Eversense 365 Continuous Glucose Monitoring (CGM) System
Device Facts
| Record ID | K241335 |
|---|---|
| Device Name | Eversense 365 Continuous Glucose Monitoring (CGM) System |
| Applicant | Senseonics, Incorporated |
| Product Code | SBA · Clinical Chemistry |
| Decision Date | Sep 16, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1357 |
| Device Class | Class 2 |
Indications for Use
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.
Device Story
Subcutaneously inserted RF-powered sensor measures interstitial fluid glucose via fluorescence intensity; sensor contains dexamethasone acetate for local inflammation reduction. Externally worn rechargeable transmitter powers sensor, calculates glucose values, and transmits data via BLE to mobile app. App displays real-time glucose, trends, and alerts; enables calibration; supports data upload to cloud-based management system. Used in home environment by patients with diabetes; transmitter provides vibration alerts independent of app. Output aids clinical decision-making for insulin dosing and diabetes management. System supports integration with automated insulin dosing (AID) systems.
Clinical Evidence
Prospective, multi-center ENHANCE study (n=110, age 18-77). Accuracy evaluated against YSI 2300 STAT Plus comparator. Overall MARD 9.0% (70-180 mg/dL range). 92.0% of readings within 20% of comparator overall. Confirmed event detection rates for low glucose (threshold/predictive) ranged 88.6-97.4%; high glucose detection rates ranged 93.5-98.6%. Sensor survival rate 90% at 365 days. Capture rate 99.9%.
Technological Characteristics
Implantable sensor with silicone collar containing dexamethasone acetate; RF-powered; BLE connectivity. Transmitter: rechargeable battery, vibration alert motor. Materials biocompatibility per ISO 10993. Sterilization: Ethylene Oxide (ISO 11135). Standards: IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), ISO 14708-1 (ultrasound/particulate). Software: IEC 62304 compliant.
Indications for Use
Indicated for people 18+ years with diabetes for continuous glucose monitoring up to 1 year. Replaces fingerstick measurements for treatment decisions. Contraindicated in patients with dexamethasone/dexamethasone acetate contraindications. Not tested in pregnant/nursing women, patients <18, critically ill/hospitalized, those on immunosuppressants, chemotherapy, anticoagulants, or systemic glucocorticoids, or those with active implantable devices (e.g., defibrillators).
Regulatory Classification
Identification
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. It consists of a glucose sensor (the Eversense AP Sensor) containing dexamethasone acetate, which is inserted under the skin; an externally worn Eversense AP Smart Transmitter; and the Eversense Mobile Medical Application (MMA). The system is indicated for continually measuring glucose levels for up to 6 months in people (18 years and older) with diabetes, to replace fingerstick blood glucose measurements for treatment decisions, and to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems.
Special Controls
Dexamethasone acetate-eluting integrated continuous glucose monitoring systems must comply with the following special controls:
Predicate Devices
- Senseonics Eversense AP Continuous Glucose Monitoring (CGM) System (DEN230052)
Related Devices
- DEN230052 — Eversense AP CGM System · Senseonics, Incorporated · Apr 29, 2024
- K243214 — Dexcom G7 15 Day Continuous Glucose Monitoring System · Dexcom, Inc. · Apr 9, 2025
- DEN170088 — Dexcom G6 Continuous Glucose Monitoring System · Dexcom, Inc. · Mar 27, 2018
- P160007 — Guardian Connect system · Medtronic Minimed · Mar 8, 2018
Submission Summary (Full Text)
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FDA
U.S. FOOD & DRUG
ADMINISTRATION
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
ASSAY AND INSTRUMENT
## I Background Information:
A 510(k) Number
K241335
B Applicant
Senseonics, Incorporated
C Proprietary and Established Names
Eversense 365 Continuous Glucose Monitoring (CGM) System
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| SBA | Class II | 21 CFR 862.1357 - Integrated Continuous Glucose Monitoring System With Sensor | Clinical Chemistry |
## II Submission/Device Overview:
A Purpose for Submission:
New device.
B Measurand:
Glucose in interstitial fluid.
C Type of Test:
Quantitative, fluorescent based.
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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III Intended Use/Indications for Use:
A Intended Use(s):
See Indications for Use below.
B Indication(s) for Use:
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 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 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.
C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only
The smart transmitter is incompatible with magnetic resonance imaging (MRI) procedures. The smart transmitter is MR Unsafe and MUST BE REMOVED before undergoing an MRI (magnetic resonance imaging) procedure.
The system is contraindicated in people for whom dexamethasone or dexamethasone acetate may be contraindicated.
Mannitol or sorbitol, when administered intravenously, or as a component of an irrigation solution or peritoneal dialysis solution, may increase blood mannitol or sorbitol concentrations and cause falsely elevated readings of sensor glucose results. Sorbitol is used in some artificial sweeteners, and concentration levels from typical dietary intake do not impact sensor glucose results.
Antibiotics of the tetracycline class (including tetracycline, doxycycline, minocycline and tigecycline) may falsely lower sensor glucose readings. Users should not rely on sensor glucose readings while taking tetracyclines.
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The system has not been tested in the following populations: women who are pregnant or nursing, people under the age of 18, critically ill or hospitalized patients, people receiving immunosuppressant therapy, chemotherapy or anti-coagulant therapy, those with another active implantable device, e.g., an implantable defibrillator (passive implants are allowed, e.g., cardiac stents), those with known allergies to or using systemic glucocorticoids (excluding topical, optical or nasal, but including inhaled). The system's accuracy hasn't been tested in these populations, and sensor glucose readings may be inaccurate, resulting in missing a severe low or high glucose event.
