(150 days)
No
The document describes a continuous glucose monitoring system that detects trends and patterns and aids in the detection of hyperglycemia and hypoglycemia. While this involves data analysis, the description does not mention the use of AI or ML algorithms for these functions. The performance studies and key metrics sections also do not indicate the use of AI/ML.
No
Justification: The device is a continuous glucose monitoring (CGM) system used for managing diabetes by tracking glucose levels and trends. While it aids in treatment decisions and can communicate with automated insulin dosing systems, it primarily provides diagnostic and monitoring information rather than directly delivering therapy. Its purpose is to facilitate therapy adjustments based on data, not to perform a therapeutic function itself.
Yes
Explanation: The device is a continuous glucose monitoring (CGM) system indicated for the management of diabetes, designed to replace blood glucose testing for treatment decisions, detect trends in glucose levels, and aid in the detection of hyperglycemia and hypoglycemia. These functions are diagnostic in nature as they provide information to identify or monitor a medical condition.
No
The device description explicitly states that the system consists of a "Sensor" in addition to the reader or app, indicating a hardware component is integral to the system's function. The performance studies also include evaluations of hardware-related aspects like sterility, electrical safety, mechanical engineering, and biocompatibility.
Based on the provided text, the FreeStyle Libre 2 and FreeStyle Libre 3 Systems are IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use explicitly states that the system is for the "management of diabetes" and is "intended to replace blood glucose testing for diabetes treatment decisions." Blood glucose testing is a classic example of an in vitro diagnostic test, as it involves analyzing a biological sample (blood) outside of the body to diagnose or monitor a medical condition.
- Device Description: The device description states that the systems "provide continuous glucose measurements" and that the user "may make treatment decisions based in part on the Sensor glucose results." While the sensor is placed on the body, it is measuring glucose in the interstitial fluid, which is a biological sample. The analysis and interpretation of this biological sample data for the purpose of making treatment decisions falls under the scope of in vitro diagnostics.
- Reference Device: The inclusion of a "Reference Device" which is a "Blood Glucose test strips" (K171941, FreeStyle Precision Neo Blood Glucose test strips) further reinforces the connection to in vitro diagnostic testing. The system is intended to replace or be used in conjunction with traditional blood glucose testing methods.
Therefore, while the device has a sensor that is applied to the body, its core function is to measure and analyze a biological sample (interstitial fluid glucose) for the purpose of diagnosing, monitoring, and managing a medical condition (diabetes), which aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
FreeStyle Libre 2 Flash Glucose Monitoring System:
The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 2 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated.
The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time.
The System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The System can be used alone or in conjunction with these digitally connected devices for the purpose of managing diabetes.
FreeStyle Libre 3 Continuous Glucose Monitoring System:
The FreeStyle Libre 3 Continuous Glucose Monitoring System is a real time continuous glucose monitoring (CGM) device with alarms capability indicated for the management of diabetes in persons age 2 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated.
The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time.
The System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The System can be used alone or in conjunction with these digitally connected devices for the purpose of managing diabetes.
Product codes (comma separated list FDA assigned to the subject device)
QBJ, NBW
Device Description
The FreeStyle Libre 3 Continuous Glucose Monitoring System (hereinafter also referred to as 'FSL3 System') and FreeStyle Libre 2 Flash Glucose Monitoring System (hereinafter also referred to as the 'FSL2 System') are integrated continuous glucose monitoring (iCGM) systems that provide continuous glucose measurements every minute to provide glucose levels, trends, and real-time alarms capability to aid in the management of diabetes. The FSL2 and FSL3 Systems also provide configurable alarms designed to warn the user of Low Glucose, High Glucose or Signal Loss. The user may make treatment decisions based in part on the Sensor glucose results provided by both Systems. The FSL2 and FSL3 Systems require a prescription and are intended for home use.
The FSL3 System consists of the FreeStyle Libre 3 Sensor and either the FreeStyle Libre 3 Reader or the FreeStyle Libre 3 App (iOS and Android) downloaded to a compatible smartphone as a primary display device. The FSL3 Reader and FSL3 App do not interact with each other.
The FSL2 System consists of the FreeStyle Libre 2 Sensor and either the FreeStyle Libre 2 Reader or the FreeStyle Libre 2 App (iOS and Android) downloaded to a compatible smartphone as a primary display device. The FSL2 Reader and FSL2 App do not interact with each other.
Both the FSL2 and FSL3 Systems are compatible with the Libre Data Sharing API cleared in K223537. The display device of the connected FSL2 or FSL3 Systems, which directly receives the data from the Sensor, continues to serve as a primary display device for the glucose data and alarms.
FreeStyle Libre 3 Continuous Glucose Monitoring System:
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. During Sensor application, the sensor tail is inserted below the surface of the skin through the guidance of a needle. The needle is retracted back into the applicator after insertion, and the Sensor remains attached to the skin with a medical grade adhesive. The Sensor continuously measures glucose concentration in interstitial fluid and has a 15-day memory capacity. The Sensor is factory calibrated, does not require fingerstick calibration, and can be worn for up to 15 days.
