(90 days)
No
The summary describes a continuous glucose monitoring system and its data sharing capabilities. There is no mention of AI or ML algorithms being used for data analysis, trend detection, or any other function. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is a continuous glucose monitoring (CGM) system used for managing diabetes by tracking glucose levels and trends, which aids in treatment decisions and therapy adjustments, but it does not directly administer therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "aids in the detection of episodes of hyperglycemia and hypoglycemia" and is intended for the "management of diabetes," which are diagnostic purposes for monitoring and understanding a health condition.
No
The device description explicitly states that the system consists of a Sensor and either a Reader or a smartphone app. The Sensor is a hardware component that is applied to the user's arm. While the submission focuses on a software component (Libre Data Sharing API), the overall system includes hardware.
Based on the provided text, the FreeStyle Libre 2 and FreeStyle Libre 3 Flash/Continuous Glucose Monitoring Systems are IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use explicitly states that the systems are for the "management of diabetes" and are "intended to replace blood glucose testing for diabetes treatment decisions." This clearly indicates that the device is used to examine specimens (glucose in interstitial fluid) from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The device measures glucose data from a sensor inserted into the user's arm. This sensor is collecting a biological sample (interstitial fluid) for analysis.
- Comparison to Predicate/Reference Devices: The text mentions predicate devices that are also glucose monitoring systems and a reference device which is a blood glucose test strip. These are all devices used for in vitro diagnostic purposes.
While the system has components that communicate wirelessly and integrate with other devices, the core function of measuring glucose levels from a biological sample for medical decision-making aligns with the definition of an In Vitro Diagnostic device.
N/A
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
QLG, NBW
Device Description
The FreeStyle Libre 2 and FreeStyle Libre 3 are integrated continuous glucose monitoring (iCGM) Systems designed to be used alone or in conjunction with digitally connected devices. The FreeStyle Libre 2 System consists of a Sensor and either a Reader or the FreeStyle Libre 2 App downloaded to a compatible smartphone as a primary display device. The FreeStyle Libre 3 System consists of a Sensor and the FreeStyle Libre 3 App downloaded to a compatible smartphone as a primary display device. Both Systems can communicate glucose data and other information wirelessly and securely to and from these digitally connected devices as described below:
- Wireless communication from the FreeStyle Libre 2 Sensor or FreeStyle Libre 3 Sensor directly to an interoperable receiver device, which connects with the Sensor using the near field communication (NFC) and Bluetooth Low Energy wireless interfaces provided by the Sensor
- The FreeStyle Libre 2 App or FreeStyle Libre 3 App communicates through the . cloud to another software device, such as LibreView.
Compared to the respective predicate devices, the proposed subject devices include an additional software component, the Libre Data Sharing API. The Libre Data Sharing API is a cloud-based application programming interface (API) that enables communication of glucose data including alarms through the cloud from the FreeStyle Libre 2 System or FreeStyle Libre 3 System to authorized client software on digitally connected devices. The data transmitted by the API to authorized client software can be used for specific and permitted use cases, including nonmedical device applications, medical device data analysis, CGM secondary display alarm, active patient monitoring, and treatment decisions. Use of the Libre Data Sharing API and the CGM information it transmits is limited by the indications for use of the iCGM systems with which it is used.
The Libre Data Sharing API does not have any command or control over the client software, nor does it allow for the client software to have any command or control over the FreeStyle Libre 2 or FreeStyle Libre 3 Systems. Additionally, glucose data and alarms from the connected iCGM system are not modified or manipulated by the Libre Data Sharing API through its transmission to the authorized client software.
The display device of the connected FreeStyle Libre 2 or FreeStyle Libre 3 Systems, which directly receives the data from the Sensor, continues to serve as a primary display device for the glucose data and alarms. The current components of the FreeStyle Libre 2 and FreeStyle Libre 3 Systems (sensor/applicator and primary display devices) have not been modified as a result of the added the Libre Data Sharing API.
