FreeStyle Libre 3 Continuous Glucose Monitoring System

K213996 · Abbott Diabetes Care, Inc. · QLG · May 26, 2022 · Clinical Chemistry

Device Facts

• Record ID: K213996
• Device Name: FreeStyle Libre 3 Continuous Glucose Monitoring System
• Applicant: Abbott Diabetes Care, Inc.
• Product Code: QLG · Clinical Chemistry
• Decision Date: May 26, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1355
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended Use

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

System provides real-time continuous glucose monitoring (CGM) for diabetes management; consists of disposable subcutaneous sensor and Android mobile application. Sensor uses amperometric electrochemical principle to measure interstitial glucose; transmits data via Bluetooth Low Energy (BLE) to smartphone app. App displays real-time glucose values, trend arrows, and historical graphs; provides mandatory and optional glucose/system alarms. Used in home environment by patients (age 4+); app must run in background for alarm functionality. Data can be shared with cloud-based repositories (LibreView/LibreLinkUp) for caregiver viewing. System replaces blood glucose testing for treatment decisions; facilitates therapy adjustments by detecting hyperglycemia/hypoglycemia trends. Benefits include continuous monitoring without manual scanning, improved trend awareness, and automated alerts for glucose excursions.

Clinical Evidence

No new clinical data provided. Analytical performance, precision, reproducibility, and accuracy were previously established in K212132. Current submission relies on software verification/validation, cybersecurity assessment, wireless coexistence testing (AAMI TIR69/ANSI C63.27), and EMC testing (IEC 60601-1-2) to support the addition of the Android application.

Technological Characteristics

Amperometric electrochemical sensor; factory calibrated. Transmits via BLE (33 ft range). Android mobile app interface. Sensor worn up to 14 days; disposable. Software verification per EN 62304. Cybersecurity controls include risk management, CBOM, and malware-free manufacturing processes. EMC compliance per IEC 60601-1-2. Wireless coexistence per AAMI TIR69/ANSI C63.27.

Indications for Use

Indicated for management of diabetes in persons age 4 and older. Contraindicated for use with automated insulin dosing (AID) systems, including closed loop and insulin suspend systems. Must be removed prior to MRI, CT scan, or diathermy.

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 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) (K210943)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and full name on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.

May 26, 2022

Abbott Diabetes Care Inc. Rodney Huang Director, Regulatory Affairs 1360 South Loop Road Alameda, California 94502

Re: K213996

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 Rodney Huang:

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Marianela Perez-Torres, Ph.D. Deputy Director Division of Chemistry and Toxicological Devices OHT7: Office of Invitro 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)

k213996

Device Name

FreeStyle Libre 3 Continuous Glucose Monitoring System

Indications for Use (Describe)

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

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 aquestments. 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.

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, black letters. Below "Abbott" is the text "Diabetes Care" in a smaller, non-bold font, also in black. The overall design is clean and professional, representing the brand identity of Abbott Diabetes Care.

# 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: K213996

# Submitter

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

Contact: Rodney Huang Title: Director, Regulatory Affairs Phone: [phone] Fax: [phone]

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, Factory<br>Calibrated, 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<br>Libre 2 App) (K210943) |
|-------------------|---------------------------------------------------------------------------------------------|
|-------------------|---------------------------------------------------------------------------------------------|

The 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 font on the top line and "Diabetes Care" in a smaller, regular black font on the second line. The overall design is clean and corporate, representing the company's brand identity.

# Indications for Use

## Indications for Use

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

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.

### 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

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 on Android 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.

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Image /page/5/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 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's name and area of expertise.

