(88 days)
Not Found
Unknown
The document mentions an "onboard algorithm" used to convert sensor measurements into estimated glucose values, but it does not specify if this algorithm utilizes AI or ML techniques. The focus of the summary is on the device's function and components, not the specifics of the data processing algorithm.
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, which are all therapeutic actions. Additionally, it can communicate with automated insulin dosing (AID) systems, which are therapeutic devices.
No
The device is a continuous glucose monitoring device intended for the management of diabetes, not specifically for diagnosing a condition. It aids in the detection of episodes of hyperglycemia and hypoglycemia and facilitates therapy adjustments, which are aspects of management rather than initial diagnosis.
No
The device description explicitly states that the system consists of hardware components including a sensor/applicator and a transmitter, in addition to the software components (receiver and/or mobile application).
Based on the provided text, the Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System, and Dexcom G6 Professional Continuous Glucose Monitoring System are IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use clearly states that these devices are for the "management of diabetes" and are "intended to replace fingerstick blood glucose testing for diabetes treatment decisions." This indicates that the devices are used to obtain information about a physiological state (glucose levels) for the purpose of diagnosis, monitoring, or treatment.
- Device Description: The description explains that the sensor converts glucose in subcutaneous tissue into an electrical current, which is then converted into estimated glucose values. This process involves analyzing a biological sample (interstitial fluid, which is in equilibrium with blood glucose) to obtain a measurement relevant to a medical condition.
- Regulatory Context: The text mentions that the devices were verified and validated "in accordance with special controls for integrated continuous glucose monitors" and references predicate devices with K numbers (K201328, K203089, K191833). Devices subject to FDA special controls and requiring 510(k) clearance (indicated by K numbers) are typically medical devices, and given the nature of glucose monitoring, they fall under the IVD category.
While the device measures glucose in interstitial fluid rather than directly in blood, the principle of analyzing a biological sample to provide diagnostic information for the management of a disease aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
The Dexcom G6 Glucose Program Continuous Glucose Monitoring System (Dexcom Glucose Program System) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons 2 years and older.
The Dexcom Glucose Program System is intended to replace fingerstick blood glucose testing for diabetes treatment decisions for persons with diabetes who are not at significant risk of severe hypoglycemia. Interpretation of the Dexcom Glucose Program System results should be based on the glucose trends and several sequential sensor readings over time. The Dexcom Glucose Program System also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating long-term therapy adjustments.
The Dexcom Glucose Program System is also intended to autonomously communicate with digitally connected devices. The Dexcom Glucose Program System can be used alone or in conjunction with these digitally connected devices or services for the purpose of managing diabetes.
The Dexcom G6 Professional Continuous Glucose Monitoring System (Dexcom G6 Pro System) is a real time continuous glucose monitoring device indicated for the management of diabetes in persons age 2 years and older in a home environment while under the supervision of a healthcare professional. The Dexcom G6 Pro System is intended to replace fingerstick blood glucose testing for diabetes treatment decisions. Interpretation of the real-time Dexcom G6 Pro System results should be based on the glucose trends and several sequential readings over time.
The Dexcom G6 Pro System may also be used as a retrospective glucose recording device indicated for assessing glycemic variability in persons age 2 years and older in a home environment while under the supervision of a healthcare professional. Retrospective interpretation of data recorded by the Dexcom G6 Pro System should be conducted solely by a healthcare professional.
The Dexcom G6 Pro System aids in detecting glucose excursions facilitating care plan adjustments. The Dexcom G6 Pro System is also intended to interface with digitally connected devices. The Dexcom G6 Pro System can be used alone or in conjunction with these digitally connected medical devices for managing diabetes or assessing glycemic variability.
Product codes (comma separated list FDA assigned to the subject device)
QBJ, QDK, QII
Device Description
The proposed Dexcom G6 CGM System, Dexcom G6 Glucose Program CGM System, and Dexcom G6 Professional CGM System are based on the same physical principles and fundamental design as the predicate for each respective system but includes a modified adhesive patch. The adhesive patch adheres the transmitter holder to the user's body. The Dexcom G6 CGM System, Dexcom G6 Glucose Program CGM System, and the Dexcom G6 Professional CGM System are designed to function as intended with either the proposed or current adhesive patch. The proposed adhesive patch has the same form, fit, and function as the commercial adhesive patch and, from the users' perspective, functions identically.
Dexcom G6 CGM System
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 glucose 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 glucose 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.
