The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 4 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated.

The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time.

The System is also intended to autonomously communicate with digitally connected devices. The System can be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions.

Libre 2 Plus Sensor users:

The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 2 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated.

The System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The System can be used alone or in conjunction with these digitally connected devices for the purpose of managing diabetes.

Libre 3 Sensor users:

The FreeStyle Libre 3 Continuous Glucose Monitoring System is a real time continuous glucose monitoring (CGM) device with alarms capability indicated for the management of diabetes in persons age 4 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated.

Libre 3 Plus Sensor users:

The FreeStyle Libre 3 Continuous Glucose Monitoring System is a real time continuous glucose monitoring (CGM) device with alarms capability indicated for the management of diabetes in persons age 2 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated.

Device Description

The FreeStyle Libre 3 Continuous Glucose Monitoring System (hereinafter also referred to as 'FSL3 System') and FreeStyle Libre 2 Flash Glucose Monitoring System (hereinafter also referred to as the 'FSL2 System') are integrated continuous glucose monitoring (iCGM) systems that provide continuous glucose measurements every minute to provide glucose levels, trends, and real-time alarms capability to aid in the management of diabetes. The FSL2 and FSL3 Systems also provide configurable alarms designed to warn the user of Low Glucose, High Glucose or Signal Loss. The user may make treatment decisions based in part on the sensor glucose results provided by both Systems. The FSL2 and FSL3 Systems require a prescription and are intended for home use.

The subject FSL3 System consists of a sensor (the FreeStyle Libre 3 Sensor (FSL3 Sensor) or FreeStyle Libre 3 Plus Sensor (FSL3 Plus Sensor)) and a primary display device (the FreeStyle Libre 3 Reader (FSL3 Reader) or the FreeStyle Libre App (FSL App) [iOS and Android] downloaded to a compatible phone). The FSL3 Reader and the FSL App do not interact with each other.

The subject FSL2 System consists of a sensor (the FreeStyle Libre 2 Sensor (FSL2 Sensor) or FreeStyle Libre 2 Plus Sensor (FSL2 Plus Sensor)) and a primary display device (the FreeStyle Libre 2 Reader (FSL2 Reader) or the FSL App (iOS and Android) downloaded to a compatible phone). The FSL2 Reader and FSL App do not interact with each other.

Both the FSL2 and FSL3 Systems are compatible with the Libre Data Sharing API cleared in K223537. The display device of the connected FSL2 or FSL3 Systems, which directly receives the data from the sensor, continues to serve as a primary display device for the glucose data and alarms.

AI/ML Overview

This document is a 510(k) summary from Abbott Diabetes Care Inc. regarding their FreeStyle Libre 3 Continuous Glucose Monitoring System and FreeStyle Libre 2 Flash Glucose Monitoring System. It outlines the device details, indications for use, comparison to predicate devices, and a summary of performance testing.

Acceptance Criteria and Study Proving Device Meets Criteria

The provided text focuses on the substantial equivalence of the new FreeStyle Libre 2 Plus and 3 Plus sensors and updated app features to their predicate devices, rather than establishing new acceptance criteria for the entire system's glucose monitoring accuracy. The document states that clinical performance and human factors were "established in the predicate device (K223435) and are not affected by the introduction of the FSL App in this 510(k)." This implies that the glucose accuracy and user interface performance metrics (e.g., MARD, % in Zones A+B, usability outcomes) for the core glucose monitoring function were previously accepted for the predicate devices and are assumed to hold true for the current submission due to the nature of the changes being primarily related to sensor life, age ranges, and app features.

Therefore, the acceptance criteria and performance data discussed below are extrapolated from the types of performance studies conducted to demonstrate substantial equivalence for the modifications presented in this 510(k), particularly regarding safety and compatibility, and from the implied reliance on the predicate device's established clinical performance.

Please note: This response does not contain specific quantitative acceptance criteria or precise performance metrics for glucose accuracy (e.g., MARD values) as these details are explicitly referred to as having been established in the predicate device (K223435) and are not re-evaluated in this submission. The focus of this 510(k) is on the changes from the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) (modifications to existing systems), the presented "acceptance criteria" are derived from the tests conducted to demonstrate that the changes do not adversely affect safety and effectiveness.

Category	Specific Test/Feature	Acceptance Criteria (Implied/Stated)	Reported Device Performance/Conclusion
Software	Software Verification and Validation	Compliant with IEC 62304 and FDA Guidance "Content of Premarket Submissions for Device Software Functions" (June 14, 2023) and "Multiple Function Device Products: Policy and Considerations" (July 29, 2020).	Results of executed protocols met the acceptance criteria and therefore support that the system software is acceptable for its intended use.
Cybersecurity	Cybersecurity Risk Management	Compliant with FDA guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions'' (September 27, 2023). Appropriate risk mitigation for identified threats and vulnerabilities.	Risk assessment performed, appropriate risk mitigation controls implemented and tested.
Bench Testing	Removal of CT/MRI Contraindications, X-ray Caution	Functionality testing acceptance criteria met for sensor performance after exposure to CT, MRI (MR conditional), and X-ray.	The test results showed all functionality testing acceptance criteria was met. (Previous mechanical, electrical, and functional testing established in the predicate device are not affected).
App Feature: Auto-Display (FSL2)	Automatic display of glucose results without user-initiated scan.	Functionality: Glucose data automatically displays via BLE without user scan, while NFC scan option remains.	Functionality confirmed. (Users may still perform NFC scan as an option, consistent with predicate FSL2 App behavior.)
App Feature: Alarms Escalation	Incremental volume increase for alarms (High, Low, Urgent Low, Signal Loss).	Volume increases incrementally over 30 seconds until maximum volume, equal to predicate device alarm volume.	Functionality confirmed: Alarms increase volume over 30 seconds to the maximum level of predicate device alarms.
Core Glucose Monitoring Performance	Clinical Performance (e.g., Accuracy)	Established in predicate device K223435. (No new evaluation specified in this 510(k) summary for these aspects).	Established in the predicate device (K223437) and not affected by the introduction of the FSL App in this 510(k). (This implies that the existing performance data from K223435 is deemed sufficient for these modified devices).
Human Factors	Usability and User Interface (new features)	Established in predicate device K223435. (No new evaluation specified in this 510(k) summary for these aspects beyond software V&V).	Established in the predicate device (K223437) and not affected by the introduction of the FSL App in this 510(k). (The app navigation change to "Bottom bar navigation menu" from "Side panel navigation", and the "App Stopped Alarm" for Android were likely part of software V&V and user acceptance testing, implied by overall software V&V acceptance).