FreeStyle Libre 2 Flash Glucose Monitoring System
The FreeStyle Libre 2 Flash Glucose Monitoring System is an iCGM that provides continuous glucose measurements every minute to provide glucose levels, trends, and real time alarms capability to aid in the management of diabetes. The System requires a prescription and is intended for home use. The System consists of the following components: a Sensor which transmits via BLE, a BLE enabled display device (Reader), and an Android or iOS mobile app (FreeStyle Libre 2 App) downloaded to a compatible smartphone. Scanning of the Sensor via Reader or App 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 configurable alarms designed to warn the user of Low Glucose, High Glucose or Signal Loss.
FreeStyle Libre 2 Sensor:
The Sensor is single use, disposable, and powered by a silver oxide battery. The ● Sensor is provided as two secondary components, Sensor Applicator and Sensor Pack (electron beam sterilized device) which are used to assemble and apply the Sensor to the back of the user's arm. During Sensor application, the sensor tail is inserted about 5.5 millimeters below the surface of the skin through the guidance of a needle. The needle is retracted back into the applicator after insertion, and the Sensor remains attached to the skin with a medical grade adhesive. The Sensor continuously measures glucose concentration in interstitial fluid and has an 8-hour memory capacity. The Sensor is factory calibrated, does not require fingerstick calibration, and can be worn for up to 14 days.
FreeStyle Libre 2 Reader
The Reader is a small handheld device that is powered by a lithium-ion ● rechargeable battery and uses NFC communication to start new Sensors and to scan Sensors to display and record data and uses BLE communication to issue alarms that notify the user to scan his/her sensor when glucose values pass a high or low glucose threshold. The Reader also has a built-in strip port with blood glucose functionality (that is intended to work with the FreeStyle Precision Neo Blood Glucose test strips, cleared under K171941), and a user interface that includes event logging features.
FreeStyle Libre 2 App (iOS or Android)
The App's design, functionality and user interface is based on the handheld Reader. ● When downloaded to a compatible smartphone, the App uses NFC communication to start new Sensors and to scan Sensors to display and record data and uses BLE communication to issue alarms. As a mobile application, the FreeStyle Libre 2 App allows connectivity with cloud-based applications. The FreeStyle Libre 2 App is an alternative primary display for the System and does not interact with the Reader. The FreeStyle Libre 2 App is distributed using the Apple App Store and Google Play Store, and a list of compatible devices is accessible in the App via the Help feature or product website.
FreeStyle Libre 3 Continuous Glucose Monitoring System
The FreeStyle Libre 3 Continuous Glucose Monitoring System is an 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 BLE, and an Android or iOS mobile app (FreeStyle Libre 3 App) downloaded to a compatible smartphone. 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 configurable alarms designed to warn the user of Low Glucose, High Glucose or Signal Loss.
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 14-day memory capacity. The Sensor is factory calibrated, does not require fingerstick calibration, and can be worn for up to 14 days.
FreeStyle Libre 3 App (iOS or Android)
When downloaded to a compatible smartphone, the FreeStyle Libre 3 App uses NFC 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 cloudbased applications. The FreeStyle Libre 3 App is distributed using the Apple App Store and Google Play Store and a list of compatible devices is accessible in the App via the Help feature or product website.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
back of the user's arm
Indicated Patient Age Range
age 4 and older
Intended User / Care Setting
Home use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The proposed subject devices with the Libre Data Sharing API were verified and validated according to ADC's internal design control process and in accordance with the applicable special controls for integrated continuous glucose monitoring systems. The testing demonstrated that the subject devices conform to the iCGM special controls per 21 CFR 862.1355 and that they performed according to specifications and met their technological and performance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1355 Integrated continuous glucose monitoring system.
(a)
Identification. An integrated continuous glucose monitoring system (iCGM) is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time. iCGM systems are designed to reliably and securely transmit glucose measurement data to digitally connected devices, including automated insulin dosing systems, and are intended to be used alone or in conjunction with these digitally connected medical devices for the purpose of managing a disease or condition related to glycemic control.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include the following:
(i) Robust clinical data demonstrating the accuracy of the device in the intended use population.
