(59 days)
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 Pro Q Continuous Glucose Monitoring System (Dexcom Pro Q System) is a continuous glucose monitor that offers an altered feature set versus the predicate Dexcom G6 CGM System.
The Dexcom Pro Q System consists of two main components: 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).
Here's an analysis of the provided text, focusing on the acceptance criteria and study information:
The provided document is a 510(k) summary for the Dexcom Pro Q Continuous Glucose Monitoring System, comparing it to the Dexcom G6 CGM System. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting extensive new clinical studies for efficacy. Therefore, a traditional "study that proves the device meets the acceptance criteria" in the sense of a novel clinical trial with specific performance endpoints outlined in detail isn't fully present in this document. Instead, it relies on the predicate's established performance and verifies that the new device performs similarly.
Based on the available information, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state quantitative "acceptance criteria" in a typical table format for a clinical study. Instead, it claims substantial equivalence to the predicate device (Dexcom G6), which implies that its performance should be comparable. The relevant performance claims are related to its function as a continuous glucose recording device for retrospective analysis.
| Criteria (Implied by Substantial Equivalence and Device Description) | Reported Device Performance (Dexcom Pro Q System) |
|---|---|
| Intended Use Equivalence: Retrospective discovery, analysis, and interpretation of glycemic variability in persons aged 2+ under healthcare professional supervision. | Matches the Indications for Use for the Dexcom Pro Q System. The document explicitly states the "Dexcom Pro Q System is substantially equivalent to the Dexcom G6 CGM System as they are identical with regard to intended use" (Page 8, Section 5.8). |
| Data Collection & Processing: Collects and processes data for aiding in glycemic control management. | "The Dexcom Pro Q System collects and processes data for aiding in the management of a disease or condition related to glycemic control." (Page 4, Section 5.5) |
| Glucose Measurement Mechanism: Amperometric measurement of current proportional to glucose concentration via glucose oxidase chemical reaction. | Matches the predicate device's principle of operation. (Page 6, Table under "Principle of Operation") |
| Duration of Sensor Wear: Up to 10 days. | Functions for "up to 10 days" (Page 4, Section 5.4). |
| Logging Frequency: Logs estimated glucose values every 5 minutes. | "The transmitter logs estimated glucose values every 5 minutes" (Page 4, Section 5.4). |
| Factory Calibration: The device is factory calibrated. | Explicitly stated as "factory calibrated" (Page 4, Section 5.5). |
| Accuracy/Performance Comparability to Predicate: Performs according to specifications and is comparable to the predicate device. | "This testing demonstrated that the system performed according to its specifications and that the technological and performance criteria are comparable to the predicate device." (Page 8, Section 5.7) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on the sample size for a test set for the Dexcom Pro Q, nor does it specify data provenance (country of origin, retrospective/prospective). This is typical for a 510(k) submission not requiring new clinical trials, as it relies on the predicate's established performance and the new device's verification against its own specifications. The "performance testing" mentioned is likely internal validation and verification processes rather than a new clinical study with a distinct test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided. Given the nature of a 510(k) submission based on substantial equivalence and typical device verification/validation, a panel of experts for ground truth establishment in a clinical context isn't a stated component of the testing summarized here. Ground truth would be based on reference glucose measurements if any clinical data was collected, but details are absent.
4. Adjudication Method for the Test Set
No information is provided regarding an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done or at least not described in this 510(k) summary. This type of study is more common for diagnostic imaging devices where human interpretation is a critical factor. For a CGM device, the primary "output" is a glucose value, not an interpretation by a reader.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The document heavily implies standalone algorithm performance as a core component of its functioning. The "transmitter samples the electrical current... and converts these measurements into glucose readings using an onboard algorithm" (Page 4). The "performance testing" mentioned in Section 5.7 would have verified the accuracy of this algorithm against specified targets, although the specifics of the test protocol are not provided in this summary.
7. The Type of Ground Truth Used
The type of ground truth is not explicitly stated in this summary. For CGM devices, the ground truth for glucose values would typically be obtained from a highly accurate laboratory reference method (e.g., YSI glucose analyzer) applied to blood samples taken simultaneously with CGM readings. This would be part of the predicate device's original clinical validation. For the Dexcom Pro Q, if any new clinical data were collected, similar reference methods would be used.
8. The Sample Size for the Training Set
The document does not provide information about the training set size for the algorithm. It states the Dexcom Pro Q System uses an "onboard algorithm" but doesn't detail its development or training.
9. How the Ground Truth for the Training Set Was Established
This information is not provided. Similar to point 8, the document is a 510(k) summary focused on substantial equivalence rather than a detailed algorithm development document.
§ 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.