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.

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 age 4 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated.

Device Description

The FreeStyle Libre 2 and FreeStyle Libre 3 are integrated continuous glucose monitoring (iCGM) Systems designed to be used alone or in conjunction with digitally connected devices. The FreeStyle Libre 2 System consists of a Sensor and either a Reader or the FreeStyle Libre 2 App downloaded to a compatible smartphone as a primary display device. The FreeStyle Libre 3 System consists of a Sensor and the FreeStyle Libre 3 App downloaded to a compatible smartphone as a primary display device. Both Systems can communicate glucose data and other information wirelessly and securely to and from these digitally connected devices as described below:

Wireless communication from the FreeStyle Libre 2 Sensor or FreeStyle Libre 3 Sensor directly to an interoperable receiver device, which connects with the Sensor using the near field communication (NFC) and Bluetooth Low Energy wireless interfaces provided by the Sensor
The FreeStyle Libre 2 App or FreeStyle Libre 3 App communicates through the cloud to another software device, such as LibreView.

Compared to the respective predicate devices, the proposed subject devices include an additional software component, the Libre Data Sharing API. The Libre Data Sharing API is a cloud-based application programming interface (API) that enables communication of glucose data including alarms through the cloud from the FreeStyle Libre 2 System or FreeStyle Libre 3 System to authorized client software on digitally connected devices. The data transmitted by the API to authorized client software can be used for specific and permitted use cases, including nonmedical device applications, medical device data analysis, CGM secondary display alarm, active patient monitoring, and treatment decisions. Use of the Libre Data Sharing API and the CGM information it transmits is limited by the indications for use of the iCGM systems with which it is used.

The Libre Data Sharing API does not have any command or control over the client software, nor does it allow for the client software to have any command or control over the FreeStyle Libre 2 or FreeStyle Libre 3 Systems. Additionally, glucose data and alarms from the connected iCGM system are not modified or manipulated by the Libre Data Sharing API through its transmission to the authorized client software.

The display device of the connected FreeStyle Libre 2 or FreeStyle Libre 3 Systems, which directly receives the data from the Sensor, continues to serve as a primary display device for the glucose data and alarms. The current components of the FreeStyle Libre 2 and FreeStyle Libre 3 Systems (sensor/applicator and primary display devices) have not been modified as a result of the added the Libre Data Sharing API.

AI/ML Overview

This document is a 510(k) Summary for the FreeStyle Libre 2 Flash Glucose Monitoring System and FreeStyle Libre 3 Continuous Glucose Monitoring System. It describes the devices and argues for their substantial equivalence to previously cleared predicate devices.

Here's an analysis of the acceptance criteria and study information provided in the document:

1. Acceptance Criteria and Reported Device Performance:

The document doesn't present a table of numerical acceptance criteria with corresponding performance statistics. Instead, it argues for substantial equivalence based on the technological characteristics and intended use being the same as the predicate devices, with the addition of the Libre Data Sharing API.

The key acceptance criteria, implicitly, are that the devices continue to perform according to specifications and meet their technological and performance criteria, as demonstrated by verification and validation, aligning with the predicate devices' cleared performance.

Acceptance Criteria Category (Implicit)	Reported Device Performance
Technological Characteristics	Identical to predicate devices (amperometric measurement, glucose oxidase chemical reaction).
Intended Use / Indications for Use	Same as predicate devices. The Libre Data Sharing API enables communication of iCGM data for specific, permitted use cases, but does not change the core indications.
Primary Display Device Function	Unchanged. Continues to act as the primary display and issue glucose alarms.
Safety and Effectiveness	No impact from the Libre Data Sharing API. The API has no command/control over client software or the iCGM systems, and glucose data/alarms are not modified during transmission.
Adherence to Special Controls	Conforms to iCGM special controls per 21 CFR 862.1355.

