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510(k) Data Aggregation
(126 days)
Trade/Device Name: Eversense 365 Continuous Glucose Monitoring (CGM) System Regulation Number: 21 CFR 862.1357
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| Classification Regulation: | 21 CFR 862.1357
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| Regulation:
Product Code:
Common Name: | 21 CFR 862.1357
| 21 CFR 862.1357
The Eversense 365 Continuous Glucose Monitoring (CGM) System is indicated for continually measuring glucose levels for up to 1 year in people (18 years or older) with diabetes. The system is indicated for use to replace fingerstick blood glucose measurements for diabetes treatment decisions.
The system is intended to:
· Provide real-time glucose readings.
· Provide glucose trend information.
· Provide alerts for the detection of episodes of low blood glucose (hypoglycemia) and high blood glucose (hyperglycemia).
Historical data from the system can be interpreted to aid in providing therapy adjustments. These adjustments should be based on patterns and trends seen over time.
The Eversense 365 CGM System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The Eversense 365 CGM System can be used alone or in conjunction with these digitally connected medical devices for the purpose of managing diabetes.
The system is intended for single patient use and requires a prescription.
The Eversense 365 Continuous Glucose Monitoring (CGM) System provides continuous glucose measurements over a 40-400 mg/dL range. The system calculates glucose, trends and provides alerts for high and low glucose available for display on a mobile platform. It consists of a glucose Sensor (the Eversense 365 Sensor) that is inserted under the skin using Insertion Tools; an externally worn Eversense 365 Smart Transmitter); and the Eversense 365 App, which runs on a compatible handheld device (HHD), such as a smartphone. The inserted Sensor is a radiofrequency (RF)-powered device that collects readings and sends them to the Transmitter. The Transmitter calculates, stores, and transmits the glucose data via Bluetooth Low Energy (BLE) to the Eversense 365 App on an HHD.
The CGM System consists of three principal components.
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- Sensor: The Sensor, inserted subcutaneously, receives RF-power from the Transmitter to measure interstitial fluid glucose every 5 minutes. The Sensor sends fluorescence readings or data to the Transmitter for calculation and storage of glucose values. The Sensor has a silicone collar component that contains an anti-inflammatory steroid drug (dexamethasone acetate) that elutes locally to reduce tissue inflammation around the Sensor. The Sensor operating life is up to one year or until the device's end-of-life is reached, whichever occurs first. The Sensor is provided sterile, for single use in a Sensor Holder. The Sensor is inserted using the provided Insertion Tools.
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- Transmitter: The Transmitter, worn externally over the inserted Sensor, is a device with rechargeable battery that powers the Sensor, calculates the glucose values from the Sensor-measured fluorescence readings, and using secure BLE wirelessly sends the glucose information to the Eversense 365 App for display on the HHD. An adhesive patch holds the Transmitter in place. The Transmitter is charged using the provided power cord and charge adapter. The Transmitter also provides vibration signals for alerts and notifications, such as low glucose levels, irrespective of whether the Eversense 365 App is in the vicinity or not.
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- App: The Eversense 365 App is a software application that runs on an HHD (e.g., compatible mobile device) for display of glucose information provided by the Transmitter. The Eversense 365 App receives and displays the calculated glucose information from the Transmitter, including glucose trend information and glucose alerts. The Eversense 365 App also allows the user to calibrate the CGM System. It also communicates with the Senseonics server for a one-time download of calibration parameters specific for each Sensor following the insertion as part of the linking process. The Eversense 365 App also provides the user an option to upload the data to Senseonics Data Management System (DMS) for historic viewing and storing of glucose data.
The provided text is a summary of a 510(k) premarket notification for the Eversense 365 Continuous Glucose Monitoring (CGM) System. It details the device, its intended use, comparison to a predicate device, and performance data from a clinical study.
Here's a breakdown of the acceptance criteria and study details based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from the "iCGM Special Controls" listed in Tables 4, 5, and 6. The reported device performance is the "Eversense 365 CGM System Performance" and "Eversense 365 Results" columns.