The Apple Watch is a secondary display of data and should not be used in place of the primary CGM display.
## D Special Instrument Requirements:
Not applicable.
## IV Device/System Characteristics:
## A Device Description:
The Eversense 365 Continuous Glucose Monitoring (CGM) System 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 365 Sensor) that is inserted by a healthcare provider under the skin using Insertion Tools (Eversense Insertion Tools); an externally worn Transmitter (Eversense 365 Smart Transmitter); and the Eversense Mobile Medical Application (MMA, Eversense 365 Mobile App), which runs on a handheld device, such as a Smartphone running on Android or iOS operating systems (see Figure 1). 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).
Figure 1. Eversense 365 Continuous Glucose Monitoring System
Sensor
Smart Transmitter
Mobile Application (iOS, Android)
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B Principle of Operation:
The Eversense 365 CGM System detects glucose levels in the interstitial fluid just beneath the skin. The Eversense 365 Sensor uses a selective, fully reversible binding between glucose and a proprietary fluorescent indicator macromolecule that is grafted on the surface of the Sensor. Glucose binding by the indicator macromolecule results in an increase in fluorescence intensity. Glucose signal transduction is accomplished by measuring the fluorescence intensity modulation using the Sensor's optical system. The transmitter converts the signal using an algorithm to a glucose value read in $\mathrm{mg/dL}$, which is then transmitted to the MMA for the user to see and use accordingly.
C Instrument Description Information:
1. Instrument Name:
Eversense 365 Continuous Glucose Monitoring (CGM) System
2. Specimen Identification:
Not applicable.
3. Specimen Sampling and Handling:
Not applicable.
4. Calibration:
There are three periodic calibration phases during the wear life of the sensor:
A. Initialization Phase (after 24-hour Warm-Up Phase)
During this phase, 4 fingerstick blood glucose calibrations are required.
- The 4 calibrations must be spaced 2 to 12 hours apart. All 4 calibrations must be completed within a 36 hour period. After 8 hours without a calibration entry, no glucose data will be displayed.
B. 1 Daily Calibration Phase Through Day 13
After the initialization phase, the 1 Daily Calibration Phase requires a blood glucose fingerstick calibration every 24 hours for 13 days.
- 24 hours after your last successful calibration, the system prompts you to calibrate.
C. 1 Weekly Calibration Phase Starting Day 14
The 1 Weekly Calibration Phase requires a blood glucose fingerstick calibration once a week.
- 1 week after your last successful calibration, the system prompts the user to calibrate.
5. Quality Control:
Not applicable.
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V Substantial Equivalence Information:
A Predicate Device Name(s): Eversense AP CGM System
B Predicate 510(k) Number(s): DEN230052
C Comparison with Predicate(s):
| Device & Predicate Device(s): | K241335 | DEN230052 |
| --- | --- | --- |
| Device Trade Name | Eversense 365 CGM System | Eversense AP CGM System |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | 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. | Same |
| Measurement Range | 40-400 mg/dL | Same |
| Glucose Sensing Element of Indicator Hydrogel | Indicator monomer (TFM) – fully reversible binding of glucose | Same |
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| Method of Measuring Glucose | Fluorescence | Same |
| --- | --- | --- |
| Sensor Dimensions | Approximately 3.5mm x 18.3mm | Same |
| DXA Collar | A silicone collar attached to the encasement (using a silicone adhesive) which elutes locally an anti-inflammatory steroid (1.75 mg of DXA) to minimize local foreign body reaction | Same |
| Storage Conditions | 2-8°C | Same |
| Shelf-Life | 13 months (from the date of application of the glucose-indicating hydrogel) | Same |
| Operational Condition | Temperature: 5-40°C
Humidity: 15-90% RH
Atmospheric Pressure: 700-1,060 hPa | Same |
| General Device Characteristic Differences | | |
| Sensor Life | Up to 1 year (Automatically shuts down after grace period) | Up to 6 months (Automatically shuts down, no grace period) |
| Cal Frequency | Varies during wear: 4 cals in 36 hours
1 cal/day through Day 13
1 cal/week starting Day 14 | Varies during wear: 4 cals in 36 hours
2 cals/day through Day 21
1 cal/day starting Day 22 |
VI Standards/Guidance Documents Referenced:
60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION, Medical electrical equipment – General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic compatibility – Requirements and Tests
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60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION, Medical electrical equipment – General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
IEC 62133-2 2017/AMD1:2021, Secondary cells and batteries containing alkaline or other non-acid electrolytes – Safety requirements for portable sealed secondary cells, and batteries made from them, for use in portable applications – Part 2: Lithium systems.
IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
ISO 14708-1, 2014, Active Implantable Medical Devices - Part 1: General Requirements for Safety, Marking, and for Information to be provided by the Manufacturer
IEC 62366-1 :2015+AMD1 :2020 (Consolidated Text), Medical devices Part 1: Application of usability engineering to medical devices including Amendment 1
UL 1642, 5th Edition. Standard for Safety – Lithium Batteries
IEEE ANSI USEMCSC C63.27-2021, American National Standard for Evaluation of Wireless Coexistence
ISO TS 10974 Second edition 2018, Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
ASTM F2052-21, Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
ASTM F2213-17, Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
ISO 10993-1:2018, Biological evaluation of medical devices - Part 1: Evaluation and testing
ISO 10993-3 Third edition 2014-10-1, Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
ANSI AMMI ISO 10993-5:2009/(R)2014, Biological evaluation of medical devices - Part 5: Tests for cytotoxicity: in vitro methods
ISO 1110993-6 Third edition 2016-12-01, Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
ISO 10993-10 Fourth edition 2021-11, Biological evaluation of medical devices - Part 10: Tests for skin sensitization
ISO 10993-11:2017, Biological evaluation of medical devices Part 11: Tests for systemic toxicity.