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide specific sample sizes for the detailed technical tests (Software V&V, Cybersecurity, Bench Testing for CT/MRI/X-ray). These types of tests typically involve controlled laboratory environments rather than human subject test sets in the traditional sense for clinical performance.

For the core clinical performance (glucose accuracy, etc.), the document explicitly states these characteristics were "established in the predicate device (K223435) and are not affected." Therefore, any sample size for these fundamental performance aspects would refer to those used in the studies for the predicate device, which are not detailed in this 510(k) summary.

Data Provenance: The document does not specify the country of origin for any testing data. The nature of the tests (Software V&V, Cybersecurity, Bench Testing) suggests they are likely conducted in a controlled environment, potentially in-house or by a certified testing facility. The "retrospective or prospective" nature is not specified, but these are typically prospective tests conducted as part of the development and verification process.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information (number of experts, qualifications, and ground truth establishment) is typically relevant for clinical studies involving expert adjudication (e.g., for diagnostic imaging devices). Given that the 510(k) summary indicates clinical performance was "established in the predicate device" and that the current submission primarily addresses technical and software improvements/modifications, there's no mention of a new clinical study involving multiple experts to establish ground truth for this specific submission.

For the bench testing related to CT/MRI/X-ray compatibility, ground truth would be established by physical measurements and functional checks against engineering specifications, not by human experts.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies, particularly for diagnostic accuracy where multiple human readers interpret data. As explained above, this 510(k) focuses on technical and software changes, and refers back to the predicate device for clinical performance. Therefore, no information on an adjudication method for a test set is provided or expected in this context.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done, and it is not typically relevant for a CGM device. MRMC studies are primarily conducted for diagnostic imaging devices to assess how AI assistance impacts human reader performance (e.g., radiologists interpreting scans). CGM devices provide quantitative glucose measurements, and their performance is evaluated directly against a reference method (e.g., laboratory glucose measurements), not through human reader interpretation of complex images or cases.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, for the core glucose algorithm, a standalone performance evaluation is inherent to a CGM device. The document explicitly states:

Glucose Algorithm: "ADC Glucose Algorithm"
Location of Glucose Algorithm: "FSL2 System: Receiver", "FSL3 System: Sensor"

This implies that the algorithm processes the sensor's raw electrical signals to calculate a glucose value and trend independently. The clinical performance of this algorithm (e.g., MARD against a reference method) would have been part of the studies for the predicate device (K223435). This 510(k) does not present new data for this, but rather relies on the predicate's established performance, stating that ADC (Abbott Diabetes Care) Glucose Algorithm is the "Same" for the subject device.

7. The Type of Ground Truth Used

For Continuous Glucose Monitoring (CGM) devices, the ground truth for establishing accuracy is typically obtained from laboratory reference methods for blood glucose concentration, such as:

YSI analysis (Yellow Springs Instrument): This is a widely accepted laboratory reference method for measuring glucose in blood or plasma samples.

While not explicitly stated in this 510(k) summary for the ground truth method, it is the standard for CGM accuracy studies which would have been performed for the predicate device to which this submission refers for clinical performance.

8. The Sample Size for the Training Set

The document does not provide a sample size for the training set of the glucose algorithm. This information would typically be detailed in the original predicate device's submission which established the clinical performance. The current 510(k) refers to the "ADC Glucose Algorithm" as being the same as the predicate, indicating no retraining or significant algorithm changes that would necessitate reporting new training data.

9. How the Ground Truth for the Training Set was Established

Similar to the sample size, the specifics of how the ground truth was established for the training set would have been detailed in the original submission for the predicate device. For CGM algorithms, this involves comparing the sensor's raw electrical signals to paired blood glucose values obtained from a highly accurate laboratory reference method (like YSI), collected over time from a cohort of study participants under various glycemic conditions. This establishes the true glucose concentration against which the algorithm learns to convert sensor signals into accurate glucose readings.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out in a sans-serif font.

April 23, 2024

Abbott Diabetes Care Inc. Sapna Ghelani Regulatory Affairs Project Manager 1360 South Loop Road Alameda, California 94202

Re: K233537

Trade/Device Name: FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System Regulation Number: 21 CFR 862.1355 Regulation Name: Integrated Continuous Glucose Monitoring System Regulatory Class: Class II Product Code: OBJ, OLG, NBW Dated: March 18, 2024 Received: March 19, 2024

Dear Sapna Ghelani:

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 (the 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/cdrb/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" (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).

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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 QS 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.

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-devices/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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

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Indications for Use

510(k) Number (if known) K233537

Device Name

FreeStyle Libre 2 Flash Glucose Monitoring System

Indications for Use (Describe)

Libre 2 Sensor users:

Libre 2 Plus Sensor users:

The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 2 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated.