| iCGM Special Control (Acceptance Criteria) | iCGM Glucose Range (mg/dL) | Matched Pairs (N) | Acceptance Criteria (95% Lower Bound) | Reported Device Performance (Point Estimate) | Reported Device Performance (95% Lower Bound) |
|---|---|---|---|---|---|
| System Agreement to Reference within ± 15 mg/dL/15% | |||||
| (1)(v)(A) | 85% | 87.2% | 86.3% | ||
| (1)(v)(B) | 70-180 | 23049 | >70% | 81.9% | 81.5% |
| (1)(v)(C) | >180 | 14408 | >80% | 89.3% | 88.9% |
| System Agreement to Reference within ± 40 mg/dL/40% | |||||
| (1)(v)(D) | 98% | 99.0% | 98.7% | ||
| (1)(v)(E) | 70-180 | 23049 | >99% | 99.4% | 99.3% |
| (1)(v)(F) | >180 | 14408 | >99% | 99.8% | 99.7% |
| Overall iCGM Glucose Range: (1)(v)(G) | Overall (40-400) | 40497 | >87% | 92.0% | 91.8% |
| iCGM Special Controls (1)(v)(H)-(K) Through 365 Days | |||||
| (1)(v)(H) | 180 mg/dL | 0 values > 180 mg/dL | N/A | ||
| (1)(v)(I) | >180 | 40497 | No blood glucose value 1mg/dL/min when the corresponding true negative rate of change is 2mg/dL/min | 0.4% (3/806) | N/A |
All reported Eversense 365 CGM System Performance values meet or exceed the specified Special Control (acceptance criteria) thresholds.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 110 adult subjects (ages 18 years and older). The document also refers to
Matched Pairs (N)for accuracy metrics, which sum up to 40497 for the overall accuracy, representing individual CGM readings matched with reference glucose values. - Data Provenance: The ENHANCE Study was a prospective, multi-center study conducted at 4 sites in the United States.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
The text does not specify the number of experts or their qualifications used to establish the ground truth. It states that "The accuracy of the Eversense 365 CGM System was evaluated during clinic visits comparing CGM glucose values and plasma glucose values measured using a bedside glucose analyzer."
4. Adjudication Method for the Test Set
The text does not specify an adjudication method. The ground truth was established by a laboratory-based glucose analyzer.
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
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a Continuous Glucose Monitoring (CGM) system, which directly measures glucose and provides readings, trend information, and alerts. It does not involve human readers interpreting images or data with or without AI assistance in the context of diagnostic imaging. The "AI" component would be the algorithm within the CGM system itself (e.g., for calculating glucose values from sensor readings, trend analysis, and alerts), not an interpretative aid for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the performance data presented (Tables 4-6) reflect the standalone performance of the Eversense 365 CGM System. The accuracy metrics compare the device's generated glucose values directly against a laboratory reference method (YSI 2300 Stat Plus Glucose & Lactate Analyzer). The device is designed to "replace fingerstick blood glucose measurements for diabetes treatment decisions" and "autonomously communicate with digitally connected devices" – implying its ability to function without human interpretation of its raw sensor data.
7. The Type of Ground Truth Used
The ground truth used was plasma glucose values measured using a bedside glucose analyzer (specifically, a Yellow Springs Instruments (YSI) 2300 Stat Plus Glucose & Lactate Analyzer, which is an FDA-accepted laboratory-based glucose measurement method). This is a type of reference standard or outcome data (measured physiological parameter).
8. The Sample Size for the Training Set
The text does not provide information regarding the sample size of the training set for the device's algorithms. The clinical study (ENHANCE Study) is described as an evaluation of the device's accuracy and safety, implying it served as a test or validation set rather than a training set.
9. How the Ground Truth for the Training Set Was Established
Since the text does not mention the training set size, it also does not specify how ground truth for any training set was established.
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(264 days)
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| SBA | II | 21 CFR 862.1357
monitoring system with sensor containing dexamethasone acetate Class: II (Special controls) Regulation: 862.1357
The Eversense AP CGM System is indicated for continually measuring glucose levels for up to 6 months in people (18 years and older) with diabetes. The system is indicated for use to replace fingerstick blood glucose measurements for diabetes treatment decisions. The system is intended to:
· Provide real-time glucose readings.
- · Provide glucose trend information.
· Provide alerts for the detection and prediction of episodes of low blood glucose (hypoglycemia) and high blood glucose (hyperglycemia).
Historical data from the system can be interpreted to aid in providing therapy adjustments. These adjustments should be based on patterns and trends seen over time.
The Eversense AP CGM System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The Eversense AP CGM System can be used alone or in conjunction with these digitally connected medical devices for the purpose of managing diabetes.
The system is intended for single patient use and requires a prescription.
The Eversense AP CGM System is a continuous glucose monitoring system (CGM) that provides glucose measurements every 5 minutes over a 40-400 mg/dL range. The system calculates glucose, trends and provides alerts for high and low glucose available for display on a mobile platform. It consists of a glucose sensor (the Eversense AP Sensor) that is inserted by a healthcare provider under the skin using Insertion Tools; an externally worn Eversense AP Smart Transmitter (Transmitter); and the Eversense Mobile Medical Application (MMA), which runs on a handheld device, such as a smartphone running on Android or iOS operating systems. The inserted sensor is a radiofrequency (RF)-powered device that collects readings and sends them to the Transmitter. The Transmitter calculates, stores, and transmits the glucose data via Bluetooth Low Energy (BLE) to an MMA on a handheld device (HHD).
The Eversense AP CGM System can communicate glucose readings and other information wirelessly and securely to and from interoperable electronic interfaces: including compatible AID systems. The Eversense AP CGM System is designed to communicate with interoperable devices in several ways, such as described below:
- · Wireless communication from the transmitter directly to an interoperable device communicating through the same protocol.
- · The app communicates through the cloud to another software device.
