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 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, 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.

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 FSL3 System consists of the FreeStyle Libre 3 Sensor and either the FreeStyle Libre 3 Reader or the FreeStyle Libre 3 App (iOS and Android) downloaded to a compatible smartphone as a primary display device. The FSL3 Reader and FSL3 App do not interact with each other.

The FSL2 System consists of the FreeStyle Libre 2 Sensor and either the FreeStyle Libre 2 Reader or the FreeStyle Libre 2 App (iOS and Android) downloaded to a compatible smartphone as a primary display device. The FSL2 Reader and FSL2 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

1. A table of acceptance criteria and the reported device performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed table of clinical acceptance criteria and specific numerical performance. However, it does state that "System accuracy was demonstrated to meet the iCGM special controls requirements per 21 CFR 862.1355." This regulation for Integrated Continuous Glucose Monitoring Systems outlines performance standards.

Based on the document, the following aspects were evaluated:

Acceptance Criteria Category	Reported Device Performance
Accuracy (Clinical)	Met iCGM special controls requirements per 21 CFR 862.1355.
Sterility	Sterility Assurance Level (SAL) of 10^-6 achieved with minimum sterilization dose of 25 kGy, established by VDmax25 method and ISO 11137-1/11137-2.
Shelf-Life, Packaging Integrity, Shipping	Seal integrity, user accessibility, and device functionality met acceptance criteria after worst-case testing.
Electrical Safety	Compliant with IEC 60601-1: 2005(r)2012, IEC 60601-1-6:2010+A1:2013, and IEC 60601-1-11:2015.
Electromagnetic Compatibility (EMC)	Compliant with IEC 60601-1-2 and IEC CISPR 11. Wireless coexistence testing confirmed functionality within acceptable limits in presence of common radiating electronic devices (AAMI TIR69, ANSI C63.27, FDA Guidance). Compliant with FCC Regulations Part 15.225 and Part 15.247, and FAA Advisory Circular RTCA DO-160.
Mechanical Engineering	Met acceptance criteria for mechanical, electrical, and functional testing at system level and for individual Sensor Applicator components.
Biocompatibility	Demonstrated biocompatibility per ISO10993-1 and FDA Guidance "Use of International Standard ISO 10993-1."
Software Verification and Validation	Met acceptance criteria for executed protocols per IEC 62304 and FDA Guidance "Content of Premarket Submissions for Software Contained in Medical Devices."
Cybersecurity	Cybersecurity risk management documentation analyzed confidentiality, integrity, and availability of data, information, and software. Appropriate risk mitigation controls implemented and tested per October 2014 FDA Guidance.
Human Factors	Risk analysis demonstrated design changes met usability requirements per ANSI/AAMI/IEC 62366, IEC 60601-1-6, and FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices."
Interoperability	Incorporated an approach for interoperability in alignment with FDA Guidance "Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices."

2. Sample size used for the test set and the data provenance:

The document does not explicitly state the sample size for clinical test sets. For the "Clinical Performance" section, it only mentions that "System accuracy was demonstrated to meet the iCGM special controls requirements per 21 CFR 862.1355." This often implies a clinical trial or study, but specific numbers are not provided in this 510(k) summary. The provenance of the data (country of origin, retrospective/prospective) is also not detailed in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. For glucose monitoring systems, "ground truth" is typically established by laboratory reference methods (e.g., YSI glucose analyzer) rather than expert human interpretation.

4. Adjudication method for the test set:

This information is not provided in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable to the FreeStyle Libre Continuous Glucose Monitoring System. This device is a standalone diagnostic tool that provides glucose readings directly to the user (or digitally connected devices), not a system designed to assist human readers in interpreting medical images or data. Therefore, an MRMC study comparing human reader improvement with/without AI assistance would not be conducted for this type of device.