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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Indications for Use

510(k) Number (if known) K233537

Device Name

FreeStyle Libre 3 Continuous Glucose Monitoring System

Indications for Use (Describe)

Libre 3 Sensor users:

Libre 3 Plus Sensor users:

The FreeStyle Libre 3 Continuous Glucose Monitoring System is a real time continuous glucose monitoring (CGM) device with alarms capability indicated for the management of diabetes in persons age 2 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated.

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/5/Picture/0 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a blue, stylized letter "a" on the left, followed by the words "Abbott" in bold, black letters on the top line, and "Diabetes Care" in smaller, black letters on the bottom line. The logo is clean and modern, and the colors are simple and professional.

ડ. 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

510(k) Number: K233537

5.1 Submitter:

Abbott Diabetes Care, Inc. 1360 South Loop Road Alameda, CA 94502

Contact: Sapna Ghelani Title: Regulatory Affairs Project Manager Phone: (805) 750-2721 Fax: (510) 864-4791

Date Prepared: April 21, 2024

5.2 Device Names and Classification:

Name of Device:	FreeStyle Libre 3 Continuous Glucose Monitoring System
Common Name:	Integrated Continuous Glucose Monitoring System, Factory Calibrated
Regulatory Section:	21 CFR 862.1355, 21 CFR 862.1345
Classification:	Class II
Product Code(s):	QBJ, QLG, NBW
Review Panel:	Clinical Chemistry
Name of Device:	FreeStyle Libre 2 Flash Glucose Monitoring System
Common Name:	Integrated Continuous Glucose Monitoring System, Factory Calibrated
Regulatory Section:	21 CFR 862.1355, 21 CFR 862.1345
Classification:	Class II
Product Code(s):	QBJ, QLG, NBW
Review Panel:	Clinical Chemistry

5.3 Predicate Device

Predicate Devices: Freestyle Libre 3 Continuous Glucose Monitoring System and FreeStyle Libre 2 Flash Glucose Monitoring System (K223435)

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Image /page/6/Picture/0 description: The image contains the logo for Abbott Diabetes Care. The logo consists of a blue, stylized "a" on the left, followed by the text "Abbott" in bold, black letters. Below "Abbott" is the text "Diabetes Care" in a smaller, non-bold font, also in black.

5.4 Indications for Use:

5.4.1 FreeStyle Libre 3 Continuous Glucose Monitoring System

Libre 3 Sensor users:

Libre 3 Plus Sensor users:

The FreeStyle Libre 3 Continuous Glucose Monitoring System is a real time continuous glucose monitoring (CGM) device with alarms capability indicated for the management of diabetes in persons age 2 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated.

Contraindication

Diathermy: Remove all parts of your System before high-frequency electrical heat (diathermy) treatment. The effect of diathermy on the System hasn't been tested. The exposure may damage the Sensor, which could impact proper device function and cause inaccurate readings.

Automated Insulin Dosing: Libre 3 Sensors must not be used with automated insulin dosing (AID) systems, including closed loop and insulin suspend systems.

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Image /page/7/Picture/0 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a blue, stylized letter "a" on the left, followed by the words "Abbott" in bold, black letters on the top line, and "Diabetes Care" in smaller, black letters on the bottom line. The logo is simple and modern, and the use of blue and black gives it a professional look.

5.4.2 FreeStyle Libre 2 Flash Glucose Monitoring System

Libre 2 Sensor users:

Libre 2 Plus Sensor users:

The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 2 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated.

Contraindication

Automated Insulin Dosing: Libre 2 Sensors must not be used with automated insulin dosing (AID) systems, including closed loop and insulin suspend systems.

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Image /page/8/Picture/0 description: The image contains the logo for Abbott Diabetes Care. The logo consists of a blue, stylized "a" on the left, followed by the text "Abbott" in bold, black letters. Below "Abbott" is the text "Diabetes Care" in a smaller, non-bold font, also in black.

ર્સ્ટ Device Description

5.5.1 FreeStyle Libre 3 Continuous Glucose Monitoring System

FreeStyle Libre 3 Sensor and FreeStyle Libre 3 Plus Sensor

The sensor is single use, disposable, and powered by a silver oxide battery. The sensor is ● provided through a sensor applicator (which includes an electron beam sterilized subcomponent) which is used to apply the sensor to the back of the user's arm. During sensor application, the sensor tail is inserted below the surface of the skin through the guidance of a needle. The needle is retracted back into the applicator after insertion, and the sensor remains attached to the skin with a medical grade adhesive. The sensor continuously measures glucose concentration in interstitial fluid, is factory calibrated, and does not require fingerstick calibration. The FSL3 Sensor has a 14-day memory capacity and can be worn for up to 14 days. The FSL3 Plus Sensor has a 15-day memory capacity and can be worn for up to 15 days.
FreeStyle Libre App
. When downloaded to a compatible phone, the FSL App uses Near Field Communication (NFC) to start new sensors and uses Bluetooth Low Energy (BLE) to receive glucose data from the sensor. The user can view current glucose information, trend information, historical information and alarms on the app. The FSL App is compatible with the FSL3

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Image /page/9/Picture/0 description: The image contains the logo for Abbott Diabetes Care. The logo consists of a blue, stylized letter "a" on the left, followed by the text "Abbott" in bold, black letters on the top line. Below "Abbott" is the text "Diabetes Care" in a smaller, non-bold font.

family of sensors (includes FSL3 Sensor and FSL3 Plus Sensor). As a mobile application, the FSL App allows connectivity with cloud-based applications. The FSL App is distributed using the App Store and Google Play Store and a list of compatible phones is accessible in the app via the Help feature or FreeStyle Libre consumer website.