ISO 10993-12:2021, Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
ISO 10993-17:2002/(R)2012, Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
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ISO 10993-18:2020-01, Biological evaluation of medical devices – Part 18: Chemical characterization of materials
ISO 1110993-23 First edition 2021-01, Biological evaluation of medical devices – Part 23: Tests for Irritation
ISO 10993-7 Second edition 2008-10-15, Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals
EN ISO 11135:2014/Al:2018, Sterilization of Health Care Products – Ethylene oxide – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
EN ISO 111737-1 Third edition 2018-01 [Including AMDI:2021], Sterilization of medical devices – Microbiological methods – Part 1: Determination of a population of microorganisms on products
ISO 11737-2: 2019, Sterilization of medical devices – Microbiological methods – Part 2: test of sterility performance in the definition, validation and maintenance of a sterilization process
ISO 11607-1:2019, Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 11607-2:2019, Packaging for terminally sterilized Medical Devices – Part 2: Validation Requirements for forming, sealing and assembly processes
ASTM F1980-16, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
ASTM F1886/F1886M-16, Standard Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
ASTM F2096-11 (Reapproved 2019), Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
ASTM D3078-02 (Reapproved 2021) e 1, Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
ASTM F88/F88M-23, Standard Test Method for Seal Strength of Flexible Barrier Materials
AAMI TIR57:2016, Principles for medical device security - Risk management
AAMI TIR97:2019, Principles for medical device security - Postmarket risk management for device manufacturers
CLSI. EP07 3rd Edition Interference Testing in Clinical Chemistry
ISO 14155 Third edition 2020-07, Clinical investigation of medical devices for human subjects - Good Clinical Practice
ISO 14971:2019, Medical devices – Application of Risk Management to Medical Devices
ISO 15223-1:2021, Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 1: General requirements
ISO 14708-1:2014 Implants for surgery -- Active implantable medical devices -- Part 1: General requirements for safety, marking an Implants for surgery -- Active implantable medical devices -
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Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
IEC 62304:2006/A 1 :2016, Medical Device Software – Software life cycle processes
Content of Premarket Submissions for Device Software Functions – Guidance for Industry and Food and Drug Administration Staff, document issued on June 14, 2023
Off-The-Shelf Software Use in Medical Devices - Guidance for Industry and Food and Drug Administration Staff, document issued on September 27, 2019
Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff, document issued on August 14, 2013
Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" – Guidance for Industry and Food and Drug Administration Staff, document issued on September 4, 2020
## VII Performance Characteristics (if/when applicable):
## A Analytical Performance:
### 1. Precision/Reproducibility:
iCGM performance was evaluated in clinical studies described in Section C(3) below. A subset of subjects (n=36) subjects wore two Eversense 365 Sensors concurrently to evaluate precision. The between-Sensor precision was characterized based on the paired CGM system readings from Sensors in each arm worn simultaneously; one on the left arm and one on the right arm. The precision data are shown in the table below. Precision is described as Standard Deviation (SD), Paired Absolute Difference (PAD), Paired Absolute Relative Difference (PARD) and Coefficient of Variation (CV%).
| Range of Mean CGM Glucose (mg/dL) | Number (CGM, CGM) pairs | Number of subjects | SD (mg/dL) | PAD (mg/dL) | PARD (%) | CV (%) |
| --- | --- | --- | --- | --- | --- | --- |
| Overall | 82,731 | 32 | 17.5 | 12.3 | 8.0 | 5.7 |
| <70 | 3,911 | 28 | 10.1 | 7.4 | 12.6 | 8.9 |
| 70-180 | 50,997 | 32 | 14.0 | 10.2 | 8.2 | 5.8 |
| >180 | 27,823 | 32 | 23.2 | 16.8 | 7.0 | 4.9 |
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2. Linearity:
The reportable range for the Eversense 365 CGM System is 40 to 400 mg/dL. Data supporting this claimed measurement range were generated in the clinical study described in Section C(3) below.
3. Analytical Specificity/Interference:
Mannitol or sorbitol, when administered intravenously, or as a component of an irrigation solution or peritoneal dialysis solution, may increase blood mannitol or sorbitol concentrations and cause falsely elevated readings of the sensor glucose results. Sorbitol is used in some artificial sweeteners, and concentration levels from typical dietary intake do not impact sensor glucose results.
With the Eversense 365 CGM System, medications of the tetracycline class, such as tetracycline, doxycycline, minocycline, tigecycline, may falsely lower glucose. A negative bias may create a situation in which a user inappropriately increases their carbohydrate intake or does not dose with insulin during a time in which their blood glucose concentration is euglycemic or hypoglycemic, hazardous situations which do not present imminent risk to the user but which do increase risks associated with hyperglycemia. Risks resulting from tetracycline interference are mitigated through the information provided to users and healthcare providers (HCPs) in the "Warning", "Medication", "Making Treatment Decisions with Eversense 365" and the "Troubleshooting: Making Treatment Decisions" sections of the patient User Guide and the "Warnings" section of the HCP instructions for use.
