FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System

K233537 · Abbott Diabetes Care, Inc. · QBJ · Apr 23, 2024 · Clinical Chemistry

Device Facts

• Record ID: K233537
• Device Name: FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System
• Applicant: Abbott Diabetes Care, Inc.
• Product Code: QBJ · Clinical Chemistry
• Decision Date: Apr 23, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1355
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 4 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated. The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time. The System is also intended to autonomously communicate with digitally connected devices. The System can be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions. The FreeStyle Libre 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 4 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated. The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time. The System is also intended to autonomously communicate with digitally connected devices. The System can be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions. The FreeStyle Libre 3 Continuous Glucose Monitoring System is a real time continuous glucose monitoring (CGM) device with alarms capability indicated for the management of diabetes 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.

Device Story

Integrated continuous glucose monitoring (iCGM) system; measures interstitial fluid glucose via subcutaneous electrochemical sensor (glucose oxidase). Sensor transmits data via Bluetooth Low Energy (BLE) to primary display (smartphone app or dedicated reader). App/reader displays real-time glucose levels, trends, and alarms for hypo/hyperglycemia. Used at home by patients for diabetes management; replaces routine fingerstick testing. System supports connectivity with cloud-based applications and automated insulin dosing (AID) systems (Plus sensors). Healthcare providers use historical data for therapy adjustments. Modification includes new compatible app display and updated MRI/CT/X-ray labeling.

Clinical Evidence

No new clinical data provided. Substantial equivalence supported by software verification/validation, cybersecurity risk management, and bench testing for sensor compatibility with medical imaging (MR conditional).

Technological Characteristics

Electrochemical glucose oxidase sensor; silver oxide battery; medical grade adhesive; subcutaneous insertion via needle. Connectivity: NFC (sensor start), BLE (data streaming). Software: Mobile app (iOS/Android) and handheld reader. Sterilization: Electron beam. Standards: IEC 62304, ISO 14971, AAMI TIR69, AAMI TIR57.

Indications for Use

Indicated for management of diabetes in persons age 2 and older (Plus sensors) or 4 and older (standard sensors). Contraindicated for dialysis, critically ill patients, and during diathermy. Not for use with AID systems for Libre 2/3 standard sensors.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• FreeStyle Libre 3 Continuous Glucose Monitoring System (K223435)
• FreeStyle Libre 2 Flash Glucose Monitoring System (K223435)

Reference Devices

• FreeStyle Precision Neo Blood Glucose test strips (K171941)

Submission Summary (Full Text)

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

April 23, 2024

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

# Re: K233537

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

# Dear Sapna Ghelani:

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

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

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A ) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

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

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

Sincerely,

# Joshua Balsam -S

Joshua M. Balsam, Ph.D. Branch Chief Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if known) K233537

### Device Name

FreeStyle Libre 2 Flash Glucose Monitoring System

### Indications for Use (Describe)

Libre 2 Sensor users:

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

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

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

Libre 2 Plus Sensor users:

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

The System 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.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

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

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"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) K233537

### Device Name

FreeStyle Libre 3 Continuous Glucose Monitoring System

# Indications for Use (Describe)

Libre 3 Sensor users:

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

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

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

Libre 3 Plus Sensor users:

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

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.

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

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

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

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

#### ડ. 510(k) Summary

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

510(k) Number: K233537

#### 5.1 Submitter:

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

Contact: Sapna Ghelani Title: Regulatory Affairs Project Manager Phone: [phone] Fax: [phone]

Date Prepared: April 21, 2024

#### 5.2 Device Names and Classification:

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

#### 5.3 Predicate Device

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

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

#### 5.4 Indications for Use:

#### 5.4.1 FreeStyle Libre 3 Continuous Glucose Monitoring System

# Libre 3 Sensor users:

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.

Libre 3 Plus Sensor users:

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

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.

# Contraindication

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

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

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

#### 5.4.2 FreeStyle Libre 2 Flash Glucose Monitoring System

# Libre 2 Sensor users:

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

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

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

Libre 2 Plus Sensor users:

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

The System 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.

### Contraindication

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

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

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

#### ર્સ્ટ Device Description

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

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

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

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

#### 5.5.1 FreeStyle Libre 3 Continuous Glucose Monitoring System

FreeStyle Libre 3 Sensor and FreeStyle Libre 3 Plus Sensor

- The sensor is single use, disposable, and powered by a silver oxide battery. The sensor is ● provided through a sensor applicator (which includes an electron beam sterilized subcomponent) which is used to apply the sensor to the back of the user's arm. During sensor application, the sensor tail is inserted below the surface of the skin through the guidance of a needle. The needle is retracted back into the applicator after insertion, and the sensor remains attached to the skin with a medical grade adhesive. The sensor continuously measures glucose concentration in interstitial fluid, is factory calibrated, and does not require fingerstick calibration. The FSL3 Sensor has a 14-day memory capacity and can be worn for up to 14 days. The FSL3 Plus Sensor has a 15-day memory capacity and can be worn for up to 15 days.
FreeStyle Libre App