FreeStyle Libre 3 Reader

The FSL3 Reader is a small handheld device that is powered by a lithium-ion rechargeable ● battery and uses NFC communication to start new sensors and BLE communication to display glucose data and issue alarms that notify the user to scan his/her sensor when glucose values pass a high or low glucose threshold. The reader also has a built-in strip port with blood glucose functionality (that is intended to work with the FreeStyle Precision Neo Blood Glucose test strips, cleared under K171941), and a user interface that includes event logging features.

5.5.2 FreeStyle Libre 2 Flash Glucose Monitoring System

FreeStyle Libre 2 Sensor and FreeStyle Libre 2 Plus Sensor

The sensor is single use, disposable, and powered by a silver oxide battery. The sensor is ● provided as two secondary components, sensor applicator and sensor pack (electron beam sterilized device) which are used to assemble and apply the sensor to the back of the user's arm. During sensor application, the sensor tail is inserted below the surface of the skin through the guidance of a needle. The needle is retracted back into the applicator after insertion, and the sensor remains attached to the skin with a medical grade adhesive. The sensor continuously measures glucose concentration in interstitial fluid and has an 8-hour memory capacity. The sensor is factory calibrated and does not require fingerstick calibration. The FSL2 Sensor can be worn for up to 14 days. The FSL2 Plus Sensor can be worn for up to 15 days.
FreeStyle Libre App
. When downloaded to a compatible phone, the FSL App uses NFC to start new sensors and uses BLE to receive glucose data from the sensor. The user can view current glucose information, trend information, historical information and alarms on the app. The FSL App is compatible with the FSL2 family of sensors (includes FSL2 Sensor and FSL2 Plus Sensor). As a mobile application, the FSL App allows connectivity with cloud-based applications. The FSL App is distributed using the Apple App Store and Google Play Store and a list of compatible phones is accessible in the app via the Help feature or FreeStyle Libre consumer website.
FreeStyle Libre 2 Reader
The reader is a small handheld device that is powered by a lithium-ion rechargeable battery and uses NFC communication to start new sensors and to scan sensors to display and record data. The reader uses BLE communication to issue alarms that notify the user to scan his/her sensor when glucose values pass a high or low glucose threshold. The reader also has a built-in strip port with blood glucose functionality (that is intended to work with the FreeStyle Precision Neo Blood Glucose test strips, cleared under K171941), and a user interface that includes event logging features.

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Image /page/10/Picture/0 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a blue abstract symbol on the left, followed by the words "Abbott" in bold black letters on the top line and "Diabetes Care" in smaller black letters on the bottom line. The logo is simple and modern, with a focus on the company name and its area of expertise.

Substantial Equivalence 5.6

The similarities and differences between the subject and the predicate devices are highlighted in the tables below.

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Image /page/11/Picture/0 description: The image contains the logo for Abbott Diabetes Care. The logo consists of a blue abstract symbol on the left, followed by the word "Abbott" in bold, black letters. Below "Abbott" is the phrase "Diabetes Care" in a smaller, non-bold font, also in black. The overall design is clean and professional, representing the brand's identity in the diabetes care industry.

