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.

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.

Device Description

The FreeStyle Libre 3 Continuous Glucose Monitoring System (herein referred to as the 'FreeStyle Libre 3 System' or 'System') is an integrated continuous glucose monitoring system (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 Bluetooth Low Energy (BLE), and a mobile application, FreeStyle Libre 3 App, downloaded to a compatible smartphone running iOS operating system. 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 fixed and configurable alarms designed to warn the user of Low Glucose, High Glucose, or Signal Loss.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the FreeStyle Libre 3 Continuous Glucose Monitoring System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a specific table of numerical acceptance criteria for clinical performance (like MARD values with defined thresholds). Instead, it states that the device "met the iCGM special controls requirements per 21 CFR 862.1355." However, it does list several performance characteristics that were "confirmed to support substantial equivalence," implying that specific acceptance criteria were met for each. Without the actual criteria for each, here's a general table based on the information provided:

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Sterility	Sterility Assurance Level (SAL) of 10^-6	Achieved SAL of 10^-6 with minimum sterilization dose of 25 kGy (established by VDmax25 method described in ISO 11137-2).
Shelf-Life & Packaging	Seal integrity, user accessibility, and device functionality met	Attributes related to seal integrity, user accessibility, & device functionality (including sterile barrier system integrity) met acceptance criteria after subjecting units to worst-case sealing, sterilization, shipping, storage, handling, and transit challenges.
Electrical Safety	Compliance to IEC 60601-1, IEC 60601-1-6, IEC 60601-1-11	Demonstrated compliance to IEC 60601-1: 2005(r)2012, IEC 60601-1-6:2010+A1:2013, and IEC 60601-1-11:2015.
Electromagnetic	Withstand EMI and emissions (IEC 60601-1-2, CISPR 11)	Verified system withstands EMI and emissions in compliance with IEC 60601-1-2 and IEC CISPR 11. Wireless coexistence testing confirmed functionality within acceptable limits in presence of common radiating electronic devices (FDA Guidance, AAMI TIR69, ANSI C63.27). Complied with FCC Part 15.225, Part 15.247, and FAA Advisory Circular RTCA DO-160.
Mechanical Engineering	Mechanical, electrical, and functional testing met	Test results showed mechanical, electrical, and functional testing all met acceptance criteria at system and component level.
Biocompatibility	Compliance with ISO 10993-1 and FDA Guidance	Evaluation and testing performed in accordance with ISO10993-1 and FDA Guidance.
Software V&V	Met established specifications and IEC 62304	Results of executed protocols met acceptance criteria, supporting the System's embedded software is acceptable for intended use (in accordance with IEC 62304 and FDA Guidance).
Cybersecurity	Analysis of confidentiality, integrity, availability, risk mgmt.	Provided cybersecurity risk management documentation (analysis of confidentiality, integrity, availability for data, info, & software per FDA Draft Guidance). Risk assessment performed for identified threats/vulnerabilities, and appropriate risk mitigation controls implemented/tested.
Clinical performance	Met iCGM special controls requirements per 21 CFR 862.1355	A bridging clinical study demonstrated comparability of performance to the predicate FreeStyle Libre 2 System, and the combined System accuracy of the FreeStyle Libre 3 and FreeStyle Libre 2 System met the iCGM special controls.
Human Factors	Met usability requirements for intended use (ANSI/AAMI/IEC 62366)	Risk analysis of design and user interface (in accordance with ANSI/AAMI/IEC 62366, IEC 60601-1-6, and FDA Guidance) demonstrated design changes met usability requirements.
Interoperability	Alignment with FDA Guidance "Design Considerations..."	Incorporated an approach for interoperability developed in alignment with FDA Guidance.

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

Sample Size: The document mentions "a bridging clinical study" but does not explicitly state the number of subjects or data points used in this study.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). The phrasing "bridging clinical study" generally implies a prospective study designed to bridge results from a previous study or device.

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

This information is not provided in the document. For glucose monitoring systems, ground truth is typically established using a highly accurate reference method (e.g., YSI glucose analyzer) rather than expert consensus on images.