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 (Android)

- The FreeStyle Libre 3 App design, functionality and user interface is based on the ● FreeStyle Libre 2 Android app of the predicate device. When downloaded to a compatible Android-enabled smartphone, 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 Google Play Store and a list of compatible devices is accessible in the Help feature or product website.
# Substantial Equivalence

#### Predicate Device Name A.

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

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

K210943

#### 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 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, representing the company's brand identity.

| Similarities | | |
|---------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Device | Subject Device: FreeStyle Libre 3 Continuous Glucose<br>Monitoring System | Predicate Device: FreeStyle Libre 2 Flash<br>Glucose Monitoring System (with<br>FreeStyle Libre 2 App) (K210943) |
| Intended Use | The System is intended to monitor interstitial fluid glucose<br>concentrations and communicate with digitally connected devices for<br>the purpose of managing a disease or condition related to glycemic<br>control. | Same |
| Device Type | Integrated CGM | Same |
| Principle of Operation | Amperometric measurement of current proportional to glucose<br>concentration in interstitial fluid via glucose oxidase chemical<br>reaction | Same |
| Test Range | 40 to 400 mg/dL | Same |
| Clinical Application | Management of diabetes mellitus | Same |
| Intended Use Population | Persons with diabetes age 4 and older | Same |
| Clinical Setting/Sites of Use | Home use | Same |
| Data Displayed | Current glucose value, current glucose trend, graph with recent<br>glucose history, user entered events | Same |
| Method of Sensor Activation | Near Field Communication (NFC) | Same |
| Wireless Communication | NFC: 13.56 MHz RFID | Same |
| Protocol | Bluetooth Low Energy (BLE) | |
| Sensor Glucose Algorithm | ADC Glucose Algorithm established for the predicate device | Same |
| Glucose Reading Update<br>Interval | Every 1 minute | Same |
| Glucose History | Graph and other reports can be used to view logged data | Same |
| Glucose Trend Arrows | ↑, > +2 mg/dL/min<br>7, +1 to +2 mg/dL/min<br>→, -1 to +1 mg/dL/min<br>ン, -2 to -1 mg/dL/min<br>J, < -2 mg/dL/min | Same |
| Situations where Fingerstick<br>Test is Required to Confirm<br>Sensor Reading (Adjunctive<br>Use) | · The user's symptoms do not match the glucose values displayed<br>by the device.<br>The device does not show a glucose value | Same |
| Similarities | | |
| Device | Subject Device: FreeStyle Libre 3 Continuous Glucose Monitoring System | Predicate Device: FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) (K210943) |
| | • During the first 12 hours of wear during which the check blood glucose icon is displayed | |
| Mandatory Alarms | Glucose Alarms: Urgent Low Glucose<br>System Alarms: Replace Sensor, Sensor Ended, Check Sensor | Same |
| | These alarms are mandatory (set to 'On') and cannot be turned off or modified by the user. It will always sound regardless of the phone sound and vibe or Do Not Disturb settings. | Note: The Check Sensor condition is checked during the NFC scan, and detects when a Sensor has not been activated. |
| Optional Alarms | Glucose Alarms: Low Glucose Alarm, High Glucose Alarm<br>System Alarm: Signal Loss Alarm | Same |
| Blood Glucose Meter (BGM) | While using the App, user must have access to a blood glucose monitoring system as the App does not provide one. | Same |
| Method of Communication and Connectivity with Cloud-based Applications for the App | App can communicate wirelessly to LibreView. Through LibreView, can communicate to LibreLinkUp App | Same |
| Compatibility with Connected Devices | Compatible with digitally connected devices where the user manually controls actions for therapy decisions | Same |
| Compatible Operating Systems for the Android App | The App is compatible with Android operating system (OS) and Android-enabled smartphones. | Same |
| Sensor Calibration | Factory Calibrated | Same |
| Compatible Sensor Warmup time | 1 hour | Same |

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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 word "Abbott" in bold black letters. Below "Abbott" is the phrase "Diabetes Care" in a smaller, non-bold font. The logo is clean and professional, conveying a sense of trust and reliability.