Dexcom G6 Glucose Program CGM System
The Dexcom G6 Glucose Program Continuous Glucose Monitoring System measures and displays glucose values and trends for patients with diabetes who are not at significant risk of severe hypoglycemia. The system is factory calibrated and provides continuous glucose readings at five-minute intervals for up to ten days of use. The system consists of a sensor/applicator, a Bluetooth Low Energy (BLE) transmitter, and a mobile CGM software module (app module) that is embedded within a third-party program provider's mobile app (host app).
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 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 app module, which displays the current glucose reading (updated every 5 minutes) and glucose trends. The app module does not include any glucose related alarm or alerts but will alert the user when important system conditions occur.
Dexcom G6 Professional CGM System
The Dexcom G6 Professional CGM System is a continuous glucose monitor that offers an introduction to CGM for users who would benefit from the supervision of their qualified Healthcare Professional (HCP) during early or initial use of CGM.
The G6 Professional CGM System consists of three main components: a sensor/applicator delivery system, a transmitter, and a mobile application (app). The sensor is a small and flexible wire inserted into subcutaneous tissue where it converts glucose into electrical current. The G6 Professional CGM System transmitter is connected to the sensor and is worn on the body. It samples the electrical current produced by the sensor and converts these measurements into glucose readings using an onboard algorithm. The G6 Professional CGM System transmitter's firmware includes an auto-start feature which enables the transmitter to start a session immediately upon attachment of the transmitter to the on-body wearable. The G6 Professional CGM System transmitter can be used as a retrospective CGM data logger, and it can also send real-time estimated glucose values to the G6 Mobile Application. The HCP elects which type of CGM session the patient receives (retrospective vs. real-time). The G6 Professional CGM System transmitter firmware supports a single-use 10-day sensor session per transmitter. The G6 Mobile Application displays the current glucose reading (updated every 5 minutes) and glucose trends (up to 24 hours) from the transmitter.
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
Home environment while under the supervision of a healthcare professional (for Professional system); users and healthcare professionals. The Professional system's sensor insertion, transmitter attachment and retrospective glucose data download occurs in a clinic with a healthcare professional.
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, Dexcom G6 Glucose Program CGM System, and Dexcom G6 Professional CGM System were verified and validated according to Dexcom's internal design control process and in accordance with special controls for integrated continuous glucose monitors. This testing demonstrated that the proposed systems performed according to their respective specifications; and the proposed systems have met their technological and performance criteria which have not changed from the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
July 29, 2022
Dexcom, Inc. Rachel Ellena Senior Specialist, Regulatory Affairs 6340 Sequence Dr. San Diego, California 92121
Re: K221259
Trade/Device Name: Dexcom G6 Continuous Glucose Monitoring (CGM) System Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System Dexcom G6 Professional 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, QDK, QII Dated: April 29, 2022 Received: May 2, 2022
Dear Rachel Ellena:
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.
1
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, Ph.D. Deputy 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K221259
Device Name
Dexcom G6 Professional Continuous Glucose Monitoring (CGM) System
Indications for Use (Describe)
The Dexcom G6 Professional Continuous Glucose Monitoring System (Dexcom G6 Pro System) is a real time continuous glucose monitoring device indicated for the management of diabetes in persons age 2 years and older in a home environment while under the supervision of a healthcare professional. The Dexcom G6 Pro System is intended to replace fingerstick blood glucose testing for diabetes treatment decisions. Interpretation of the real-time Dexcom G6 Pro System results should be based on the glucose trends and several sequential readings over time.
The Dexcom G6 Pro System may also be used as a retrospective glucose recording device indicated for assessing glycemic variability in persons age 2 years and older in a home environment while under the supervision of a healthcare professional. Retrospective interpretation of data recorded by the Dexcom G6 Pro System should be conducted solely by a healthcare professional.
The Dexcom G6 Pro System aids in detecting glucose excursions facilitating care plan adjustments. The Dexcom G6 Pro System is also interface with digitally connected devices. The Dexcom G6 Pro System can be used alone or in conjunction with these digitally connected medical devices for managing diabetes or assessing glycemic variability.
| 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) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☑ 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."
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K221259
Device Name
Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System
Indications for Use (Describe)
The Dexcom G6 Glucose Program Continuous Glucose Monitoring System (Dexcom Glucose Program System) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons 2 years and older.
The Dexcom Glucose Program System is intended to replace fingerstick blood glucose testing for diabetes treatment decisions for persons with diabetes who are not at significant risk of severe hypoglycemia. Interpretation of the Dexcom Glucose Program System results should be based on the glucose trends and several sequential sensor readings over time. The Dexcom Glucose Program System also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating long-term therapy adjustments.