(ii) The clinical data must include a comparison between iCGM values and blood glucose values in specimens collected in parallel that are measured on an FDA-accepted laboratory-based glucose measurement method that is precise and accurate, and that is traceable to a higher order (
e.g., an internationally recognized reference material and/or method).(iii) The clinical data must be obtained from a clinical study designed to fully represent the performance of the device throughout the intended use population and throughout the measuring range of the device.
(iv) Clinical study results must demonstrate consistent analytical and clinical performance throughout the sensor wear period.
(v) Clinical study results in the adult population must meet the following performance requirements:
(A) For all iCGM measurements less than 70 milligrams/deciliter (mg/dL), the percentage of iCGM measurements within ±15 mg/dL of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 85 percent.
(B) For all iCGM measurements from 70 mg/dL to 180 mg/dL, the percentage of iCGM measurements within ±15 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 70 percent.
(C) For all iCGM measurements greater than 180 mg/dL, the percentage of iCGM measurements within ±15 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 80 percent.
(D) For all iCGM measurements less than 70 mg/dL, the percentage of iCGM measurements within ±40 mg/dL of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 98 percent.
(E) For all iCGM measurements from 70 mg/dL to 180 mg/dL, the percentage of iCGM measurements within ±40 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 99 percent.
(F) For all iCGM measurements greater than180 mg/dL, the percentage of iCGM measurements within ±40 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 99 percent.
(G) Throughout the device measuring range, the percentage of iCGM measurements within ±20 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 87 percent.
(H) When iCGM values are less than 70 mg/dL, no corresponding blood glucose value shall read above 180 mg/dL.
(I) When iCGM values are greater than 180 mg/dL, no corresponding blood glucose value shall read less than 70 mg/dL.
(J) There shall be no more than 1 percent of iCGM measurements that indicate a positive glucose rate of change greater than 1 mg/dL per minute (/min) when the corresponding true negative glucose rate of change is less than −2 mg/dL/min as determined by the corresponding blood glucose measurements.
(K) There shall be no more than 1 percent of iCGM measurements that indicate a negative glucose rate of change less than −1 mg/dL/min when the corresponding true positive glucose rate of change is greater than 2 mg/dL/min as determined by the corresponding blood glucose measurements.
(vi) Data demonstrating similar accuracy and rate of change performance of the iCGM in the pediatric population as compared to that in the adult population, or alternatively a clinical and/or technical justification for why pediatric data are not needed, must be provided and determined by FDA to be acceptable and appropriate.
(vii) Data must demonstrate that throughout the claimed sensor life, the device does not allow clinically significant gaps in sensor data availability that would prevent any digitally connected devices from achieving their intended use.
(2) Design verification and validation must include a detailed strategy to ensure secure and reliable means of iCGM data transmission to provide real-time glucose readings at clinically meaningful time intervals to devices intended to receive the iCGM glucose data.
(3) Design verification and validation must include adequate controls established during manufacturing and at product release to ensure the released product meets the performance specifications as defined in paragraphs (b)(1) and (b)(2) of this section.
(4) The device must demonstrate clinically acceptable performance in the presence of clinically relevant levels of potential interfering substances that are reasonably present in the intended use population, including but not limited to endogenous substances and metabolites, foods, dietary supplements, and medications.
(5) The device must include appropriate measures to ensure that disposable sensors cannot be used beyond its claimed sensor wear period.
(6) Design verification and validation must include results obtained through a usability study that demonstrates that the intended user can use the device safely and obtain the expected glucose measurement accuracy.
(7) The labeling required under § 809.10(b) of this chapter must include a separate description of the following sensor performance data observed in the clinical study performed in conformance with paragraph (b)(1) of this section for each intended use population, in addition to separate sensor performance data for each different iCGM insertion or use sites (
e.g., abdomen, arm, buttock):(i) A description of the accuracy in the following blood glucose concentration ranges: less than 54 mg/dL, 54 mg/dL to less than 70 mg/dL, 70 to 180 mg/dL, greater than 180 to 250 mg/dL, and greater than 250 mg/dL.
(ii) A description of the accuracy of positive and negative rate of change data.
(iii) A description of the frequency and duration of gaps in sensor data.