FreeStyle Libre 3 App (iOS and Android)
- When downloaded to a compatible smartphone, the FreeStyle Libre 3 App uses Near Field Communication (NFC) to start new Sensors and BLE communication to display glucose data and issue alarms based on the measurements calculated by the Sensor. As a mobile application, the FreeStyle Libre 3 App allows connectivity with cloud-based applications. The FreeStyle Libre 3 App is distributed using the 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 Reader
- The FreeStyle Libre 3 Reader is a small handheld device that is powered by a lithium-ion rechargeable battery and uses NFC communication to start new Sensors and BLE communication to display glucose data and issue alarms that notify the user to scan his/her sensor when glucose values pass a high or low glucose threshold. The Reader also has a built-in strip port with blood glucose functionality (that is intended to work with the FreeStyle Precision Neo Blood Glucose test strips, cleared under K171941), and a user interface that includes event logging features.
FreeStyle Libre 2 Flash Glucose Monitoring System:
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 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 15 days.
FreeStyle Libre 2 App (iOS and Android)
- When downloaded to a compatible smartphone, the FreeStyle Libre 2 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 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 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Back of the upper arm
Indicated Patient Age Range
age 2 and older
Intended User / Care Setting
Home use
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance characteristics were evaluated to support substantial equivalence:
- Sterility - Electron beam sterilization validation in relation to the introducer needle and sensor tail was performed per ISO11137-1 and ISO 11137-2. Sterilization validation confirmed that the Sterility Assurance Level (SAL) of 106 is achieved with the minimum sterilization dose of 25 kGy. The sterilization dose was established by the VDmax25 method described in ISO 11137-2.
- Shelf-Life, Packaging Integrity, and Shipping - Device shelf life and packaging integrity over the shelf life was demonstrated by subjecting test units to worst case sealing parameters, sterilization parameters, and shipping configuration. Units were also conditioned through a worst case sequence of storage, handling and transit challenges prior to testing. Attributes related to seal integrity, user accessibility, and device functionality including sterile barrier system integrity met acceptance criteria.
- Electrical Safety - Electrical Safety testing demonstrated that the basic safety and essential performance of the System is in compliance to IEC 60601-1: 2005(r)2012, IEC 60601-1-6:2010+A1:2013, and IEC 60601-1-11:2015.
- Electromagnetic Compatibility Electromagnetic compatibility (EMC) testing demonstrated that the System is able to withstand the electromagnetic interference and emissions in compliance with IEC 60601-1-2 and IEC CISPR 11. Wireless coexistence testing was performed to confirm that the subject device remains functional and perform within acceptable limits while in the presence of common radiating electronic devices in accordance with FDA Guidance "Radio Frequency Wireless Technology in Medical Devices." The subject device underwent coexistence testing consistent with AAMI TIR69 and ANSI C63.27 and included test challenges from in-band interference sources defined in ANSICC63.27 as well as other expected wireless interference sources from the intended use environment. The System also successfully demonstrated compliance with Federal Communication Commission (FCC) Regulations Part 15.225 and Part 15.247, and Federal Aviation Administration (FAA) Advisory Circular RTCA DO-160.
- Mechanical Engineering The subject device underwent performance testing at the System level as well as on individual components of the Sensor Applicator. The test results showed that mechanical, electrical, and functional testing all met the acceptance criteria.
- Biocompatibility Biocompatibility evaluation and testing in accordance with ISO10993-1 and FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process," was performed to demonstrate biocompatibility of the device.
- Software Verification and Validation Software verification and validation testing and evaluation was conducted in accordance with IEC 62304 and documentation was provided as recommended by FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Results of executed protocols met the acceptance criteria and therefore support that the System software is acceptable for its intended use.
- Cybersecurity - ADC has provided cybersecurity risk management documentation for the System that includes analysis of confidentiality, integrity, and availability for data, information and software related to the System accordance with the October 2014 FDA Guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices." For each identified threat and vulnerability risk event scenario, risk assessment of impact to confidentiality integrity, and availability was performed and documented within the cybersecurity risk management documentation. Appropriate risk mitigation controls have been implemented and tested.
- Clinical Performance –The subject device calculates glucose information identically to the predicate device. System accuracy was demonstrated to meet the iCGM special controls requirements per 21 CFR 862.1355.
- Human Factors - ADC conducted a risk analysis of the design and user interface in accordance with ANSI/AAMI/IEC 62366, IEC 60601-1-6, and FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices." The analysis demonstrated that the design changes implemented for the subject device meet usability requirements for its intended use.
- Interoperability - The subject device incorporated an approach for interoperability developed in alignment with FDA Guidance "Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and 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.
April 13, 2023
Abbott Diabetes Care, Inc. Katherine Doll Kanne Principal Regulatory Affairs Specialist 1360 South Loop Road Alameda, CA 94502
Re: K223435
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: QBJ, NBW Dated: March 13, 2023 Received: March 14, 2023
Dear Katherine Doll Kanne:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
listing (21 CFR Part 807); labeling (21 CFR Part
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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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/6 description: The image shows a digital signature. The signature is by Paula V. Caposino -S. The date of the signature is 2023.04.13. The time of the signature is 13:12:26 -04'00'.