The Dexcom Glucose Program System is also intended to autonomously communicate with digitally connected devices. The Dexcom Glucose Program System can be used alone or in conjunction with these digitally connected devices or services 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) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☑ 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."
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K221259
Device Name
Dexcom G6 Continuous Glucose Monitoring (CGM) System
Indications for Use (Describe)
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.
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."
5
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: K221259
7.1. Submitter
Dexcom, Inc. 6340 Sequence Dr. San Diego, CA 92121 Contact: Rachel Ellena Position/Title: Senior Specialist, Regulatory Affairs Phone: 858-203-6046 Email: rachel.ellena@dexcom.com
Secondary Contact: Linda Wang Position/Title: Manager, Regulatory Affairs Phone: 858-203-6397 Email: linda.wang@dexcom.com
Date Prepared: July 26, 2022
| 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 |
| Proprietary Name | Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System |
| Class | II |
| Classification Regulation | 21 CFR 862.1355 |
| Product Code | QDK |
| Review Panel | Clinical Chemistry |
| Proprietary Name | Dexcom G6 Professional Continuous Glucose Monitoring (CGM) System |
| Class | II |
| Classification Regulation | 21 CFR 862.1355 |
| Product Code | QII |
| Review Panel | Clinical Chemistry |
7.2. Device Names and Classification
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7.3. Predicate Device
Dexcom G6 Continuous Glucose Monitoring (CGM) System (K201328, cleared July 15, 2021) Dexcom G6 Glucose Program CGM System (K203089, cleared August 17, 2021) Dexcom G6 Professional CGM System (K191833, cleared October 7, 2019)
7.4. Device Description
The proposed Dexcom G6 CGM System, Dexcom G6 Glucose Program CGM System, and Dexcom G6 Professional CGM System are based on the same physical principles and fundamental design as the predicate for each respective system but includes a modified adhesive patch. The adhesive patch adheres the transmitter holder to the user's body. The Dexcom G6 CGM System, Dexcom G6 Glucose Program CGM System, and the Dexcom G6 Professional CGM System are designed to function as intended with either the proposed or current adhesive patch. The proposed adhesive patch has the same form, fit, and function as the commercial adhesive patch and, from the users' perspective, functions identically.
Dexcom G6 CGM System 7.4.1.
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 glucose 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 glucose 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.
7.4.2. Dexcom G6 Glucose Program CGM System
The Dexcom G6 Glucose Program Continuous Glucose Monitoring System measures and displays glucose values and trends for patients with diabetes who are not at significant risk of severe hypoglycemia. The system is factory calibrated and provides continuous qlucose readings at five-minute intervals for up to ten days of use. The system consists of a sensor/applicator, a Bluetooth Low Energy (BLE) transmitter, and a mobile CGM software module (app module) that is embedded within a third-party program provider's mobile app (host app).
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 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
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onboard algorithm. The transmitter sends glucose data to the app module, which displays the current glucose reading (updated every 5 minutes) and glucose trends. The app module does not include any glucose related alarm or alerts but will alert the user when important system conditions occur.
7.4.3. Dexcom G6 Professional CGM System
The Dexcom G6 Professional CGM System is a continuous glucose monitor that offers an introduction to CGM for users who would benefit from the supervision of their qualified Healthcare Professional (HCP) during early or initial use of CGM.
The G6 Professional CGM System consists of three main components: a sensor/applicator delivery system, a transmitter, and a mobile application (app). The sensor is a small and flexible wire inserted into subcutaneous tissue where it converts glucose into electrical current. The G6 Professional CGM System transmitter is connected to the sensor and is worn on the body. It samples the electrical current produced by the sensor and converts these measurements into glucose readings using an onboard algorithm. The G6 Professional CGM System transmitter's firmware includes an auto-start feature which enables the transmitter to start a session immediately upon attachment of the transmitter to the on-body wearable. The G6 Professional CGM System transmitter can be used as a retrospective CGM data logger, and it can also send real-time estimated glucose values to the G6 Mobile Application. The HCP elects which type of CGM session the patient receives (retrospective vs. real-time). The G6 Professional CGM System transmitter firmware supports a single-use 10-day sensor session per transmitter. The G6 Mobile Application displays the current glucose reading (updated every 5 minutes) and qlucose trends (up to 24 hours) from the transmitter.
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 hypoqlycemia, 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.
Dexcom G6 Glucose Program CGM System 7.5.2.
The Dexcom G6 Glucose Program Continuous Glucose Monitoring System (Dexcom Glucose Program System) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons 2 years and older.