Item	Predicate Devices (K223435)	Subject Device:FreeStyle Libre 2 Flash GlucoseMonitoring System	Subject Device:FreeStyle Libre 3 ContinuousGlucose Monitoring System
	FreeStyle Libre 2 Flash GlucoseMonitoring System FreeStyle Libre 3 Continuous GlucoseMonitoring System
Compatible Sensor1	FSL2 SystemFreeStyle Libre 2 SensorFSL3 SystemFreeStyle Libre 3 Sensor	FreeStyle Libre 2 Plus SensorFreeStyle Libre 2 Sensor	FreeStyle Libre 3 Plus SensorFreeStyle Libre 3 Sensor
Compatible SensorLife	Up to 15 days(Additionally, Predicate FSL2 System iscompatible with FSL2 Sensor with 14 daysensor life and predicate FSL3 System iscompatible with FSL3 Sensor with 14 daysensor life)	Same	Same
Similarities
Item	Predicate Devices (K223435)	Subject Device:	Subject Device:
	FreeStyle Libre 2 Flash GlucoseMonitoring System FreeStyle Libre 3 Continuous GlucoseMonitoring System	FreeStyle Libre 2 Flash GlucoseMonitoring System	FreeStyle Libre 3 ContinuousGlucose Monitoring System
Indications for Use	The FreeStyle Libre 2 Flash GlucoseMonitoring System is a continuous glucosemonitoring (CGM) device with real timealarms capability indicated for themanagement of diabetes in persons age 2 andolder. It is intended to replace blood glucosetesting for diabetes treatment decisions, unlessotherwise indicated.The System also detects trends and trackspatterns and aids in the detection of episodes ofhyperglycemia and hypoglycemia, facilitatingboth acute and long-term therapy adjustments.Interpretation of the System readings should bebased on the glucose trends and severalsequential readings over time.The System is also intended to autonomouslycommunicate with digitally connected devices,including automated insulin dosing (AID)Systems. The System can be used alone or inconjunction with these digitally connecteddevices for the purpose of managing diabetes.(Predicate FSL2 System is compatible withlegacy FSL2 Sensor with 14 day sensor life)	Same	NA
Similarities
Item	Predicate Devices (K223435)	Subject Device:FreeStyle Libre 2 Flash GlucoseMonitoring System	Subject Device:FreeStyle Libre 3 ContinuousGlucose Monitoring System
Indications for Use	FreeStyle Libre 2 Flash GlucoseMonitoring System FreeStyle Libre 3 Continuous GlucoseMonitoring System The FreeStyle Libre 3 Continuous GlucoseMonitoring System is a real time continuousglucose monitoring (CGM) device with alarmscapability indicated for the management ofdiabetes in persons age 2 and older. It isintended to replace blood glucose testing fordiabetes treatment decisions, unless otherwiseindicated.The System also detects trends and trackspatterns and aids in the detection of episodes ofhyperglycemia and hypoglycemia, facilitatingboth acute and long-term therapy adjustments.Interpretation of the System readings should bebased on the glucose trends and severalsequential readings over time.The System is also intended to autonomouslycommunicate with digitally connected devices,including automated insulin dosing (AID)Systems. The System can be used alone or inconjunction with these digitally connecteddevices for the purpose of managing diabetes.(Predicate FSL3 System is compatible withFSL3 Sensor with 14 day sensor life)	NA	Same
Similarities
Item	Predicate Devices (K223435)FreeStyle Libre 2 Flash Glucose Monitoring System FreeStyle Libre 3 Continuous Glucose Monitoring System	Subject Device:FreeStyle Libre 2 Flash GlucoseMonitoring System	Subject Device:FreeStyle Libre 3 ContinuousGlucose Monitoring System
Principle ofOperation	Amperometric measurement of currentproportional to glucose concentration ininterstitial fluid via glucose oxidase chemicalreaction	Same	Same
Device type	Integrated CGM	Same	Same
Intended UsePopulation	Persons with diabetes age 2 and older(Additionally, predicate FSL2 System iscompatible with legacy FSL2 Sensor withintended use population of age 4 and older, andpredicate FSL3 System is compatible withFSL3 Sensor with intended use population ofage 4 and older)	Same	Same
Test Range	40 to 400 mg/dL	Same	Same
Clinical Application	Management of diabetes mellitus	Same	Same
Clinical Setting/Sitesof Use	Home Use	Same	Same
Data Displayed	Current glucose value, current glucose trend,graph with recent glucose history, user enteredevents	Same	Same
Similarities
Item	Predicate Devices (K223435)• FreeStyle Libre 2 Flash GlucoseMonitoring System• FreeStyle Libre 3 Continuous GlucoseMonitoring System	Subject Device:FreeStyle Libre 2 Flash GlucoseMonitoring System	Subject Device:FreeStyle Libre 3 ContinuousGlucose Monitoring System
WirelessCommunicationProtocol	Near Field Communication (NFC): 13.56 MHzRFIDBluetooth Low Energy (BLE)	Same	Same
Method of SensorActivation	Near Field Communication (NFC): 13.56 MHzRFID	Same	Same
Mandatory Alarms	Glucose Alarm: Urgent Low GlucoseSystem Alarm: Replace Sensor, Sensor Ended,Check Sensor(Note: Check Sensor is an alarm for FSL3System whereas Check Sensor is notconsidered an alarm for the FSL2 Systemwhere the condition is checked during the NFCscan and detects when a sensor has not beenactivated).	Same	Same
Optional Alarms	Glucose Alarms: Low Glucose Alarm, HighGlucose AlarmSystem Alarm: Signal Loss Alarm	Same	Same
Silent Mode	All App users have option to silence theUrgent Low Glucose Alarm, Low GlucoseAlarm, High Glucose Alarm, and the SignalLoss Alarm. This feature is turned off bydefault but can be turned on by the user for amaximum of 6 hours.	Same	Same
Item	Predicate Devices (K223435)	Subject Device:FreeStyle Libre 2 Flash GlucoseMonitoring System	Subject Device:FreeStyle Libre 3 ContinuousGlucose Monitoring System
	• FreeStyle Libre 2 Flash GlucoseMonitoring System• FreeStyle Libre 3 Continuous GlucoseMonitoring System
Scan-Based Alerts	FSL2 System only:Scan Error, Sensor Error, Replace Sensor,Sensor Ended, Check Sensor	Same as predicate FSL2 System	N/A
BLE CommunicationRange	FSL2 System:20 feet unobstructedFSL3 System:33 feet unobstructed	Same as predicate FSL2 System	Same as predicate FSL3 System
Method of DataTransfer for BackfillData Gap fromSignal Loss	FSL2 SystemNFC – upon user-initiated scanFSL3 SystemBLE - data automatically transfers withoutuser-initiated scan (streaming data).	Same as predicate FSL2 System	Same as predicate FSL3 System
Glucose Algorithm	ADC Glucose Algorithm	Same
Location of GlucoseAlgorithm	FSL2 System:ReceiverFSL3 System:Sensor	Same as predicate FSL2 System	Same as predicate FSL3 System
Glucose ReadingUpdate Interval	Every 1 minute	Same
Similarities
Item	Predicate Devices (K223435)FreeStyle Libre 2 Flash GlucoseMonitoring SystemFreeStyle Libre 3 Continuous GlucoseMonitoring System	Subject Device:FreeStyle Libre 2 Flash GlucoseMonitoring System	Subject Device:FreeStyle Libre 3 ContinuousGlucose Monitoring System
Glucose TrendArrow	↑, > +2 mg/dL/min↗, +1 to +2 mg/dL/min→, -1 to +1 mg/dL/min↘, -2 to -1 mg/dL/min↓, < -2 mg/dL/min	Same	Same
Situations whereFingerstick Test isRequired to ConfirmSensor Reading(Adjunctive Use)	The user's symptoms do not match the glucose values displayed by the device.The device does not show a glucose value during the first 12 hours of wear during which the check blood glucose icon is displayed	Same	Same
Compatibility withConnected Devices	Compatible with digitally connected devices	Same	Same
Sensor Calibration	Factory calibrated		Same
Compatible SensorWarmup Time	1 hour	Same	Same
Blood Glucose Meter	An integrated BGM is provided with thereader.While using the app, user must have access toa blood glucose monitoring system as the appdoes not provide one.	Same	Same
Similarities
Item	Predicate Devices (K223435)	Subject Device:FreeStyle Libre 2 Flash GlucoseMonitoring System	Subject Device:FreeStyle Libre 3 ContinuousGlucose Monitoring System
Anatomical SensorWear Locations	Back of the upper arm	Same	Same
CompatibleOperating Systemsand HardwarePlatform	App is compatible with:• iOS operating system and Apple iPhone• Android operating system and Android-enabled phones	Same	Same
Method ofCommunication andConnectivity withCloud-BasedApplications	App can communicate wirelessly to LibreView. Through LibreView, can communicate to LibreLinkUp App.Reader can communicate and connect with LibreView through the USB port connection with the desktop computer.	Same	Same
ApplicationProgrammingInterfaces (APIs)	Enables users to share their glucose data with authorized client software.Can communicate iCGM data wirelessly and securely to and from digitally connected devices (client software) through a cloud-based communication method, the Libre Data Sharing API.	Same	Same
Item	Predicate Devices (K223435)• FreeStyle Libre 2 Flash GlucoseMonitoring System• FreeStyle Libre 3 ContinuousGlucose Monitoring System	Subject Device:FreeStyle Libre 2 Flash GlucoseMonitoring System	Subject Device:FreeStyle Libre 3 ContinuousGlucose Monitoring System
ContraindicationsAgainstMRI/Diathermy/CT	MRI, Diathermy and CT	Diathermy
Caution and WarningAgainst X-Rays	Yes		No
Method to DisplayCurrent GlucoseResult and TrendArrow	FSL2 SystemBLE for glucose data transfer to issuealarms. User-initiated scan via NFCrequired to display glucose data.FSL3 SystemBluetooth Low Energy (BLE). Dataautomatically transfers to issue alarmsand display glucose data without user-initiated scan (streaming data).	Bluetooth Low Energy (BLE). Dataautomatically transfers to issue alarms anddisplay glucose data without user-initiatedscan (streaming data).A user-initiated scan via NFC can also beperformed to display real-time glucose dataand recent historical data, consistent withthe predicate FSL2 App.	Same as predicate FSL3 System.
Primary DisplayDevice	FSL2 SystemFreeStyle Libre 2 AppFreeStyle Libre 2 ReaderFSL3 SystemFreeStyle Libre 3 AppFreeStyle Libre 3 Reader	FreeStyle Libre AppFreeStyle Libre 2 Reader	FreeStyle Libre AppFreeStyle Libre 3 Reader
Differences
Item	Predicate Devices (K223435)	Subject Device:	Subject Device:
	FreeStyle Libre 2 Flash Glucose Monitoring System FreeStyle Libre 3 Continuous Glucose Monitoring System	FreeStyle Libre 2 Flash Glucose Monitoring System	FreeStyle Libre 3 Continuous Glucose Monitoring System
App Stopped Alarm	FSL2 SystemiOS onlyFSL3 SystemiOS and Android	Same as Predicate FSL3 System
App User InterfaceNavigation	Side panel navigation	Bottom bar navigation menu
App Alarm VolumeEscalation	No App Alarm Volume Escalation	Increases the volume of alarms (High Glucose Alarm, Low Glucose Alarm, UrgentLow Glucose Alarm and Signal Loss Alarm) in custom tone until it reaches amaximum volume, over 30 seconds, equal in volume to that of the predicate devicealarms.

