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

K210943 · Abbott Diabetes Care, Inc. · QLG · Nov 22, 2021 · Clinical Chemistry

Device Facts

• Record ID: K210943
• Device Name: FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)
• Applicant: Abbott Diabetes Care, Inc.
• Product Code: QLG · Clinical Chemistry
• Decision Date: Nov 22, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1355
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

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

Device Story

Integrated continuous glucose monitoring (iCGM) system; provides real-time glucose levels, trends, and alarms. Components: disposable subcutaneous sensor (glucose oxidase, interstitial fluid), handheld reader, and mobile app (iOS/Android). Sensor transmits data via Bluetooth Low Energy (BLE) and Near Field Communication (NFC). User scans sensor to view glucose values, trends, and history. System provides configurable alarms for high/low glucose and signal loss. Used in home setting by patients for diabetes management; replaces fingerstick testing for treatment decisions. App connects to cloud-based applications (LibreView). Benefits: continuous monitoring, trend detection, and hypoglycemia/hyperglycemia alerts to facilitate therapy adjustments.

Clinical Evidence

No new clinical data provided. Android App utilizes the identical algorithm and wireless interfaces as the predicate device (Reader and iOS App). Substantial equivalence supported by bench testing, software verification/validation, human factors, wireless coexistence, and cybersecurity assessments.

Technological Characteristics

Amperometric glucose oxidase sensor; factory calibrated. Connectivity via NFC (activation) and BLE (data transfer). Compatible with Android/iOS smartphones. Software-based glucose calculation. Sterilization via radiation (ISO 11137). Complies with IEC 60601-1, IEC 60601-1-2, and AAMI TIR69 for wireless coexistence.

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, 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) (K201761)

Reference Devices

• FreeStyle Precision Neo Blood Glucose test strips (K171941)
• K193371
• K211102

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

INSTRUMENT ONLY

## I Background Information:

A 510(k) Number

K210943

B Applicant

Abbott Diabetes Care Inc.

C Proprietary and Established Names

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

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| QLG | Class II | 21 CFR 862.1355 - Integrated Continuous Glucose Monitoring System | CH - Clinical Chemistry |
| NBW | Class II | 21 CFR 862.1345 - Glucose test system | CH - Clinical Chemistry |

## II Submission/Device Overview:

A Purpose for Submission:

Modification to an existing device to add the Android mobile app as an alternate primary display, and to add the FreeStyle Libre 2 MediRx sensor as another compatible continuous glucose monitoring (CGM) sensor.

B Type of Test:

Quantitative, amperometric assay (Glucose Oxidase)

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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## III Intended Use/Indications for Use:

### A Intended Use(s):
See Indications for Use below.

### B Indication(s) for 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 System can be used with the FreeStyle Libre 2 Sensor (14 day) or the FreeStyle Libre 2 MediRx Sensor (10 day).

### C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only

- The System must not be used with automated insulin dosing (AID) systems, including closed loop and insulin suspend systems.
- Taking ascorbic Acid (Vitamin C) supplements while wearing the Sensor may falsely raise Sensor glucose readings. Inaccurate sensor readings due to ascorbic acid interference may be clinical significant and result in harm if relied on to make treatment decisions. Taking more than 500 mg of ascorbic acid per day may affect the Sensor readings which could cause you to miss a severe low glucose event.
- 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.
- Do not use this system if you are pregnant, on dialysis, or critically ill. The System is not cleared for use in these groups and it is not known how different conditions or medications common to these populations may affect performance of the System.
- Do not ignore symptoms that may be due to low or high blood glucose: if you are experiencing symptoms that are not consistent with the glucose readings, consult your health care professional.
- Do not use the System in people less than 4 years of age.
- Use your blood glucose meter to make diabetes treatment decisions when you see the "check blood glucose" symbol during the first 12 hours or wearing a Sensor. In addition, use your blood glucose meter to make diabetes treatment decisions, if your Sensor

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glucose reading does not match how you feel, or if the reading does not include a number.