2. Sample Size and Data Provenance:

The document states: "The proposed subject devices with the Libre Data Sharing API were verified and validated according to ADC's internal design control process and in accordance with the applicable special controls for integrated continuous glucose monitoring systems. The testing demonstrated that the subject devices conform to the iCGM special controls per 21 CFR 862.1355 and that they performed according to specifications and met their technological and performance criteria."

Sample Size: The document does not specify the sample sizes used for the test set or the training set. It refers broadly to "performance testing" and "data provided in this pre-market notification."
Data Provenance: The document does not explicitly state the country of origin or whether the studies were retrospective or prospective. Given it's a 510(k) submission for a medical device, it's highly likely that the underlying performance data comes from clinical studies, often multi-site and prospective, but this document does not detail them. The focus of this 510(k) is specifically on the added software component (Libre Data Sharing API) and its impact on substantial equivalence, rather than re-proving the core glucose monitoring accuracy which would have been established in previous 510(k) clearances.

3. Number of Experts and Qualifications for Ground Truth:

The document concerns the addition of a data sharing API to existing glucose monitoring systems. It does not mention the use of experts to establish ground truth in the context of a reader study for the new component. The primary ground truth for glucose monitoring devices is typically derived from lab reference methods (e.g., YSI analyzer for blood glucose), rather than expert adjudication of images or clinical assessments.

4. Adjudication Method for the Test Set:

Not applicable in the context of this submission. The submission is about an API for device data sharing, not a diagnostic imaging or clinical assessment device requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC study was not conducted or mentioned. This type of study is relevant for AI-assisted diagnostic tools that impact human reader performance, typically in radiology or pathology. This submission is for a continuous glucose monitoring system and an API to share its data.

6. Standalone (Algorithm Only) Performance:

The document states: "The Libre Data Sharing API does not have any command or control over the client software, nor does it allow for the client software to have any command or control over the FreeStyle Libre 2 and FreeStyle Libre 3 Systems. Additionally, glucose data and alarms from the FreeStyle Libre 2 and FreeStyle Libre 3 Systems are not modified or manipulated by the Libre Data Sharing API through its secured transmission to the authorized client software."

This implies that the core algorithm performance (i.e., glucose measurement accuracy) of the FreeStyle Libre 2 and 3 systems, which operates independently of the Libre Data Sharing API, has already been established in previous clearances (K210943, K213996, K212132). This submission focuses on the safety and effectiveness of the data sharing mechanism, not the standalone performance of the glucose measurement algorithms themselves. The API itself is primarily a data transmission layer, not a
diagnostic algorithm.

7. Type of Ground Truth Used:

For the underlying glucose monitoring systems (FreeStyle Libre 2 and 3), the ground truth for performance studies is typically laboratory reference measurements (e.g., plasma glucose values obtained from a YSI glucose analyzer) against which the accuracy of the interstitial glucose readings are compared. The document does not specifically detail how the ground truth was established for the "performance testing" related to the API, as the API's function is data transmission, not direct measurement. The ground truth for the API's performance would likely focus on the integrity, security, and timeliness of data transfer.

8. Sample Size for the Training Set:

The document does not specify the sample size for any training set. This submission is for a device modification (adding an API), not a de novo AI/ML algorithm that typically undergoes distinct training and test phases. The core glucose algorithms were already developed and cleared.

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

Not applicable, as this submission pertains to an API for data sharing and refers to "verification and validation" for "performance testing" of the modified device, rather than the development and training of a new algorithm requiring a specific ground truth establishment for a training set. The underlying glucose measurement algorithms would have had their own ground truth established during their prior development and clearance, likely using reference lab methods.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & 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.

February 21, 2023

Abbott Diabetes Care, Inc. Simon Yuan Official Correspondent 1360 South Loop Road Alameda, CA 94502

Re: K223537

Trade/Device Name: FreeStyle Libre 2 Flash Glucose Monitoring System, FreeStyle Libre 3 Continuous Glucose Monitoring System Regulation Number: 21 CFR 862.1355 Regulation Name: Integrated Continuous Glucose Monitoring System Regulatory Class: Class II Product Code: QLG, NBW Dated: November 21, 2022 Received: November 23, 2022

Dear Simon Yuan:

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 (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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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.