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Image /page/8/Picture/0 description: The image contains the logo for Abbott Diabetes Care. The logo consists of a stylized letter "a" in blue on the left, followed by the text "Abbott" in bold black font on the first line, and "Diabetes Care" in a regular black font on the second line. The overall design is clean and corporate, representing the brand identity of Abbott Diabetes Care.

| Differences | | |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | Subject Device: FreeStyle Libre 3 Continuous<br>Glucose Monitoring System | Predicate Device: FreeStyle Libre 2 Flash Glucose<br>Monitoring System (with FreeStyle Libre 2 App) |
| | | (K210943) |
| Indications for Use | The FreeStyle Libre 3 Continuous Glucose<br>Monitoring System is a real time continuous glucose<br>monitoring (CGM) device with alarms capability<br>indicated for the management of diabetes in persons<br>age 4 and 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 patterns and<br>aids in the detection of episodes of hyperglycemia and<br>hypoglycemia, facilitating both acute and long-term<br>therapy adjustments. Interpretation of the System<br>readings should be based on the glucose trends and<br>several sequential readings over time.<br><br>The System is also intended to autonomously<br>communicate with digitally connected devices. The<br>System can be used alone or in conjunction with these<br>digitally connected devices where the user manually<br>controls actions for therapy decisions. | The FreeStyle Libre 2 Flash Glucose Monitoring<br>System is a continuous glucose monitoring (CGM)<br>device with real time alarms capability indicated for<br>the management of diabetes in persons age 4 and<br>older. It is intended to replace blood glucose testing<br>for diabetes treatment decisions, unless otherwise<br>indicated.<br><br>The System also detects trends and tracks patterns<br>and aids in the detection of episodes of<br>hyperglycemia and hypoglycemia, facilitating both<br>acute and long-term therapy adjustments.<br>Interpretation of the System readings should be based<br>on the glucose trends and several sequential readings<br>over time.<br><br>The System is also intended to autonomously<br>communicate with digitally connected devices. The<br>System can be used alone or in conjunction with<br>these digitally connected devices where the user<br>manually controls actions for therapy decisions.<br><br>The System can be used with the FreeStyle Libre 2<br>Sensor (14 day) or the FreeStyle Libre 2 MediRx<br>Sensor (10 day). |
| System Components | On-body Sensor<br>(No Sensor Applicator assembly required by user<br>prior to applying the Sensor) | On-body Sensor<br>(User assembles Sensor Applicator and Sensor<br>Container prior to applying the Sensor) |
| | FreeStyle Libre 3 App | FreeStyle Libre 2 App or FreeStyle Libre 2 Reader |
| Primary display device | FreeStyle Libre 3 App (Android) | FreeStyle Libre 2 App (iOS or Android) or |
| Differences | | |
| Device | Subject Device: FreeStyle Libre 3 Continuous Glucose Monitoring System | Predicate Device: FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) (K210943) |
| | | FreeStyle Libre 2 Reader |
| Compatible Sensor Life | FreeStyle Libre 3 Sensor (14 day) | FreeStyle Libre 2 Sensor (14 day)<br>FreeStyle Libre 2 MediRx Sensor (10 day) |
| Sensor Dimension | 2.9 mm height / 21 mm diameter | 5 mm height / 30 mm diameter |
| Location of Glucose Algorithm | Sensor | Receiver (Reader or App) |
| Method of Data Transfer from Sensor | Bluetooth Low Energy (BLE). Data automatically transfers without user initiated scan (streaming data). | BLE for glucose data transfer to issue alarms. |
| | | User-initiated scan via NFC required to display glucose data |
| BLE Communication Range | 33 feet unobstructed | 20 feet unobstructed |
| Information provided with Glucose Alarm | Alarm type, glucose result and trend arrow | Alarm type |

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Image /page/9/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 'A' is the text 'Abbott' in bold black font, with the text 'Diabetes Care' in a smaller, non-bold black font below it. The logo is simple and professional, and the colors are clean and modern.

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Image /page/10/Picture/0 description: The image contains the logo for Abbott Diabetes Care. On the left is a blue abstract symbol that looks like a stylized letter 'a'. To the right of the symbol is the text "Abbott" in bold, black letters, with "Diabetes Care" in a smaller, non-bold font below it.

# 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/11/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, regular black letters on the bottom line. The logo is simple and modern, with a focus on the company's name and area of expertise.

# 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 K210943. 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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# 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.