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

No MRMC study was mentioned. The FreeStyle Libre 3 is a Continuous Glucose Monitoring (CGM) system, which provides direct glucose readings to the user, not an AI system that assists human "readers" in interpreting diagnostic images or data where MRMC studies are typically performed. The device is intended to replace blood glucose testing for treatment decisions, not to aid human interpretation of complex medical cases.

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

Yes, a standalone performance assessment was done. The document states, "The subject device calculates glucose information identically to the predicate device, and the combined System accuracy of the FreeStyle Libre 3 System and FreeStyle Libre 2 System met the iCGM special controls requirements per 21 CFR 862.1355." This refers to the accuracy of the algorithm itself in determining glucose values from the sensor data. The "clinical performance" testing directly assesses the device's accuracy without human intervention influencing the glucose measurement.

7. The Type of Ground Truth Used

Reference Glucose Methods: While not explicitly named, for CGM devices, the standard ground truth for clinical accuracy studies is typically venous blood samples analyzed by a laboratory reference method, such as a YSI glucose analyzer. The document states accuracy was demonstrated, which implies comparison to such a reference.

8. The Sample Size for the Training Set

Not provided. The document describes a "bridging clinical study" for performance validation but does not detail the size of any training sets used for algorithm development. It does state that the "Sensor Glucose Algorithm established for the predicate device" is the same, implying the algorithm's core might have been trained previously for the FreeStyle Libre 2.

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

Not provided. Given that the subject device uses the "ADC Glucose Algorithm established for the predicate device," the ground truth establishment for any original training would have likely involved comparisons to laboratory reference glucose measurements in clinical studies. However, details of such a training process or ground truth for a training set are not in this document.

Summary

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May 26, 2022

Abbott Diabetes Care Inc. Naveen Thuramalla Divisional Vice President, Regulatory Affairs 1360 South Loop Road Alameda, California 94502

Re: K212132

Trade/Device Name: 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 Dated: April 8, 2022 Received: April 11, 2022

Dear Naveen Thuramalla:

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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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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,

Marianela Perez-Torres, Ph.D. Deputy Director Division of Chemistry and Toxicological 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)

Device Name

Freetyle Libre 3 Continuous 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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Image /page/3/Picture/0 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a teal-colored abstract shape 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.

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: K212132

Submitter

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

Contact: Naveen Thuramalla Title: Divisional Vice President, Regulatory Affairs Phone: (510) 239-2618 Fax: (510) 864-4791

Date Prepared: May 16, 2022

Device Names and Classification

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

Predicate Device: FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) (K201761)
The predicate device has not been subject to a recall

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Image /page/4/Picture/0 description: The image contains the logo for Abbott Diabetes Care. On the left is a blue, stylized letter 'A'. To the right of the logo are the words "Abbott" in bold, black letters, with the words "Diabetes Care" underneath in a smaller, non-bold font. The logo is simple and professional, and the text is clear and easy to read.

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 mav impact proper function of the device which could cause incorrect readings.

Device Description

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

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 14day 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)
The FreeStyle Libre 3 App design, functionality and user interface is based on the ● FreeStyle Libre 2 iOS App of the predicate device. When downloaded to a compatible iPhone, the FreeStyle Libre 3 App uses Near Field 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 cloud-based applications. The FreeStyle Libre 3 App is distributed using the Apple App Store and a list of compatible devices is accessible in the App via the Help feature or product website.

Substantial Equivalence

A. Predicate Device Name

FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)

Predicate 510(k) Number(s) B.

K201761

C. Comparison with Predicate

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

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Image /page/6/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 words "Abbott" in bold black letters on the top line and "Diabetes Care" in smaller black letters on the bottom line. The logo is simple and modern, and the use of blue and black gives it a professional look.