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,

Image /page/1/Picture/5 description: The image shows a digital signature. The name "Paula Caposino -S" is written in a large font on the left side of the image. On the right side, it says "Digitally signed by Paula Caposino -S" followed by the date "2023.02.21" and the time "11:19:41 -05'00'".

Paula Caposino, Ph.D. Acting Deputy Director 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

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Indications for Use

510(k) Number (if known) K223537

Device Name

FreeStyle Libre 2 Flash Glucose Monitoring System

Indications for Use (Describe)

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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Indications for Use

510(k) Number (if known) K223537

Device Name

FreeStyle Libre 3 Continous Glucose Monitoring System

Indications for Use (Describe)

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.

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)

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 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/4/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 text "Abbott" in bold, black letters on the top line. Below "Abbott" is the text "Diabetes Care" in a smaller, non-bold font, also in black.

1. 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: K223537

1.1 Submitter:

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

Contact: Simon Yuan Title: Principal Regulatory Affairs Specialist Phone: (510) 206-6719 Fax: (510) 864-4791

Date Prepared: February 17, 2023

Device Names and Classification: 1.2

Name of Device:	FreeStyle Libre 2 Flash Glucose Monitoring System
Common Name:	Integrated Continuous Glucose Monitoring System, FactoryCalibrated, Not for use with automated insulin delivery systems
Regulatory Section:	21 CFR 862.1355, 21 CFR 862.1345
Classification:	Class II
Product Code(s):	QLG, NBW
Review Panel:	Clinical Chemistry
Name of Device:	FreeStyle Libre 3 Continuous Glucose Monitoring System
Common Name:	Integrated Continuous Glucose Monitoring System, FactoryCalibrated, Not for use with automated insulin delivery systems
Regulatory Section:	21 CFR 862.1355
Classification:	Class II
Product Code(s):	QLG
Review Panel:	Clinical Chemistry

Predicate Device 1.3

Predicate Device:	FreeStyle Libre 2 Flash Glucose Monitoring System (withFreeStyle Libre 2 App), K210943 cleared November 22, 2021
	FreeStyle Libre 3 Continuous Glucose Monitoring System, K213996and K212132 cleared May 26, 2022

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Image /page/5/Picture/0 description: The image shows 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 letters on the top line. Below "Abbott" is the text "Diabetes Care" in a smaller, non-bold font, also in black.

1.4 Indications for Use

FreeStyle Libre 2 Flash Glucose Monitoring System 1.4.1

Indications for Use

Contraindication

Automated Insulin Dosing: The System must not be used with automated insulin dosing (AID) systems, including closed loop and insulin suspend systems.
MRI/CT/Diathermy: The System must be removed prior to Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment. The effect of MRI, CT scans, or diathermy on the performance of the System has not been evaluated. The exposure may damage the Sensor and may impact proper function of the device which could cause incorrect readings.

1.4.2 FreeStyle Libre 3 Continuous Glucose Monitoring System

Indications for Use

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.

510(k) Summary

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Contraindication

Automated Insulin Dosing: The System must not be used with automated insulin dosing . (AID) systems, including closed loop and insulin suspend systems.
. MRI/CT/Diathermy: The System must be removed prior to Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment. The effect of MRI, CT scans, or diathermy on the performance of the System has not been evaluated. The exposure may damage the Sensor and may impact proper function of the device which could cause incorrect readings.

1.5 Device Description

Wireless communication from the FreeStyle Libre 2 Sensor or FreeStyle Libre 3 Sensor directly to an interoperable receiver device, which connects with the Sensor using the near field communication (NFC) and Bluetooth Low Energy wireless interfaces provided by the Sensor
The FreeStyle Libre 2 App or FreeStyle Libre 3 App communicates through the . cloud to another software device, such as LibreView.

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Image /page/7/Picture/0 description: The image contains the logo for Abbott Diabetes Care. The logo consists of a stylized blue 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 overall design is clean and professional, representing the brand identity of Abbott Diabetes Care.

