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

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

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

The System can be used with the FreeStyle Libre 2 Sensor (14 day) or the FreeStyle Libre 2 MediRx Sensor (10 day).

Device Description

The FreeStyle Libre 2 Flash Glucose Monitoring System is an integrated continuous glucose monitoring (iCGM) system that provides continuous glucose measurements every minute to provide glucose levels, trends, and real-time alarms capability to aid in the management of diabetes. The FreeStyle Libre 2 System consists of two primary components: a Sensor that transmits via Bluetooth Low Energy (BLE), and a BLE enabled display device (Reader). User initiated RFID scanning of the Sensor via Reader provides the user with real-time glucose measurements (glucose values) accompanied by trend information (glucose arrows) and historical glucose information (glucose graph). Users may use the Sensor glucose results and information provided by the System in making treatment decisions. The System also provides configurable alarms designed to warn the user of Low Glucose, High Glucose or Signal Loss. The system is intended for single-patient use at home and requires a prescription.

The Sensor is single use, disposable, and powered by a silver oxide battery. The Sensor is provided as two secondary components, Sensor Applicator and Sensor Pack (electron beam sterilized device) which are used to assemble and apply the Sensor to the back of the user's arm. During Sensor application, the sensor tail is inserted about 5.5 millimeters below the surface of the skin through the guidance of a needle. The needle is retracted back into the applicator after insertion, and the Sensor remains attached to the skin with a medical grade adhesive. The Sensor continuously measures glucose concentration in interstitial fluid and has an 8-hour memory capacity. The Sensor is factory calibrated, does not require fingerstick calibration, and can be worn for up to 14 days.

The Reader is a small handheld device that is powered by a lithium-ion rechargeable battery and uses RFID 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.

The proposed subject device is a modified FreeStyle Libre 2 Flash Glucose Monitoring System that adds compatibility with the FreeStyle Libre 2 MediRx Sensor, which can be worn for up to 10 days. The FreeStyle Libre 2 MediRx Sensor design is unchanged from that of the predicate FreeStyle Libre 2 Sensor, which remains compatible with the modified System. In addition, the Sensor glucose algorithm and Reader design of the modified System remain unchanged from those of the predicate.

The alternate 10-day wear duration of the FreeStyle Libre 2 MediRx Sensor is achieved by changing a Sensor configuration parameter at manufacturing, which is detected by the predicate Reader to automatically determine the wear duration and accordingly adjust the user interface display of remaining Sensor wear time and ensure the Sensor cannot report data beyond the configured wear duration. In addition, each Sensor type has an end of life parameter, which determines when the Sensor will automatically shut down. This functionality is already built into the Sensor and Reader and was validated as part of previously conducted software validation under K193371.

Other than the differences related to wear duration, the FreeStyle Libre 2 MediRx Sensor is identical to the predicate Sensor, and the predicate Reader functions as intended with either the predicate FreeStyle Libre 2 Sensor (14 day) or FreeStyle Libre 2 MediRx Sensor (10 day).

AI/ML Overview

The provided text is related to a 510(k) premarket notification for the FreeStyle Libre 2 Flash Glucose Monitoring System, specifically for a modification to include compatibility with a 10-day wear sensor (FreeStyle Libre 2 MediRx Sensor).

The document does not describe an AI/ML-based device where the performance is presented in terms of AI metrics (e.g., accuracy, precision, recall, AUC, etc.) or a multi-reader multi-case (MRMC) study. Instead, it concerns a medical device for continuous glucose monitoring (CGM). The "algorithm" mentioned (Sensor Glucose Algorithm) refers to the internal processing of sensor signals to derive glucose values, not an AI/ML model in the context of clinical decision support or image analysis.

Therefore, many of the requested criteria (e.g., sample size for test/training set in AI context, number of experts for ground truth, adjudication method, MRMC study, standalone performance for AI, type of ground truth for AI) are not applicable to this device's submission.

However, I can extract information related to the device's clinical performance evaluation based on the provided text, which supports its substantial equivalence.