4. Assay Reportable Range:
See linearity section above.
5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
The Eversense 365 Sensor has a storage shelf-life of 13 months that was evaluated at 2-8° C (35-46° F).
The Eversense 365 Transmitter requires daily charging. The internal battery of the transmitter is sufficiently durable to function for 12 months as intended following its maximum storage time of 12 months. Shelf life was evaluated by functional test after 40 days of accelerated aging at 131°F (equivalent to 1 year real-time).
6. Detection Limit:
If a glucose measurement is less than 40 mg/dL, the result is displayed by the system as 'LO'. If a glucose measurement exceeds 400 mg/dL, the result is displayed as 'HI'. Data supporting this claimed measurement range was generated in the clinical study described in Section C(3) below.
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7. Assay Cut-Off:
Not applicable.
8. Accuracy (Instrument):
Not applicable.
9. Carry-Over:
Not applicable.
## B Comparison Studies:
1. Method Comparison with Predicate Device:
Not applicable. Accuracy is determined by comparing iCGM values to an FDA cleared laboratory grade glucose analyzer (Yellow Springs Instrument 2300 STAT Plus™ Glucose Analyzer) and referred to as the “comparator method” in Section C(3) below.
2. Matrix Comparison:
Not applicable. Interstitial fluid is the only indicated matrix.
## C Clinical Studies:
1. Clinical Sensitivity:
Not applicable.
2. Clinical Specificity:
Not applicable.
3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):
The ENHANCE study is a prospective, multi-center study, whereby 110 subjects (≥ 18 years of age) were inserted with the Eversense 365 CGM System at 4 sites in the United States. The investigation included both clinic visits and home use of the Eversense 365 CGM System. Thirty-six (36) subjects had two Eversense 365 Sensors inserted, and 74 subjects were inserted with one Eversense 365 Sensor in one arm.
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# Demographics
A summary of demographic characteristics for all Eversense 365 CGM System subjects is presented in the table below. Subjects had a mean age of 47 years and a mean body mass index (BMI) of $32\mathrm{kg} / \mathrm{m}^2$ . Both males and females were represented in the study population.
| Demographic | Value |
| --- | --- |
| Gender n (%) | |
| Male | 69 (62.7) |
| Female | 41 (37.3) |
| Age (years) [mean (SD)] | 47.2 (13.7) |
| Min, Max | 18, 77 |
| Ethnicity n (%) | |
| Non-Hispanic | 86 (78.2) |
| Hispanic | 24 (21.8) |
| Race n(%) | |
| Caucasian | 102 (92.7) |
| Black or African American | 4 (3.6) |
| Asian | 1 (0.9) |
| American Indian or Alaska Native | 1 (0.9) |
| Native Hawaiian or Other Pacific Islander | 0 (0.0) |
| More than One Race | 2 (1.8) |
| Body Mass Index Class [mean (SD)] kg/m2 | 32.0 (6.8) |
| Min, Max | 19, 52 |
| Normal (<25 kg/m2) n (%) | 12 (10.9) |
| Overweight (>25 and <30) n (%) | 30 (27.3) |
| Obese (>30) n (%) | 68 (61.8) |
All accuracy data were collected during the in-clinic visits. The accuracy of the CGM glucose reading was assessed using metrics based on 40,718 matched pairs for the primary Sensor through clinic visits on Days 1, 7, 14, 22, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, and 365 per protocol.
Accuracy was evaluated using paired CGM readings to comparator method values for the Eversense 365 CGM System. For values less than $70\mathrm{mg / dL}$ , the absolute difference in $\mathrm{mg / dL}$ between the two glucose results was calculated. For values greater than or equal to $70\mathrm{mg / dL}$ , the absolute difference (\%) relative to Comparator Method values was calculated. The percentages of readings within $15 / 15\%$ of Comparator Method values or $40 / 40\%$ of Comparator Method values by CGM glucose ranges are shown in the table below.
Percent and Point Accuracy by iCGM Glucose Range (N=110)
| iCGM Glucose Range | Matched Pairs (N) | Percent Within 15 mg/dL (95% LB) | Percent Within 40 mg/dL (95% LB) | Percent Within 15% (95% LB) | Percent Within 40% (95% LB) | Mean Bias (mg/dL) (95% UB) |
| --- | --- | --- | --- | --- | --- | --- |
| <70 mg/dL | 3,040 | 87.2 (86.3) | 99.0 (98.7) | --- | --- | -5.4 (-5.0) |
| 70-180 mg/dL | 23,049 | --- | --- | 81.9 (81.5) | 99.4 (99.3) | -1.9 (-1.7) |
| >180 mg/dL | 14,408 | --- | --- | 89.3 (88.9) | 99.8 (99.7) | 0.7 (1.1) |
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Percentages of readings within 15/15% or 40/40% of comparator method values by Comparator glucose ranges.