FreeStyle Libre 2 Flash Glucose Monitoring System 1.5.1

The FreeStyle Libre 2 Flash Glucose Monitoring System is an iCGM that provides continuous glucose measurements every minute to provide glucose levels, trends, and real time alarms capability to aid in the management of diabetes. The System requires a prescription and is intended for home use. The System consists of the following components: a Sensor which transmits via BLE, a BLE enabled display device (Reader), and an Android or iOS mobile app (FreeStyle Libre 2 App) downloaded to a compatible smartphone. Scanning of the Sensor via Reader or App provides the user with real-time glucose measurements (glucose values) accompanied by trend information (glucose arrows) and historical glucose information (glucose graph). The user may make treatment decisions based in part on the Sensor glucose results provided by the System. The System also provides configurable alarms designed to warn the user of Low Glucose, High Glucose or Signal Loss.

FreeStyle Libre 2 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 about 5.5 millimeters 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, does not require fingerstick calibration, and can be worn for up to 14 days.
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 and 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.
FreeStyle Libre 2 App (iOS or Android)
The App's design, functionality and user interface is based on the handheld Reader. ● When downloaded to a compatible smartphone, the App uses NFC communication to start new Sensors and to scan Sensors to display and record data and uses BLE communication to issue alarms. As a mobile application, the FreeStyle Libre 2 App allows connectivity with cloud-based applications. The FreeStyle Libre 2 App is an alternative primary display for the System and does not interact with the Reader.

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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 square with a stylized "a" inside, followed by the text "Abbott" in bold, and "Diabetes Care" in a smaller, non-bold font. The text is aligned to the right of the blue square.

The FreeStyle Libre 2 App is distributed using the Apple App Store and Google Play Store, and a list of compatible devices is accessible in the App via the Help feature or product website.

1.5.2 FreeStyle Libre 3 Continuous Glucose Monitoring System

The FreeStyle Libre 3 Continuous Glucose Monitoring System is an iCGM that provides real time continuous glucose measurements every minute to provide glucose levels, trends, and alarms. The System requires a prescription and is intended for home use. The System consists of the following components: a Sensor which transmits via BLE, and an Android or iOS mobile app (FreeStyle Libre 3 App) downloaded to a compatible smartphone. The FreeStyle Libre 3 System provides the user with real-time glucose measurements (glucose values) accompanied by trend information (glucose arrows) and historical glucose information (glucose graph). The user may make treatment decisions based in part on the Sensor glucose results provided by the System. The System also provides configurable alarms designed to warn the user of Low Glucose, High Glucose or Signal Loss.

FreeStyle Libre 3 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 sub-component) which is used to apply the Sensor to the back of the user's arm. The Sensor continuously measures glucose concentration in interstitial fluid and has a 14-day memory capacity. The Sensor is factory calibrated, does not require fingerstick calibration, and can be worn for up to 14 days.

FreeStyle Libre 3 App (iOS or Android)

. When downloaded to a compatible smartphone, the FreeStyle Libre 3 App uses NFC communication to start new Sensors and BLE communication to display glucose data and issue alarms based on the measurements calculated by the Sensor. As a mobile application, the FreeStyle Libre 3 App allows connectivity with cloudbased applications. The FreeStyle Libre 3 App is distributed using the Apple App Store and Google Play Store and a list of compatible devices is accessible in the App via the Help feature or product website.

