(126 days)
No
The document describes a standard CGM system with a sensor, transmitter, and app. It focuses on glucose measurement, trend analysis, and alerts based on predefined thresholds. There is no mention of AI, ML, or any learning algorithms used for glucose prediction, pattern recognition beyond simple trends, or personalized therapy adjustments. The "Historical data... can be interpreted to aid in providing therapy adjustments" suggests human interpretation of historical data, not an AI/ML system making those adjustments.
Yes
The device is intended to replace fingerstick blood glucose measurements for diabetes treatment decisions, provide real-time glucose readings, and alert for low and high blood glucose, which directly aids in managing the disease. It can also autonomously communicate with automated insulin dosing (AID) systems for managing diabetes.
Yes.
The device is intended for continually measuring glucose levels and providing real-time glucose readings, trend information, and alerts for low and high blood glucose. Historical data can be interpreted to aid in providing therapy adjustments. These functions are characteristic of a diagnostic device, as they provide information about a patient's physiological state to assist in disease management.
No
The device description clearly states that the system consists of a Sensor (inserted under the skin) and a Transmitter (worn externally), in addition to the software App. These are hardware components essential to the device's function of measuring and transmitting glucose data.
Based on the provided information, the Eversense 365 Continuous Glucose Monitoring (CGM) System is an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The primary intended use is to "continually measuring glucose levels" and "to replace fingerstick blood glucose measurements for diabetes treatment decisions." This involves analyzing a biological sample (interstitial fluid glucose) to provide information for medical diagnosis and treatment.
- Device Description: The system measures "interstitial fluid glucose" using a sensor inserted under the skin. This is a direct measurement of a substance within the body's fluids.
- Performance Studies: The performance studies evaluate the accuracy of the system by comparing its glucose readings to plasma glucose values measured using a laboratory-based glucose analyzer (YSI 2300 Stat Plus Glucose & Lactate Analyzer). This comparison against a reference method for measuring a biological analyte is characteristic of IVD device evaluation.
While the system has components that are implanted (sensor) and external (transmitter, app), the core function of measuring glucose in interstitial fluid for diagnostic and treatment purposes aligns with the definition of an IVD. The fact that it replaces fingerstick blood glucose measurements, which are a common IVD test, further supports this classification.
N/A
Intended Use / 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 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.
Product codes
SBA
Device Description
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.
- 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.
- 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.
- 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper arm (for sensor wear location)
Indicated Patient Age Range
18 years or older
Intended User / Care Setting
Users: People with diabetes (18 years or older)
Use Environment: Home
Prescription: Yes
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
The ENHANCE Study, conducted under IDE application G210196, evaluated the accuracy and safety of the Eversense 365 CGM System through 365 days post-insertion.
The ENHANCE Study is a prospective, multi-center study, whereby 110 adult subjects (ages 18 years and older) were inserted with the Eversense 365 CGM System at 4 sites in the United States. One hundred and ten (110) participants with diabetes had at least one sensor inserted into their upper arms by trained Investigators.
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. For qualified subjects, hyperglycemia and hypoglycemia challenges were performed during clinic visits to measure accuracy over a range of glucose values. The study utilized an FDA-accepted laboratory-based glucose measurement method (2300 Stat Plus Glucose & Lactate Analyzer, Yellow Springs Instruments, Yellow Springs, OH, USA) to evaluate the accuracy of the Eversense 365 CGM System.
Accuracy visits were conducted from insertion and through Day 365 to assess performance in the early post Sensor insertion period and through 12 months. In the interest of testing Sensor performance across the entire reporting range of the device (40-400 mg/dL), data were collected in the hypoglycemic and hyperglycemic ranges by having eligible participants participate in either hypoglycemia and hyperglycemia challenges at each visit, where participant's glucose levels were artificially raised or lowered to certain levels for prescribed periods of time.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Clinical Performance - The ENHANCE Study, a prospective, multi-center study.
