(30 days)
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, 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 proposed Dexcom G6 Glucose Program Continuous Glucose Monitoring System consists of three main components: the sensor/applicator delivery system, transmitter, and 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 either the Android app (part of the predicate system) or iOS app (part of the proposed system). The app displays the current glucose reading (updated every 5 minutes) and glucose trends from the transmitter. The app alert users of important system conditions, when it enters an error state, or when it requires the user to enter information. The app also supports connectivity to Dexcom Share and the Follow mobile application.
This document describes a 510(k) premarket notification for the Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System. The submission, K193642, seeks to add an iOS mobile application to an existing Android-based system. As such, the performance data provided largely defers to the existing predicate and reference devices.
Here's an analysis of the provided information concerning acceptance criteria and study data:
Overall Assessment:
The document does not contain explicit acceptance criteria tables with numerical targets, nor does it present detailed performance study results from a new test set for K193642. This is because the core technology (sensor, transmitter, underlying algorithm) and the intended use remain unchanged from the predicate device (K192787) and reference device (K182041). The current submission is primarily for the addition of an iOS application that functions identically to the already cleared Android application. Therefore, performance claims and acceptance are based on the previously cleared devices.
The document states: "All testing performed on the predicate device and reference device in accordance with special controls for integrated continuous glucose monitors remain applicable." and "Therefore, performance testing and software verification and validation testing completed for the predicate device (K192787) remain applicable."
Given this, I will extract information related to what would be the basis for acceptance for such a device, and explicitly note where the information is not present in this specific submission document as a new study.
1. Table of Acceptance Criteria and Reported Device Performance
As noted, this document (K193642) does not present a new table of acceptance criteria with numerical targets and corresponding performance data from a new study specific to the iOS app's glucose measurement accuracy. Instead, it relies on the predicate (K192787) and reference (K182041) devices for performance.
For a CGM system, typical acceptance criteria and performance metrics would include:
| Metric (Hypothetical for CGM) | Acceptance Criteria (Example) | Reported Device Performance (Likely from K192787/K182041) | Comments (Based on provided text) |
|---|---|---|---|
| Accuracy (MARD) | Overall MARD 95% of points in Zones A+B | Not explicitly reported in K193642 | Similar to MARD, this is a standard accuracy metric for CGM. Performance data for the predicate devices would have included this. |
| Hypoglycemic Detection Accuracy | Sensitivity/Specificity > X% for low glucose | Not explicitly reported in K193642 | Critical for safety, especially given the "replace fingerstick" indication. Data from predicate submissions would cover this. |
| Hyperglycemic Detection Accuracy | Sensitivity/Specificity > Y% for high glucose | Not explicitly reported in K193642 | Important for therapy adjustments. Data from predicate submissions would cover this. |
| Sensor Wear Time (Usability/Reliability) | Consistent performance over 10-day wear period | "updated every 5 minutes" (implied continuous) | The device's continuous monitoring and 10-day wear are fundamental, but specific metrics like sensor failures or premature removals are not detailed here for this specific submission. This would have been part of the original G6 clearance. |
| Software Functionality (iOS App) | All specified features (display, alerts, connectivity) function correctly and identically to Android app. | Software testing completed to ensure all requirements are fulfilled. | The core of this submission is validating the iOS app. The document confirms software testing was done to ensure the iOS app meets its requirements and functions similarly to the Android app. No specific detailed performance metrics for the iOS app's new software verification are presented beyond this general statement. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated for this specific submission (K193642) regarding new clinical performance data. The submission relies on the data from the predicate (K192787) and reference (K182041) devices. These previous submissions would have contained the sample sizes for their clinical studies.
- Data Provenance: Not explicitly stated for this specific submission. Given Dexcom's nature, previous studies would likely be prospective clinical trials conducted with human subjects. The country of origin for previous studies is not specified in this document, but typically for a US FDA submission, significant clinical data would either be from the US or internationally recognized clinical trials. It implies that data is prospective as it's from clinical trials for performance verification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This document does not describe the establishment of a "ground truth" using human experts for image or signal interpretation, as it's a CGM device, not an AI diagnostic imaging algorithm. For CGM devices, the ground truth is typically established by laboratory reference methods for blood glucose, not expert consensus. These methods are highly accurate and standardized (e.g., YSI instrument measurements).
4. Adjudication Method for the Test Set
Not applicable in the context of a CGM device performing direct physiological measurements against a reference lab method. Adjudication (e.g., 2+1, 3+1) is typically used in studies where human readers are interpreting complex data (like medical images) and their opinions need to be reconciled to form a ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done? No, an MRMC study was not done. MRMC studies are relevant for evaluating the impact of AI on human reader performance for tasks involving interpretation (e.g., radiology). This is a continuous glucose monitor; its function is to measure glucose, not to assist human interpretation in the way an AI would.
- Effect Size of Human Improvement: Not applicable, as no MRMC study was performed.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance
- Was it done? Yes, the core performance of the Dexcom G6 system (sensor, transmitter, and onboard algorithm) is evaluated in a standalone manner against laboratory reference methods. The system autonomously measures and processes glucose data.
- Details: While K193642 itself doesn't present new standalone performance data, it explicitly states that the previous standalone performance testing for the predicate (K192787) and reference (K182041) devices remains applicable. The device "samples the electrical current produced by the sensor and converts these measurements into glucose readings using an onboard algorithm." This "onboard algorithm" is the standalone component, and its accuracy is assessed by comparing its output directly to reference glucose values.
7. The Type of Ground Truth Used
The ground truth for CGM devices is established by laboratory reference blood glucose measurements. These are highly accurate measurements from a venipuncture blood sample, typically performed in a clinical setting using a YSI glucose analyzer or similar highly accurate laboratory method. This is a form of "outcomes data" or "pathology" in the sense of a gold standard for a physiological measurement.
8. The Sample Size for the Training Set
- Not explicitly stated in K193642. The G6 system's core algorithm was likely developed and trained using extensive datasets from previous clinical studies and internal data. The training set size for the original G6 algorithm (from predicate/reference devices) would have been substantial, but this specific submission does not provide those details. Since the algorithm itself is not being fundamentally changed, new training is not the focus of this 510(k).
9. How the Ground Truth for the Training Set Was Established
- Not explicitly stated in K193642. For the development and training of the original G6 algorithm (from predicate/reference devices), the ground truth for the training set would have also been established using laboratory reference blood glucose measurements, similar to the test set ground truth. These measurements would be collected concurrently with the sensor readings over a long period from a diverse group of individuals to train the algorithm to accurately translate interstitial fluid glucose signals into blood glucose estimates.
§ 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.