¹ ADC decided to rebrand the FSL3 Sensors with a modified sensor tail (K223435) as FreeStyle Libre 2 Plus Sensor and FreeStyle Libre 3 Plus Sensor, respectively. This is a change in brand name only.

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Image /page/12/Picture/0 description: The image contains the logo for Abbott Diabetes Care. The logo consists of a blue abstract symbol on the left, followed by the word "Abbott" in bold, black letters. Below "Abbott" is the phrase "Diabetes Care" in a smaller, non-bold font, also in black. The overall design is clean and professional, representing the brand's identity in the diabetes care industry.

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Image /page/13/Picture/0 description: The image contains the logo for Abbott Diabetes Care. The logo consists of a blue abstract symbol on the left, followed by the word "Abbott" in bold, black letters. Below "Abbott" is the phrase "Diabetes Care" in a smaller, non-bold font, also in black. The overall design is clean and professional, representing the brand's identity in the diabetes care industry.

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Image /page/14/Picture/0 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a blue abstract symbol on the left, followed by the text "Abbott" in bold black letters on the first line. Below "Abbott" is the text "Diabetes Care" in a smaller, non-bold font, also in black. The logo is clean and professional, likely used for branding purposes by the company.

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Image /page/15/Picture/0 description: The image contains the logo for Abbott Diabetes Care. The logo consists of a blue abstract symbol on the left, followed by the word "Abbott" in bold, black letters. Below "Abbott" is the phrase "Diabetes Care" in a smaller, non-bold font, also in black. The overall design is clean and professional, representing the brand's identity in the diabetes care industry.

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Image /page/16/Picture/0 description: The image contains the logo for Abbott Diabetes Care. The logo consists of a stylized "A" symbol in blue on the left, followed by the text "Abbott" in bold, black font. Below "Abbott" is the text "Diabetes Care" in a smaller, non-bold, black font. The overall design is clean and professional, representing the brand identity of Abbott Diabetes Care.