- Wash application site on the back of your upper arm using a plain soap, dry, and then clean with an alcohol wipe. This will help remove any oily residue that may prevent the sensor from sticking properly. Allow site to air dry before proceeding. Carefully preparing the site according to these instructions will help the Sensor stay on your body for the full wear duration specified by your Snesor insert and help prevent it from falling off early.
- Store the Sensor Kit between 36°F and 82°F. Storage outside of this range may cause inaccurate Sensor glucose readings. If you suspect that the temperature may exceed 82°F (e.g., an un-airconditioned home in the summer), you should refrigerate your Sensor Kit. Do not freeze your Sensor Kit.
- The Readers's built-in meter is not for use on people who are dehydrated, hypotensive, in shock, or for individuals in hyperglycemic-hyperosmolar state, with or without ketosis.
- The Reader's built-in meter is not for use on neonates, in critically-ill patients, or for diagnosis or screening of diabetes.
- The Reader's built-in meter is for use by a single person. Use of the Reader's built-in meter on multiple patients may lead to transmission of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), or other bloodborne pathogens.
- Use of the Sensor with devices, apps, and software that are not listed (as compatible) may cause inaccurate glucose readings.
- If a Sensor breaks inside a user's body, call your health care professional.
- Alarms you receive do not include your glucose reading. You must scan the Sensor to get your real-time current glucose level as the Reader and App will not provide this information without a scan.
- For you to receive alarms, they must be on in your Reader. If you want to receive the App's optional alarms, make sure these are turned on. The Reader or phone should be within 20 feet of you at all times. The transmission range is 20 feet unobstructed. If you are out of range, you may not receive glucose alarms.
- To prevent missed alarms, make sure the Reader has sufficient charge and that sound and/or vibration are turned on.
- The App will ask for phone permissions which are needed to receive alarms. Allow these permissions when requested.
- Check to make sure that you have the correct phone settings and permissions enabled. If your phone is not configured properly, you will not be able to use the App, so you will not receive alarms or be able to check your glucose.
- Do not force close the App (iOS). The App must be running in the background to receive alarms. If you force close the App you will not receive alarms. Re-open the App to ensure you will receive alarms.
- If you adjust the phone ringer volume (iPhone) or Media volume (Android) to silent or use the phone Do Not Disturb setting, keep 'Override Do Not Disturb' setting in the App ON for Low Glucose, High Glucose, and Signal Loss alarms to ensure you receive audible alarms.
- You should disconnect headphones or speakers from your phone when you are not using them as you may not hear audio for alarms. If using headphones, keep them in your ears.
- If you are using peripheral devices connected to your phone, such as wireless headphones or a smartwatch, you may receive alarms on only one device or peripheral, not all.

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- Some operating system features may impact your ability to receive alarms. For example, if you use an iPhone and the iOS Screen Time feature, add FreeStyle Libre 2 to the list of Always Allowed apps to ensure that you receive alarms or if you use an Android Phone do not use the Android Digital Wellbeing app.
- Keep your phone well charged and turned on.
- If you are using FreeStyle Libre 2 App, you must have access to a blood glucose monitoring system as the App does not provide one.
- FreeStyle Libre 2 System is intended for use by a single person. It must not be used by more than one person due to the risk of misinterpreting glucose information.

## IV Device/System Characteristics:

## A Device Description:

The subject device is the FreeStyle Libre 2 (“FSL2”) Flash Glucose Monitoring System (with FreeStyle Libre 2 App for Android) and is modified from the previously cleared system with the iOS app in K201761. This submission adds the FreeStyle Libre 2 App for Android (‘FSL2 App’ or ‘App’), which is an alternative primary display option for the FSL2 System. No changes are proposed to the previously cleared sensor or Reader. When used with the FSL2 Sensor (or “Patch”) cleared in K193371, or the FreeStyle Libre 2 MediRx Sensor (10 day), cleared in K211102, the proposed mobile app allows the user to:

- activate FSL2 Sensors,
- view important safety information, alarm status, and measured interstitial fluid (ISF) glucose levels, and
- connect with cloud-based applications to store and share data (e.g., LibreView).