Sample Size: 110 adult subjects with diabetes.
Key Results:
The results from the ENHANCE Study demonstrated that accuracy of the Eversense 365 CGM System and that it met all Special Controls for accuracy. The safety profile was also comparable to Eversense CGM Systems. The majority of Eversense 365 Sensors (90%) functioned through 12 months.
Point Accuracy Between iCGM and YSI by iCGM Glucose Ranges:
- System Agreement to Reference within ± 15 mg/dL/15%
- 85%
- 70-180 mg/dL: 81.9% (95% LB: 81.5%), Special Control >70%
-
180 mg/dL: 89.3% (95% LB: 88.9%), Special Control >80%
- System Agreement to Reference within ± 40 mg/dL/40%
- 98%
- 70-180 mg/dL: 99.4% (95% LB: 99.3%), Special Control >99%
-
180 mg/dL: 99.8% (95% LB: 99.7%), Special Control >99%
iCGM System Agreement to Reference within Overall iCGM Glucose Range:
- Overall (40-400) mg/dL: Point Estimate of Percent Within 20% = 92.0% (95% LB: 91.8%), Special Control 95% LB >87%
iCGM Special Controls through 365 Days:
- (1)(v)(H) 180 mg/dL. Results: 0 values > 180 mg/dL.
- (1)(v)(I) >180 mg/dL: No blood glucose value 1mg/dL/min when the corresponding true negative rate of change is 2mg/dL/min. Results: 0.4% (3/806).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not directly provided as sensitivity, specificity, PPV, NPV. The accuracy metrics provided are:
- Percent and Point Accuracy Between iCGM and YSI by iCGM Glucose Ranges
- System Agreement to Reference within ± 15 mg/dL/15%
- System Agreement to Reference within ± 40 mg/dL/40%
- Overall Percent Within 20%
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 16, 2024
Senseonics. Incorporated Mukul Jain Chief Operating Officer 20451 Seneca Meadows Parkway Germantown, Maryland 20876-7005
Re: K241335
Trade/Device Name: Eversense 365 Continuous Glucose Monitoring (CGM) System Regulation Number: 21 CFR 862.1357 Regulation Name: Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate Regulatory Class: Class II Product Code: SBA Dated: May 10, 2024 Received: May 13, 2024
Dear Mukul Jain:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
2
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Joshua Balsam -S
Joshua M. Balsam, Ph.D. Branch Chief Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K241335
Device Name
Eversense 365 Continuous Glucose Monitoring (CGM) System
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
510(k) SUMMARY
Applicant Information
| Applicant/
510(k) Owner: | Senseonics, Incorporated
20451 Seneca Meadows Parkway
Germantown, Maryland 20876-7005
Registration Number: 3009862700 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mukul Jain, Ph.D.
Chief Operating Officer
Senseonics, Incorporated
20451 Seneca Meadows Parkway
Germantown, Maryland 20876-7005
Phone: (301) 556-1653
Fax: (301) 515-0988
E-mail: Mukul.Jain@senseonics.com |
Date of Preparation: 13 September 2024
510(k) Number: K241335
Device and Classification Information
| Trade Name: | Eversense 365 Continuous Glucose Monitoring (CGM)
System |
|----------------------------|-------------------------------------------------------------------------------------------------|
| Common Name: | iCGM |
| Classification Regulation: | 21 CFR 862.1357 |
| Regulation Name: | Integrated continuous glucose monitoring system with
sensor containing dexamethasone acetate |
| Product Code: | SBA |
| Class: | 2 |
| Panel: | Clinical Chemistry |
Device Description
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;
5
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.
-
- 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.
-
- 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.
-
- 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.
Indication for Use
The indication for use is shown below.
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.
6
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.
