(237 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and does not describe any features or algorithms that are characteristic of AI/ML, such as training sets, test sets, or specific AI/ML model types. The description focuses on standard signal processing, trend tracking, and alarm functions.
Yes
The device is indicated for "management of diabetes" and "facilitating both acute and long-term therapy adjustments," which are therapeutic actions. It also aids in "diabetes treatment decisions."
Yes
The device is indicated for the "management of diabetes" and "aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments." This indicates its role in diagnosing and monitoring a medical condition.
No
The device description explicitly states that the system consists of a Sensor (hardware) and a Reader (hardware), in addition to the software components (mobile app). Therefore, it is not a software-only medical device.
Yes, the FreeStyle Libre 2 Flash Glucose Monitoring System is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "management of diabetes" and is "intended to replace blood glucose testing for diabetes treatment decisions." This indicates it's used to obtain information about a physiological state (glucose levels) from a sample (interstitial fluid, which is a body fluid).
- Device Description: The description mentions it provides "continuous glucose measurements" and that the user "may make treatment decisions based in part on the Sensor glucose results." This further reinforces its role in providing diagnostic information.
- Nature of the Measurement: While it measures glucose in interstitial fluid rather than directly in blood, the principle is still about analyzing a biological sample to gain diagnostic information about the body's state. IVD devices are not limited to just blood.
The fact that it's a "continuous glucose monitoring system (CGM)" and an "integrated continuous glucose monitoring system (iCGM)" also aligns with the types of devices often classified as IVDs when used for diagnostic purposes like managing diabetes.
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 System can be used with the FreeStyle Libre 2 Sensor (14 day) or the FreeStyle Libre 2 MediRx (10 day).
Product codes
QLG, NBW
Device Description
The FreeStyle Libre 2 Flash Glucose Monitoring System with the FreeStyle Libre 2 App -Android (herein referred to as the 'FreeStyle Libre 2 System' or 'System') is an integrated continuous glucose monitoring system (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 yia Bluetooth Low Energy (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 (14 day) and FreeStyle Libre 2 MediRx Sensor (10 day)
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 and does not require fingerstick calibration. The FreeStyle Libre 2 Sensor can be worn for up to 14 days while the FreeStyle Libre 2 MediRx Sensor can be worn for up to 10 days.
FreeStyle Libre 2 Reader
The Reader is a small handheld device that is powered by a lithium-ion rechargeable battery and uses RFID communication to start new Sensors and to scan Sensors to display and record data and uses BLE communication to issue alarms that notify the user to scan his/her sensor when glucose values pass a high or low glucose threshold. The Reader also has a built-in strip port with blood glucose functionality (that is intended to work with the FreeStyle Precision Neo Blood Glucose test strips, cleared under K171941), and a user interface that includes event logging features.
FreeStyle Libre 2 App (iOS and Android)
The App's design, functionality and user interface is based on the handheld Reader. When downloaded to a compatible smartphone, the App uses RFID 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 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 (for sensor placement measuring interstitial fluid)
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)
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 document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," May 11, 2005. Results of executed protocols met the acceptance criteria and therefore support that the Android App software is acceptable for its intended use.
Human Factors - human factors testing of the System was conducted in accordance with ANSI/AAMI/IEC 62366, IEC 60601-1-6, and FDA Guidance document "Applying Human Factors and Usability Engineering to Medical Devices," dated February 3, 2016. Results demonstrated that the System met usability requirements.
Wireless Coexistence the System 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. Test results showed the System could tolerate interference generated by these RF interfering devices and still meet the target performance criteria.
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. 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.
Electrical Safety and Electromagnetic Compatibility (EMC) - the System underwent electrical safety and EMC evaluation. Results of the evaluation demonstrated that the System complies with electrical safety and EMC requirements per IEC 60601-1:2005(r)2012 and IEC 60601-1-2:2014, respectively.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s):
Reference Device(s):
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
November 22, 2021
Abbott Diabetes Care Inc. Ono Bacani Regulatory Affairs Project Manager 1360 South Loop Rd. Alameda, California 94502
Re: K210943
Trade/Device Name: FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) Regulation Number: 21 CFR 862.1355 Regulation Name: Integrated Continuous Glucose Monitoring System Regulatory Class: Class II Product Code: QLG, NBW Dated: March 29, 2021 Received: March 30, 2021
Dear Ono Bacani:
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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 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.
Marianela Perez-Torres, Ph.D. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210943
Device Name
FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)
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.
The System can be used with the FreeStyle Libre 2 Sensor (14 day) or the FreeStyle Libre 2 MediRx (10 day).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff 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
Image /page/3/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 first line. Below "Abbott" is the text "Diabetes Care" in a smaller, regular black font. The logo is simple and professional, conveying a sense of trust and reliability.
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.