The device is intended for use in people with diabetes mellitus, age 4 and older. The user downloads the app either from the Apple App Store for iOS, or from the Google Play Store for Android OS.

## Principle of Operation

Upon user-initiated scan enabled by near-field communication (NFC) technology, the FSL2 App can wirelessly query glucose data from the sensor by bringing a compatible smartphone in proximity of the sensor. An app can only be paired with one sensor. The FSL2 system uses Bluetooth Low Energy (BLE) to transfer glucose data each minute from the Sensor, which allows for alarms to be presented to the user.

Upon scanning, glucose values are calculated by the app using the same algorithm as in the previously cleared reader (K193371). The scan results include glucose measurements, trend information, historic 8-hr glucose results, and any applicable glucose messages. Glucose information is accompanied by background colors, which indicates how a glucose measurement compares with a user-specified range. Before obtaining glucose measurements, a 1-hour warm-up period is required after sensor activation. A check blood glucose icon appears notifying the user that a blood glucose test must be used to confirm sensor readings during the first 12 hours of wear before making treatment decisions. The app supports manual entry of blood glucose values as well as event logging. The user may generate and share a range of report types, stratified by 7, 14, 30, or 90 days. The app stores up to 90 days of data.

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System Components and Features

Alarms: The App is designed to issue glucose alarms that notify the user to perform a scan when glucose has passed a glucose threshold. The FSL2 App can issue the following glucose and system alarms:

- Mandatory Alarms: Urgent Low Glucose, Replace Sensor, Sensor Ended, App Stopped (only in iOS where App can be force closed)
- These alarms cannot be turned off or modified and will always sound regardless of the phone's sound and vibe or DND settings.

- Optional Alarms: Low Glucose Alarm, High Glucose Alarm, Signal Loss Alarm
- For the optional alarms above, the Override Do Not Disturb (DND) setting is turned on by default; therefore, the user receives these alarms regardless of the phone's sound, vibe or DND settings. If the user wishes to have the optional alarms follow the phone's sound and vibe settings, the user must turn off Override DND from the App.

Hardware / Software compatibility: The FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) is intended for use with NFC and BLE-enabled smartphones running compatible iOS and Android operating systems. The FSL2 app is compatible with FSL2 Sensors and FreeStyle Libre 2 MediRx Sensors.

Secondary Viewers: LibreView and LibreLinkUp (LLU) provide a cloud-based repository for glucose measurement data and mobile app that allows caregivers to receive and view glucose data (including glucose alarms) from users who use the FSL2 App with their sensor. Secondary viewers are not intended to be used for immediate clinical decision making.

## B Instrument Description Information:

1. Instrument Name: FreeStyle Libre 2 Flash Glucose Monitoring System
2. Specimen Identification: N/A
3. Specimen Sampling and Handling: N/A
4. Calibration: The sensor is factory calibrated and does not require calibration from the user/operator.
5. Quality Control: N/A

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V Substantial Equivalence Information:

A Predicate Device Name(s):
FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)

B Predicate 510(k) Number(s):
K201761

C Comparison with Predicate(s):

| Device & Predicate Device(s): | K210943 | K201761 |
| --- | --- | --- |
| Device Trade Name | FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) | FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For 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. | Same |
| Device Type | Integrated CGM | Same |