Percent and Point Accuracy by Comparator Glucose Range (N=110)
| Comparator Glucose Range | Matched Pairs (N) | Percent Within 15 mg/dL (95% LB) | Percent Within 40 mg/dL (95% LB) | Percent Within 15% (95% LB) | Percent Within 40% (95% LB) | Mean Bias (mg/dL) (95% UB) |
| --- | --- | --- | --- | --- | --- | --- |
| <70 mg/dL | 2,804 | 89.8 (88.9) | 99.6 (99.4) | --- | --- | 1.5 (1.9) |
| 70-180 mg/dL | 23,130 | --- | --- | 82.4 (82) | 99.4 (99.3) | -0.3 (-0.1) |
| >180 mg/dL | 14,563 | --- | --- | 88.2 (87.8) | 99.9 (99.9) | -3.3 (-2.9) |
*95% LB is the lower bound of the confidence interval and 95% UB is the upper bound of the confidence interval
Percentage of readings within 20% of comparator method values, including the 95% lower bound confidence interval, for the overall 40-400 mg/dL iCGM range is shown in the Table below.
iCGM agreement to Comparator through 365 Days
| iCGM Glucose Range | Matched Pairs (N) | Percent Within 20% (95% LB) |
| --- | --- | --- |
| Overall (40-400 mg/dL) | 40,497 | 92.0 (91.8) |
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Percent of values within 15/15% mg/dL, 20/20% mg/dL, and 40/40% mg/dL stratified by glucose ranges of <54, 54-69, 70-180, 181-250, and >250 mg/dL for CGM and comparator method were also provided.
## Eversense 365 CGM System Accuracy to Comparator within iCGM Glucose Ranges (N=110)
| iCGM Glucose Range (mg/dL) | Number of paired iCGM-Comp | Percent Within 15 mg/dL | Percent Within 20 mg/dL | Percent Within 40 mg/dL | Percent Within 15% | Percent Within 20% | Percent Within 40% | Mean Bias (mg/dL) | MARD (%) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| <54 | 687 | 76.3 | 88.2 | 98.3 | -- | -- | -- | -11.0 | 17.9 |
| 54-69 | 2,353 | 90.4 | 94.8 | 99.2 | -- | -- | -- | -3.8 | 11.1 |
| 70-180 | 23,049 | -- | -- | -- | 81.9 | 90.9 | 99.4 | -1.9 | 9.0 |
| 181-250 | 8,198 | -- | -- | -- | 88.0 | 94.9 | 99.7 | -2.4 | 7.7 |
| >250 | 6,210 | -- | -- | -- | 91.1 | 97.1 | 99.8 | 5.3 | 7.2 |
## Eversense 365 CGM System Accuracy to Comparator within Comparator Glucose Ranges (N=110)
| Comparator Glucose Range (mg/dL) | Number of paired iCGM-Comp | Percent Within 15 mg/dL | Percent Within 20 mg/dL | Percent Within 40 mg/dL | Percent Within 15% | Percent Within 20% | Percent Within 40% | Mean Bias (mg/dL) | MARD (%) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| <54 | 358 | 90.2 | 95.0 | 99.4 | -- | -- | -- | 3.9 | 15.8 |
| 54-69 | 2,446 | 89.8 | 96.7 | 99.6 | -- | -- | -- | 0.8 | 12.5 |
| 70-180 | 23,130 | -- | -- | -- | 82.4 | 91.4 | 99.4 | -0.3 | 9.0 |
| 181-250 | 7,997 | -- | -- | -- | 87.1 | 94.5 | 99.9 | -3.1 | 7.8 |
| >250 | 6,566 | -- | -- | -- | 89.5 | 95.9 | 100.0 | -2.9 | 7.5 |
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Concurrence of iCGM values compared to the comparator method across the entire measuring range was also evaluated. iCGM glucose ranges of <40, 40-60, 61-80, 81-120, 121-160, 161-200, 201-250, 251-300, 301-350, 351-400, and >400 mg/dL were evaluated against comparator glucose ranges and percent of iCGM values within those ranges were reported.
Concurrence of Eversense 365 CGM System Reading and Comparator Values by iCGM Glucose Range (N=110)
| iCGM (mg/dL) | Comparator Glucose Values (mg/dL) | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | <40 | 40-60 | 61-80 | 81-120 | 121-160 | 161-200 | 201-250 | 251-300 | 301-350 | 351-400 | >400 | Total |
| <40 | 14.5 % | 71.1 % | 9.2% | 5.3% | | | | | | | | 76 |
| 40-60 | 0.2% | 52% | 44.6 % | 3% | 0.1% | | | | | | | 1,411 |
| 61-80 | | 13% | 61.8 % | 24.7 % | 0.6% | | | | | | | 3,449 |
| 81-120 | | 0.3% | 6.8% | 76.1 % | 16.4 % | 0.5% | 0% | | | | | 9,149 |
| 121-160 | | 0% | 0.1% | 14.2 % | 71.2 % | 13.7 % | 0.8% | 0% | | | | 8,638 |
| 161-200 | | | | 0.1% | 17% | 65% | 17.2 % | 0.7% | 0% | | | 6,292 |
| 201-250 | | | | | 0.4% | 15.8 % | 66% | 16.8 % | 1% | | | 5,348 |
| 251-300 | | | | | 0.1% | 0.4% | 17.5 % | 63.8 % | 17.4 % | 0.7% | | 3,494 |
| 301-350 | | | | | | | 0.5% | 28.1 % | 64.5 % | 6.6% | 0.2% | 2,052 |
| 351-400 | | | | | | | | 3.3% | 61.3 % | 34% | 1.4% | 664 |
| >400 | | | | | | | | 0.6% | 22.4 % | 55.1 % | 21.8 % | 156 |
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Concurrence of Eversense 365 CGM System Reading and Comparator Values by Comparator Glucose Range (N=110)