K210943 510(k) Number:
1.1 Submitter:
Abbott Diabetes Care, Inc. 1360 South Loop Road Alameda, CA 94502
Contact: Ono Bacani Title: Sr. Manager, Regulatory Affairs Phone: 510-239-2622 Fax: (510) 864-4791
Date Prepared: November 14, 2021
1.2 Device Names and Classification:
| Name of Device: | FreeStyle Libre 2 Flash Glucose Monitoring System
(with FreeStyle Libre 2 App) |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------|
| 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 |
1.3 Predicate Device
| Predicate Device: | FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle
Libre 2 App), K201761 cleared on July 30, 2021 |
|-------------------|---------------------------------------------------------------------------------------------------------------------|
| | This predicate device has not been subject to a recall |
4
Image /page/4/Picture/0 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a blue abstract shape on the left, followed by the text "Abbott" in bold black font on the top line. Below "Abbott" is the text "Diabetes Care" in a regular black font. The logo is simple and professional, conveying a sense of trust and reliability.
Indications for Use: 1.4
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).
Contraindications
- . Automated Insulin Dosing: The System must not be used with automated insulin dosing (AID) systems, including closed loop and insulin suspend systems.
- . MRI/CT/Diathermy: The System must be removed prior to Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment. The effect of MRI, CT scans, or diathermy on the performance of the System has not been evaluated. The exposure may damage the Sensor and may impact proper function of the device which could cause incorrect readings.
1.5 Device Description
The FreeStyle Libre 2 Flash Glucose Monitoring System with the FreeStyle Libre 2 App -Android (herein referred to as the 'FreeStyle Libre 2 System' or 'System') is an integrated continuous glucose monitoring system (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 yia Bluetooth Low Energy (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
5
Image /page/5/Picture/0 description: The image shows the Abbott Diabetes Care logo. The logo consists of a blue abstract symbol on the left, followed by the words "Abbott" in bold black letters on the top line and "Diabetes Care" in regular black letters on the bottom line. The logo is simple and modern, with a focus on the company's name and its area of expertise.
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 (14 day) and FreeStyle Libre 2 MediRx Sensor (10 day)
-
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 and does not require fingerstick calibration. The FreeStyle Libre 2 Sensor can be worn for up to 14 days while the FreeStyle Libre 2 MediRx Sensor can be worn for up to 10 days.
FreeStyle Libre 2 Reader -
The Reader is a small handheld device that is powered by a lithium-ion rechargeable ● battery and uses RFID communication to start new Sensors and to scan Sensors to display and record data and uses BLE communication to issue alarms that notify the user to scan his/her sensor when glucose values pass a high or low glucose threshold. The Reader also has a built-in strip port with blood glucose functionality (that is intended to work with the FreeStyle Precision Neo Blood Glucose test strips, cleared under K171941), and a user interface that includes event logging features.
FreeStyle Libre 2 App (iOS and Android) -
The App's design, functionality and user interface is based on the handheld Reader. ● When downloaded to a compatible smartphone, the App uses RFID 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 App Store and Google Play Store, and a list of compatible devices is accessible in the App via the Help feature or product website.
6
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 font on the first line, and "Diabetes Care" in a smaller, regular black font on the second line. The logo is clean and professional, representing the company's brand identity.
Substantial Equivalence 1.6
- A. Predicate Device Name: FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)
- B. Predicate 510(k) Number(s): K201761
- C. Comparison with Predicate:
The similarities and differences between the subject and the predicate device are highlighted in the tables below.
7
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 text "Abbott" in bold black letters on the top line. Below "Abbott" is the text "Diabetes Care" in a smaller, non-bold font. The overall design is clean and corporate, representing the brand identity of Abbott Diabetes Care.
| Similarities | ||
|---|---|---|
| Item | Subject Device: FreeStyle Libre 2 Flash Glucose | |
| Monitoring System (with FreeStyle Libre 2 App) | Predicate Device: FreeStyle Libre 2 Flash Glucose | |
| Monitoring System (with FreeStyle Libre 2 App) | ||
| (K201761) | ||
| 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 |
| Similarities | | |
| Item | Subject Device: FreeStyle Libre 2 Flash Glucose
Monitoring System (with FreeStyle Libre 2 App) | Predicate Device: FreeStyle Libre 2 Flash Glucose
Monitoring System (with FreeStyle Libre 2 App)
(K201761) |
| 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 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 |
| Optional Alarms | Low Glucose Alarm, High Glucose Alarm, Signal Loss
Alarm | Same |
| Mandatory Alarms | For Low and High Glucose alarms, a user-initiated action
is required to see glucose reading
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 with version number | Near Field Communication (NFC): (13.56 MHz RFID)
Bluetooth Low Energy (BLE): 4.0 | 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 |
| Similarities | | |
| Item | Subject Device: FreeStyle Libre 2 Flash Glucose
Monitoring System (with FreeStyle Libre 2 App) | Predicate Device: FreeStyle Libre 2 Flash Glucose
Monitoring System (with FreeStyle Libre 2 App)
(K201761) |
| Glucose Trend Arrow | ↑, > +2 mg/dL/min
↗, +1 and +2 mg/dL/min
→, -1 to +1 mg/dL/min
↘, -2 to -1 mg/dL/min
↓,