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

Yes, the device is inherently designed to operate in a standalone manner (algorithm only) to provide glucose readings. The "Clinical Performance" section implicitly refers to this standalone performance when stating "System accuracy was demonstrated to meet the iCGM special controls requirements per 21 CFR 862.1355." The FSL3 System's glucose algorithm resides in the Sensor, and for FSL2, it resides in the Receiver (App or Reader), generating glucose values without human real-time intervention for each reading.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For Continuous Glucose Monitoring (CGM) systems, the ground truth for accuracy studies is typically established by laboratory reference methods, such as those using a YSI glucose analyzer, which provides highly accurate and precise blood glucose measurements. While not explicitly stated in this summary, this is standard practice for CGM device validation.

8. The sample size for the training set:

The document does not provide information about the training set size. This 510(k) summary focuses on the substantial equivalence and performance of the final device, not the specifics of its development or algorithm training.

9. How the ground truth for the training set was established:

This information is not provided in the document. Similar to the test set, it would typically involve comparison to highly accurate laboratory reference methods.

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). 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.

April 13, 2023

Abbott Diabetes Care, Inc. Katherine Doll Kanne Principal Regulatory Affairs Specialist 1360 South Loop Road Alameda, CA 94502

Re: K223435

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: QBJ, NBW Dated: March 13, 2023 Received: March 14, 2023

Dear Katherine Doll Kanne:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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listing (21 CFR Part 807); labeling (21 CFR Part

Page 2

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 (OS) 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 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,

Image /page/1/Picture/6 description: The image shows a digital signature. The signature is by Paula V. Caposino -S. The date of the signature is 2023.04.13. The time of the signature is 13:12:26 -04'00'.

Paula Caposino, Ph.D. Acting Deputy Division 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) K223435

Device Name

FreeStyle Libre 2 Flash Glucose Monitoring System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

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.

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:

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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Indications for Use

510(k) Number (if known) K223435

Device Name

FreeStyle Libre 3 Continuous Glucose Monitoring System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

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 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 shows 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 font on the top line and "Diabetes Care" in a smaller, regular black font on the bottom line. The logo is clean and professional, conveying a sense of trust and reliability.

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: K223435

5.1 Submitter:

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

Contact: Katherine Doll Kanne Title: Principal Regulatory Affairs Specialist Phone: (612) 394-9209 Fax: (510) 864-4791

Date Prepared: April 13, 2023

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, 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, 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 (K222447)

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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 abstract shape 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. The logo is clean and professional, conveying a sense of trust and reliability.

5.4 Indications for Use:

5.4.1 FreeStyle Libre 3 Continuous Glucose Monitoring System

Indications for Use:

Contraindication

MRVCT/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.

5.4.2 FreeStyle Libre 2 Flash Glucose Monitoring System

Indications for Use:

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Image /page/6/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, suggesting a focus on healthcare and technology.

Contraindication

ર્સ્ડ Device Description

FreeStyle Libre 3 Continuous Glucose Monitoring System 5.5.1

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. 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 a 15-day memory capacity. The Sensor is factory calibrated, does not require fingerstick calibration, and can be worn for up to 15 days.

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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 "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 bottom line. The logo is clean and professional, conveying a sense of trust and reliability.

FreeStyle Libre 3 App (iOS and Android)

When downloaded to a compatible smartphone, the FreeStyle Libre 3 App uses Near Field Communication (NFC) 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 cloud-based 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.

FreeStyle Libre 3 Reader

The FreeStyle Libre 3 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

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, does not require fingerstick calibration, and can be worn for up to 15 days.

FreeStyle Libre 2 App (iOS and Android)

When downloaded to a compatible smartphone, the FreeStyle Libre 2 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 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.
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.

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Image /page/8/Picture/0 description: The image shows the Abbott Diabetes Care logo. The logo consists of a blue abstract shape on the left, followed by the text "Abbott" in bold black font on the top right. Below "Abbott" is the text "Diabetes Care" in a regular black font. The logo is clean and professional, representing the company's brand identity.