Substantial Equivalence 1.6

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

1.6.1 FreeStyle Libre 2 Flash Glucose Monitoring System

Device	Predicate Device: FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App), K210943	Subject Device: FreeStyle Libre 2 Flash Glucose Monitoring System (with Libre Data Sharing API), K223537
Trade Name	FreeStyle Libre 2 Flash Glucose Monitoring System	Same
Device	Predicate Device: FreeStyle Libre 2Flash Glucose Monitoring System(with FreeStyle Libre 2 App),K210943	Subject Device:FreeStyle Libre 2 Flash GlucoseMonitoring System (with Libre DataSharing API), K223537
Intended Use	The System is intended to monitorinterstitial fluid glucoseconcentrations and communicatewith digitally connected devices forthe purpose of managing a disease orcondition related to glycemic control.	Same
Indications forUse	The FreeStyle Libre 2 Flash GlucoseMonitoring System is a continuousglucose monitoring (CGM) devicewith real time alarms capabilityindicated for the management ofdiabetes in persons age 4 and older. Itis intended to replace blood glucosetesting for diabetes treatmentdecisions, unless otherwise indicated.The System also detects trends andtracks patterns and aids in thedetection of episodes ofhyperglycemia and hypoglycemia,facilitating both acute and long-termtherapy adjustments. Interpretation ofthe System readings should be basedon the glucose trends and severalsequential readings over time.The System is also intended toautonomously communicate withdigitally connected devices. TheSystem can be used alone or inconjunction with these digitallyconnected devices where the usermanually controls actions for therapydecisions.The System can be used with theFreeStyle Libre 2 Sensor (14 day) orthe FreeStyle Libre 2 MediRx Sensor(10 day).	The FreeStyle Libre 2 Flash GlucoseMonitoring System is a continuousglucose monitoring (CGM) device withreal time alarms capability indicatedfor the management of diabetes inpersons age 4 and older. It is intendedto replace blood glucose testing fordiabetes treatment decisions, unlessotherwise indicated.The System also detects trends andtracks patterns and aids in the detectionof episodes of hyperglycemia andhypoglycemia, facilitating both acuteand long-term therapy adjustments.Interpretation of the System readingsshould be based on the glucose trendsand several sequential readings overtime.The System is also intended toautonomously communicate withdigitally connected devices. TheSystem can be used alone or inconjunction with these digitallyconnected devices where the usermanually controls actions for therapydecisions.
Device Type	Integrated CGM	Same
Principle ofOperation	Amperometric measurement ofcurrent proportional to glucoseconcentration in interstitial fluid viaglucose oxidase chemical reaction	Same
Test Range	40 to 400 mg/dL	Same
ClinicalApplication	Management of diabetes mellitus	Same
Device	Predicate Device: FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App), K210943	Subject Device: FreeStyle Libre 2 Flash Glucose Monitoring System (with Libre Data Sharing API), K223537
Intended Use Population	Persons with diabetes age 4 and older	Same
Clinical Setting/Sites of Use	Home use	Same
Data Displayed	Current glucose value, current glucose trend, graph with recent glucose history, user entered events	Same
Method of Sensor Activation	NFC communication	Same
Method of Data Transfer from Sensor	NFC – upon user-initiated scan BLE – for glucose data to support glucose alarms	Same
Optional Alarms	Low Glucose Alarm, High Glucose Alarm, Signal Loss AlarmFor Low and High Glucose alarms, a user-initiated action is required to see glucose reading	Same