Predicate Device Identification for Substantial Equivalence Comparison
For purposes of demonstrating substantial equivalence, the following predicate devices was selected:
-
Senseonics Eversense AP Continuous Glucose Monitoring (CGM) System by Senseonics, Incorporated authorized via DEN230052
The predicate device has been authorized by FDA for marketing in the US and has not been subject to a design-related recall.
Comparison of the Indication for Use and Intended Use between the Eversense 365 CMG System and the Predicate Eversense AP CGM System
The Eversense 365 CGM System has the same intended use as the predicate device Eversense AP CGM System (Table 1). There is one difference in the indication for use statements: the Eversense 365 CGM System is used for up to 1 year while the Eversense AP CGM System is used for up to 6 months. Importantly, both CGM systems are for long-term use to provide realtime glucose levels to guide diabetes treatment decisions and manage diabetes for patients (18 years or older), including communicating digitally with other medical devices, such as automated insulin dosing systems.
| Table-1. Comparison of the Intended Use of the Eversense 365 CGM System to the Predicate |
|---|
| Eversense AP CGM System (DEN230052) |
| Characteristic | Eversense 365 CGM
System | Eversense AP CGM System
(DEN230052) | Comparison |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Senseonics | Senseonics | Same |
| Class: | 2 | 2 | Same |
| Characteristic | Eversense 365 CGM System | Eversense AP CGM System (DEN230052) | Comparison |
| Regulation:
Product Code:
Common Name: | 21 CFR 862.1357
SBA
iCGM | 21 CFR 862.1357
SBA
iCGM | |
| Indication for Use | ... is indicated for continually
measuring interstitial fluid
glucose levels for up to 1
year 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).
...is also indicated to
communicate with digitally
connected medical devices,
including automated insulin
dosing (AID) systems. The
CGM can be used alone or in
conjunction with these
digitally connected medical
devices for the purpose of
managing diabetes. | ...is indicated for continually
measuring interstitial fluid
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).
...is also indicated to
communicate with digitally
connected medical devices,
including automated insulin
dosing (AID) systems. The
CGM can be used alone or in
conjunction with these
digitally connected medical
devices for the purpose of
managing diabetes. | Different: Different
length of Sensor
wear time.
Difference in Sensor
wear does not affect
intended use as both
CGM Systems share
the same purpose,
function, principles
of operation, and
clinical use in
addition to other
factors. |
| Purpose: | • To provide real-time
glucose measurements
for diabetes treatment
decisions and to manage
diabetes | • To provide real-time
glucose measurements
for diabetes treatment
decisions and to manage
diabetes | Same |
| Functions: | • Provides real-time
glucose measurements
• Provides glucose trend
information | • Provides real-time
glucose measurements
• Provides glucose trend
information | Same |
| Characteristic | Eversense 365 CGM
System | Eversense AP CGM System
(DEN230052) | Comparison |
| | Provides alerts and predictive alerts for hypoglycemia and hyperglycemia Provides remote monitoring capabilities Communicates digitally with medical devices (automated insulin dosing systems) | Provides alerts and predictive alerts for hypoglycemia and hyperglycemia Provides remote monitoring capabilities Communicates digitally with medical devices (automated insulin dosing systems) | |
| Principle of
Operation: | Glucose binds to the Sensor indicator molecule causing increase in fluorescence intensity. Fluorescence is measured by the Sensor's internal optical system. Transmitter calculates glucose values from the fluorescence measurements and communicates these values to other devices. | Glucose binds to the Sensor indicator molecule causing increase in fluorescence intensity. Fluorescence is measured by the Sensor's internal optical system. Transmitter calculates glucose values from the fluorescence measurements and communicates these values to other devices. | Same |