- . When downloaded to a compatible phone, the FSL App uses Near Field Communication (NFC) to start new sensors and uses Bluetooth Low Energy (BLE) to receive glucose data from the sensor. The user can view current glucose information, trend information, historical information and alarms on the app. The FSL App is compatible with the FSL3

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

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

# FreeStyle Libre 3 Reader

- The FSL3 Reader is a small handheld device that is powered by a lithium-ion rechargeable ● battery and uses NFC communication to start new sensors and BLE communication to display glucose data and issue alarms that notify the user to scan his/her sensor when glucose values pass a high or low glucose threshold. The reader also has a built-in strip port with blood glucose functionality (that is intended to work with the FreeStyle Precision Neo Blood Glucose test strips, cleared under K171941), and a user interface that includes event logging features.
#### 5.5.2 FreeStyle Libre 2 Flash Glucose Monitoring System

FreeStyle Libre 2 Sensor and FreeStyle Libre 2 Plus Sensor

- The sensor is single use, disposable, and powered by a silver oxide battery. The sensor is ● provided as two secondary components, sensor applicator and sensor pack (electron beam sterilized device) which are used to assemble and apply the sensor to the back of the user's arm. During sensor application, the sensor tail is inserted below the surface of the skin through the guidance of a needle. The needle is retracted back into the applicator after insertion, and the sensor remains attached to the skin with a medical grade adhesive. The sensor continuously measures glucose concentration in interstitial fluid and has an 8-hour memory capacity. The sensor is factory calibrated and does not require fingerstick calibration. The FSL2 Sensor can be worn for up to 14 days. The FSL2 Plus Sensor can be worn for up to 15 days.
FreeStyle Libre App

- . When downloaded to a compatible phone, the FSL App uses NFC to start new sensors and uses BLE to receive glucose data from the sensor. The user can view current glucose information, trend information, historical information and alarms on the app. The FSL App is compatible with the FSL2 family of sensors (includes FSL2 Sensor and FSL2 Plus Sensor). As a mobile application, the FSL App allows connectivity with cloud-based applications. The FSL App is distributed using the Apple App Store and Google Play Store and a list of compatible phones is accessible in the app via the Help feature or FreeStyle Libre consumer website.
FreeStyle Libre 2 Reader