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The Dexcom Glucose Program System is intended to replace fingerstick blood ducose testing for diabetes treatment decisions for persons with diabetes who are not at significant risk of severe hypoglycemia. Interpretation of the Dexcom Glucose Program System results should be based on the glucose trends and several sequential sensor readings over time. The Dexcom Glucose Program System also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating long-term therapy adjustments.
The Dexcom Glucose Program System is also intended to autonomously communicate with digitally connected devices. The Dexcom Glucose Program System can be used alone or in conjunction with these digitally connected devices or services for the purpose of managing diabetes.
Dexcom G6 Professional CGM System 7.5.3.
The Dexcom G6 Professional Continuous Glucose Monitoring System (Dexcom G6 Pro System) is a real time continuous glucose monitoring device indicated for the management of diabetes in persons age 2 years and older in a home environment while under the supervision of a healthcare professional. The Dexcom G6 Pro System is intended to replace fingerstick blood qlucose testing for diabetes treatment decisions. Interpretation of the real-time Dexcom G6 Pro System results should be based on the glucose trends and several sequential readings over time.
The Dexcom G6 Pro System may also be used as a retrospective glucose recording device indicated for assessing glycemic variability in persons age 2 years and older in a home environment while under the supervision of a healthcare professional. Retrospective interpretation of data recorded by the Dexcom G6 Pro System should be conducted solely by a healthcare professional.
The Dexcom G6 Pro System aids in detecting glucose excursions facilitating care plan adjustments. The Dexcom G6 Pro System is also intended to interface with digitally connected devices. The Dexcom G6 Pro System can be used alone or in coniunction with these digitally connected medical devices for managing diabetes or assessing glycemic variability.
Comparison with the Predicate Device 7.6.
| Device | Predicate Device (K201328) | Subject Device |
|---|---|---|
| Trade Name | Dexcom G6 Continuous Glucose Monitoring (CGM) | |
| System | Same | |
| 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 | Same | |
| Device | Predicate Device (K201328) | Subject Device |
| purpose of managing a disease or condition related | ||
| to glycemic control. | ||
| 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 | Easy to understand UI/UX. | |
| Commonly understood navigation tools and | ||
| features. | ||
| Color-coded graphics. | Same | |
| Compatibility with | ||
| Intended | ||
| Environments | Android OS and Apple iOS | Same |
| Device | Predicate Device (K201328) | Subject Device |
| Adhesive Patch | Dermamed patch | |
| MA-91/MA-128 patch | Substantially | |
| Equivalent with no | ||
| adverse impact on | ||
| safety or | ||
| effectiveness. | ||
| The proposed Dexcom | ||
| G6 CGM System uses | ||
| a medical grade MA- | ||
| 173 adhesive patch |
Dexcom G6 CGM System 7.6.1.
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7.6.2. Dexcom G6 Glucose Program CGM System
| Device | Predicate Device (K203089) | Subject Device |
|---|---|---|
| Trade Name | Dexcom G6 Glucose Program Continuous Glucose | |
| Monitoring (CGM) System | Same | |
| 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 G6 Glucose Program Continuous | |
| Glucose Monitoring System (Dexcom Glucose | ||
| Program System) is a real time, continuous glucose | ||
| monitoring device indicated for the management of | ||
| diabetes in persons age 2 years and older. | ||
| The Dexcom Glucose Program System is intended | ||
| to replace fingerstick blood glucose testing for | ||
| diabetes treatment decisions for persons with | ||
| diabetes who are not at significant risk of severe | ||
| hypoglycemia. Interpretation of the Dexcom | ||
| Glucose Program System results should be based | ||
| on the glucose trends and several sequential sensor | ||
| readings over time. The Dexcom Glucose Program | ||
| System also aids in the detection of episodes of | ||
| hyperglycemia and hypoglycemia, facilitating long- | ||
| term therapy adjustments. | ||
| The Dexcom Glucose Program System is also | ||
| intended to autonomously communicate with | ||
| digitally connected devices. The Dexcom Glucose | ||
| Program System can be used alone or in | ||
| conjunction with these digitally connected devices or | ||
| services for the purpose of managing diabetes. | Same | |
| Clinical Application | Management of diabetes mellitus | Same |
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| Device | Predicate Device (K203089) | Subject Device |
|---|---|---|
| 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. | ||
| Time in Range: Users can view the percent of time | ||
| they spend in their target glucose range based on | ||
| their configured high/low glucose thresholds. | Same | |
| Glucose Value | ||
