(12 days)
Unknown
The summary mentions an "onboard algorithm" used by the transmitter to convert sensor measurements into estimated glucose values. While this is a computational process, the summary does not provide enough detail to determine if this algorithm utilizes AI or ML techniques. The lack of mention of AI, ML, DNN, training sets, or test sets further supports the "Unknown" determination.
Yes
The device is indicated for the management of diabetes, aids in the detection of hyperglycemia, and can be used with automated insulin dosing systems, all of which are directly related to therapy adjustments and overall patient management.
Yes
The device measures and displays glucose values, aids in the detection of hyperglycemia, and helps with therapy adjustments, which are all diagnostic functions for managing diabetes.
No
The device description explicitly states that the system consists of a sensor/applicator, a transmitter, and a display device (receiver and/or mobile application). These are physical hardware components, not solely software.
Based on the provided text, the Dexcom G6 Continuous Glucose Monitoring System is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "management of diabetes" and "to replace fingerstick blood glucose testing for diabetes treatment decisions." This indicates it's used to obtain information about a physiological state (glucose levels) from a sample (subcutaneous tissue fluid, which is a biological sample).
- Device Description: The device description explains that the sensor converts glucose into electrical current, which is then processed to provide estimated glucose values. This process involves analyzing a biological sample (glucose in subcutaneous tissue fluid) to provide diagnostic information.
- Nature of the Measurement: While the sensor is inserted into subcutaneous tissue, the measurement is of glucose, a chemical substance in the body's fluids. This aligns with the definition of an in vitro diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
Although the sample is collected in vivo (within the body), the analysis of the glucose in the interstitial fluid is considered an in vitro process in the context of regulatory definitions for devices that measure substances in bodily fluids.
Therefore, the Dexcom G6 System fits the criteria of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Dexcom G6 Continuous Glucose Monitoring System) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons age 2 years and older.
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 sequential readings over time. The Dexcom G6 System also aids in the detection of evisodes of hyperglycemia, 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.
Product codes
QBJ
Device Description
The proposed Dexcom G6 CGM System is based on the same physical principles and fundamental design as the predicate but includes an alternative receiver. This receiver has identical hardware to the G7 receiver (K213919). The Dexcom G6 CGM System is designed to function as intended with either the proposed or current commercial receiver. The proposed receiver has the same function as the commercial receiver.
The Dexcom G6 Continuous Glucose Monitoring System is an interoperable connected device that measures and displays glucose values for patients with diabetes. The G6 CGM System consists of three main components: a sensor/applicator, a Bluetooth Low Energy (BLE) transmitter, and a BLE enabled display device (receiver and/or mobile application). The sensor is a small and flexible wire, which is inserted by the applicator into subcutaneous tissue where it converts ducose into electrical current. The sensor has an expected wear time of up to 10 days. The transmitter is connected to the sensor and is worn on the body. The transmitter samples the electrical current produced by the sensor and converts these measurements into estimated glucose values (EGV) using an onboard algorithm. The transmitter sends glucose data to the receiver and/or mobile app, which displays the current qlucose reading (updated every 5 minutes) and glucose trends. The receiver and/or mobile app also alerts the user when glucose levels are outside of a target zone and when other important system conditions occur. The G6 CGM System is designed to be used alone or in conjunction with digitally connected devices. The G6 CGM System can communicate Estimated Glucose Values (EGV) and other information wirelessly and securely to and from these digitally connected devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous tissue
Indicated Patient Age Range
2 years and older
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The proposed Dexcom G6 CGM System was verified and validated according to Dexcom's internal design control process and in accordance with special controls for integrated continuous glucose monitoring systems. This testing demonstrated that the proposed system performs according to specifications and meets the technological and performance criteria which have not changed from the predicate device. The proposed system uses the same sensor, applicator, transmitter, and app requirements and design specifications as the predicate device. Therefore, performance testing and software verification and validation testing completed for the predicate device (K221259) remain applicable. Firmware and hardware testing was completed to ensure all requirements of the proposed receiver are fulfilled. This testing demonstrated that the proposed system performs according to specifications and meets the technological and performance criteria which have not changed from the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Dexcom G6 Continuous Glucose Monitoring (CGM) System (K221259
Reference Device(s)
Dexcom G6 Continuous Glucose Monitoring (CGM) System (DEN170088), Dexcom G7 Continuous Glucose Monitoring (CGM) System (K213919)
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 contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which 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.
January 11, 2023
Dexcom, Inc. Brittney Shaver Senior Specialist, Regulatory Affairs 6340 Sequence Drive San Diego, California 92121
Re: K223931
Trade/Device Name: Dexcom G6 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: December 29, 2022 Received: December 30, 2022
Dear Brittney Shaver:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 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,
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) K223931
Device Name
Dexcom G6 Continuous Glucose Monitoring (CGM) System
Indications for Use (Describe)
The Dexcom G6 Continuous Glucose Monitoring System) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons age 2 years and older.
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 sequential readings over time. The Dexcom G6 System also aids in the detection of evisodes of hyperglycemia, 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.
| Type of Use (Select one or both, as applicable) |
|---|
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary 7.