5.6 Substantial Equivalence

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

Similarities
	Subject Device: FreeStyle Libre 3 Continuous GlucoseMonitoring System	Predicate Device: FreeStyle Libre 3Continuous Glucose Monitoring System(K222447)
Indications for Use	The FreeStyle Libre 3 Continuous Glucose Monitoring System is areal time continuous glucose monitoring (CGM) device with alarmscapability indicated for the management of diabetes in persons age2 and older. It is intended to replace blood glucose testing fordiabetes treatment decisions, unless otherwise indicated.The System also detects trends and tracks patterns and aids in thedetection of episodes of hyperglycemia and hypoglycemia,facilitating both acute and long-term therapy adjustments.Interpretation of the System readings should be based on theglucose trends and several sequential readings over time.The System is also intended to autonomously communicate withdigitally connected devices, including automated insulin dosing(AID) systems. The System can be used alone or in conjunctionwith these digitally connected devices for the purpose of managingdiabetes.	Same
Intended Use Population	Persons with diabetes age 2 and older	Same
Device Type	Integrated CGM	Same
Compatible operating systemsand hardware platform forApp	App is compatible with iOS and Apple smartphone; Androidoperating system (OS) and Android-enabled smartphones.	Same
Principle of Operation	Amperometric measurement of current proportional to glucoseconcentration in interstitial fluid via glucose oxidase chemicalreaction	Same
Similarities
	Subject Device: FreeStyle Libre 3 Continuous GlucoseMonitoring System	Predicate Device: FreeStyle Libre 3Continuous Glucose Monitoring System(K222447)
Test Range	40 to 400 mg/dL	Same
Clinical Application	Management of diabetes mellitus	Same
Clinical Setting/Sites of Use	Home use	Same
Data Displayed	Current glucose value, current glucose trend, graph with recentglucose history, user entered events	Same
Method of Sensor Activation	Near Field Communication (NFC)	Same
Wireless communicationsprotocol	NFC: 13.56 MHz RFIDBluetooth Low Energy (BLE)	Same
Method of Data Transferfrom Sensor	Bluetooth Low Energy (BLE). Data automatically transfers withoutuser initiated scan (streaming data).	Same
BLE Communication Range	33 feet unobstructed	Same
Sensor Glucose Algorithm	ADC Glucose Algorithm established for the predicate device	Same
Location of glucose algorithm	Sensor	Same
Glucose Reading UpdateInterval	Every 1 minute	Same
Glucose History	Graph and other reports can be used to view logged data	Same
Glucose Trend Arrows	↑, > +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
App method ofcommunication andconnectivity with cloud-basedapplications	App can communicate wirelessly to LibreView. ThroughLibreView, can communicate to LibreLinkUp App.	Same
Situations Where FingerstickTest is Required to ConfirmSensor Reading (AdjunctiveUse)	The user's symptoms do not match the glucose values displayed by the device. The device does not show a glucose value	Same
Similarities
	Subject Device: FreeStyle Libre 3 Continuous GlucoseMonitoring System	Predicate Device: FreeStyle Libre 3Continuous Glucose Monitoring System(K222447)
	During the first 12 hours of wear during which the check blood glucose icon is displayed
Mandatory Alarms	Glucose Alarm: Urgent Low Glucose	Same
	System Alarm: Replace Sensor, Sensor Ended, Check Sensor, AppStopped (iOS only)
Optional Alarms	Glucose Alarms: Low Glucose Alarm, High Glucose Alarm	Same
	System Alarm: Signal Loss Alarm
Information provided withglucose alarm	Alarm type, glucose result and trend arrow	Same
Compatible Sensors	FreeStyle Libre 3 Sensor	Same
Sensor Calibration	Factory Calibrated	Same
Compatible Sensor Warmuptime	1 hour	Same
Compatible Sensor Life	Up to 15 days (automatic Sensor shut off)	Same
Anatomical Sensor wearlocations	Back of the upper arm	Same
Sensor Tail Dimension	5.5 mm depth, 0.3 mm width	Same
Application ProgrammingInterfaces (APIs)	Enables users to share their glucose data with authorized clientsoftware.Can communicate iCGM data wirelessly and securely to andfrom digitally connected devices (client software) through acloud based communication method.	Same
Differences
	Subject Device: FreeStyle Libre 3 Continuous GlucoseMonitoring System	Predicate Device: FreeStyle Libre 3 ContinuousGlucose Monitoring System (K222447)
System Components	FreeStyle Libre 3 SensorFreeStyle Libre 3 App (iOS or Android)FreeStyle Libre 3 Reader	FreeStyle Libre 3 SensorFreeStyle Libre 3 App (iOS or Android)
Primary display device	FreeStyle Libre 3 App (iOS or Android) orFreeStyle Libre 3 Reader	FreeStyle Libre 3 App (iOS or Android) only
Reader method ofcommunication andconnectivity with cloud-based applications	Reader can communicate and connect with LibreView throughthe USB port connection with the desktop computer.	No Reader
Blood Glucose Meter (BGM)	An integrated BGM is provided with the Reader	No Reader
	While using the App, user must have access to a blood glucosemonitoring system as the App does not provide one.	While using the App, user must have access to ablood glucose monitoring system as the App doesnot provide one.
Silent Mode Feature	App user has option to silence the Urgent Low Glucose Alarm,Low Glucose Alarm, High Glucose Alarm and Signal LossAlarm. This feature is turned off by default but can be turned onby the user for a maximum of 6 hours.	No Silent Mode feature