| Comparator Glucose Range (mg/dL) | iCGM Glucose Values (mg/dL) | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | <40 | 40-60 | 61-80 | 81-120 | 121-160 | 161-200 | 201-250 | 251-300 | 301-350 | 351-400 | >400 | Total |
| <40 | 78.6% | 21.4% | | | | | | | | | | 14 |
| 40-60 | 4.3% | 58.2% | 35.4% | 2% | 0.1% | | | | | | | 1,261 |
| 61-80 | 0.2% | 18.6% | 62.8% | 18.2% | 0.2% | | | | | | | 3,392 |
| 81-120 | 0% | 0.5% | 9.4% | 76.5% | 13.5% | 0.1% | | | | | | 9,098 |
| 121-160 | | 0% | 0.2% | 17.1% | 70.2% | 12.2% | 0.2% | 0% | | | | 8,755 |
| 161-200 | | | | 0.7% | 19.1% | 66.2% | 13.7% | 0.2% | | | | 6,179 |
| 201-250 | | | | 0% | 1.4% | 20.4% | 66.5% | 11.5% | 0.2% | | | 5,308 |
| 251-300 | | | | | 0% | 1.1% | 23.8% | 59.1% | 15.3% | 0.6% | 0% | 3,774 |
| 301-350 | | | | | | 0% | 2.1% | 25.1% | 54.5% | 16.8% | 1.4% | 2,427 |
| 351-400 | | | | | | | | 5.3% | 28.8% | 47.8% | 18.2% | 473 |
| >400 | | | | | | | | | 10.4% | 18.8% | 70.8% | 48 |
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# Trend Accuracy
Trend accuracy describes the accuracy of the sensor during times of rapidly changing glucose and is characterized by slopes, such as from $>2\mathrm{mg/dL}$ to $<-2\mathrm{mg/dL}$ . Trend accuracy was assessed by the concurrence rate of the glucose rate of change (changes in $\mathrm{mg/dL}$ of glucose per minute) determined by the comparator values and the corresponding iCGM values for each CGM-comparator measured pairs (typically once every 15 minutes).
| Comparator Rate Range (mg/dL/Min) | iCGM Rate Range (mg/dL/min) | | | | | iCGM-Comparator Pairs (n) |
| --- | --- | --- | --- | --- | --- | --- |
| | < -2 | [-2, -1) | [-1, 1] | (1, 2] | > 2 | |
| < -2 | 41.4% | 37.1% | 21.0% | 0.5% | | 210 |
| [-2, -1) | 13.4% | 40.2% | 44.2% | 1.8% | 0.4% | 2,026 |
| [-1,1] | 1.1% | 6.5% | 85.3% | 5.8% | 1.3% | 32,531 |
| (1,2] | 0.2% | 0.7% | 43.9% | 36.9% | 18.2% | 2,861 |
| > 2 | | 0.4% | 21.7% | 28.6% | 49.3% | 803 |
# Agreement when iCGM reads "LO" or "HI"
The Eversense 365 CGM System reports glucose readings between 40 and $400\mathrm{mg / dL}$ . When the system determines that the glucose reading is below $40\mathrm{mg / dL}$ , it displays "LO" in the MMA. When the system determines that the glucose level is $>400\mathrm{mg / dL}$ , it displays "HI" in the MMA. Because the system does not display glucose values below $40\mathrm{mg / dL}$ or above $400\mathrm{mg / dL}$ , the comparisons to the actual blood glucose levels (using the laboratory comparator method) when the iCGM value is classified as "LO" or "HI" was evaluated separately. The cumulative percentages when the laboratory comparator values were less than certain glucose levels (for "LO"), and greater than certain glucose values (for "HI") are presented in the table below.
| iCGM Readings | iCGM Comparator Readings | <55 | <60 | <70 | <80 | >=80 | Total |
| --- | --- | --- | --- | --- | --- | --- | --- |
| “LO” | N Cumulative Percent | 54 71.1% | 64 84.2% | 71 93.4% | 72 94.7% | 4 5.3% | 76 |
| iCGM Readings | iCGM Comparator Readings | >340 | >320 | >280 | >250 | <=250 | Total |
| --- | --- | --- | --- | --- | --- | --- | --- |
| “HI” | N Cumulative Percent | 134 85.9% | 143 91.7% | 156 100.0% | 156 100.0% | 0 0% | 156 |
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Alert Performance
The tables in this section show the accuracy of the Eversense 365 CGM System's Low and High Glucose Alarms. The Alarm Rate tells the user how often the alarm is right or wrong. The Detection Rate tells the user how often the Eversense 365 CGM System is able to recognize and notify the user about a low or high glucose event (within 15 minutes before or after the event).
## Low Glucose Alarm Performance
The low glucose alert rate shows how often the alert is right or wrong. The true alert rate is the % of time the iCGM alarmed when the blood glucose level was at or below the alert setting within 15 minutes before or after the iCGM alarmed (as confirmed by the comparator method). The false alert rate is the % of time the iCGM alarmed when the blood glucose level was above the alert setting within 15 minutes before or after the iCGM alarmed. The confirmed detection rate is the % of time the iCGM alarmed when the blood glucose level was at or below the alert setting within 15 minutes before or after the hypoglycemic event. The missed detection rate is the % of time the iCGM did not alarm when the blood glucose was at or below the alert setting within 15 minutes before and after the low glucose event.