Here's a summary of the relevant information:

1. Acceptance Criteria and Device Performance:

The document states: "Clinical data from the adult and pediatric iCGM clinical studies that supported clearance of the predicate device were re-analyzed to show that use of the subject device with the FreeStyle Libre 2 MediRx Sensor for a 10-day wear duration meets the iCGM special controls for clinical performance set forth in 21 CFR 862.1355."

This indicates that the acceptance criteria are based on the iCGM special controls outlined in 21 CFR 862.1355. The document does not provide a specific table of numerical acceptance criteria or reported device performance metrics (e.g., MARD values, clinical accuracy zones) for the FreeStyle Libre 2 MediRx Sensor in this specific 510(k) submission. It relies on the re-analysis of data from the predicate device's clearance.

Acceptance Criteria (General)	Reported Device Performance (as stated)
Meets iCGM special controls for clinical performance set forth in 21 CFR 862.1355 for 10-day wear duration.	"Clinical data from the adult and pediatric iCGM clinical studies that supported clearance of the predicate device were re-analyzed to show that use of the subject device with the FreeStyle Libre 2 MediRx Sensor for a 10-day wear duration meets the iCGM special controls..."

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

Sample Size Used for Test Set: Not explicitly stated for this particular 510(k). The clinical performance is based on "re-analyzed" data from "clinical studies that supported clearance of the predicate device (K193371)." To find specific sample sizes, one would need to refer to the original K193371 submission.
Data Provenance: Not explicitly stated regarding country of origin. The data is based on "clinical studies that supported clearance of the predicate device." It's retrospective in the sense that existing data was re-analyzed for the new sensor configuration.

3. Number of Experts and Qualifications for Ground Truth:

This question is not applicable in the context of this device. The "ground truth" for a glucose monitoring system is typically a high-accuracy reference method for blood glucose (e.g., YSI analyzer in a controlled lab setting), not expert consensus from radiologists or similar.

4. Adjudication Method for the Test Set:

Not applicable for this type of device. Adjudication methods like '2+1' or '3+1' are common in image analysis studies where human readers provide interpretations and discrepancies are resolved. This is a continuous glucose monitoring device where performance is measured against reference glucose values.

5. MRMC Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done as described for AI assistance. This device is a direct-to-patient glucose monitoring system, not an AI-assisted diagnostic tool that human readers would use to improve their performance.

6. Standalone Performance:

Yes, in essence, standalone performance was done. The device itself provides glucose readings without human interpretation or intervention in the measurement process. The "re-analysis" of clinical data to meet iCGM special controls essentially evaluates this standalone performance of the FreeStyle Libre 2 MediRx Sensor. The output of the device (glucose value) is directly compared against a reference method.

7. Type of Ground Truth Used:

The ground truth used for glucose monitoring devices is typically central laboratory reference glucose measurements (e.g., from a YSI glucose analyzer) taken from blood samples during clinical studies. The document states a re-analysis of "clinical studies," implying the use of such a reference method from the predicate device's trials.

8. Sample Size for the Training Set:

Not explicitly stated/applicable in the context of AI/ML training. The "Sensor Glucose Algorithm" mentioned is likely a deterministic or model-based algorithm, not a trainable deep learning model in the sense of a "training set" for AI. If the algorithm involves parameters that were "trained" or optimized, the document does not specify the sample size used for this internal process. The primary evaluation here is of the modified sensor with an unchanged algorithm.

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

Not explicitly stated/applicable in the context of AI/ML training. As above, the ground truth for any underlying algorithm development would refer to the reference glucose measurements used to build or validate that algorithm, but this is not typically referred to as a "training set" in the AI sense for this type of device. The document explicitly states: "the Sensor glucose algorithm... of the modified System remain unchanged from those of the predicate."

Summary

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Image /page/0/Picture/0 description: The image shows 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.

August 11, 2021

Abbott Diabetes Care, Inc. Catherine Yang Sr. Regulatory Affairs Manager 1360 South Loop Road Alameda, California 94502

Re: K211102

Trade/Device Name: FreeStyle Libre 2 Flash Glucose Monitoring System Regulation Number: 21 CFR 862.1355 Regulation Name: Integrated Continuous Glucose Monitoring System Regulatory Class: Class II Product Code: OLG Dated: April 12, 2021 Received: April 13, 2021

Dear Catherine Yang:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-

combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Marianela Perez-Torres, Ph.D. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health 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) K211102

Device Name

FreeStyle Libre 2 Flash Glucose Monitoring System

Indications for Use (Describe)

The System can be used with the FreeStyle Libre 2 Sensor (14 day) or the FreeStyle Libre 2 MediRx Sensor (10 day).