(iv) A description of the true, false, missed, and correct alert rates and a description of the available glucose concentration alert settings, if applicable.
(v) A description of the observed duration of iCGM life for the device.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 21, 2023
Abbott Diabetes Care, Inc. Simon Yuan Official Correspondent 1360 South Loop Road Alameda, CA 94502
Re: K223537
Trade/Device Name: FreeStyle Libre 2 Flash Glucose Monitoring System, 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, NBW Dated: November 21, 2022 Received: November 23, 2022
Dear Simon Yuan:
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
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/5 description: The image shows a digital signature. The name "Paula Caposino -S" is written in a large font on the left side of the image. On the right side, it says "Digitally signed by Paula Caposino -S" followed by the date "2023.02.21" and the time "11:19:41 -05'00'".
Paula Caposino, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223537
Device Name
FreeStyle Libre 2 Flash Glucose Monitoring System
Indications for Use (Describe)
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.
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) |
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 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."
3
Indications for Use
510(k) Number (if known) K223537
Device Name
FreeStyle Libre 3 Continous 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 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.
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) |
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 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."
4
Image /page/4/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 on the top line. Below "Abbott" is the text "Diabetes Care" in a smaller, non-bold font, also in black.
1. 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: K223537
1.1 Submitter:
Abbott Diabetes Care, Inc. 1360 South Loop Road Alameda, CA 94502
Contact: Simon Yuan Title: Principal Regulatory Affairs Specialist Phone: (510) 206-6719 Fax: (510) 864-4791
Date Prepared: February 17, 2023
Device Names and Classification: 1.2
| Name of Device: | FreeStyle Libre 2 Flash Glucose Monitoring System |
|---|---|
| Common Name: | Integrated Continuous Glucose Monitoring System, Factory |
| Calibrated, Not for use with automated insulin delivery systems | |
| Regulatory Section: | 21 CFR 862.1355, 21 CFR 862.1345 |
| Classification: | Class II |
| Product Code(s): | QLG, NBW |
| Review Panel: | Clinical Chemistry |
| Name of Device: | FreeStyle Libre 3 Continuous Glucose Monitoring System |
| Common Name: | Integrated Continuous Glucose Monitoring System, Factory |
| 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 1.3
| Predicate Device: | FreeStyle Libre 2 Flash Glucose Monitoring System (with
FreeStyle Libre 2 App), K210943 cleared November 22, 2021 |
|-------------------|----------------------------------------------------------------------------------------------------------------------|
| | FreeStyle Libre 3 Continuous Glucose Monitoring System, K213996
and K212132 cleared May 26, 2022 |
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Image /page/5/Picture/0 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a stylized blue "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, also in black.
1.4 Indications for Use
FreeStyle Libre 2 Flash Glucose Monitoring System 1.4.1
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.
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 may impact proper function of the device which could cause incorrect readings.
1.4.2 FreeStyle Libre 3 Continuous Glucose Monitoring System
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.
510(k) Summary
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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.
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 may impact proper function of the device which could cause incorrect readings.
1.5 Device Description
The FreeStyle Libre 2 and FreeStyle Libre 3 are integrated continuous glucose monitoring (iCGM) Systems designed to be used alone or in conjunction with digitally connected devices. The FreeStyle Libre 2 System consists of a Sensor and either a Reader or the FreeStyle Libre 2 App downloaded to a compatible smartphone as a primary display device. The FreeStyle Libre 3 System consists of a Sensor and the FreeStyle Libre 3 App downloaded to a compatible smartphone as a primary display device. Both Systems can communicate glucose data and other information wirelessly and securely to and from these digitally connected devices as described below:
- Wireless communication from the FreeStyle Libre 2 Sensor or FreeStyle Libre 3 Sensor directly to an interoperable receiver device, which connects with the Sensor using the near field communication (NFC) and Bluetooth Low Energy wireless interfaces provided by the Sensor
- The FreeStyle Libre 2 App or FreeStyle Libre 3 App communicates through the . cloud to another software device, such as LibreView.
