(188 days)
The Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System (Dexcom G7 15 Day CGM System or G7 15 Day) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons 18 years and older.
The Dexcom G7 15 Day CGM System is intended to replace fingerstick BG testing for diabetes treatment decisions. Interpretation of the Dexcom G7 15 Day CGM System results should be based on the glucose trends and several sequential sensor readings over time. The Dexcom G7 15 Day CGM System also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments.
The Dexcom G7 15 Day CGM System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The Dexcom G7 15 Day CGM System can be used alone or in conjunction with these digitally connected medical devices for the purpose of managing diabetes.
The Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System (Dexcom G7 15 Day CGM System or G7 15 Day) is an interoperable continuous glucose monitoring system intended to continuously measure the glucose in the interstitial fluid, calculate the glucose reading and make this available to the user. The Dexcom G7 15 Day CGM System is intended for single patient use at home and requires a prescription.
The G7 15 Day consists of the following primary components: a wearable, consisting of a sensor and transmitter worn on the body and a display device, which can be a G7 Mobile Application (Mobile App) on an iOS or Android OS smart device or a G7 Receiver (Receiver).
To achieve the intended functions and performance of the G7 15 Day, one sensor and at least one display device (App or Receiver) must be used together. The user must pair the display device(s) with each unique sensor to enable communication and start a sensor session. During an active session, the sensor reports new glucose data to the display device every 5-minutes. The display device then displays glucose data and provides alerts and information signals to the user. The reportable glucose range for the G7 15 Day is 40 mg/dL to 400 mg/Dl. Glucose values below this range are reported as 'LOW' and glucose values above this range are reported as 'HIGH'. The sensor has an expected wear period of up to 15 days with an extended 12-hour grace period after the sensor session. The grace period allows additional time for the user to change the sensor at a convenient time.
The Dexcom G7 15 Day CGM System is an interoperable connected device that can communicate glucose readings and other information wirelessly and securely to and from compatible electronic interfaces via the following secure wireless connections:
- Wireless communication from the transmitter directly to an interoperable device communicating through the same protocol
- The Mobile App communicates to another app on a single mobile platform
- The Mobile App communicates through the cloud to another software device
- Dexcom Partner Web APIs: The Dexcom Partner Web APIs enable secure and reliable communication of CGM data to authorized client software intended to receive the data through the cloud. The Partner Web APIs is not intended to be used by automated insulin delivery systems (AID).
Principle of Operation:
The principles of operation for the Dexcom G7 15 Day CGM System remain the same as prior generations of Dexcom CGM Systems. The System uses a wire-type sensing mechanism that continuously measures interstitial glucose levels and uses a radio transmitter to wirelessly communicate glucose data to the display device for the user to see and use accordingly.
The provided FDA 510(k) clearance letter and summary for the Dexcom G7 15 Day CGM System outlines several acceptance criteria and the studies performed to meet them. However, it's important to note that the document primarily focuses on demonstrating substantial equivalence to a predicate device and fulfilling regulatory requirements. It does not provide the detailed numerical performance metrics typically found in a full clinical study report, nor does it specify exact numerical "acceptance criteria" in all cases, instead referring to meeting "specifications" or "special controls."
Here's an attempt to extract the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (as implied or stated) | Reported Device Performance (as stated in document) |
|---|---|---|
| Clinical Performance (iCGM Special Controls) | Meeting iCGM special controls for clinical performance set forth in 21 CFR 862.1355. | "Analysis of the results from the clinical study showed that the subject device meets the iCGM special controls for clinical performance set forth in 21 CFR 862.1355." |
| Safety (Adverse Events) | Acceptable incidence of device-related adverse events. | "The safety of the device was evaluated by the incidence of device-related adverse events (AEs) experienced by study subjects. The reported device-related AEs included local infection, skin irritation (edema), and pain or discomfort. The clinical study demonstrated that the Dexcom G7 15 Day CGM System is safe and effective for its intended use." (Specific thresholds or rates not given, but deemed acceptable) |
| Shelf-Life | Stability under real-time anticipated storage conditions, supporting a useful life up to 18 months. | "Shelf-Life testing was performed to evaluate the stability of the G7 15 Day under real time anticipated storage conditions and supported its useful life to be up to 18 months. The test results for the G7 15 Day met specifications." |
| Human Factors/Usability | Safe and effective use by intended users. | "Results of the human factors study support that the intended users can use the Dexcom G7 15 Day CGM System safely and effectively." |
| Battery Life | Sufficient capacity to meet product performance specifications. | "An engineering analysis concluded that the G7 15 Day transmitter battery has sufficient capacity to meet the product performance specifications." |
| Software Verification & Validation | Software performs in accordance with established specifications, IEC 62304, and FDA Guidance. | "Software verification and validation testing was conducted to confirm that the software used in the Dexcom G7 15 Day CGM System performed in accordance with established specifications, IEC 62304 and FDA Guidance document... which verified functionality of the device against established software requirements." |
| Cybersecurity | Acceptable risk management for confidentiality, integrity, and availability; device firmware/software/components are malware-free. | "Dexcom provided cybersecurity risk management documentation... Appropriate risk mitigation controls have been implemented and tested... controls and processes in place to ensure continued support for keeping the device secure and to ensure that the device firmware, software and components are malware free." |