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 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, and "Diabetes Care" in a smaller font size below it. The text is black, contrasting with the white background.

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.

The assigned 510(k) number is: K211102

1.1 Submitter:

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

Contact: Catherine Yang Title: Sr. Regulatory Affairs Manager Phone: (510) 206-9452 Fax: (510) 864-4791

Date Prepared: April 12, 2021

1.2 Device Names and Classification:

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

1.3 Predicate Device

Predicate Device:	FreeStyle Libre 2 Flash Glucose Monitoring System
	(K193371, cleared on June 12, 2020)

This predicate device has not been subject to a recall

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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 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. The logo is clean and professional, likely used for branding purposes.

Indications for Use: 1.4

Indications for Use:

The System can be used with the FreeStyle Libre 2 Sensor (14 day) or the FreeStyle Libre 2 MediRx Sensor (10 day).

Contraindications

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

Device Description 1.5

Predicate Device

The FreeStyle Libre 2 Flash Glucose Monitoring System (K193371, cleared on June 12, 2020) is an integrated continuous glucose monitoring (iCGM) system that provides continuous glucose measurements every minute to provide glucose levels, trends, and real-time alarms capability to aid in the management of diabetes. The FreeStyle Libre 2 System consists of two primary components: a Sensor that transmits via Bluetooth Low Energy (BLE), and a BLE enabled display device (Reader). User initiated RFID scanning of the Sensor via Reader provides the user with real-time glucose measurements (glucose values) accompanied by trend information (glucose arrows) and historical glucose information (glucose graph). Users may use the Sensor glucose results and information provided by the System in making treatment decisions. The System also provides configurable alarms designed to warn the user of Low Glucose, High Glucose or Signal Loss. The system is intended for single-patient use at home and requires a prescription.

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Image /page/5/Picture/0 description: The image shows the logo for Abbott Diabetes Care. On the left is a blue, stylized letter 'a'. To the right of the 'a' is the text 'Abbott' in bold, black letters, with the text 'Diabetes Care' underneath in a smaller, non-bold font. The logo is simple and professional, and the colors are clean and modern.

FreeStyle Libre 2 Sensor

. The Sensor is single use, disposable, and powered by a silver oxide battery. The Sensor is provided as two secondary components, Sensor Applicator and Sensor Pack (electron beam sterilized device) which are used to assemble and apply the Sensor to the back of the user's arm. During Sensor application, the sensor tail is inserted about 5.5 millimeters below the surface of the skin through the guidance of a needle. The needle is retracted back into the applicator after insertion, and the Sensor remains attached to the skin with a medical grade adhesive. The Sensor continuously measures glucose concentration in interstitial fluid and has an 8-hour memory capacity. The Sensor is factory calibrated, does not require fingerstick calibration, and can be worn for up to 14 days.

FreeStyle Libre 2 Reader

. The Reader is a small handheld device that is powered by a lithium-ion rechargeable battery and uses RFID 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.

Subject Device

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

Test Principle

Both the predicate and modified FreeStyle Libre 2 Flash Glucose Monitoring Systems use a Sensor that incorporates a subcutaneously implanted electrochemical sensor to monitor glucose levels in the interstitial fluid (ISF) and associated electronics. The sensor uses a 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 handheld Reader.

Substantial Equivalence 1.6

A. Predicate Device Name:

FreeStyle Libre 2 Flash Glucose Monitoring System

B. Predicate 510(k) Number(s):

K193371

Comparison with Predicate: C.