Mandatory Alarms	The App includes mandatory alarms for Urgent Low Glucose, Replace Sensor, Sensor Ended, App Stopped (iOS only)These alarms are mandatory (set to ‘On’) and cannot be modified by the user. For Urgent Low Glucose alarm, a user-initiated action is required to see glucose reading	Same
Scan-Based Alerts	Scan Error, Sensor Error, Replace Sensor, Sensor Ended	Same
Wireless Communication Protocol	NFC: 13.56 MHz RFID Bluetooth Low Energy (BLE)	Same
BLE Communication Range	20 feet unobstructed	Same
Sensor Glucose Algorithm	ADC Glucose Algorithm	Same
Glucose Reading Update Interval	Every 1 minute	Same
Device	Predicate Device: FreeStyle Libre 2Flash Glucose Monitoring System(with FreeStyle Libre 2 App),K210943	Subject Device:FreeStyle Libre 2 Flash GlucoseMonitoring System (with Libre DataSharing API), K223537
Trend GraphGlucose History	8 hours, 24-hour graph and otherreports can be used to view loggeddata	Same
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
Situations WhereFingerstick Test isRequired toConfirm SensorReading(Adjunctive Use)	The user's symptoms do notmatch the glucose valuesdisplayed by the device. The device does not show aglucose value During the first 12 hours of wearduring which the check bloodglucose icon is displayed	Same
Compatibilitywith ConnectedDevices	Compatible with digitally connecteddevices where the user manuallycontrols actions for therapy decisions	Same
Method ofcommunicationand connectivitywith cloud-basedapplications	The Reader can communicate andconnect with LibreView through theUSB port connection with the desktopcomputer.App only: can communicate wirelesslyto LibreView. Through LibreView,can communicate to LibreLinkUpApp.	Same
SensorCalibration	Factory calibrated	Same
CompatibleSensor WarmupTime	1 hour	Same
Trend GraphGlucose HistoryCapabilities	8 hours, 24-hour graph and otherreports can be used to view loggeddata	Same
Blood GlucoseMeter	While using the App, user must haveaccess to a blood glucose monitoringsystem as the App does not provideone.	Same
Primary DisplayDevice(s)	FreeStyle Libre 2 Reader or FreeStyleLibre 2 App (iOS or Android)	Same
Device	Predicate Device: FreeStyle Libre 2Flash Glucose Monitoring System(with FreeStyle Libre 2 App),K210943	Subject Device:FreeStyle Libre 2 Flash GlucoseMonitoring System (with Libre DataSharing API), K223537
CompatibleOperatingSystems andHardwarePlatform for theApp	Compatible with Apple iOS; Androidoperating system and Android-enabled smartphones	Same
Interoperability	Designed to enable communicationof glucose data and otherinformation wirelessly and securelyto and from digitally connecteddevices as described below:Wireless communication from the FreeStyle Libre 2 Sensor directly to interoperable receiver devices, which connect with the Sensor using the NFC and BLE wireless interfaces provided by the Sensor The FreeStyle Libre 2 App communicates through the cloud to another software device.	The FreeStyle Libre 2 System withLibre Data Sharing API allows the samewireless and secure communications asthe predicate device and additionallyenables users to communicate iCGMdata wirelessly and securely to and fromdigitally connected devices (clientsoftware) through a cloud-basedcommunication method, the Libre DataSharing API.An interoperability communicationplan will be provided to potentialpartners/developers. Thisinteroperability communication planspecifies expectations, requirementsand interface specifications to ensurethe data is transmitted and receivedsecurely and reliably by the digitallyconnected devices.Software verification conducted toensure predefined requirementsincluding but not limited to dataconfidentiality, integrity, and timelyavailability were fulfilled.