| Mechanical Functional Testing | Meeting pre-defined acceptance criteria. | "The following supportive performance characteristics were established through nonclinical testing... and are applicable... met specifications." (Implied) |
| Electrical Functional Testing | Meeting pre-defined acceptance criteria (except battery life). | "The following supportive performance characteristics were established through nonclinical testing... and are applicable... met specifications." (Implied) |
| Wireless Performance Testing | Meeting pre-defined acceptance criteria. | "The following supportive performance characteristics were established through nonclinical testing... and are applicable... met specifications." (Implied) |
| Medical Electrical System Safety Testing | Meeting pre-defined acceptance criteria (except IEC 62304). | "The following supportive performance characteristics were established through nonclinical testing... and are applicable... met specifications." (Implied) |
| Electromagnetic Compatibility & Radio Approval Testing | Meeting pre-defined acceptance criteria. | "The following supportive performance characteristics were established through nonclinical testing... and are applicable... met specifications." (Implied) |
| Biocompatibility | Meeting pre-defined acceptance criteria. | "The following supportive performance characteristics were established through nonclinical testing... and are applicable... met specifications." (Implied) |
| Sterilization Validation | Meeting pre-defined acceptance criteria. | "The following supportive performance characteristics were established through nonclinical testing... and are applicable... met specifications." (Implied) |
| Packaging Validation | Meeting pre-defined acceptance criteria. | "The following supportive performance characteristics were established through nonclinical testing... and are applicable... met specifications." (Implied) |
| Substance Restrictions and Product Waste Regulations | Meeting pre-defined acceptance criteria. | "The following supportive performance characteristics were established through nonclinical testing... and are applicable... met specifications." (Implied) |
| Data Transmission Reliability | Reliable data transmission rate to connected devices over 15-day wear. | "The results from the study demonstrate the reliable data transmission rate to connected devices." (Specific rates not given) |
2. Sample Size Used for the Test Set and Data Provenance
The document states:
- "A clinical study was conducted to evaluate the safety and effectiveness of the Dexcom G7 15 Day CGM System... in adult (18 years and older) participants with diabetes."
- "A subsequent clinical study was performed to assess the impact of a new sensor patch intended to improve survival rate."
- "A separate clinical study was performed in adults with type 1 and type 2 diabetes to assess the data transmission reliability over the 15-day wear period."
Sample Size: The exact sample size (number of participants) for these clinical studies is not specified in the provided text.
Data Provenance:
- Country of Origin: Not specified in the document.
- Retrospective or Prospective: Clinical studies are generally prospective, especially when evaluating safety and effectiveness of a new device. The phrasing "A clinical study was conducted to evaluate..." implies a prospective study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the given document. For a CGM device, the ground truth for glucose measurements is typically established using a highly accurate reference method, such as a YSI glucose analyzer, rather than expert interpretation of images or observations.
4. Adjudication Method for the Test Set
Adjudication methods like "2+1" or "3+1" are typically used in studies involving subjective assessment (e.g., image interpretation by multiple readers). For a continuous glucose monitoring system, the ground truth is established by objective laboratory measurements (YSI). Therefore, an adjudication method for the test set in the traditional sense is not applicable or described.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
An MRMC study is relevant for devices where human readers interpret data, often with or without AI assistance.
- Was an MRMC study done? No, an MRMC study was not described. The Dexcom G7 is a diagnostic device that provides quantitative glucose values, not an imaging or interpretive AI, so comparative effectiveness with human readers in the traditional MRMC sense is not relevant here.
- Effect size of human readers improvement with AI vs without AI assistance: Not applicable, as no MRMC study was conducted or described for this type of device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone performance assessment was done. The clinical study evaluating "safety and effectiveness of the Dexcom G7 15 Day CGM System... with respect to reference venous plasma sample YSI measurements" directly assesses the algorithm's performance without human interpretation of the CGM readings. The device is intended "to generate continuous glucose measurements and make this available to the user," and the study uses these generated measurements against a gold standard.
7. Type of Ground Truth Used
The primary ground truth for the clinical effectiveness study was:
- Reference venous plasma sample YSI measurements.
This is a highly accurate laboratory method for measuring glucose in blood, considered the gold standard for comparing CGM performance.
8. Sample Size for the Training Set
The document focuses on the new clinical data submitted for the Dexcom G7 15 Day CGM System and refers to its substantial equivalence to the predicate "Dexcom G7 Continuous Glucose Monitoring System." The sample size for the training set (i.e., data used to develop the algorithms for the CGM) is not mentioned in this 510(k) summary. This information would typically be developed during the device's original design and development phase, not necessarily recounted in each subsequent 510(k) submission unless there were significant algorithm changes requiring new training data.
9. How the Ground Truth for the Training Set Was Established
Similar to item 8, the process for establishing ground truth for the training set used during the development of the Dexcom G7 algorithms is not described in this document. It is highly probable that similar reference methods (like YSI venous plasma measurements) would have been used during the development and training phases as well.
§ 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.