FreeStyle Libre 3 Continuous Glucose Monitoring System 5.6.1

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Image /page/9/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. Below "Abbott" is the text "Diabetes Care" in a smaller, non-bold font, also in black.

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Image /page/10/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 bottom line. The logo is clean and professional, suggesting a focus on healthcare and technology.

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Image /page/11/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 font on the top line and "Diabetes Care" in a smaller, regular black font on the bottom line. The logo is clean and professional, conveying a sense of trust and reliability.

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Image /page/12/Picture/0 description: The image contains the logo for Abbott Diabetes Care. The logo consists of two parts: a stylized blue "a" symbol on the left and the text "Abbott Diabetes Care" on the right. The word "Abbott" is in bold, while "Diabetes Care" is in a regular font.

5.6.2 FreeStyle Libre 2 Flash Glucose Monitoring System

Similarities
	Subject Device: FreeStyle Libre 2 Flash Glucose MonitoringSystem	Predicate Device: FreeStyle Libre 2 FlashGlucose Monitoring System (K222447)
Indications for Use	The FreeStyle Libre 2 Flash Glucose Monitoring System is acontinuous glucose monitoring (CGM) device with real time alarmscapability indicated for the management of diabetes in persons age 2and older. It is intended to replace blood glucose testing for diabetestreatment decisions, unless otherwise indicated.The System also detects trends and tracks patterns and aids in thedetection of episodes of hyperglycemia and hypoglycemia,facilitating both acute and long-term therapy adjustments.Interpretation of the System readings should be based on the glucosetrends and several sequential readings over time.The System is also intended to autonomously communicate withdigitally connected devices, including automated insulin dosing(AID) systems. The System can be used alone or in conjunction withthese digitally connected devices for the purpose of managingdiabetes.	Same
Intended Use Population	Persons with diabetes age 2 and older	Same
Device Type	Integrated CGM	Same
Compatible operating systemsand hardware platform forApp	App is compatible with iOS and Apple smartphone; Androidoperating system (OS) and Android-enabled smartphones.	Same
Principle of Operation	Amperometric measurement of current proportional to glucoseconcentration in interstitial fluid via glucose oxidase chemicalreaction	Same
Test Range	40 to 400 mg/dL	Same
Clinical Application	Management of diabetes mellitus	Same
Clinical Setting/Sites of Use	Home use	Same
Data Displayed	Current glucose value, current glucose trend, graph with recentglucose history, user entered events	Same
Similarities
	Subject Device: FreeStyle Libre 2 Flash Glucose Monitoring System	Predicate Device: FreeStyle Libre 2 FlashGlucose Monitoring System (K222447)
Method of Sensor Activation	Near Field Communication (NFC)	Same
Wireless communicationsprotocol	NFC: 13.56 MHz RFIDBluetooth Low Energy (BLE)	Same
Method of Data Transferfrom Sensor	BLE for glucose data transfer to issue alarms.User-initiated scan via NFC required to display glucose data.	Same
BLE Communication Range	20 feet unobstructed	Same
Sensor Glucose Algorithm	ADC Glucose Algorithm established for the predicate device	Same
Location of glucose algorithm	Receiver (App or Reader)	Same
Glucose Reading UpdateInterval	Every 1 minute	Same