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

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

#### Substantial Equivalence 5.6

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

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

| Item | Predicate Devices (K223435) | Subject Device:<br>FreeStyle Libre 2 Flash Glucose<br>Monitoring System | Subject Device:<br>FreeStyle Libre 3 Continuous<br>Glucose Monitoring System |
|------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| | FreeStyle Libre 2 Flash Glucose<br>Monitoring System FreeStyle Libre 3 Continuous Glucose<br>Monitoring System | | |
| Compatible Sensor1 | FSL2 System<br>FreeStyle Libre 2 Sensor<br><br>FSL3 System<br>FreeStyle Libre 3 Sensor | FreeStyle Libre 2 Plus Sensor<br>FreeStyle Libre 2 Sensor | FreeStyle Libre 3 Plus Sensor<br>FreeStyle Libre 3 Sensor |
| Compatible Sensor<br>Life | Up to 15 days<br>(Additionally, Predicate FSL2 System is<br>compatible with FSL2 Sensor with 14 day<br>sensor life and predicate FSL3 System is<br>compatible with FSL3 Sensor with 14 day<br>sensor life) | Same | Same |
| Similarities | | | |
| Item | Predicate Devices (K223435) | Subject Device: | Subject Device: |
| | FreeStyle Libre 2 Flash Glucose<br>Monitoring System FreeStyle Libre 3 Continuous Glucose<br>Monitoring System | FreeStyle Libre 2 Flash Glucose<br>Monitoring System | FreeStyle Libre 3 Continuous<br>Glucose Monitoring System |
| Indications for Use | The FreeStyle Libre 2 Flash Glucose<br>Monitoring System is a continuous glucose<br>monitoring (CGM) device with real time<br>alarms capability indicated for the<br>management of diabetes in persons age 2 and<br>older. It is intended to replace blood glucose<br>testing for diabetes treatment decisions, unless<br>otherwise indicated.<br><br>The System also detects trends and tracks<br>patterns and aids in the detection of episodes of<br>hyperglycemia and hypoglycemia, facilitating<br>both acute and long-term therapy adjustments.<br>Interpretation of the System readings should be<br>based on the glucose trends and several<br>sequential readings over time.<br><br>The System is also intended to autonomously<br>communicate with digitally connected devices,<br>including automated insulin dosing (AID)<br>Systems. The System can be used alone or in<br>conjunction with these digitally connected<br>devices for the purpose of managing diabetes.<br><br>(Predicate FSL2 System is compatible with<br>legacy FSL2 Sensor with 14 day sensor life) | Same | NA |
| Similarities | | | |
| Item | Predicate Devices (K223435) | Subject Device:<br>FreeStyle Libre 2 Flash Glucose<br>Monitoring System | Subject Device:<br>FreeStyle Libre 3 Continuous<br>Glucose Monitoring System |
| Indications for Use | FreeStyle Libre 2 Flash Glucose<br>Monitoring System FreeStyle Libre 3 Continuous Glucose<br>Monitoring System The FreeStyle Libre 3 Continuous Glucose<br>Monitoring System is a real time continuous<br>glucose monitoring (CGM) device with alarms<br>capability indicated for the management of<br>diabetes in persons age 2 and older. It is<br>intended to replace blood glucose testing for<br>diabetes treatment decisions, unless otherwise<br>indicated.<br><br>The System also detects trends and tracks<br>patterns and aids in the detection of episodes of<br>hyperglycemia and hypoglycemia, facilitating<br>both acute and long-term therapy adjustments.<br>Interpretation of the System readings should be<br>based on the glucose trends and several<br>sequential readings over time.<br><br>The System is also intended to autonomously<br>communicate with digitally connected devices,<br>including automated insulin dosing (AID)<br>Systems. The System can be used alone or in<br>conjunction with these digitally connected<br>devices for the purpose of managing diabetes.<br><br>(Predicate FSL3 System is compatible with<br>FSL3 Sensor with 14 day sensor life) | NA | Same |
| Similarities | | | |
| Item | Predicate Devices (K223435)<br>FreeStyle Libre 2 Flash Glucose Monitoring System FreeStyle Libre 3 Continuous Glucose Monitoring System | Subject Device:<br>FreeStyle Libre 2 Flash Glucose<br>Monitoring System | Subject Device:<br>FreeStyle Libre 3 Continuous<br>Glucose Monitoring System |
| Principle of<br>Operation | Amperometric measurement of current<br>proportional to glucose concentration in<br>interstitial fluid via glucose oxidase chemical<br>reaction | Same | Same |
| Device type | Integrated CGM | Same | Same |
| Intended Use<br>Population | Persons with diabetes age 2 and older<br>(Additionally, predicate FSL2 System is<br>compatible with legacy FSL2 Sensor with<br>intended use population of age 4 and older, and<br>predicate FSL3 System is compatible with<br>FSL3 Sensor with intended use population of<br>age 4 and older) | Same | Same |
| Test Range | 40 to 400 mg/dL | Same | Same |
| Clinical Application | Management of diabetes mellitus | Same | Same |
| Clinical Setting/Sites<br>of Use | Home Use | Same | Same |
| Data Displayed | Current glucose value, current glucose trend,<br>graph with recent glucose history, user entered<br>events | Same | Same |
| Similarities | | | |
| Item | Predicate Devices (K223435)<br>• FreeStyle Libre 2 Flash Glucose<br>Monitoring System<br>• FreeStyle Libre 3 Continuous Glucose<br>Monitoring System | Subject Device:<br>FreeStyle Libre 2 Flash Glucose<br>Monitoring System | Subject Device:<br>FreeStyle Libre 3 Continuous<br>Glucose Monitoring System |
| Wireless<br>Communication<br>Protocol | Near Field Communication (NFC): 13.56 MHz<br>RFID<br>Bluetooth Low Energy (BLE) | Same | Same |
| Method of Sensor<br>Activation | Near Field Communication (NFC): 13.56 MHz<br>RFID | Same | Same |
| Mandatory Alarms | Glucose Alarm: Urgent Low Glucose<br>System Alarm: Replace Sensor, Sensor Ended,<br>Check Sensor<br>(Note: Check Sensor is an alarm for FSL3<br>System whereas Check Sensor is not<br>considered an alarm for the FSL2 System<br>where the condition is checked during the NFC<br>scan and detects when a sensor has not been<br>activated). | Same | Same |
| Optional Alarms | Glucose Alarms: Low Glucose Alarm, High<br>Glucose Alarm<br>System Alarm: Signal Loss Alarm | Same | Same |
| Silent Mode | All App users have option to silence the<br>Urgent Low Glucose Alarm, Low Glucose<br>Alarm, High Glucose Alarm, and the Signal<br>Loss Alarm. This feature is turned off by<br>default but can be turned on by the user for a<br>maximum of 6 hours. | Same | Same |
| Item | Predicate Devices (K223435) | Subject Device:<br>FreeStyle Libre 2 Flash Glucose<br>Monitoring System | Subject Device:<br>FreeStyle Libre 3 Continuous<br>Glucose Monitoring System |
| | • FreeStyle Libre 2 Flash Glucose<br>Monitoring System<br>• FreeStyle Libre 3 Continuous Glucose<br>Monitoring System | | |
| Scan-Based Alerts | FSL2 System only:<br>Scan Error, Sensor Error, Replace Sensor,<br>Sensor Ended, Check Sensor | Same as predicate FSL2 System | N/A |
| BLE Communication<br>Range | FSL2 System:<br>20 feet unobstructed<br>FSL3 System:<br>33 feet unobstructed…