(422 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 sequential readings over time. The Dexcom G6 System also aids in the detection of episodes of hyperglycemia, facilitating both acute and long-term therapy adjustments.
The Dexcom G6 System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The Dexcom G6 System can be used alone or in conjunction with these digitally connected medical devices for the purpose of managing diabetes.
The Dexcom G6 Continuous Glucose Monitoring System (G6 System) is an interoperable connected device that measures and displays glucose values for patients with diabetes. The G6 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 System is designed to be used alone or in conjunction with digitally connected devices. The G6 System can communicate Estimated Glucose Values (EGV) and other information wirelessly and securely to and from these digitally connected devices in several ways, such as described below:
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- Wireless communication from the transmitter directly to an interoperable device communicating through the same protocol.
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- The app communicates to another app on a single mobile platform.
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- The app communicates through the cloud to another software device.
The proposed G6 CGM System is based on the same physical principles and fundamental design as the commercially available G6 CGM System (K200876), but it includes an additional software component.
The added software component, which consists of cloud-based Application Programming Interfaces (APIs), is identified as Dexcom Partner Web APIs (Partner Web APIs). The Partner Web APIs enables communication of iCGM data to client software intended to receive the data through the cloud. The transmitted data can be used by authorized client software for specific and permitted use cases including non-medical device application, medical device data analysis, CGM secondary display alarm, active patient monitoring, and treatment decisions. The software application may not be used in environments not currently cleared for Dexcom G6 CGM System (e.g. hospital for inpatient care). The Partner Web APIs is not intended to be used by automated insulin delivery systems (AID).
Dexcom display devices (receiver and mobile app) continues to serve as a primary display device for the (iCGM) data, which directly receives the data from the transmitter. Identical to the G6 CGM System cleared in K200876, the mobile app includes a design mitigation that overrides Do Not Disturb settings on the smart device with the users' consent. With this app design mitigation, the G6 CGM system functions as intended to provide users with critical alarm and alerts (e.g. Urgent Low alarm) regardless of the user's smart device settings for Do Not Disturb. The current components of the Dexcom G6 System (sensor/applicator, transmitter, and display devices) have not been changed as a result of the added Partner Web APIs.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Dexcom G6 Continuous Glucose Monitoring System (K201328):
*The provided document is primarily a 510(k) summary for a premarket notification to the FDA. It does not contain specific details about acceptance criteria and the comprehensive study that proves the device meets those criteria, particularly the clinical performance data often found in a full submission. Instead, it focuses on demonstrating substantial equivalence to a predicate device (K2008776) due to an added software component.
Therefore, many of your requested points cannot be fully addressed from the given text. I will provide information where available and note when it is not present.
Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria and reported device performance for K201328. It states that the proposed system's technological and performance criteria have not changed from the predicate device (K2008776).
However, it implicitly relies on the performance of the predicate device. For a typical CGM, acceptance criteria would include metrics like:
- Accuracy (MARD - Mean Absolute Relative Difference): A measure of how close the CGM readings are to a reference blood glucose measurement.
- Accuracy (Consensus Error Grid Analysis): A visual representation of clinical accuracy, indicating how many CGM readings fall within clinically acceptable zones compared to reference values.
- Alert Performance: Accuracy of hyperglycemia/hypoglycemia alerts.
- Operating Conditions: Performance across various blood glucose levels, temperature, and wear time.
Since the submission is for an added software component (cloud-based APIs) to an already cleared device, the core clinical performance (e.g., MARD) is assumed to be carried over from the predicate. The "performance testing" mentioned in the document focuses on the new software component's specifications.
Therefore, a table of acceptance criteria and reported device performance cannot be generated from this document for the core CGM functionality, as it defers to the predicate device's performance.
The document does state that the added software component's own performance criteria were met:
| Acceptance Criteria (for added software component) | Reported Device Performance (for added software component) |
|---|---|
| Data confidentiality fulfilled | Fulfilled (software verification) |
| Data integrity fulfilled | Fulfilled (software verification) |
| Timely availability fulfilled | Fulfilled (software verification) |
| Interoperability communication plan met | Substantially equivalent with no adverse impact on safety or effectiveness. |
| Secure and reliable data transmission | Ensured by interoperability communication plan. |
Study Information (Based on available text)
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Sample size used for the test set and the data provenance:
- Not explicitly stated in this document. The document refers to "software verification" for the new component. For the underlying CGM performance (which is attributed to the predicate), this information would be in the predicate's 510(k) submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not stated. This type of information is typically for studies involving human interpretation (e.g., imaging studies). The Dexcom G6 is an automated glucose measurement device. Its "ground truth" would be established by a laboratory reference method, not expert consensus.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not stated. See point 2.
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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:
- Not applicable. The Dexcom G6 is a continuous glucose monitoring system, not an AI-assisted diagnostic imaging device that requires human "readers." The "AI" would be the algorithm that processes raw sensor data into glucose values.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The Dexcom G6 CGM system, by its nature, is a standalone device that measures glucose values algorithmically. The "human-in-the-loop" refers to the user observing the displayed values and trends. The core performance data (MARD, etc.) typically evaluates the algorithm's accuracy against a lab reference. The current submission focuses on the communication of these algorithmically derived values.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For glucose monitoring devices, the ground truth is typically established using a laboratory reference method for blood glucose measurement (e.g., YSI analyzer, hexokinase method). The document refers to "estimated glucose values (EGV)" generated by an "onboard algorithm" compared to which the system's accuracy would be assessed.
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The sample size for the training set:
- Not stated in this document. The document describes an "onboard algorithm" for converting sensor data to glucose values, which would have been developed and trained using a dataset. This information would be part of the original K2008776 submission, not this update.
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How the ground truth for the training set was established:
- Not stated in this document, but inferred to be laboratory reference methods. Similar to the test set ground truth, the training data for the internal algorithm would have been paired with accurate laboratory blood glucose measurements.
In summary, this 510(k) submission (K201328) is for a modification (added software component, Partner Web APIs) to an already cleared device (K2008776). Therefore, it largely emphasizes the substantial equivalence of the modified device to its predicate, particularly regarding the core glucose monitoring functionality. The explicit details about the original clinical performance study (acceptance criteria, sample sizes, ground truth methodology) for the glucose measurement itself are not provided in this document but are presumed to be part of the predicate's submission.
The performance testing mentioned in this document (Section 5.8, "Summary of Performance Testing") specifically refers to software verification of the new cloud-based API component, ensuring it meets its specifications for data confidentiality, integrity, and timely availability.
§ 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.