| Estimation Algorithm | Joint Probability Algorithm | Same |
| Factory Calibration | Yes | Same |
| Optional Calibration | No | Same |
| Features | Chat feature can be accessed through the host app | Same |
| Human Factors | Easy to understand UI/UX. | |
| Commonly understood navigation tools and | ||
| features. | ||
| Color-coded graphics. | Same | |
| Compatibility with | ||
| Intended | ||
| Environments | Android OS and Apple iOS | Same |
| Adhesive Patch | Dermamed patch | |
| MA-91/MA-128 patch | Substantially | |
| Equivalent with no | ||
| adverse impact on safety | ||
| or effectiveness. | ||
| The proposed Dexcom | ||
| G6 Glucose Program | ||
| CGM System uses a | ||
| medical grade MA-173 | ||
| adhesive patch |
7.6.3. Dexcom G6 Professional CGM System
| Device | Predicate Device (K191833) | Subject Device |
|---|---|---|
| Trade Name | Dexcom G6 Professional Continuous Glucose | |
| Monitoring (CGM) System | Same | |
| 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 | Same | |
| Device | Predicate Device (K191833) | Subject Device |
| 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. | ||
| Indications for Use | The Dexcom G6 Professional Continuous Glucose | |
| Monitoring System (Dexcom G6 Pro System) is a real | ||
| time continuous glucose monitoring device indicated for | ||
| the management of diabetes in persons age 2 years and | ||
| older in a home environment while under the | ||
| supervision of a healthcare professional. The Dexcom | ||
| G6 Pro System is intended to replace fingerstick blood | ||
| glucose testing for diabetes treatment decisions. | ||
| Interpretation of the real-time Dexcom G6 Pro System | ||
| results should be based on the glucose trends and | ||
| several sequential readings over time. | ||
| The Dexcom G6 Pro System may also be used as a | ||
| retrospective glucose recording device indicated for | ||
| assessing glycemic variability in persons age 2 years | ||
| and older in a home environment while under the | ||
| supervision of a healthcare professional. Retrospective | ||
| interpretation of data recorded by the Dexcom G6 Pro | ||
| System should be conducted solely by a | ||
| healthcare professional. | ||
| The Dexcom G6 Pro System aids in detecting glucose | ||
| excursions facilitating care plan adjustments. The | ||
| Dexcom G6 Pro System is also intended to interface | ||
| with digitally connected devices. The Dexcom G6 Pro | ||
| System can be used alone or in conjunction with these | ||
| digitally connected medical devices for managing | ||
| diabetes or assessing glycemic variability. | Same | |
| Clinical Application | Management of diabetes mellitus or assessing glycemic | |
| control in other conditions | Same | |
| Clinical Setting/Sites | ||
| of Use | Home use (sensor insertion, transmitter attachment and | |
| retrospective glucose data download occurs in a clinic | ||
| with a healthcare professional) | 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 | No | Same |
| Human Factors | Easy to understand UI/UX. | |
| Commonly understood navigation tools and features. | Same | |
| Device | Predicate Device (K191833) | Subject Device |
| Color-coded graphics. | ||
| Compatibility with | ||
| Intended | ||
| Environments | Android OS and Apple iOS | Same |
| Adhesive Patch | Dermamed patch | |
| MA-91/MA-128 patch | Substantially | |
| Equivalent with no | ||
| adverse impact on | ||
| safety or | ||
| effectiveness. | ||
| The proposed | ||
| Dexcom G6 | ||
| Professional CGM | ||
| System uses a | ||
| medical grade MA- | ||
| 173 adhesive patch |
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7.7. Technological Characteristics
The proposed Dexcom G6 CGM System, Dexcom G6 Glucose Program CGM System, and Dexcom G6 Professional CGM System are used to measure glucose values via amperometric measurement of current proportional to glucose concentration in interstitial fluid via glucose oxidase chemical reaction. The proposed Dexcom G6 CGM System, Dexcom G6 Glucose Program CGM System, and Dexcom G6 Professional CGM System share the same technological characteristics as their respective predicates (K201328, K203089, K191833).
7.8. Summary of Performance Testing
The proposed Dexcom G6 CGM System, Dexcom G6 Glucose Program CGM System, and Dexcom G6 Professional CGM System were verified and validated according to Dexcom's internal design control process and in accordance with special controls for integrated continuous glucose monitors. This testing demonstrated that the proposed systems performed according to their respective specifications; and the proposed systems have met their technological and performance criteria which have not changed from the predicate devices.
Conclusions 7.9.
The proposed Dexcom G6 CGM System, Dexcom G6 Glucose Program CGM System, and Dexcom G6 Professional CGM System are substantially equivalent to their respective predicates as they are identical with regard to intended use and indications for use: and there are no differences in technological characteristics that raise different questions of safety and effectiveness.