Glucose History	Graph and other reports can be used to view logged data	Same
Glucose Trend Arrows	↑, > +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
Method of communicationand connectivity with cloud-based applications	App can communicate wirelessly to LibreView. ThroughLibreView, can communicate to LibreLinkUp App.Reader can communicate and connect with LibreView through theUSB port connection with the desktop computer.	Same
Situations Where FingerstickTest is Required to ConfirmSensor Reading (AdjunctiveUse)	• The user's symptoms do not match the glucose values displayedby the device.• The device does not show a glucose value• During the first 12 hours of wear during which the check bloodglucose icon is displayed	Same
Similarities
	Subject Device: FreeStyle Libre 2 Flash Glucose MonitoringSystem	Predicate Device: FreeStyle Libre 2 FlashGlucose Monitoring System (K222447)
Mandatory Alarms	Glucose Alarm: Urgent Low GlucoseSystem Alarm: Replace Sensor, Sensor Ended, Check Sensor, AppStopped (iOS only)For Urgent Low Glucose alarm, a user-initiated action is required tosee glucose reading.	Same
Optional Alarms	Glucose Alarms: Low Glucose Alarm, High Glucose AlarmSystem Alarm: Signal Loss AlarmFor Low and High Glucose alarms, a user-initiated action isrequired to see glucose reading.	Same
Compatible Sensors	FreeStyle Libre 2 Sensor	Same
Sensor Calibration	Factory Calibrated	Same
Compatible Sensor Warmuptime	1 hour	Same
Compatible Sensor Life	Up to 15 days (automatic Sensor shut off)	Same
Anatomical Sensor wearlocations	Back of the upper arm	Same
Sensor Tail Dimension	5.5 mm depth, 0.3 mm width	Same
Blood Glucose Meter	An integrated BGM is provided with the Reader.While using the App, user must have access to a blood glucosemonitoring system as the App does not provide one.	Same
Application ProgrammingInterfaces (APIs)	Enables users to share their glucose data with authorized clientsoftware.Can communicate iCGM data wirelessly and securely to andfrom digitally connected devices (client software) through acloud-based communication method	Same
Differences
	Subject Device: FreeStyle Libre 2 Flash Glucose Monitoring System	Predicate Device: FreeStyle Libre 2 Continuous Glucose Monitoring System (K222447)
Silent Mode Feature	App user has option 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.	No Silent Mode feature

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Image /page/13/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. Below "Abbott" is the text "Diabetes Care" in a smaller, non-bold font, also in black.

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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 stylized letter "a" on the left, followed by the words "Abbott" in bold black font on the top line and "Diabetes Care" in a smaller, regular black font on the bottom line. The logo is clean and professional, conveying a sense of trust and reliability.

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Image /page/15/Picture/0 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a stylized letter "a" in blue, followed by the words "Abbott" in bold black font and "Diabetes Care" in a regular black font. The logo is simple and modern, and it is likely used to represent the company's brand.

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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 stylized letter "a" on the left, followed by the words "Abbott" in bold black font on the top line and "Diabetes Care" in a smaller, regular black font on the bottom line. The logo is clean and professional, with a focus on the company's name and area of expertise.