| Clinical Use: | Manage diabetes | Manage diabetes | Same |
| Analyte: | Glucose | Glucose | Same |
| Specimen: | Interstitial fluid | Interstitial fluid | Same |
| Wear Location: | Upper arm | Upper arm | Same |
| Sensor Contact: | Tissue | Tissue | Same |
| Transmitter
Contact: | Intact skin | Intact skin | Same |
| Sensor Life: | Up to 1 year
(Automatically shuts down
after grace period) | Up to 6 months
(Automatically shuts down,
no grace period) | Different |
| Users: | People with diabetes
(18 years or older) | People with diabetes
(18 years or older) | Same |
| Prescription: | Yes | Yes | Same |
| Use Environment: | Home | Home | Same |
| Technological
Characteristic | Eversense 365 CGM
System | Eversense AP CGM
System (DEN230052) | Comparison |
| System Components | Sensor
Insertion Tools
Transmitter
Adhesive Patches
Mobile App (MMA) | Sensor
Insertion Tools
Transmitter
Adhesive Patches
Mobile App (MMA) | Same |
| Sensor | Eversense 365 Sensor | Eversense AP Sensor | Different |
| Insertion Tools | Eversense Insertion
Tools | Eversense Insertion
Tools | Same |
| Transmitter | Eversense 365
Transmitter | Eversense AP
Transmitter | Different |
| Adhesive Patch | Eversense 365 Adhesive
Patches | Eversense Adhesive
Patches | Same |
| Mobile Medical App
(MMA) | Eversense 365 App | Eversense AP App | Different |
| Principles of Operation | • Glucose binds to the
Sensor indicator
molecule causing
increase in
fluorescence
intensity.
• Fluorescence is
measured by the
Sensor's internal
optical system.
• Transmitter
calculates glucose
values from the
fluorescence
measurements and
communicates these
values to other
devices. | • Glucose binds to the
Sensor indicator
molecule causing
increase in
fluorescence
intensity.
• Fluorescence is
measured by the
Sensor's internal
optical system.
• Transmitter
calculates glucose
values from the
fluorescence
measurements and
communicates these
values to other
devices. | Same |
7
8
Comparison of the Technological Characteristics between the Eversense 365 CGM System and the Predicate Eversense AP CGM System
9
There are many similarities in technological characteristics between the Eversense 365 CGM System and the predicate Eversense AP System, but there are some differences.
Each CGM system consists of the same components: an implantable sensor, insertion tools, transmitter, adhesive patch for the transmitter, and a mobile medical application (MMA) (see Table 2). Two components have been updated to achieve the longer Sensor life and reduced calibration frequency: the sensor and the transmitter. The software application has also been updated to accommodate the longer Sensor life and reduced calibration frequency.
Comparison of the System Components of the Eversense 365 CGM System and the Table-2. Predicate Eversense AP CGM System
10
Performance Data
This 510(k) notification provided performance data to establish the substantial equivalence of the Eversense 365 CGM System and to demonstrate the Eversense 365 CGM System meets the Special Controls.
Sterility and Shelf-Life: The Eversense 365 Sensor with its holder and the Insertion Tools are provided sterile for single-use, and are sterilized using ethylene oxide (EO). The sterilization process was validated in accordance with ISO 11135-1 and in consideration of ISO 11135-2 to a sterility assurance level (SAL) of 106. The shelf-life has been established at 13 months with recommended storage between 2°C and 8°C (36°F and 46°F).
Biocompatibility: Biocompatibility studies were selected and performed in consultation with international recognized safety standards (ISO 10993-1, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing) and in accordance with the FDA guidance document. All studies were conducted in compliance with 21 CFR Part 58 - Good Laboratory Practice for Nonclinical Laboratory Studies (GLPs). All studies had passing results (see table).