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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 abstract shape on the left, followed by the text "Abbott" in bold black font on the top line. Below "Abbott" is the text "Diabetes Care" in a smaller, regular black font.

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Image /page/10/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 text "Abbott" in bold, black letters. Below "Abbott" is the text "Diabetes Care" in a smaller, non-bold font, also in black.

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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 text "Abbott" in bold, black letters. Below "Abbott" is the text "Diabetes Care" in a smaller, non-bold font, also in black.

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Image /page/12/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 font and "Diabetes Care" in a regular black font below it. The logo is simple and professional, conveying a sense of trust and reliability.

1.6.2 FreeStyle Libre 3 Continuous Glucose Monitoring System

Device	Predicate Device: FreeStyle Libre3 Continuous Glucose MonitoringSystem, K213996 and K212132	Subject Device:FreeStyle Libre 3 ContinuousGlucose Monitoring System (withLibre Data Sharing API), K223537
Trade Name	FreeStyle Libre 3 ContinuousGlucose Monitoring System	Same
Device	Predicate Device: FreeStyle Libre3 Continuous Glucose MonitoringSystem, K213996 and K212132	Subject Device:FreeStyle Libre 3 ContinuousGlucose Monitoring System (withLibre Data Sharing API), K223537
Intended Use	The System is intended to monitorinterstitial fluid glucoseconcentrations and communicatewith digitally connected devices for	Same
Indications for Use	The FreeStyle Libre 3 ContinuousGlucose Monitoring System is a realtime continuous glucose monitoring(CGM) device with alarms capabilityindicated for the management ofdiabetes in persons age 4 and older.It is intended to replace bloodglucose testing for diabetes treatmentdecisions, unless otherwise indicated.The System also detects trends andtracks patterns and aids in thedetection of episodes ofhyperglycemia and hypoglycemia,facilitating both acute and long-termtherapy adjustments. Interpretationof the System readings should bebased on the glucose trends andseveral sequential readings overtime.The System is also intended toautonomously communicate withdigitally connected devices. TheSystem can be used alone or inconjunction with these digitallyconnected devices where the usermanually controls actions for therapydecisions.	Same
Device Type	Integrated CGM	Same
Principle ofOperation	Amperometric measurement ofcurrent proportional to glucoseconcentration in interstitial fluid viaglucose oxidase chemical reaction	Same
Test Range	40 to 400 mg/dL	Same
ClinicalApplication	Management of diabetes mellitus	Same
Intended UsePopulation	Persons with diabetes age 4 andolder	Same
Device	Predicate Device: FreeStyle Libre3 Continuous Glucose MonitoringSystem, K213996 and K212132	Subject Device:FreeStyle Libre 3 ContinuousGlucose Monitoring System (withLibre Data Sharing API), K223537
ClinicalSetting/Sites of Use	Home use	Same
Data Displayed	Current glucose value, currentglucose trend, graph with recentglucose history, user entered events	Same
Method of SensorActivation	Near Field Communication (NFC)	Same
WirelessCommunicationProtocol	NFC: 13.56 MHz RFIDBluetooth Low Energy (BLE)	Same
BLECommunicationRange	33 feet unobstructed	Same
Method of DataTransfer fromSensor	Bluetooth Low Energy (BLE). Dataautomatically transfers without userinitiated scan (streaming data).	Same
Sensor GlucoseAlgorithm	ADC Glucose Algorithm	Same
Glucose ReadingUpdate Interval	Every 1 minute	Same
Glucose History	Graph and other reports can be used toview logged data	Same
Glucose TrendArrows	↑, > +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
Situations whereFingerstick Test isRequired toConfirm SensorReading(Adjunctive Use)	• The user's symptoms do not matchthe glucose values displayed by thedevice.• The device does not show a glucosevalue• During the first 12 hours of wearduring which the check bloodglucose icon is displayed	Same
Device	Predicate Device: FreeStyle Libre3 Continuous Glucose MonitoringSystem, K213996 and K212132	Subject Device:FreeStyle Libre 3 ContinuousGlucose Monitoring System (withLibre Data Sharing API), K223537
MandatoryAlarms	Glucose Alarms: Urgent Low GlucoseSystem Alarms: Replace Sensor,Sensor Ended, Check Sensor, AppStopped (iOS only)These alarms are mandatory (set to'On') and cannot be turned off ormodified by the user. It will alwayssound regardless of the phone soundand vibe or Do Not Disturb settings.	Same
Optional Alarms	Glucose Alarms: Low Glucose Alarm,High Glucose AlarmSystem Alarm: Signal Loss Alarm	Same
Blood GlucoseMeter	While using the App, user must haveaccess to a blood glucose monitoringsystem as the App does not provideone.	Same
Primary displaydevice	FreeStyle Libre 3 App	Same
Method ofCommunicationand Connectivitywith Cloud-basedApplications forthe App	App can communicate wirelessly toLibreView. Through LibreView, cancommunicate to LibreLinkUp App.	Same
Compatibility withConnected Devices	Compatible with digitally connecteddevices where the user manuallycontrols actions for therapy decisions	Same
CompatibleOperating Systemsand HardwarePlatform for theApp	The App is compatible withCompatible with Apple iOS andAndroid operating system (OS) andAndroid-enabled smartphones.	Same
Sensor Calibration	Factory Calibrated	Same
Compatible SensorWarmup time	1 hour	Same
Device	Predicate Device: FreeStyle Libre3 Continuous Glucose MonitoringSystem, K213996 and K212132	Subject Device:FreeStyle Libre 3 ContinuousGlucose Monitoring System (withLibre Data Sharing API), K223537
Interoperability	Designed to enable communicationof glucose data and otherinformation wirelessly and securelyto and from digitally connecteddevices as described below:Wireless communication fromthe FreeStyle Libre 3 Sensordirectly to interoperable receiverdevices, which connect with theSensor using the NFC and BLEwireless interfaces provided bythe Sensor The FreeStyle Libre 3 Appcommunicates through the cloudto another software device.	The FreeStyle Libre 3 System withLibre Data Sharing API allows thesame wireless and securecommunications as the predicatedevice and additionally enables usersto communicate iCGM data wirelesslyand securely to and from digitallyconnected devices (client software)through a cloud-based communicationmethod, the Libre Data Sharing API.An interoperability communicationplan will be provided to potentialpartners/developers. Thisinteroperability communication planspecifies expectations, requirementsand interface specifications to ensurethe data is transmitted and receivedsecurely and reliably by the digitallyconnected devices.Software verification conducted toensure predefined requirementsincluding but not limited to dataconfidentiality, integrity, and timely