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

Similarities
Item	Predicate Device: FreeStyle Libre 2 Flash GlucoseMonitoring System (K193371)	Subject Device:ModifiedFreeStyle Libre2 Flash GlucoseMonitoringSystem
Intended Use	The System is intended to monitor interstitial fluidglucose concentrations and communicate with digitallyconnected devices for the purpose of managing a diseaseor condition related to glycemic control.	Same
Intended Use Population	Persons with diabetes age 4 and older	Same
Device type	Integrated CGM	Same
Principle of Operation	Amperometric measurement of current proportional toglucose concentration in interstitial fluid via glucoseoxidase chemical reaction	Same
Sample Type	Interstitial fluid	Same
Enzyme	Glucose oxidase	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 withrecent glucose history, user entered events	Same
Primary display device	FreeStyle Libre 2 Reader	Same
Similarities (Continued)
Item	Predicate Device: FreeStyle Libre 2 Flash GlucoseMonitoring System (K193371)	Subject Device:ModifiedFreeStyle Libre2 Flash GlucoseMonitoringSystem
Alerts and Alarms	Low Glucose Alarm, High Glucose Alarm, Signal Loss Alarm,Scan Error, Sensor Error	Same
Wirelesscommunicationprotocol	Near Field Communication (NFC): (13.56 MHz RFID)Bluetooth Low Energy (BLE): 4.0	Same
BLECommunicationrange	20 feet unobstructed	Same
Sensor GlucoseAlgorithm	FreeStyle Libre 2 Reader algorithm	Same
Method of SensorActivation	RFID communication	Same
Method of Datatransfer from Sensor	RFID – upon user-initiated scanBLE - for glucose data to support glucose alarms	Same
Glucose readingupdate interval	Every 1 minute	Same
Trend GraphGlucose History	8 hours, 24-hour graph and other reports can be used to viewlogged data	Same
Glucose TrendArrow	↑, > +2 mg/dL/min↗, +1 and +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 the glucose values displayed by the device. The device does not show a glucose value During the first 12 hours of wear during which the check blood glucose icon is displayed	Same
Compatibility withconnected devices	Compatible with digitally connected devices where the user manually controls actions for therapy decisions	Same
Sensor calibration	Factory calibrated	Same
Anatomical Sensorwear locations	Back of the upper arm	Same
Sensor warmup time	1 hour	Same
FreeStyle Libre 2Sensor life	Up to 14 days (automatic sensor shut off)	Same
Storage Conditions(Sensor Kit)	Temperature: 36°F – 82°F Humidity: 10-90% RH	Same
Retail packagingconfiguration forFreeStyle Libre 2Sensor Kits	One (1) packaging configuration option:One (1) Sensor Kit carton with no additional outer carton	Same
	Differences
Item	Predicate Device:FreeStyle Libre 2 Flash GlucoseMonitoring System (K193371)	Subject Device: Modified FreeStyle Libre 2 FlashGlucose Monitoring System
Indications for Use	The FreeStyle Libre 2 Flash Glucose Monitoring System is acontinuous glucose monitoring (CGM) device with real timealarms capability indicated for the management of diabetes inpersons age 4 and older. It is intended to replace blood glucosetesting for diabetes treatment decisions, unless otherwiseindicated.The System also detects trendsand tracks patterns and aids in thedetection of episodes ofhyperglycemia andhypoglycemia, facilitating bothacute and long-term therapyadjustments. Interpretation of theSystem readings should be basedon the glucose trends and severalsequential readings over time.The System is also intended toautonomously communicate withdigitally connected devices. TheSystem can be used alone or inconjunction with these digitallyconnected devices where the usermanually controls actions fortherapy decisions.	The FreeStyle Libre 2 Flash Glucose MonitoringSystem is a continuous glucose monitoring (CGM)device with real time alarms capability indicated forthe management of diabetes in persons age 4 andolder. It is intended to replace blood glucose testingfor diabetes treatment decisions, unless otherwiseindicated.The System also detects trends and tracks patternsand aids in the detection of episodes ofhyperglycemia and hypoglycemia, facilitating bothacute and long-term therapy adjustments.Interpretation of the System readings should be basedon the glucose trends and several sequential readingsover time.The System is also intended to autonomouslycommunicate with digitally connected devices. TheSystem can be used alone or in conjunction withthese digitally connected devices where the usermanually controls actions for therapy decisions.The System can be used with the FreeStyle Libre 2Sensor (14 day) or the FreeStyle Libre 2 MediRxSensor (10 day).
Compatible Sensors	FreeStyle Libre 2 Sensor	FreeStyle Libre 2 Sensor orFreeStyle Libre 2 MediRx Sensor
FreeStyle Libre 2MediRx Sensor Life	N/A	Up to 10 days (automatic sensor shut off)
Retail packagingconfiguration forFreeStyle Libre 2MediRx Sensor Kits	N/A	Two (2) packaging configuration options:One (1) Sensor Kit carton with no additional outer cartonThree (3) individual Sensor Kit cartons packaged within an outer carton