Similarities
Device	Subject Device: FreeStyle Libre 3Continuous Glucose Monitoring System	Predicate Device: FreeStyle Libre 2Flash Glucose Monitoring System(with FreeStyle Libre 2 App)(K201761)
Intended Use	The System is intended to monitorinterstitial fluid glucose concentrationsand communicate with digitallyconnected devices for the purpose ofmanaging a disease or condition relatedto glycemic control.	Same
Device Type	Integrated CGM	Same
Principle ofOperation	Amperometric measurement of currentproportional to glucose concentration ininterstitial fluid via glucose oxidasechemical reaction	Same
Test Range	40 to 400 mg/dL	Same
Clinical Application	Management of diabetes mellitus	Same
Intended UsePopulation	Persons with diabetes age 4 and older	Same
Clinical Setting/Sitesof Use	Home use	Same
Data Displayed	Current glucose value, current glucosetrend, graph with recent glucosehistory, user entered events	Same
Method of SensorActivation	Near Field Communication (NFC)	Same
WirelessCommunicationProtocol	NFC: 13.56 MHz RFIDBluetooth Low Energy (BLE)	Same
Sensor GlucoseAlgorithm	ADC Glucose Algorithm establishedfor the predicate device	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 to ConfirmSensor Reading(Adjunctive Use)	• The user's symptoms do not match theglucose values displayed by thedevice.• The device does not show a glucosevalue• During the first 12 hours of wearduring which the check blood glucose	Same
Similarities
Device	Subject Device: FreeStyle Libre 3Continuous Glucose MonitoringSystem	Predicate Device: FreeStyle Libre 2Flash Glucose Monitoring System(with FreeStyle Libre 2 App)(K201761)
Mandatory Alarms	Glucose Alarms: Urgent Low GlucoseSystem Alarms: Replace Sensor,Sensor Ended, Check Sensor, AppStoppedThese 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.	SameNote: The Check Sensor condition ischecked during the NFC scan, anddetects when a Sensor has not beenactivated.
Optional Alarms	Glucose Alarms: Low Glucose Alarm,High Glucose Alarm;System Alarm: Signal Loss Alarm	Same
Blood Glucose Meter(BGM)	While using the App, user must haveaccess to a blood glucose monitoringsystem as the App does not provideone.	Same
Method ofCommunication andConnectivity withCloud-basedApplications for theApp	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 the App	Compatible with Apple iOS	Same
Sensor Calibration	Factory Calibrated	Same
Compatible SensorWarmup time	1 hour	Same
Compatible SensorLife	Up to 14 days (automatic Sensor shutoff)	Same
Differences
Device	Subject Device: FreeStyle Libre 3Continuous Glucose Monitoring System	Predicate Device: FreeStyle Libre 2Flash Glucose Monitoring System (withFreeStyle Libre 2 App) (K201761)
Indications forUse	The FreeStyle Libre 3 ContinuousGlucose Monitoring System is a real timecontinuous glucose monitoring (CGM)device with alarms capability indicated forthe management of diabetes in personsage 4 and older. It is intended to replaceblood glucose testing for diabetestreatment decisions, unless otherwiseindicated.The System also detects trends and trackspatterns and aids in the detection ofepisodes of hyperglycemia andhypoglycemia, facilitating both acute andlong-term therapy adjustments.Interpretation of the System readingsshould be based on the glucose trends andseveral sequential readings over time.The System is also intended toautonomously communicate with digitallyconnected devices. The System can beused alone or in conjunction with thesedigitally connected devices where the usermanually controls actions for therapydecisions.	The FreeStyle Libre 2 Flash GlucoseMonitoring System is a continuousglucose monitoring (CGM) device withreal time alarms capability indicated forthe management of diabetes in personsage 4 and older. It is intended to replaceblood glucose testing for diabetestreatment decisions, unless otherwiseindicated.The System also detects trends and trackspatterns and aids in the detection ofepisodes of hyperglycemia andhypoglycemia, facilitating both acute andlong-term therapy adjustments.Interpretation of the System readingsshould be based on the glucose trends andseveral sequential readings over time.The System is also intended toautonomously communicate with digitallyconnected devices. The System can beused alone or in conjunction with thesedigitally connected devices where the usermanually controls actions for therapydecisions.
SystemComponents	On-body Sensor(No Sensor Applicator assembly requiredby user prior to applying the Sensor)FreeStyle Libre 3 App	On-body Sensor(User assembles Sensor Applicator andSensor Container prior to applying theSensor)FreeStyle Libre 2 App or FreeStyle Libre2 Reader
Primarydisplay device	FreeStyle Libre 3 App (iOS)	FreeStyle Libre 2 App (iOS) orFreeStyle Libre 2 Reader
SensorDimension	2.9 mm height / 21 mm diameter	5 mm height / 30 mm diameter
Location ofGlucoseAlgorithm	Sensor	Receiver (Reader or App)
Differences
Device	Subject Device: FreeStyle Libre 3Continuous Glucose Monitoring System	Predicate Device: FreeStyle Libre 2Flash Glucose Monitoring System (withFreeStyle Libre 2 App) (K201761)
Method of DataTransfer fromSensor	Bluetooth Low Energy (BLE). Dataautomatically transfers without userinitiated scan (streaming data).	BLE for glucose data transfer to issuealarms. User-initiated scan via NFCrequired to display glucose data
BLECommunicationRange	33 feet unobstructed	20 feet unobstructed
Informationprovided withGlucose Alarm	Alarm type, glucose result and trendarrow	Alarm type