Low Glucose Alert and Detection Rate Evaluations (Threshold only, N=110)
| Alert Setting | Hypo Events (n) | Confirmed Event Detection Rate (%) | Missed Event Detection Rate (%) | Hypo Alerts (n) | True Alert Rate (%) | False Alert Rate (%) |
| --- | --- | --- | --- | --- | --- | --- |
| 55 mg/dL | 590 | 76.9 | 23.1 | 952 | 54.5 | 45.5 |
| 60 mg/dL | 1,275 | 78.2 | 21.8 | 1,487 | 72.0 | 28.0 |
| 70 mg/dL | 3,053 | 91.4 | 8.6 | 3,274 | 86.7 | 13.3 |
| 80 mg/dL | 4,667 | 94.0 | 6.0 | 4,936 | 88.8 | 11.2 |
| 90 mg/dL | 6,477 | 94.0 | 6.0 | 6,436 | 91.7 | 8.3 |
Low Glucose Alert and Detection Rate Evaluations (Threshold and Predictive, n=110)
| Alert Setting | Hypo Events (n) | Confirmed Event Detection Rate (%) | Missed Event Detection Rate % | Hypo Events (n) | True Alert Rate (%) | False Alert Rate (%) |
| --- | --- | --- | --- | --- | --- | --- |
| 55 mg/dL | 590 | 88.6 | 11.4 | 1,295 | 51.0 | 49.0 |
| 60 mg/dL | 1,275 | 90.5 | 9.5 | 1,925 | 66.7 | 33.3 |
| 70 mg/dL | 3,053 | 96.6 | 3.4 | 3,779 | 81.5 | 18.5 |
| 80 mg/dL | 4,667 | 97.2 | 2.8 | 5,488 | 84.6 | 15.4 |
| 90 mg/dL | 6,477 | 97.4 | 2.6 | 7,070 | 88.0 | 12.0 |
## High Glucose Alarm Performance
The high glucose alert rate shows how often the alert is right or wrong. The true alert rate is the % of time the iCGM alarmed when the blood glucose level was at or above the alert setting within 15 minutes before or after the iCGM alarmed (as confirmed by the comparator method). The false alert rate is the % of time the iCGM alarmed when the blood glucose level was below
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the alert setting within 15 minutes before or after the iCGM alarmed. The confirmed detection rate is the % of time the iCGM alarmed when the blood glucose level was at or above the alert setting within 15 minutes before or after the hypoglycemic event. The missed detection rate is the % of time the iCGM did not alarm when the blood glucose was at or above the alert setting within 15 minutes before and after the high glucose event.
High Glucose Alert and Detection Rate Evaluations (Threshold only, N=110)
| High Alert Setting (mg/dL) | Hyper Events (n) | Confirmed Event Detection Rate (%) | Missed Event Detection Rate (%) | Hyper Events (n) | True Alert Rate (%) | False Alert Rate (%) |
| --- | --- | --- | --- | --- | --- | --- |
| 120 mg/dL | 27,247 | 97.6 | 2.4 | 26,866 | 97.5 | 2.5 |
| 140 mg/dL | 22,520 | 97.4 | 2.6 | 22,253 | 97.2 | 2.8 |
| 180 mg/dL | 14,874 | 96.4 | 3.6 | 14,720 | 95.5 | 4.5 |
| 200 mg/dL | 12,150 | 95.3 | 4.7 | 11,845 | 95.4 | 4.6 |
| 220 mg/dL | 9,762 | 94.5 | 5.5 | 9,376 | 95.3 | 4.7 |
| 240 mg/dL | 7,728 | 93.7 | 6.3 | 7,371 | 94.5 | 5.5 |
| 300 mg/dL | 3,010 | 89.6 | 10.4 | 2,945 | 87.8 | 12.2 |
High Glucose Alert and Detection Rate Evaluations (Threshold and Predictive, N=110)
| High Alert Setting (mg/dL) | Hyper Events (n) | Confirmed Event Detection Rate (%) | Missed Event Detection Rate (%) | Hyper Events (n) | True Alert Rate (%) | False Alert Rate (%) |
| --- | --- | --- | --- | --- | --- | --- |
| 120 mg/dL | 27,247 | 98.6 | 1.4 | 27,495 | 96.7 | 3.3 |
| 140 mg/dL | 22,520 | 98.4 | 1.6 | 22,921 | 96.0 | 4.0 |
| 180 mg/dL | 14,784 | 97.9 | 2.1 | 15,324 | 94.0 | 6.0 |
| 200 mg/dL | 12,150 | 97.2 | 2.8 | 12,429 | 93.5 | 6.5 |
| 220 mg/dL | 9,762 | 96.4 | 3.6 | 9,910 | 93.0 | 7.0 |
| 240 mg/dL | 7,728 | 95.8 | 4.2 | 7,799 | 92.1 | 7.9 |
| 300 mg/dL | 3,010 | 93.5 | 6.5 | 3,294 | 83.0 | 17.0 |
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Sensor Stability
Sensor stability describes the performance over the sensor lifetime. Sensors can be worn for up to 365 days. Performance was estimated by calculating the percentage of Eversense 365 CGM System readings within $\pm 15\mathrm{mg/dL}$ or $15\%$ (15/15%), $\pm 20\mathrm{mg/dL}$ or $20\%$ (20/20%), or $\pm 40\mathrm{mg/dL}$ or $40\%$ (40/40%) of laboratory comparator values in 30-day successive intervals.