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| Device & Predicate Device(s): | K210943 | K201761 |
| --- | --- | --- |
| Clinical Setting / Sites of Use | Home use | Same |
| Data Displayed | Current glucose value, current glucose trend, graph with recent glucose history, user entered events | Same |
| Method of Sensor Activation | RFID communication | Same |
| Method of Data Transfer from Sensor | RFID – upon user-initiated scan BLE – for glucose data to support glucose alarms | Same |
| BLE Communication Range | 20 feet unobstructed | Same |
| Sensor Glucose Algorithm | The app uses the same algorithm as the FreeStyle Libre 2 Reader | Same |
| Glucose Reading Update Interval | Every 1 minute | Same |
| Trend Graph Glucose History | 8 hours, 24-hour graph and other reports can be used to view logged data | Same |
| Optional Alarms | Low Glucose Alarm, High Glucose Alarm, Signal Loss Alarm For Low and High Glucose alarms, a user-initiated action is required to see glucose reading | Same |
| Mandatory alarms | The App includes mandatory alarms for Urgent Low Glucose, Replace Sensor, Sensor Ended, App Stopped (iOS App only) These alarms are mandatory (set to ‘On’) and cannot be modified by the user. For Urgent Low Glucose alarm, a user-initiated action is required to see glucose reading | Same |
| Blood glucose meter | While using the App, user must have access to a blood glucose monitoring system as the App does not provide one. | Same |
| General Device Characteristic Differences | | |
| Primary display device(s) | FreeStyle Libre 2 Reader, FreeStyle Libre 2 App (iOS or Android) | FreeStyle Libre 2 Reader or FreeStyle Libre 2 App (iOS) |

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| Device & Predicate Device(s): | K210943 | K201761 |
| --- | --- | --- |
| Compatible sensors | Compatible with FSL2 Sensors and FreeStyle Libre 2 MediRx Sensors. | Compatible with FSL2 Sensors |

VI Standards/Guidance Documents Referenced:

- 21 CFR 862.1355 (integrated continuous glucose monitoring system (iCGM)) special controls
- ISO14971-“Medical Devices-Application of Risk Management to Medical Devices”
- AAMI/IEC 62366-1-“Medical Devices-Application of Usability Engineering to Medical Devices”
- AAMI/ANSI HE75-“Human Factors Engineering -Design of Medical Devices”
- IEC 60601-1-“Medical Electrical Equipment -Part 1: General Requirements for Basic Safety and Essential Performance”
- IEC 60601-1-11-“Medical electrical equipment — Part 1-11: General requirements for basic safety and essential performance — Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment”
- IEC 60601-1-2-“Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests”
- ANSI C63.27-2017- “American National Standard for Evaluation of Wireless Coexistence”
- AAMI TIR69-“Risk Management of Radio-Frequency Wireless Coexistence for Medical Devices and Systems”
- EN 62304-“Medical Device Software-Software Life Cycle Processes”
- AAMI/ANSI/ISO 10993-1-“Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing within a Risk Management Process”
- ISO 11137-1-“Sterilization of Health Care Products-Radiation Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices”
- ISO11137-2-“Sterilization of Health Care Products-Radiation Part 2: Establishing of the Sterilization Dose”
- ISO 11607-1-“Packaging for Terminally Sterilized Medical Devices-Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems”
- ISO 11607-2-“Packaging for Terminally Sterilized Medical Devices-Part 2: Validation Requirements for Forming, Sealing and Assembly Processes”
- ASTM D4169-“Standard Practice for Performance Testing of Shipping Containers and System”
- ISO 15223-1-“Medical Device-Symbols to be used with Medical Device Labels, Labeling and Information to be Supplied-Part 1: General Requirements”
- IEC 60417-“DB Graphical Symbols for Use on Equipment”
- FAA AC no. 91.21-1C-“Use of Portable Electronic Devices Aboard Aircraft”

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- FCC Title 47: Part 15-“Radio Frequency Devices, Conducted Limits, Section 15.225 and Section 15.247”
- AAMI TIR57: 2016- “Principles for medical device security – Risk management”

## VII Performance Characteristics (if/when applicable):

### A Analytical Performance:

1. **Precision/Reproducibility:**
Previously established in k193371.

2. **Linearity:**
The reportable range for the System is 40 to 400 mg/dL.

3. **Analytical Specificity/Interference:**
Previously established in k193371.

4. **Accuracy (Instrument):**
Not applicable.

5. **Carry-Over:**
Not applicable.

