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.
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5.6 Comparison of Technological Characteristics with the Predicate Device:
| Device and Predicate
Device | Subject Device
(K213919) | Predicate Device
(K201328) |
|------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name | Dexcom G7 Continuous Glucose Monitoring
System | Dexcom G6 Continuous Glucose Monitoring System |
| Manufacturer | Dexcom, Inc. | Same |
| General Device Characteristics | | |
| Intended 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 |
| Indications for Use | The Dexcom G7 Continuous Glucose Monitoring
System (Dexcom 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 | Same except for Trade Name
The Dexcom G6 Continuous Glucose Monitoring
System (Dexcom G6 System) is a real time,
continuous glucose
monitoring device indicated for the management of
diabetes in persons age 2 years and older. |
| Device and Predicate
Device | Subject Device
(K213919) | Predicate Device
(K201328) |
| | 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 hypoglycemia, 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. | The Dexcom G6 System is intended to replace
fingerstick blood glucose testing for diabetes
treatment decisions.
Interpretation of the Dexcom G6 System results
should be based on the glucose trends and several
sequential readings
over time. The Dexcom G6 System also aids in the
detection of episodes of hyperglycemia and
hypoglycemia, facilitating both acute and long-term
therapy adjustments.
The Dexcom G6 System is also intended to
autonomously communicate with digitally connected
devices, including
automated insulin dosing (AID) systems. The
Dexcom G6 System can be used alone or in
conjunction with these digitally
connected medical devices for the purpose of
managing diabetes. |
| Principle of Operation | Amperometric measurement of current
proportional to glucose concentration in interstitial
fluid via glucose oxidase chemical reaction | Same |
| Sample Type | Interstitial fluid | Same |
| Enzyme | Glucose Oxidase | Same |
| Clinical Setting | Home use | Same |
| Intended Use Population | Persons with diabetes age 2 and above | Same |
| Measuring Range | 40-400 mg/dL | Same |
| Interferent Substances | Hydroxyurea, Acetaminophen (e.g. > 1 gram
every 6 hours in adults) | Same |
| Anatomical Wear Locations | Arm (age 2+ years);
Upper buttocks (age 2-6 years) | Abdomen (age 2+ years);
Upper buttocks (age 2-17 years) |
| Device and Predicate
Device | Subject Device
(K213919) | Predicate Device
(K201328) |
| Data Displayed | Current glucose value, current glucose trend,
graph with recent glucose history, user entered
events | Same |
| Calibration | Factory calibrated, optional manual calibration | Same |
| Situations when fingerstick is
required to confirm sensor
reading (adjunctive use) | User's symptoms do not match the glucose value displayed by the device No glucose value or trend is displayed by the device | Same |
| Primary Display Device | Mobile app installed on compatible smart device
or Receiver | Same |
| Compatibility with Intended
Environments | iOS and Android | Same |
| Glucose Alerts | Urgent low, urgent low soon, low glucose, high
glucose, falling rate, rising rate | Same |
| Sensor Warm Up Time | Within 30 minutes (27 minutes) | 2 hours |
| Sensor Life | Up to 10 days with a 12-hour grace period | Up to 10 days |
| Sterilization | Ethylene Oxide (EO) | Electron Beam radiation |
| Transmitter Life | Single Use (10.5 days) | Reusable (90 days) |
| Wireless Communication
protocol | Bluetooth Core Specification v4.2 | Bluetooth Core Specification v4.0 |
| Wireless Communication
range | 20 feet | Same |
| Glucose reading interval | Autonomously every 5 minutes | Same |
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5.7 Summary of Performance Testing
The Dexcom G7 CGM System was verified and validated according to Dexcom's internal design control processes and in accordance with special controls for integrated continuous qlucose monitors. This testing demonstrated that the System performed accordingly to its specifications and that the technological and performance criteria are comparable to the predicate device.
Conclusions 5.8
The Dexcom G7 CGM System is submitted as a proposed Integrated Continuous Glucose Monitoring (iCGM) designed to assist management of diabetes mellitus in persons 2 years and older. Information in this premarket notification demonstrates the Dexcom G7 CGM System conforms to the requirements of 21 CFR 862.1355 (iCGM Special Controls) and all mitigation measures necessary for identified risks to health are successfully implemented.
The submitted information in this premarket notification supports the Dexcom G7 CGM System is substantially equivalent to the Dexcom G6 CGM System as they are identical with regard to intended use and there are no differences in indications, technological characteristics or performance that raise new questions of safety and effectiveness.