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Image /page/17/Picture/0 description: The image contains the logo for Abbott Diabetes Care. The logo consists of a blue abstract symbol on the left, followed by the word "Abbott" in bold, black letters. Below "Abbott" is the phrase "Diabetes Care" in a smaller, non-bold font, also in black. The overall design is clean and corporate, representing the brand identity of Abbott Diabetes Care.

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Image /page/18/Picture/0 description: The image contains the logo for Abbott Diabetes Care. The logo consists of a blue abstract symbol on the left, followed by the word "Abbott" in bold, black letters. Below "Abbott" is the phrase "Diabetes Care" in a smaller, non-bold font, also in black. The overall design is clean and professional, representing the brand's identity in the diabetes care industry.

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Image /page/19/Picture/0 description: The image contains the logo for Abbott Diabetes Care. The logo consists of a stylized blue "a" on the left, followed by the text "Abbott" in bold black font on the top line and "Diabetes Care" in a smaller, regular black font on the second line. The logo is clean and professional, conveying a sense of trust and reliability.

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Image /page/20/Picture/0 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a blue abstract symbol on the left, followed by the words "Abbott" in bold black letters and "Diabetes Care" in regular black letters. The logo is simple and clean, with a focus on the company name and its area of expertise.

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Image /page/21/Picture/0 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a blue, stylized letter "a" on the left, followed by the words "Abbott" in bold, black letters on the top line, and "Diabetes Care" in smaller, black letters on the bottom line. The logo is simple and modern, and the colors are clean and professional.

5.7 Comparison of Technological Characteristics with the Predicate Device

Amperometric measurement of glucose concentration (via glucose oxidase chemical reaction) in the interstitial fluid is the technological principle for both the subject and predicate devices. The sensor is held in place with an adhesive pad and incorporates a subcutaneously implanted sensor component and associated electronics. The electrochemical sensor component uses glucose oxidase enzyme to oxidize glucose and transfer electrons to an electrode, producing a current. The strength of the current is proportional to the amount of glucose present in the subcutaneous space. The electrical current signal is converted to a glucose value (in mg/dL) for display to the user on the compatible receiver.

At a high-level, the subject and predicate devices are based on the following technological elements:

Compatibility with system-specific sensor. ●
Use of NFC interface for starting new sensors. ●
Use of BLE interface for wireless communication with the sensor. .
Use of software algorithm for conversion of sensor raw glucose measurements to calculate ● glucose results.
Automatic display of glucose results from FSL3 family of sensors without a user-initiated ● scan.
Ability to display of glucose results from FSL2 family of sensors after a user-initiated scan via NFC.
Inclusion of software interface to wirelessly communicate with cloud-based application (app only).
. Interoperability specification provided to authorized partners to allow compatibility with AID systems.
Libre Data Sharing API to communicate iCGM data with authorized client software for . specific and permitted use cases in accordance with the cleared intended use environments.
App Silent Mode feature to silence the Urgent Low Glucose Alarm, Low Glucose Alarm, . High Glucose Alarm and Signal Loss Alarm. This feature is turned off by default but can be turned on by the user for a maximum of 6 hours.

The following major technological differences exist between the subject and predicate devices:

When used with the FSL 2 family of sensors, the subject device FSL App allows automatic . display of glucose results without a user-initiated scan. The user may still perform a scan

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Image /page/22/Picture/0 description: The image contains the logo for Abbott Diabetes Care. The logo consists of two parts: a stylized blue letter "a" on the left and the text "Abbott Diabetes Care" on the right. The word "Abbott" is in bold, and "Diabetes Care" is below it in a smaller font size.

of sensors of the FSL2 System as an option. The predicate FSL2 App required a userinitiated scan to display glucose results.

The subject device labeling removes the contraindications against CT scan and MRI. Both subject FSL2 and FSL3 Systems are now labeled MR conditional.
The subject device labeling removes the caution and warning against X-ray.
The subject device FSL App includes an "Alarms Escalation" feature for both iOS and Android. The custom tone volume of High Glucose Alarm, Low Glucose Alarm, Urgent Low Glucose Alarm and Signal Loss Alarm increases incrementally over 30 seconds until the volume reaches maximum level. The final volume of the alarm is same as the alarm volume set in the predicate FSL2 App and FSL3 App. The predicate apps do not include this feature.

5.8 Summary of Performance Testing

The following performance characteristics were evaluated to support substantial equivalence:

Software Verification and Validation Software verification and validation testing and ● evaluation was conducted in accordance with IEC 62304 and documentation was provided as recommended by FDA Guidance "Content of Premarket Submissions for Device Software Functions" dated June 14, 2023, and FDA Guidance "Multiple Function Device Products: Policy and Considerations", dated July 29, 2020. Results of executed protocols met the acceptance criteria and therefore support that the system software is acceptable for its intended use.
Cybersecurity ADC has provided cybersecurity risk management documentation for the ● System that includes analysis of confidentiality, integrity, and availability for data, information and software related to the System accordance with the FDA guidance document, "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions'' dated September 27, 2023. For each identified threat and vulnerability risk event scenario, risk assessment of impact to confidentiality, integrity, and availability was performed and documented within the cybersecurity risk management documentation. Appropriate risk mitigation controls have been implemented and tested.
Bench Testing The subject device underwent additional safety and compatibility ● performance testing for the sensors to support removal of contraindications against X-ray and computerized tomography (CT) scans and the modification of the magnetic resonance imaging (MRI) contraindication to magnetic resonance (MR) conditional. The test results showed all functionality testing acceptance criteria was met. Previous mechanical, electrical, and functional testing established in the predicate device are not affected by the introduction of the FSL App.

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Image /page/23/Picture/0 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a stylized letter "a" in blue on the left, followed by the words "Abbott" in bold black letters on the top line and "Diabetes Care" in regular black letters on the bottom line. The logo is simple and modern, and the use of blue and black gives it a professional look.

