(88 days)
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 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 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.
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.
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 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 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 qlucose trends (up to 24 hours) from the transmitter.
This document, a 510(k) Premarket Notification from the FDA, details the equivalence of several Dexcom G6 Continuous Glucose Monitoring (CGM) Systems to previously cleared predicate devices. The core change in the subject devices compared to their predicates is a modified adhesive patch.
Therefore, the acceptance criteria and study proving the device meets these criteria would primarily relate to the performance of the device with this new adhesive patch, demonstrating it does not adversely affect the system's safety and effectiveness.
Based on the provided text, here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document states that the proposed devices performed "according to their respective specifications" and "met their technological and performance criteria which have not changed from the predicate devices." Because the submission is based on substantial equivalence due to a minor change (adhesive patch), specific performance metrics and their acceptance criteria are not explicitly detailed in this summary; rather, the underlying assumption is that the performance remains consistent with the already-cleared predicates.
Therefore, the table would look like this:
| Acceptance Criteria (Not explicitly detailed, assumed to be consistent with predicate performance) | Reported Device Performance |
|---|---|
| Demonstrated safety and effectiveness of the CGM system for its intended use. | Performed according to respective specifications. |
| Maintained technological and performance criteria of the predicate devices. | Met technological and performance criteria. |
| Adhesive patch does not adversely impact safety or effectiveness. | Substantially Equivalent with no adverse impact on safety or effectiveness. |
For a CGM system, typical performance metrics would include:
- Accuracy (e.g., MARD - Mean Absolute Relative Difference): How close the CGM readings are to reference blood glucose values.
- Time in Range (TIR): Percentage of time glucose readings are within a target range.
- Detection of Hypo/Hyperglycemia: Ability to accurately identify low and high glucose events.
- Sensor Wear Time: The specified duration the sensor can be worn (stated as up to 10 days).
- Alarm/Alert Performance (where applicable): Timeliness and accuracy of alerts.
- Adhesion Performance: Ensuring the new patch maintains the sensor on the body for the intended wear time without causing adverse skin reactions.
However, these specific quantitative criteria are not provided in this 510(k) summary, as the submission focuses on the impact of the adhesive patch change.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions that the devices "were verified and validated according to Dexcom's internal design control process." It does not provide explicit details about the sample sizes used in the testing or the specific provenance of the data (country of origin, retrospective/prospective). This level of detail is typically found in the full 510(k) submission, not the summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not provided in the document. For CGM systems, the "ground truth" for glucose values is typically established using a highly accurate laboratory reference method (e.g., YSI analyzer) for blood samples, rather than human expert consensus, as it's a quantitative measurement.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided as it's not relevant for device performance evaluation of a CGM system based on quantitative measurements against a reference. Adjudication methods like 2+1 or 3+1 are common in diagnostic image interpretation studies where human expert consensus on image findings serves as ground truth.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC study is relevant for AI-assisted image interpretation. This document describes a Continuous Glucose Monitoring (CGM) system, which is a sensor-based medical device that measures glucose levels directly. It is not an AI-assisted diagnostic imaging device, and therefore, an MRMC comparative effectiveness study would not be applicable or performed for this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
For a CGM system, the device (sensor + transmitter + algorithm) generates glucose values autonomously. The "human-in-the-loop" is the user who interprets these values for diabetes management. The system is inherently designed to provide standalone glucose readings. The "Estimated Glucose Value (EGV) using an onboard algorithm" indicates standalone algorithmic performance. The document states: "Interpretation of the Dexcom G6 System results should be based on the glucose trends and several sequential readings over time" and the system "aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments."
This confirms that the algorithm provides direct, actionable results, and its performance is evaluated as a standalone system generating glucose values.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for a CGM system is typically established by concurrent blood glucose measurements obtained using a highly accurate laboratory reference method (e.g., YSI glucose analyzer) from venous blood draws. While not explicitly stated in this summary, this is the standard for CGM validation. The device's "Estimated Glucose Values (EGV)" are compared against these laboratory reference values.
8. The sample size for the training set
This document describes a 510(k) submission for a device change (adhesive patch) to existing, cleared devices. The core algorithms (e.g., "Joint Probability Algorithm") are already established and cleared from prior submissions (the predicates). Therefore, specific training set information for the algorithms themselves is not detailed here, as the algorithms are not being fundamentally changed or retrained. The testing mentioned in this document (verification and validation) would be focused on demonstrating that the new adhesive patch does not negatively impact the already-established performance of the system.
9. How the ground truth for the training set was established
As in point 8, the algorithms are inherited from previously cleared devices. For the original development of these algorithms, the ground truth would have been established through extensive clinical studies involving human subjects, where CGM readings were compared against simultaneous, high-accuracy laboratory reference blood glucose measurements. The process would involve collecting paired data points (CGM reading and reference blood glucose) across a wide range of glucose values, physiological states, and patient populations.
§ 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.