Sensor Stability Relative to Comparator (Accuracy Over Time)
| Wear Period (Days) | Number of paired iCGM-Comparator | MARD | Percent within 15/15% | Percent within 20/20% | Percent within 40/40% |
| --- | --- | --- | --- | --- | --- |
| 1-30 | 9,129 | 9.7 | 81.5 | 90.6 | 99.3 |
| 31-60 | 3,283 | 9.0 | 84.0 | 93.4 | 99.7 |
| 61-90 | 2,858 | 9.9 | 82.7 | 90.9 | 99.4 |
| 91-120 | 3,561 | 8.4 | 88.1 | 95.1 | 99.6 |
| 121-150 | 2,745 | 7.8 | 89.0 | 96.0 | 99.7 |
| 151-180 | 2,727 | 8.1 | 86.2 | 93.7 | 100.0 |
| 181-210 | 3,076 | 7.9 | 88.7 | 95.5 | 100.0 |
| 211-240 | 2,855 | 8.2 | 88.2 | 95.0 | 99.6 |
| 241-270 | 1,951 | 9.4 | 82.7 | 91.3 | 99.9 |
| 271-300 | 2,718 | 7.9 | 88.3 | 95.4 | 99.9 |
| 301-330 | 2,257 | 8.1 | 89.0 | 94.9 | 99.9 |
| 331-365 | 3,337 | 8.8 | 86.9 | 94.8 | 99.8 |
Sensor Life
A total of 110 Sensors were evaluated to determine the percentage of Sensors that lasted through the 365-day Sensor life.
Sensor Survival Rate by Wear (n=110)
| Days since Insertion | Subjects in Study | Number of Sensors | Survival Rate (%) |
| --- | --- | --- | --- |
| 1 | 110 | 107 | 97 |
| 30 | 108 | 105 | 97 |
| 60 | 106 | 103 | 97 |
| 90 | 106 | 102 | 96 |
| 120 | 105 | 101 | 96 |
| 150 | 103 | 99 | 96 |
| 180 | 103 | 99 | 96 |
| 210 | 101 | 96 | 95 |
| 240 | 100 | 95 | 95 |
| 270 | 99 | 92 | 93 |
| 300 | 98 | 90 | 92 |
| 330 | 97 | 89 | 92 |
| 365 | 96 | 86 | 90 |
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The capture rate characterizes the reliability of the communication between components of the system. The Eversense 365 CGM System provides a glucose reading every 5 minutes, or up to 288 readings per day. The percentage of readings expected to be received for the system over the sensor life was evaluated from 110 sensors and is 99.9%. The table below describes the percent of readings received throughout the life span of the sensor (Capture rate).
Reading Capture Rate by Wear Day
| Wear Day | Number of Sensors | Capture Rate (%) |
| --- | --- | --- |
| Day 1-30 | 103 | 99.9 |
| Day 31-60 | 101 | 99.9 |
| Day 61-90 | 97 | 100 |
| Day 91-120 | 96 | 99.9 |
| Day 121-150 | 97 | 100 |
| Day 151-180 | 95 | 100 |
| Day 181-210 | 91 | 99.9 |
| Day 211-240 | 90 | 100 |
| Day 241-270 | 86 | 99.9 |
| Day 271-300 | 87 | 99.9 |
| Day 301-330 | 84 | 100 |
| Day 331-365 | 81 | 99.9 |
## Calibration Stability
A calibration study was performed after sensor insertion in which the iCGM was evaluated against the comparator.
| Time from Calibration | Number of Paired iCGM-Comp data points | Percent 15/15% of Comparator | Percent 20/20% of Comparator | Percent 30/30% of Comparator | Percent 40/40% of Comparator | Percent Greater than 40/40% of Comparator |
| --- | --- | --- | --- | --- | --- | --- |
| 0-12 hours | 10,440 | 85 | 92.7 | 97.9 | 99.3 | 0.7 |
| 12-24 hours | 4,345 | 85.9 | 93.1 | 98.5 | 99.8 | 0.2 |
| 24-36 hours | 1,953 | 87.1 | 95.5 | 99.3 | 99.8 | 0.2 |
| 36-48 hours | 2,628 | 87 | 94.4 | 99.3 | 99.8 | 0.2 |
| 48-60 hours | 1,431 | 86.8 | 94 | 98.9 | 100 | 0 |
| 60-72 hours | 2,299 | 86.3 | 94.3 | 99 | 99.9 | 0.1 |
| 72-84 hours | 1,465 | 82.9 | 90.5 | 97.7 | 99.4 | 0.6 |
| 84-96 hours | 2,309 | 87.7 | 94.8 | 98.6 | 99.7 | 0.3 |
| 96-108 hours | 1,534 | 86.1 | 93.9 | 98.7 | 99.7 | 0.3 |
| 108-120 hours | 2,567 | 84.5 | 93.6 | 98.4 | 99.5 | 0.5 |
| 120-132 hours | 2,095 | 84.8 | 93.1 | 99 | 99.8 | 0.2 |
| 132-144 hours | 2,750 | 85.6 | 93.3 | 99 | 99.9 | 0.1 |
| 144-156 hours | 1,978 | 83.9 | 93.7 | 99.5 | 100 | 0 |
| 156-168 hours | 2,627 | 85.8 | 93.8 | 98.6 | 99.6 | 0.4 |
| 168-174 hours | 76 | 86.8 | 96.1 | 97.4 | 100 | 0 |
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D Clinical Cut-Off:
Not applicable.
E Expected Values/Reference Range:
Not applicable.
F Other Supportive Instrument Performance Characteristics Data:
Not applicable.
VIII Proposed Labeling:
The labeling supports the finding of substantial equivalence for this device.
IX Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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