### B Other Supportive Instrument Performance Characteristics Data:

The following supportive instrument performance characteristics were established in the predicate for the FSL2 Continuous Glucose Monitoring System (K193371), and are not affected by the addition of the Android App in the current 510(k):

- Sterilization
- Biocompatibility
- Mechanical Engineering
- Environmental Testing
- Shelf-Life Stability
- Packaging Integrity/Shipping Integrity
- Interoperability

The following performance characteristics were verified or validated through studies of the current design:

- **Software**
Software verification and validation testing was conducted to confirm that the software used in the FreeStyle Libre 2 System performed in accordance with established specifications, EN 62304 and FDA Guidance document “Guidance for the Content of

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Premarket Submissions for Software Contained in Medical Devices," May 11, 2005. Evaluation activities included unit, system integration (SIT), and system level testing which verified functionality of the device against established software requirements. Results of the software executed protocols for FreeStyle Libre 2 met the acceptance criteria and therefore supports that the System's Android App software is acceptable for its intended use.

- Human Factors
Human factors and usability testing of the FreeStyle Libre 2 System (with FreeStyle Libre 2 App for Android) was conducted to determine whether the user interface design and labeling would impact the performance of the device. Human factors testing was conducted in accordance with:
- Applying Human Factors and Usability Engineering to Medical Devices, Guidance to FDA Staff and Industry, February 3, 2016
- ANSI/AAMI/IEC 62366: Medical devices - Application of Usability Engineering to Medical Devices
- IEC 60601-1-6: Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
Specific use scenarios and tasks the user would have to carry out correctly in order to use the device safely were identified. An analysis of hazards and risks was conducted on the FreeStyle Libre 2 System to determine safety risks associated with use of the system. All critical tasks for which a use error could lead to high severity harm were evaluated with validation testing.

- Cybersecurity
Abbott Diabetes Care (ADC) has provided cybersecurity risk management documentation for the FreeStyle Libre 2 System (with FreeStyle Libre 2 App) that includes analysis of confidentiality, integrity, and availability for data, information and software related to the System. 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. Risk mitigation controls have been implemented and tested.

ADC provides a comprehensive cybersecurity bill of materials (CBOM) describing third party software components utilized and detailing support status and known vulnerabilities for each off-the-shelf (OTS) software component.

In addition, ADC has controls and processes in place to ensure continued support for keeping the device secure and to ensure that the device firmware, software and components are malware free. Additional controls are also in place in manufacturing through distribution to ensure that the medical device firmware and software are malware free from point of origin to the hands of the end user.

- Wireless Coexistence
The FreeStyle Libre 2 System (with FreeStyle Libre 2 App -Android) underwent coexistence testing in the presence of common RF interfering devices that are likely to be encountered by users in a home environment. A representative set of devices known to operate in the same frequency band (2.4 GHz) was selected and tested following methods consistent with AAMI TIR69 and ANSI C63.27. The test results showed that the

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FreeStyle Libre 2 System could tolerate interference generated by these RF interfering devices and still meet the target performance criteria.

- Electrical Safety and Electromagnetic Compatibility
Electrical safety data from K193371 was leveraged as the Sensor and Reader have not changed since that clearance and the FreeStyle Libre 2 App only interacts with the Sensor via NFC and BLE radios on the compatible mobile phone (which independently needs to comply with applicable electrical safety standards).

Electromagnetic Compatibility (EMC) testing (radiated emissions, radiated immunity and magnetic field immunity) was performed to verify that the system was able to withstand electromagnetic interference in compliance with IEC 60601-1-2:2014. The FreeStyle Libre 2 System was tested with seven (7) compatible smartphones running Android OS. A risk management process was used to evaluate the basic safety and essential performance of the FreeStyle Libre 2 System (with FreeStyle Libre 2 App) per IEC 60601-1:2005(r)2012. Previous testing from K193371 for electrostatic discharge (ESD) and other device EMC aspects is leveraged.

## VIII Proposed Labeling:

The labeling supports the finding of substantial equivalence for this device.

## IX Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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