Acceptance Criteria and Device Performance for Eversense AP CGM System
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from 21 CFR 862.1357(b)(1)(v)) | Reported Device Performance (as presented in the submission) | Met? |
|---|---|---|
| **A. For iCGM measurements 85%. | **iCGM Glucose Range 70%. | iCGM Glucose Range 70-180 mg/dL: 83.1% (95% LB: 82.6) |
| Comparator Glucose Range 70-180 mg/dL: 82.3% (95% LB: 81.8) | Yes | |
| C. For iCGM measurements > 180 mg/dL: Percentage of iCGM measurements within +/-15% of corresponding blood glucose, with lower one-sided 95% confidence bound (LB) > 80%. | iCGM Glucose Range >180 mg/dL: 87.0% (95% LB: 86.5) | |
| Comparator Glucose Range >180 mg/dL: 88.8% (95% LB: 88.3) | Yes | |
| **D. For iCGM measurements 98%. | **iCGM Glucose Range 99%. | iCGM Glucose Range 70-180 mg/dL: 99.2% (95% LB: 99.07) |
| Comparator Glucose Range 70-180 mg/dL: 99.2% (95% LB: 99.1) | Yes | |
| F. For iCGM measurements > 180 mg/dL: Percentage of iCGM measurements within +/-40% of corresponding blood glucose, with lower one-sided 95% confidence bound (LB) > 99%. | iCGM Glucose Range >180 mg/dL: 99.3% (95% LB: 99.2) | |
| Comparator Glucose Range >180 mg/dL: 99.7% (95% LB: 99.6) | Yes | |
| G. Throughout the product measuring range (40-400 mg/dL): Percentage of iCGM measurements within +/-20% of corresponding blood glucose, with lower one-sided 95% confidence bound (LB) > 87%. | Overall (40-400 mg/dL): 92.1% (95% LB: 91.8) | Yes |
| H. When iCGM values 180 mg/dL. | Not explicitly stated in a percentage or metric for "no corresponding blood glucose value". However, the concurrence table shows that when iCGM is 80 mg/dL, and none were >120 mg/dL. The "LO" agreement table for iCGM readings shows that when iCGM reads "LO" (i.e., 180 mg/dL, no corresponding blood glucose value shall read 180 mg/dL, only a small percentage of Comparator values were below 160 mg/dL. The "HI" agreement table for iCGM readings shows that when iCGM reads "HI" (i.e., >400 mg/dL), 100% of the comparator values were >250 mg/dL. This implies the criteria is met. | Yes (Implied) |
| **J. No more than 1% of iCGM measurements indicate a positive glucose rate of change > 1 mg/dL/min when corresponding true negative glucose rate of change 2). This means less than 1% of iCGM measurements reflect a substantial positive change when the true change is substantially negative. | Yes | |
| K. No more than 1% of iCGM measurements indicate a negative glucose rate of change 2 mg/dL/min. | Comparator Rate Range >2 mg/dL/min: 0.8% (for iCGM Rate Range [-2,-1)). This means less than 1% of iCGM measurements reflect a substantial negative change when the true change is substantially positive. | Yes |
2. Sample Size and Data Provenance for Test Set
- Sample Size: 111 subjects
- Data Provenance: Prospective, multi-center study conducted in the United States at 4 sites.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not applicable, as the ground truth was established using a laboratory-based glucose measurement method, not expert consensus/interpretation of images/data.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for Test Set
- Adjudication Method: Not applicable. The accuracy was determined by comparing CGM values directly to an FDA-cleared laboratory glucose analyzer. There was no mention of an adjudication process among human readers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done?: No. The study did not involve human readers evaluating cases with and without AI assistance. It focused on the direct comparison of the device's measurements to a laboratory reference.
- Effect Size of Human Readers Improvement with AI vs. without AI assistance: Not applicable.
6. Standalone Performance (Algorithm Only)
- Standalone Performance Done?: Yes. The entire accuracy performance evaluation, including the comparison to the FDA-cleared laboratory glucose analyzer and the various statistical analyses (percentage within limits, mean bias, MARD, alert rates), represents the standalone performance of the Eversense AP CGM System algorithm. The human element was in the form of healthcare providers inserting the sensor and managing the study, not in interpreting the CGM data for comparison against the ground truth.
7. Type of Ground Truth Used
- Type of Ground Truth: Laboratory-based blood glucose values from an FDA-cleared laboratory glucose analyzer (Yellow Springs Instrument 2300 STAT Plus™ Glucose Analyzer). This is referred to as the "comparator method."
8. Sample Size for Training Set
- The document does not explicitly state the sample size for a separate "training set." The clinical study described appears to be the primary dataset for validation. Continuous Glucose Monitoring (CGM) systems typically use internal algorithms that are developed and refined using extensive datasets, but the specific details of these internal training sets are often proprietary and not fully disclosed in regulatory summaries unless it's a novel AI/ML algorithm requiring specific testing protocols for adaptive algorithms. The clinical study described here is primarily a validation study for the finalized device.
9. How Ground Truth for Training Set Was Established
- Given that a specific training set is not detailed, the method for establishing its ground truth is also not described. However, general practice for CGM systems would involve similar methods to the test set: comparison against accurate laboratory reference glucose measurements.
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