(88 days)
No
The summary describes an "onboard algorithm" for converting electrical current to glucose readings, but it does not mention AI, ML, or any related terms. The focus is on a standard continuous glucose monitoring system with an altered feature set compared to a predicate device.
Yes
The device is indicated for the management of diabetes and aids in the detection of hyperglycemia and hypoglycemia to facilitate long-term therapy adjustments, which are therapeutic actions.
Yes
Explanation: The device is a "Continuous Glucose Monitoring System" that measures glucose levels to aid in the "management of diabetes" and "aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating long-term therapy adjustments." This function of measuring physiological parameters and aiding in the detection of medical conditions directly aligns with the definition of a diagnostic device.
No
The device description clearly states that the system consists of three main components: a sensor/applicator delivery system, a transmitter, and a mobile application (app). The sensor and transmitter are hardware components that are essential to the device's function of measuring glucose.
Based on the provided text, the Dexcom G6 Glucose Program Continuous Glucose Monitoring System is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "management of diabetes" and is intended 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 (interstitial fluid, which is a body fluid).
- Device Description: The device description explains that the sensor is inserted into "subcutaneous tissue where it converts glucose into electrical current." This electrical current is then converted into "glucose readings." This process involves analyzing a biological sample (interstitial fluid containing glucose) to provide diagnostic information.
- Comparison to Fingerstick Testing: The statement that it's intended to "replace fingerstick blood glucose testing" is a strong indicator of its IVD nature, as fingerstick blood glucose testing is a classic example of an in vitro diagnostic test.
While the device is worn on the body and provides real-time data, the core function involves the analysis of a biological sample (interstitial fluid) to provide diagnostic information about glucose levels, which falls under the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
ODK
Device Description
The Dexcom G6 Glucose Program Continuous Glucose Monitoring System (Dexcom Glucose Program System) is a continuous glucose monitor (CGM) that offers an altered feature set versus the predicate Dexcom G6 CGM System.
The Dexcom Glucose Program 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 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 transmitter sends glucose data to the app. The app displays the current glucose reading (updated every 5 minutes) and glucose trends (up to 12 hours) from the transmitter. The app alerts users of important system conditions, when it enters an error state, or when requiring the user to enter information. The app also supports connectivity to Dexcom Share and Follow (DEN140016), however, the new app is a separate device from the Share and Follow apps.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
age 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Dexcom Glucose Program System was 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 system performed according to its specifications and that the technological and performance criteria are comparable to the predicate device.
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.
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.
0
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 the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
October 26, 2018
Dexcom, Inc. Luke Olson Senior Specialist, Regulatory Affairs 6340 Sequence Dr. San Diego, CA 92121
Re: K182041
Trade/Device Name: Dexcom G6 Glucose Program Continuous Glucose Monitoring System Regulation Number: 21 CFR 862.1355 Regulation Name: Integrated continuous glucose monitoring system Regulatory Class: Class II Product Code: ODK Dated: July 26, 2018 Received: July 30, 2018
Dear Luke Olson:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Kellie B. Kelm -S
for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K182041
Device Name
Dexcom G6 Glucose Program Continuous Glucose Monitoring 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 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 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) |
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510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is:
A. Submitter:
Dexcom, Inc.
6340 Sequence Dr.
San Diego, CA 92121
Contact: Luke Olson
Senior Regulatory Affairs Specialist
Phone: 858.875.5307
Fax: 858.332.0204
Email: lolson@dexcom.com
Date Prepared:
B. Device Names and Classification:
| Proprietary Name | Dexcom G6 Glucose Program Continuous Glucose
Monitoring System |
|---------------------------|------------------------------------------------------------------------|
| Common Name | Integrated Continuous Glucose Monitoring System,
Factory Calibrated |
| Class | II |
| Classification Regulation | 21 CFR 862.1355 |
| Product Code | QDK |
| Review Panel | Clinical Chemistry |
C. Predicate Device:
Dexcom G6 Continuous Glucose Monitoring System (DEN170088)
D. Device Description:
4
The Dexcom G6 Glucose Program Continuous Glucose Monitoring System (Dexcom Glucose Program System) is a continuous glucose monitor (CGM) that offers an altered feature set versus the predicate Dexcom G6 CGM System.
The Dexcom Glucose Program 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 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 transmitter sends glucose data to the app. The app displays the current glucose reading (updated every 5 minutes) and glucose trends (up to 12 hours) from the transmitter. The app alerts users of important system conditions, when it enters an error state, or when requiring the user to enter information. The app also supports connectivity to Dexcom Share and Follow (DEN140016), however, the new app is a separate device from the Share and Follow apps.
Indications for Use: ن
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 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 digitally connected devices or services for the purpose of managing diabetes.
| Device | Dexcom Glucose Program System
(K182041) | Dexcom G6 CGM System (DEN170088) |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Dexcom G6 Glucose Program
Continuous Glucose Monitoring
System | Dexcom G6 Continuous Glucose
Monitoring System |
| Manufacturer | Dexcom, Inc. | Dexcom, Inc. |
| 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 | The Dexcom G6 Continuous Glucose
Monitoring System (Dexcom G6 CGM
System) is a real time, continuous
glucose monitoring device indicated for
the management of diabetes in persons
age 2 years and older. |
| Device | Dexcom Glucose Program System
(K182041) | Dexcom G6 CGM System (DEN170088) |
| | 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 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 digitally
connected devices or services 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. |
| Clinical application | Management of diabetes mellitus | Management of diabetes mellitus |
| Clinical setting/sites
of use | Home use | Home use |
| Principle of
Operation | Amperometric measurement of
current proportional to glucose
concentration in interstitial fluid via
glucose oxidase chemical reaction | Amperometric measurement of current
proportional to glucose concentration in
interstitial fluid via glucose oxidase
chemical reaction |
| 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 six, or twelve | 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 |
| Device | Dexcom Glucose Program System
(K182041) | Dexcom G6 CGM System (DEN170088) |
| | hours of glucose data on a graph with
high/low glucose thresholds.
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. | |
| Features | Connect to Dexcom Share: Users can
share their glucose data with up to
three followers.
Chat with Wellness Coach: Users can
chat with a third-party wellness coach
for encouragement, education, and
motivation regarding their diabetes
management. | Connect to Dexcom Share: Users can
share their glucose data with up to five
followers. |
| Human Factors | Easy to understand UI/UX.
Commonly understood navigation
tools and features.
Color-coded graphics. | Easy to understand UI/UX.
Commonly understood navigation tools
and features.
Color-coded graphics. |
| Compatibility with
intended
environments | Compatible with the Samsung J3
Compatible with Android OS version
7.0 and above | Compatible with iPhone 5S through
iPhone X, Samsung Note 5, Note 8,
Galaxy S6-S9, J3, Google Pixel, LG G5-G6
Compatible with Android OS version 7.0
and above, and iOS version 10.3.2 and
above |
F. Comparison with the Predicate Device:
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6
F. Summary of Performance Testing
The Dexcom Glucose Program System was 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 system performed according to its specifications and that the technological and performance criteria are comparable to the predicate device.
G. Conclusions Drawn from Performance Testing
The Dexcom Glucose Program System is substantially equivalent to the Dexcom G6 Continuous Glucose Monitoring System as they are identical with regard to intended use and there are no differences in technological characteristics that raise different questions of safety and effectiveness. The Dexcom Glucose Program System provides a feature set
7
designed to help persons who are not at significant risk of severe hypoglycemia manage their diabetes.