(28 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 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 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.
The Dexcom Pro Q Continuous Glucose Monitoring System (Dexcom Pro Q System) is a factory calibrated continuous glucose recording device indicated for the retrospective discovery, analysis, and interpretation of glycemic variability in persons age 2 years and older under the supervision of a healthcare professional. The Dexcom Pro Q System collects and processes data for aiding in the management of a disease or condition related to glycemic control. Interpretation of the data recorded by the Dexcom Pro Q System results should be made only by a qualified healthcare professional based on glucose trends and several sequential readings over time. The Dexcom Pro Q System aids in detecting glucose excursions facilitating care plan adjustments. The Dexcom Pro Q System is also intended to interface with digitally connected devices.
The Dexcom G6 Continuous Glucose Monitoring System (Dexcom G6 System) consists of three main components: a sensor, a Bluetooth Low Energy (BLE) transmitter, and a BLE enabled display device (receiver and/or mobile 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 receiver and/or mobile app which displays the current glucose reading (updated every 5 minutes) and glucose trends (up to 12 hours) from the transmitter. The G6 System does not require calibrations using SMBG, and the sensor life has an expected wear time of up to 10 days. The receiver and/or mobile app displays the current glucose reading and glucose trends to the user. It alerts the user when glucose levels are outside of a target zone and when other important system conditions occur.
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 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 it requires the user to enter information. The app also supports connectivity to Dexcom Share and Follow (DEN140016).
The Dexcom Pro Q Continuous Glucose Monitoring System (Dexcom Pro Q System) is a continuous glucose monitor that offers an altered feature set versus the Dexcom G6 CGM System. The Dexcom Pro Q System consists of two main components: a sensor/applicator delivery system and a transmitter. 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 logs estimated glucose values every 5 minutes during the sensor wear period (up to 10 days).
The proposed Dexcom G6 System, Dexcom G6 Glucose Program System, and Dexcom Pro Q System are based on the same physical principles and fundamental design as the predicate for each respective System but includes an alternative adhesive patch. The adhesive patch adheres the transmitter wearable to the user's body. The Dexcom G6 System, Dexcom G6 Glucose Program System, and the Dexcom Pro Q 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.
The provided document is a 510(k) premarket notification for the Dexcom G6 Glucose Program Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System (a repeated entry, likely an error in the original document format), and Dexcom Pro Q Continuous Glucose Monitoring System. The purpose of this submission is to demonstrate substantial equivalence to previously cleared predicate devices, specifically the Dexcom G6 Continuous Glucose Monitoring (CGM) System (K183206), Dexcom G6 Glucose Program Continuous Glucose Monitoring System (K182041), and Dexcom Pro Q Continuous Glucose Monitoring System (K182405).
The document states that the only modification in the proposed devices compared to their respective predicates is an alternative adhesive patch (MA-91 patch vs. Dermamed patch). It explicitly mentions that the proposed systems are based on the "same physical principles and fundamental design" and that their "technological and performance criteria have not changed from the predicate devices."
Therefore, the acceptance criteria and study information would predominantly refer to the performance of the predicate device (or the device with the original adhesive), focusing on the impact of the new adhesive. However, this document does not contain detailed primary performance data, acceptance criteria, or study specifics (like sample sizes, ground truth establishment, or expert qualifications) for the glucose monitoring functionality itself. It only states that the systems were "verified and validated according to Dexcom's internal design control process and in accordance with special controls for integrated continuous glucose monitors," and that "This testing demonstrated that the proposed systems performed according to their respective specifications."
Given the limited information in this document, I can only address some of your questions based on what is provided:
1. A table of acceptance criteria and the reported device performance
This document does not provide a table of acceptance criteria for glucose accuracy (e.g., MARD values, Clarke Error Grid analysis) or device performance metrics for the glucose monitoring function. It only states that the devices met their "respective specifications" and that "technological and performance criteria ... have not changed from the predicate devices."
The primary change being submitted for K191450 is a new adhesive patch. Therefore, the "acceptance criteria" for this specific submission would likely revolve around the safety and efficacy of the new adhesive patch (e.g., biocompatibility, adhesion strength, skin irritation). However, these specific criteria and their performance results are not detailed in this document.
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 does not explicitly state the sample size for any clinical or performance test set, nor does it specify the data provenance (country, retrospective/prospective). It generally refers to "performance testing" and "verification and validation" without providing these details.
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 glucose monitoring devices, ground truth is typically established using laboratory reference methods (e.g., YSI analyzer for blood glucose), not expert consensus.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods like 2+1 are typically used in imaging studies where human readers interpret medical images. Glucose monitoring accuracy studies compare device readings to a reference method.
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
MRMC studies and human reader improvement are not applicable to this type of device (continuous glucose monitor). The Dexcom G6 systems are medical devices that measure physiological parameters, not AI interpretation aids for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The Dexcom G6 systems are standalone in the sense that they continuously measure and report glucose values via an onboard algorithm. The document mentions the transmitter "samples the electrical current ... and converts these measurements into glucose readings using an onboard algorithm." This implies a standalone algorithmic performance for glucose measurement. However, specific details of this standalone performance (e.g., MARD values, accuracy metrics) are not provided in this document, as it mainly focuses on the change in adhesive and substantial equivalence to existing predicates.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For continuous glucose monitors, the ground truth for accuracy studies is typically established using a laboratory reference method for blood glucose, such as a YSI glucose analyzer, which provides highly accurate blood glucose measurements. This document does not explicitly state the ground truth method, but this is the standard for CGM validation.
8. The sample size for the training set
The document does not mention any training sets or their sample sizes for the glucose monitoring algorithm. This submission is for devices substantially equivalent to already cleared predicates, and the core algorithm's development and initial training information would have been part of previous submissions (K183206, K182041, K182405).
9. How the ground truth for the training set was established
As above, this information is not provided in the document. If an algorithm training set were used for the underlying glucose measurement technology, the ground truth would typically be established using a laboratory reference method for blood glucose.
Summary of what the document does provide regarding acceptance/testing:
- Change: The primary change for this 510(k) is the use of an "alternative adhesive patch" (MA-91 patch) instead of the previous "Dermamed patch."
- Performance Claim: The document asserts that the proposed systems (with the new adhesive) "performed according to their respective specifications" and that "technological and performance criteria which have not changed from the predicate devices."
- Validation: It states that validation was done "according to Dexcom's internal design control process and in accordance with special controls for integrated continuous glucose monitors."
- Scope: The focus of this particular 510(k) is heavily on demonstrating that the new adhesive patch does not negatively impact the safety and effectiveness of the device, implying that the underlying glucose monitoring performance is unchanged from the predicates.
§ 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.