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:

Use of NFC interface for starting new Sensors ●
Use of BLE interface to issue alarms ●
Use of software algorithm for conversion of Sensor raw glucose measurements to ● calculate glucose results
. Display of glucose results from FreeStyle Libre 2 Sensors after a user-initiated scan via NFC. Automatic display of glucose results from FreeStyle Libre 3 Sensors without a user-initiated scan.
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

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

The subject device FreeStyle Libre 3 System includes the FreeStyle Libre 3 Reader, which is a dedicated medical device, as an alternate primary display device to the FreeStyle Libre 3 App installed on a compatible smartphone, which is a multifunctional platform.
The subject device FreeStyle Libre 3 App and FreeStyle Libre 2 App include a 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 predicate devices do not include the Silent Mode feature.

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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 letter "a" on the left, followed by the text "Abbott" in bold, and "Diabetes Care" in a smaller font size below "Abbott". The text is black.

Summary of Performance Testing 5.8

The following performance characteristics were evaluated to support substantial equivalence:

Sterility - Electron beam sterilization validation in relation to the introducer needle and sensor tail was performed per ISO11137-1 and ISO 11137-2. Sterilization validation confirmed that the Sterility Assurance Level (SAL) of 106 is achieved with the minimum sterilization dose of 25 kGy. The sterilization dose was established by the VDmax25 method described in ISO 11137-2.
. Shelf-Life, Packaging Integrity, and Shipping - Device shelf life and packaging integrity over the shelf life was demonstrated by subjecting test units to worst case sealing parameters, sterilization parameters, and shipping configuration. Units were also conditioned through a worst case sequence of storage, handling and transit challenges prior to testing. Attributes related to seal integrity, user accessibility, and device functionality including sterile barrier system integrity met acceptance criteria.
Electrical Safety - Electrical Safety testing demonstrated that the basic safety and essential performance of the System is in compliance to IEC 60601-1: 2005(r)2012, IEC 60601-1-6:2010+A1:2013, and IEC 60601-1-11:2015.
Electromagnetic Compatibility Electromagnetic compatibility (EMC) testing ● demonstrated that the System is able to withstand the electromagnetic interference and emissions in compliance with IEC 60601-1-2 and IEC CISPR 11. Wireless coexistence testing was performed to confirm that the subject device remains functional and perform within acceptable limits while in the presence of common radiating electronic devices in accordance with FDA Guidance "Radio Frequency Wireless Technology in Medical Devices." The subject device underwent coexistence testing consistent with AAMI TIR69 and ANSI C63.27 and included test challenges from in-band interference sources defined in ANSICC63.27 as well as other expected wireless interference sources from the intended use environment. The System also successfully demonstrated compliance with Federal Communication Commission (FCC) Regulations Part 15.225 and Part 15.247, and Federal Aviation Administration (FAA) Advisory Circular RTCA DO-160.
Mechanical Engineering The subject device underwent performance testing at the ● System level as well as on individual components of the Sensor Applicator. The test results showed that mechanical, electrical, and functional testing all met the acceptance criteria.
Biocompatibility Biocompatibility evaluation and testing in accordance with ● ISO10993-1 and FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process," was performed to demonstrate biocompatibility of the device.

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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 "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." 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 October 2014 FDA Guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices." 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.
Clinical Performance –The subject device calculates glucose information identically to ● the predicate device. System accuracy was demonstrated to meet the iCGM special controls requirements per 21 CFR 862.1355.
Human Factors - ADC conducted a risk analysis of the design and user interface in accordance with ANSI/AAMI/IEC 62366, IEC 60601-1-6, and FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices." The analysis demonstrated that the design changes implemented for the subject device meet usability requirements for its intended use.
Interoperability - The subject device incorporated an approach for interoperability developed in alignment with FDA Guidance "Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices."

5.9 Conclusion

The FreeStyle Libre 3 Continuous Glucose Monitoring System and the FreeStyle Libre 2 Flash Glucose Monitoring System 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.