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: K223931
7.1. Submitter
Dexcom, Inc. 6340 Sequence Dr. San Diego, CA 92121 Contact: Brittney Shaver Position/Title: Senior Specialist, Regulatory Affairs Phone: 858-203-6381 Email: brittney.shaver@dexcom.com
Secondary Contact: Linda Wanq Position/Title: Manager, Regulatory Affairs Phone: 858-203-6397 Email: linda.wang@dexcom.com
Date Prepared: January 4, 2023
Device Names and Classification 7.2.
| Proprietary Name | Dexcom G6 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 |
Predicate and Reference Devices 7.3.
| Predicate Device |
|---|
| Dexcom G6 Continuous Glucose Monitoring (CGM) System (K221259, cleared July 29, 2022) |
| Reference Devices |
| Dexcom G6 Continuous Glucose Monitoring (CGM) System (DEN170088, granted March 27, 2018) |
| Dexcom G7 Continuous Glucose Monitoring (CGM) System (K213919, cleared December 8, 2022) |
Device Description 7.4.
The proposed Dexcom G6 CGM System is based on the same physical principles and fundamental design as the predicate but includes an alternative receiver. This receiver has identical hardware to the G7 receiver (K213919). The Dexcom G6 CGM System is designed to
4
function as intended with either the proposed or current commercial receiver. The proposed receiver has the same function as the commercial receiver.
7.4.1. Dexcom G6 CGM Svstem
The Dexcom G6 Continuous Glucose Monitoring System is an interoperable connected device that measures and displays glucose values for patients with diabetes. The G6 CGM System consists of three main components: a sensor/applicator, a Bluetooth Low Energy (BLE) transmitter, and a BLE enabled display device (receiver and/or mobile application). The sensor is a small and flexible wire, which is inserted by the applicator into subcutaneous tissue where it converts ducose into electrical current. The sensor has an expected wear time of up to 10 days. The transmitter is connected to the sensor and is worn on the body. The transmitter samples the electrical current produced by the sensor and converts these measurements into estimated glucose values (EGV) using an onboard algorithm. The transmitter sends glucose data to the receiver and/or mobile app, which displays the current qlucose reading (updated every 5 minutes) and glucose trends. The receiver and/or mobile app also alerts the user when glucose levels are outside of a target zone and when other important system conditions occur. The G6 CGM System is designed to be used alone or in conjunction with digitally connected devices. The G6 CGM System can communicate Estimated Glucose Values (EGV) and other information wirelessly and securely to and from these digitally connected devices.
7.5. Indications for Use
Dexcom G6 CGM System 7.5.1.
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.
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 longterm 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.
Comparison with the Predicate Device 7.6.
| Device | Predicate Device (K221259) | Subject Device |
|---|---|---|
| Trade Name | Dexcom G6 Continuous Glucose Monitoring (CGM) | |
| System | Same | |
| Manufacturer | Dexcom, Inc. | Same |
| General Device Characteristics | ||
| Device | Predicate Device (K221259) | Subject Device |
| Indications for | ||
| Use | 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. | ||
| 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. | Same | |
| Clinical | ||
| Application | Management of diabetes mellitus | Same |
| Clinical | ||
| Setting/Sites | ||
| of Use | Home Use | Same |
| Principle of | ||
| Operation | Amperometric measurement of current proportional to | |
| glucose concentration in interstitial fluid via glucose | ||
| oxidase chemical reaction. | Same | |
| Data | ||
| Presented | Estimated Glucose Value (EGV): The EGV is the | |
| nominal glucose value presented to the user. | ||
| Glucose Trend: Based off the glucose rate of change, | ||
| users are shown their glucose trend with a | ||
| corresponding arrow. | ||
| Historical Glucose Data: Users can view their previous | ||
| three, six, twelve, or twenty-four hours of glucose data. | Same | |
| Glucose Value | ||
| Estimation | ||
| Algorithm | Joint Probability Algorithm | Same |
| Factory | ||
| Calibration | Yes | Same |
| Optional | ||
| Calibration | Yes | Same |
| Features | Connect to Dexcom Share: Users can share their | |
| glucose data with followers. | ||
| Partner Web APIs: Users can share their glucose data | ||
| with client software. | Same | |
| Human | ||
| Factors | System usability validated through human factors | |
| testing. | Same | |
| Compatibility | ||
| with Intended | ||
| Environments | Android OS and Apple iOS | Same |
| Receiver | Touchscreen Receiver | Non-touchscreen receiver. |
Dexcom G6 CGM System 7.6.1.
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7.7. Technological Characteristics
The proposed Dexcom G6 CGM System is used to measure glucose via amperometric measurement of current proportional to glucose concentration in interstitial fluid via glucose oxidase chemical reaction. The proposed Dexcom G6 CGM System shares the same technological characteristics as the predicate (K221259).
7.8. Summary of Performance Testing
The proposed Dexcom G6 CGM System was verified and validated according to Dexcom's internal design control process and in accordance with special controls for integrated continuous glucose monitoring systems. This testing demonstrated that the proposed system performs according to specifications and meets the technological and performance criteria which have not changed from the predicate device. The proposed system uses the same sensor, applicator, transmitter, and app requirements and design specifications as the predicate device. Therefore, performance testing and software verification and validation testing completed for the predicate device (K221259) remain applicable. Firmware and hardware testing was completed to ensure all requirements of the proposed receiver are fulfilled. This testing demonstrated that the proposed system performs according to specifications and meets the technological and performance criteria which have not changed from the predicate device.
7.9. Conclusions
The proposed Dexcom G6 CGM System is substantially equivalent to the predicate system as it is identical with regards to intended use and indications for use; and there are no differences in technological characteristics that raise different questions of safety and effectiveness.