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Image /page/13/Picture/0 description: The image shows the Abbott Diabetes Care logo. The logo consists of a blue stylized "a" on the left and the words "Abbott" and "Diabetes Care" on the right. The word "Abbott" is in bold, while "Diabetes Care" is in a regular font.

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Image /page/14/Picture/0 description: The image contains the logo for Abbott Diabetes Care. The logo consists of a blue abstract shape on the left, followed by the text "Abbott" in bold black font on the top line. Below "Abbott" is the text "Diabetes Care" in a smaller, regular black font.

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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, 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.

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Image /page/16/Picture/0 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a blue square with a stylized "a" inside, 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.

1.7 Comparison of Technological Characteristics with Predicate Device

The proposed FreeStyle Libre 2 and FreeStyle Libre 3 Systems have the same technological characteristics as their respective predicate devices, which measure glucose concentration in the interstitial fluid through amperometric measurement via glucose oxidase chemical reaction.

The proposed subject devices include an additional software component, the Libre Data Sharing API, which enables 'other functions', as defined in FDA guidance "Multiple Function Device Products: Policy and Considerations - Guidance for Industry and Food and Drug Administration Staff", to communicate iCGM data with authorized client software for specific and permitted use cases in accordance with the cleared intended use environments.

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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, 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.

The primary display devices of the FreeStyle Libre 2 or FreeStyle Libre 3 Systems remain unchanged and will continue to act as the primary display device and issue glucose alarms to the user when glucose levels are outside of a target zone. The Libre Data Sharing API does not have any command or control over the client software, nor does it allow for the client software to have any command or control over the FreeStyle Libre 2 and FreeStyle Libre 3 Systems. Additionally, glucose data and alarms from the FreeStyle Libre 2 and FreeStyle Libre 3 Systems are not modified or manipulated by the Libre Data Sharing API through its secured transmission to the authorized client software. Therefore, the functionality of the additional Libre Data Sharing API software component has no impact on the safety or effectiveness of the device function of the FreeStyle Libre 2 and FreeStyle Libre 3 Systems.

1.8 Summary of Performance Testing

The proposed subject devices with the Libre Data Sharing API were verified and validated according to ADC's internal design control process and in accordance with the applicable special controls for integrated continuous glucose monitoring systems. The testing demonstrated that the subject devices conform to the iCGM special controls per 21 CFR 862.1355 and that they performed according to specifications and met their technological and performance criteria.

1.9 Conclusion

The proposed FreeStyle Libre 2 and FreeStyle Libre 3 Systems are substantially equivalent to their respective predicates as they are the same with regards to intended use and indications for use and 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 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.