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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 abstract symbol on the left, followed by the text "Abbott" in bold, and "Diabetes Care" in a smaller font size below it. The text is black, and the overall design is clean and professional.

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Image /page/8/Picture/0 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a blue abstract symbol on the left, followed by the text "Abbott" in bold black letters on the first line. Below "Abbott" is the text "Diabetes Care" in a smaller, non-bold font, also in black. The overall design is clean and corporate, representing the brand identity of Abbott Diabetes Care.

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

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 Sensor converts the electrical current signal to a glucose value (in mg/dL) for display to the user on the App.

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

Compatibility with system-specific Sensor
Use of BLE interfaces for wireless communication with the Sensor ●
Use of NFC interface for starting new Sensors
Use of software algorithm for conversion of the raw glucose measurements from the ● Sensor to calculate glucose results
. Inclusion of software interface to wirelessly communicate with authorized cloud-based applications (App only for the predicate)

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

. The predicate device requires NFC interface for scanning Sensors to display glucose readings.
Glucose alarms with the subject device includes trend arrow and glucose reading; the ● predicate device only displays the alarm type and the user is required to scan the Sensor to view the glucose result.

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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 font on the top line. Below "Abbott" is the text "Diabetes Care" in a smaller, regular black font. The overall design is clean and professional, representing the brand identity of Abbott Diabetes Care.

Summary of Performance Testing

The following performance characteristics were confirmed to support substantial equivalence:

Sterility - Electron beam sterilization validation of the Sensor Applicator, which contains 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 10-6 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 - The basic safety and essential performance of the FreeStyle Libre 3 System was conducted to demonstrate 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 was ● performed for the FreeStyle Libre 3 System to verify 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 ANSI C63.27 as well as other expected wireless interference sources from the intended use environment. The FreeStyle Libre 3 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 was . conducted in accordance with established specifications and 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's embedded 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 FDA Draft 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 -ADC conducted a bridging clinical study to demonstrate comparability of the performance of the FreeStyle Libre 3 System to the predicate FreeStyle Libre 2 System. cleared under K201761. The subject device calculates glucose information identically to the predicate device, and the combined System accuracy of the FreeStyle Libre 3 System and FreeStyle Libre 2 System met 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."

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Image /page/12/Picture/0 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a teal-colored abstract shape 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.

Conclusion

The FreeStyle Libre 3 Continuous Glucose Monitoring System has the identical intended use and clinical application as the predicate device. The differences in technological characteristics have been addressed through risk control measures to provide reasonable assurance of the safety and effectiveness of the FreeStyle Libre 3 System. System performance testing confirmed that the device met all specified criteria, which supports that the System provides accurate, secure, and reliable glucose readings in accordance with the iCGM special controls. Based on the performance testing and data provided in this pre-market notification, the subject device 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.