Compared to the respective predicate devices, the proposed subject devices include an additional software component, the Libre Data Sharing API. The Libre Data Sharing API is a cloud-based application programming interface (API) that enables communication of glucose data including alarms through the cloud from the FreeStyle Libre 2 System or FreeStyle Libre 3 System to authorized client software on digitally connected devices. The data transmitted by the API to authorized client software can be used for specific and permitted use cases, including nonmedical device applications, medical device data analysis, CGM secondary display alarm, active patient monitoring, and treatment decisions. Use of the Libre Data Sharing API and the CGM information it transmits is limited by the indications for use of the iCGM systems with which it is used.
The Libre Data Sharing API does not have any command or control over the client software, nor does it allow for the client software to have any command or control over the FreeStyle Libre 2 or FreeStyle Libre 3 Systems. Additionally, glucose data and alarms from the connected iCGM system are not modified or manipulated by the Libre Data Sharing API through its transmission to the authorized client software.
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Image /page/7/Picture/0 description: The image contains the logo for Abbott Diabetes Care. The logo consists of a stylized blue symbol on the left, followed by the text "Abbott" in bold, black letters on the first line. Below "Abbott" is the text "Diabetes Care" in a smaller, non-bold font, also in black. The overall design is clean and professional, representing the brand identity of Abbott Diabetes Care.
The display device of the connected FreeStyle Libre 2 or FreeStyle Libre 3 Systems, which directly receives the data from the Sensor, continues to serve as a primary display device for the glucose data and alarms. The current components of the FreeStyle Libre 2 and FreeStyle Libre 3 Systems (sensor/applicator and primary display devices) have not been modified as a result of the added the Libre Data Sharing API.
FreeStyle Libre 2 Flash Glucose Monitoring System 1.5.1
The FreeStyle Libre 2 Flash Glucose Monitoring System is an iCGM that provides continuous glucose measurements every minute to provide glucose levels, trends, and real time alarms capability to aid in the management of diabetes. The System requires a prescription and is intended for home use. The System consists of the following components: a Sensor which transmits via BLE, a BLE enabled display device (Reader), and an Android or iOS mobile app (FreeStyle Libre 2 App) downloaded to a compatible smartphone. Scanning of the Sensor via Reader or App 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 configurable alarms designed to warn the user of Low Glucose, High Glucose or Signal Loss.
FreeStyle Libre 2 Sensor:
-
The Sensor is single use, disposable, and powered by a silver oxide battery. The ● Sensor is provided as two secondary components, Sensor Applicator and Sensor Pack (electron beam sterilized device) which are used to assemble and apply the Sensor to the back of the user's arm. During Sensor application, the sensor tail is inserted about 5.5 millimeters below the surface of the skin through the guidance of a needle. The needle is retracted back into the applicator after insertion, and the Sensor remains attached to the skin with a medical grade adhesive. The Sensor continuously measures glucose concentration in interstitial fluid and has an 8-hour memory capacity. The Sensor is factory calibrated, does not require fingerstick calibration, and can be worn for up to 14 days.
FreeStyle Libre 2 Reader -
The Reader is a small handheld device that is powered by a lithium-ion ● rechargeable battery and uses NFC communication to start new Sensors and to scan Sensors to display and record data and uses BLE communication to issue alarms that notify the user to scan his/her sensor when glucose values pass a high or low glucose threshold. The Reader also has a built-in strip port with blood glucose functionality (that is intended to work with the FreeStyle Precision Neo Blood Glucose test strips, cleared under K171941), and a user interface that includes event logging features.
FreeStyle Libre 2 App (iOS or Android) -
The App's design, functionality and user interface is based on the handheld Reader. ● When downloaded to a compatible smartphone, the App uses NFC communication to start new Sensors and to scan Sensors to display and record data and uses BLE communication to issue alarms. As a mobile application, the FreeStyle Libre 2 App allows connectivity with cloud-based applications. The FreeStyle Libre 2 App is an alternative primary display for the System and does not interact with the Reader.
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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 square with a stylized "a" inside, followed by the text "Abbott" in bold, and "Diabetes Care" in a smaller, non-bold font. The text is aligned to the right of the blue square.