| Biocompatibility Test | ISO Standard | Results |
|---|---|---|
| Cytotoxicity | ISO 10993-5 | Pass - Not cytotoxic |
| Sensitization | ISO 10993-10 | Pass - -Not Sensitizing |
| Irritation | ISO 10993-10 | Pass - Nonirritant |
| Systemic Toxicity (Material Mediated | ||
| Pyrogen) | ISO 10993-11 | Pass - Not pyrogenic |
| Subchronic Toxicity and Implantation (4 and | ||
| 13 week implant study) | ISO 10993-6 | Pass - Not systemically toxic |
| Chronic Toxicity and Implantation (26 week | ||
| implant study) | ISO 10993-6 | Pass - Not systemically toxic |
| Genotoxicity/Carcinogenicity (Bacterial | ||
| Reverse Mutation) | ISO 10993-3 | Pass - Non-mutagenic |
| Genotoxicity/Carcinogenicity | ||
| (Mouse Lymphoma) | ISO 10993-3 | Pass - Non-mutagenic |
| Chemical Characterization | ISO 10993-17 | |
| ISO 10993-18 | Pass - no leachables/extractables | |
| from the Sensor are likely to cause | ||
| adverse effects in patients | ||
| Particulate Tests | ISO 14708-1 | Pass - Particulate count did not |
| exceed requirement |
| Table-3. Summary of the Biocompatibility Tests and Results for the Eversense 365 Sensor |
|---|
Software: Software verification and validation testing has been performed in accordance with IEC 62304 and the FDA guidance document for software. Verification and validation testing included unit test, system level verification tests (which included functional testing to demonstrate the device meet its requirements), traceability linking and validation testing to ensure the software conforms to user needs and intended uses.
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Cybersecurity: Cybersecurity information in accordance with the FDA guidance document for cybersecurity has been provided to demonstrate cybersecurity risks have been mitigated and that the risk of cybersecurity threats is deemed acceptable.
Electromagnetic Compatibility (EMC): Electromagnetic Compatibility and Wireless Coexistence performance characteristics were established through nonclinical testing of the predicate device and are applicable to the Eversense 365 Transmitter. The Transmitter has undergone testing to demonstrate that the device meets the standards for EMC compatibility: IEC 60601-1-2, 4.1 Edition, Medical electrical equipment - Part 1-2, General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
Electrical, Mechanical and Thermal: Electrical Safety performance characteristics were established through nonclinical testing of the predicate device and are applicable to the Eversense 365 CGM System. The Transmitter has undergone testing to demonstrate that the device meets the international standards: IEC 60601-1, 3ª Edition, Medical electrical equipment - General requirements for basic safety and essential performance.
The environmental and mechanical requirements of the Eversense 365 Sensor and Eversense 365 Transmitter were tested to verify requirements were met.
Performance – Bench:
Appropriate testing was performed to confirm the devices meet specified performance requirements:
- Chemical interference testing following standard EP7-02. Interference Testing in Clinical . Chemistry was performed to verify that prior tests performed on the predicate device are applicable to the subject device, and that no new interference substances are identified.
- . MRI exposure testing following standard ISO/TS 10974. Assessment of the Safety of Magnetic Resonance Imaging for Patients with an Active Implantable Medical Device was performed to verify the Sensor is MRI Conditional.
- Ultrasound exposure testing following standard ISO 14708-1, Implants for surgery --. Active implantable medical devices -- Part 1: General requirements for safety, marking and for information to be provided by the manufacturer was performed to verify Sensors maintain functionality after exposure to ultrasound.
- Adhesion testing was performed to verify adhesive patches meet their functional . requirements.
- . Testing was performed to verify the Insertion Tool is capable of retaining the Sensor.
Performance – Clinical:
The ENHANCE Study, conducted under IDE application G210196, evaluated the accuracy and safety of the Eversense 365 CGM System through 365 days post-insertion.
The ENHANCE Study is a prospective, multi-center study, whereby 110 adult subjects (ages 18 years and older) were inserted with the Eversense 365 CGM System at 4 sites in the United States. One hundred and ten (110) participants with diabetes had at least one sensor inserted into their upper arms by trained Investigators.