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based

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Image /page/9/Picture/0 description: The image shows the Abbott Diabetes Care logo. The logo consists of a blue abstract shape on the left and the words "Abbott" and "Diabetes Care" on the right. The word "Abbott" is in bold, and the words "Diabetes Care" are in a smaller font size.

1.7 Summary of Performance Testing

All product development activities were performed in compliance with the Design Control requirements per 21 CFR 820.30. The implementation of the modified FreeStyle Libre 2 Flash Glucose Monitoring System is evaluated, verified, and validated under the requirements of Abbott Diabetes Care's (ADC's) internal design control process, which establishes a process for design and manufacturing changes to be assessed, tested and implemented appropriately.

The following summary of performance testing supports substantial equivalence to the predicate device:

Software Testing
The predicate Freestyle Libre 2 Reader is designed to detect the Sensor configuration parameter, which is stored in the Sensor and set at manufacturing. The predicate Reader uses this Sensor configuration parameter to automatically determine the wear duration and accordingly adjust the user interface display of remaining Sensor wear time and ensure the Sensor cannot report data beyond the configured wear duration. In addition, each Sensor type has an end of life parameter, which determines when the Sensor will automatically shut down. This functionality is already built into the predicate Sensor and Reader and was validated as part of previously conducted software validation under K193371.

The FreeStyle Libre 2 MediRx Sensor differs from the predicate FreeStyle Libre 2 Sensor only with respect to the Sensor configuration parameter. There are no other changes made to the subject device design, cybersecurity, software, glucose algorithm, or other functionality to allow for compatibility of the Reader with the FreeStyle Libre 2 MediRx Sensor.

Clinical Performance Evaluation ●
Clinical data from the adult and pediatric iCGM clinical studies that supported clearance of the predicate device were re-analyzed to show that use of the subject device with the FreeStyle Libre 2 MediRx Sensor for a 10-day wear duration meets the iCGM special controls for clinical performance set forth in 21 CFR 862.1355.

The following supportive performance characteristics were established in the predicate device in K193371 and are not affected by the introduction of the FreeStyle Libre 2 MediRx Sensor in this 510(k):

Sterilization ●
Biocompatibility ●
Mechanical Testing ●
Electrical Safety and Electromagnetic Compatibility
Environmental Testing
Shelf-Life Stability ●
Packaging Integrity/Shipping Integrity ●

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Image /page/10/Picture/0 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a blue, stylized "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.

Human Factors ●
Manufacturing Controls ●
Cybersecurity
Interoperability ●
RF Wireless Communication

1.8 Proposed Labeling

The subject device labeling informs users of the System compatibility with the predicate FreeStyle Libre 2 Sensor and proposed FreeStyle Libre 2 MediRx Sensor along with the corresponding wear durations. The System User's Manual was updated to include a separate section on the performance data of the FreeStyle Libre 2 Flash Glucose Monitoring System when used with FreeStyle Libre 2 MediRx Sensor (10-day wear duration). In addition, separate Sensor Kit retail packaging and branding are introduced for the FreeStyle Libre 2 MediRx Sensor Kit.

The proposed labeling satisfies the requirements of 21 CFR Part 801, 21 CFR Part 807. 87(e), 21 CFR Part 809, and the 21 CFR Part 862.1355 special controls.

1.9 Conclusion

The modified FreeStyle Libre 2 Flash Glucose Monitoring System has the same intended use and clinical application as the predicate device. Based on the performance testing and data provided in this pre-market notification. the subject device and predicate 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.