The FreeStyle Libre 2 App is distributed using the Apple App Store and Google Play Store, and a list of compatible devices is accessible in the App via the Help feature or product website.
1.5.2 FreeStyle Libre 3 Continuous Glucose Monitoring System
The FreeStyle Libre 3 Continuous Glucose Monitoring System is an 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 BLE, and an Android or iOS mobile app (FreeStyle Libre 3 App) downloaded to a compatible smartphone. 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 configurable alarms designed to warn the user of Low Glucose, High Glucose or Signal Loss.
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 14-day memory capacity. The Sensor is factory calibrated, does not require fingerstick calibration, and can be worn for up to 14 days.
FreeStyle Libre 3 App (iOS or Android)
- . When downloaded to a compatible smartphone, the FreeStyle Libre 3 App uses NFC 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 cloudbased applications. The FreeStyle Libre 3 App is distributed using the Apple App Store and Google Play Store and a list of compatible devices is accessible in the App via the Help feature or product website.
Substantial Equivalence 1.6
The similarities and differences between the subject devices and the predicate devices are highlighted in the tables below.
1.6.1 FreeStyle Libre 2 Flash Glucose Monitoring System
| Device | Predicate Device: FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App), K210943 | Subject Device: FreeStyle Libre 2 Flash Glucose Monitoring System (with Libre Data Sharing API), K223537 |
|---|---|---|
| Trade Name | FreeStyle Libre 2 Flash Glucose Monitoring System | Same |
| Device | Predicate Device: FreeStyle Libre 2 | |
| Flash Glucose Monitoring System | ||
| (with FreeStyle Libre 2 App), | ||
| K210943 | Subject Device: | |
| FreeStyle Libre 2 Flash Glucose | ||
| Monitoring System (with Libre Data | ||
| Sharing API), K223537 | ||
| Intended Use | The System is intended to monitor | |
| interstitial fluid glucose | ||
| concentrations and communicate | ||
| with digitally connected devices for | ||
| the purpose of managing a disease or | ||
| condition related to glycemic control. | Same | |
| 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). | 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. |
| Device Type | Integrated CGM | Same |
| Principle of
Operation | Amperometric measurement of
current proportional to glucose
concentration in interstitial fluid via
glucose oxidase chemical reaction | Same |
| Test Range | 40 to 400 mg/dL | Same |
| Clinical
Application | Management of diabetes mellitus | Same |
| Device | Predicate Device: FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App), K210943 | Subject Device: FreeStyle Libre 2 Flash Glucose Monitoring System (with Libre Data Sharing API), K223537 |
| 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 glucose history, user entered events | Same |
| Method of Sensor Activation | NFC communication | Same |
| Method of Data Transfer from Sensor | NFC – upon user-initiated scan BLE – for glucose data to support glucose alarms | 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 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 |
| Scan-Based Alerts | Scan Error, Sensor Error, Replace Sensor, Sensor Ended | Same |
| Wireless Communication Protocol | NFC: 13.56 MHz RFID Bluetooth Low Energy (BLE) | Same |
| BLE Communication Range | 20 feet unobstructed | Same |
| Sensor Glucose Algorithm | ADC Glucose Algorithm | Same |
| Glucose Reading Update Interval | Every 1 minute | Same |
| Device | Predicate Device: FreeStyle Libre 2
Flash Glucose Monitoring System
(with FreeStyle Libre 2 App),
K210943 | Subject Device:
FreeStyle Libre 2 Flash Glucose
Monitoring System (with Libre Data
Sharing API), K223537 |
| Trend Graph
Glucose History | 8 hours, 24-hour graph and other
reports can be used to view logged
data | Same |
| Glucose Trend
Arrow | ↑, > +2 mg/dL/min
↗, +1 to +2 mg/dL/min
→, -1 to +1 mg/dL/min
↘, -2 to -1 mg/dL/min
↓, +2 mg/dL/min
↗, +1 to +2 mg/dL/min
→, -1 to +1 mg/dL/min
↘, -2 to -1 mg/dL/min
↓,