The following supportive performance characteristics were established in the predicate device (K223435) and are not affected by the introduction of the FSL App in this 510(k):

Biocompatibility ●
Sterility
Shelf Life Stability
Packaging Integrity/Shipping Integrity
Electrical Safety and Electromagnetic Compatibility
Clinical Performance
Human Factors
Interoperability

5.9 Conclusion

The FreeStyle Libre 3 Continuous Glucose Monitoring Systems and the FreeStyle Libre 2 Flash Glucose Monitoring Systems have the same intended use as the predicate devices. There are no differences in technological characteristics that raise different questions of safety and effectiveness. Based on the performance testing and data provided in this pre-market notification, the subject devices and predicate device have been shown to be substantially equivalent.

Regulation Number and Section

§ 862.1355 Integrated continuous glucose monitoring system.

(a)
Identification. An integrated continuous glucose monitoring system (iCGM) is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time. iCGM systems are designed to reliably and securely transmit glucose measurement data to digitally connected devices, including automated insulin dosing systems, and are intended to be used alone or in conjunction with these digitally connected medical devices for the purpose of managing a disease or condition related to glycemic control.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include the following:
(i) Robust clinical data demonstrating the accuracy of the device in the intended use population.
(ii) The clinical data must include a comparison between iCGM values and blood glucose values in specimens collected in parallel that are measured on an FDA-accepted laboratory-based glucose measurement method that is precise and accurate, and that is traceable to a higher order (
e.g., an internationally recognized reference material and/or method).(iii) The clinical data must be obtained from a clinical study designed to fully represent the performance of the device throughout the intended use population and throughout the measuring range of the device.
(iv) Clinical study results must demonstrate consistent analytical and clinical performance throughout the sensor wear period.
(v) Clinical study results in the adult population must meet the following performance requirements:
(A) For all iCGM measurements less than 70 milligrams/deciliter (mg/dL), the percentage of iCGM measurements within ±15 mg/dL of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 85 percent.
(B) For all iCGM measurements from 70 mg/dL to 180 mg/dL, the percentage of iCGM measurements within ±15 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 70 percent.
(C) For all iCGM measurements greater than 180 mg/dL, the percentage of iCGM measurements within ±15 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 80 percent.
(D) For all iCGM measurements less than 70 mg/dL, the percentage of iCGM measurements within ±40 mg/dL of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 98 percent.
(E) For all iCGM measurements from 70 mg/dL to 180 mg/dL, the percentage of iCGM measurements within ±40 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 99 percent.
(F) For all iCGM measurements greater than180 mg/dL, the percentage of iCGM measurements within ±40 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 99 percent.
(G) Throughout the device measuring range, the percentage of iCGM measurements within ±20 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 87 percent.
(H) When iCGM values are less than 70 mg/dL, no corresponding blood glucose value shall read above 180 mg/dL.
(I) When iCGM values are greater than 180 mg/dL, no corresponding blood glucose value shall read less than 70 mg/dL.
(J) There shall be no more than 1 percent of iCGM measurements that indicate a positive glucose rate of change greater than 1 mg/dL per minute (/min) when the corresponding true negative glucose rate of change is less than −2 mg/dL/min as determined by the corresponding blood glucose measurements.
(K) There shall be no more than 1 percent of iCGM measurements that indicate a negative glucose rate of change less than −1 mg/dL/min when the corresponding true positive glucose rate of change is greater than 2 mg/dL/min as determined by the corresponding blood glucose measurements.
(vi) Data demonstrating similar accuracy and rate of change performance of the iCGM in the pediatric population as compared to that in the adult population, or alternatively a clinical and/or technical justification for why pediatric data are not needed, must be provided and determined by FDA to be acceptable and appropriate.
(vii) Data must demonstrate that throughout the claimed sensor life, the device does not allow clinically significant gaps in sensor data availability that would prevent any digitally connected devices from achieving their intended use.
(2) Design verification and validation must include a detailed strategy to ensure secure and reliable means of iCGM data transmission to provide real-time glucose readings at clinically meaningful time intervals to devices intended to receive the iCGM glucose data.
(3) Design verification and validation must include adequate controls established during manufacturing and at product release to ensure the released product meets the performance specifications as defined in paragraphs (b)(1) and (b)(2) of this section.
(4) The device must demonstrate clinically acceptable performance in the presence of clinically relevant levels of potential interfering substances that are reasonably present in the intended use population, including but not limited to endogenous substances and metabolites, foods, dietary supplements, and medications.
(5) The device must include appropriate measures to ensure that disposable sensors cannot be used beyond its claimed sensor wear period.
(6) Design verification and validation must include results obtained through a usability study that demonstrates that the intended user can use the device safely and obtain the expected glucose measurement accuracy.
(7) The labeling required under § 809.10(b) of this chapter must include a separate description of the following sensor performance data observed in the clinical study performed in conformance with paragraph (b)(1) of this section for each intended use population, in addition to separate sensor performance data for each different iCGM insertion or use sites (
e.g., abdomen, arm, buttock):(i) A description of the accuracy in the following blood glucose concentration ranges: less than 54 mg/dL, 54 mg/dL to less than 70 mg/dL, 70 to 180 mg/dL, greater than 180 to 250 mg/dL, and greater than 250 mg/dL.
(ii) A description of the accuracy of positive and negative rate of change data.
(iii) A description of the frequency and duration of gaps in sensor data.
(iv) A description of the true, false, missed, and correct alert rates and a description of the available glucose concentration alert settings, if applicable.
(v) A description of the observed duration of iCGM life for the device.