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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. For qualified subjects, hyperglycemia and hypoglycemia challenges were performed during clinic visits to measure accuracy over a range of glucose values. The study utilized an FDA-accepted laboratory-based glucose measurement method (2300 Stat Plus Glucose & Lactate Analyzer, Yellow Springs Instruments, Yellow Springs, OH, USA) to evaluate the accuracy of the Eversense 365 CGM System.
Accuracy visits were conducted from insertion and through Day 365 to assess performance in the early post Sensor insertion period and through 12 months. In the interest of testing Sensor performance across the entire reporting range of the device (40-400 mg/dL), data were collected in the hypoglycemic and hyperglycemic ranges by having eligible participants participate in either hypoglycemia and hyperglycemia challenges at each visit, where participant's glucose levels were artificially raised or lowered to certain levels for prescribed periods of time.
The ENHANCE Study relied upon many of the same design features and elements of the clinical studies that supported past Eversense CGM System approvals, including the original PMA P160048, the non-adjunctive use P160048/S006, two Panel-Track PMA Supplements (P160048 S016 and S021). The ENHANCE study also supported the De Novo request (DEN230052) that was recently granted.
The ENHANCE Study was conducted in compliance with 21 CFR Parts 50, 56, and 812.
The results from the ENHANCE Study demonstrated that accuracy of the Eversense 365 CGM System and that it met all Special Controls for accuracy (see Tables 4-6). The safety profile was also comparable to Eversense CGM Systems. The majority of Eversense 365 Sensors (90%) functioned through 12 months.
| Table-4. Percent and Point Accuracy Between iCGM and YSI by iCGM Glucose Ranges: |
|---|
| iCGM Special Controls (1)(v)(A)-(F) |
| iCGM Special
Control | iCGM
Glucose | Matched
Pairs (N) | Eversense 365 CGM
System Performance | | Special
Control |
|-----------------------------------------------------|------------------|----------------------|-----------------------------------------|--------|--------------------|
| | Range
(mg/dL) | | Point
Estimate | 95% LB | 95% LB |
| System Agreement to Reference within ± 15 mg/dL/15% | | | | | |
| (1)(v)(A) | 85% |
| (1)(v)(B) | 70-180 | 23049 | 81.9% | 81.5% | >70% |
| (1)(v)(C) | >180 | 14408 | 89.3% | 88.9% | >80% |
| System Agreement to Reference within ± 40 mg/dL/40% | | | | | |
| (1)(v)(D) | 98% |
| (1)(v)(E) | 70-180 | 23049 | 99.4% | 99.3% | >99% |
| (1)(v)(F) | >180 | 14408 | 99.8% | 99.7% | >99% |
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iCGM System Agreement to Reference within Overall iCGM Glucose Range: iCGM Table-5. Special Control (1)(v)(G)
| iCGM Glucose Range
(mg/dL) | Matched Pairs (N) | Pointe Estimate of
Percent Within
20% | 95% LB | Special Control
95% LB |
|-------------------------------|-------------------|---------------------------------------------|--------|---------------------------|
| Overall (40-400) mg/dL | 40497 | 92.0% | 91.8% | >87% |
Table-6. iCGM Special Controls (1)(v)(H)-(K) Through 365 Days
| iCGM
Special
Control | iCGM
Glucose
Range mg/dL | Matched
Pairs (N) | Performance Metric | Eversense 365
Results |
|----------------------------|--------------------------------|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| (1)(v)(H) | 180 mg/dL | 0 values > 180
mg/dL |
| (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) |
Human Factors:
No new Human Factors testing was performed to support this 510(k) notification. A comparative Use Related Risk Analysis was performed to support this 510(k) notification.
Special Controls:
Evaluation and adherence to the Special Controls for the Eversense 365 CGM System demonstrates assurance of the safety and effectiveness and substantial equivalence to the predicate device (DEN230052).
Conclusion
The comparisons and performance data demonstrate that the Eversense 365 CGM System meets the Special Controls for an integrated continuous glucose monitoring system with sensor containing dexamethasone acetate, and is substantially equivalent.