Paula Caposino, Ph.D. Acting Deputy Division 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) K223435
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 2 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated.
The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time.
The System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The System can be used alone or in conjunction with these digitally connected devices for the purpose of managing diabetes.
| 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
Indications for Use
510(k) Number (if known) K223435
Device Name
FreeStyle Libre 3 Continuous Glucose Monitoring System
Indications for Use (Describe)
The FreeStyle Libre 3 Continuous Glucose Monitoring System is a real time continuous glucose monitoring (CGM) device with alarms capability indicated for the management of diabetes in persons age 2 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated.
The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time.
The System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The System can be used alone or in conjunction with these digitally connected devices for the purpose of managing diabetes.
| 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."
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Image /page/4/Picture/0 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a blue stylized "a" on the left, followed by the text "Abbott" in bold black font on the top line and "Diabetes Care" in a smaller, regular black font on the bottom line. The logo is clean and professional, conveying a sense of trust and reliability.
ડ. 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
510(k) Number: K223435
5.1 Submitter:
Abbott Diabetes Care, Inc. 1360 South Loop Road Alameda, CA 94502
Contact: Katherine Doll Kanne Title: Principal Regulatory Affairs Specialist Phone: (612) 394-9209 Fax: (510) 864-4791
Date Prepared: April 13, 2023
5.2 Device Names and Classification:
| Name of Device: | FreeStyle Libre 3 Continuous Glucose Monitoring System |
|---|---|
| Common Name: | Integrated Continuous Glucose Monitoring System, Factory Calibrated |
| Regulatory Section: | 21 CFR 862.1355, 21 CFR 862.1345 |
| Classification: | Class II |
| Product Code(s): | QBJ, NBW |
| Review Panel: | Clinical Chemistry |
| Name of Device: | FreeStyle Libre 2 Flash Glucose Monitoring System |
| Common Name: | Integrated Continuous Glucose Monitoring System, Factory Calibrated |
| Regulatory Section: | 21 CFR 862.1355, 21 CFR 862.1345 |
| Classification: | Class II |
| Product Code(s): | QBJ, NBW |
| Review Panel: | Clinical Chemistry |
5.3 Predicate Device
Predicate Devices: Freestyle Libre 3 Continuous Glucose Monitoring System and FreeStyle Libre 2 Flash Glucose Monitoring System (K222447)
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Image /page/5/Picture/0 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a blue abstract shape on the left, followed by the word "Abbott" in bold black letters. Below "Abbott" is the phrase "Diabetes Care" in a smaller, non-bold font. The logo is clean and professional, conveying a sense of trust and reliability.
5.4 Indications for Use:
5.4.1 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 2 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated.
The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time.
The System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The System can be used alone or in conjunction with these digitally connected devices for the purpose of managing diabetes.
Contraindication
MRVCT/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.
5.4.2 FreeStyle Libre 2 Flash Glucose Monitoring System
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 2 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated.
The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time.
The System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The System can be used alone or in conjunction with these digitally connected devices for the purpose of managing diabetes.
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Image /page/6/Picture/0 description: The image contains 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 font on the top line and "Diabetes Care" in a smaller, regular black font on the second line. The logo is clean and professional, suggesting a focus on healthcare and technology.
Contraindication
MRVCT/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.
ર્સ્ડ Device Description
The FreeStyle Libre 3 Continuous Glucose Monitoring System (hereinafter also referred to as 'FSL3 System') and FreeStyle Libre 2 Flash Glucose Monitoring System (hereinafter also referred to as the 'FSL2 System') are integrated continuous glucose monitoring (iCGM) systems that provide continuous glucose measurements every minute to provide glucose levels, trends, and real-time alarms capability to aid in the management of diabetes. The FSL2 and FSL3 Systems also provide configurable alarms designed to warn the user of Low Glucose, High Glucose or Signal Loss. The user may make treatment decisions based in part on the Sensor glucose results provided by both Systems. The FSL2 and FSL3 Systems require a prescription and are intended for home use.
The FSL3 System consists of the FreeStyle Libre 3 Sensor and either the FreeStyle Libre 3 Reader or the FreeStyle Libre 3 App (iOS and Android) downloaded to a compatible smartphone as a primary display device. The FSL3 Reader and FSL3 App do not interact with each other.
The FSL2 System consists of the FreeStyle Libre 2 Sensor and either the FreeStyle Libre 2 Reader or the FreeStyle Libre 2 App (iOS and Android) downloaded to a compatible smartphone as a primary display device. The FSL2 Reader and FSL2 App do not interact with each other.
Both the FSL2 and FSL3 Systems are compatible with the Libre Data Sharing API cleared in K223537. The display device of the connected FSL2 or FSL3 Systems, which directly receives the data from the Sensor, continues to serve as a primary display device for the glucose data and alarms.
FreeStyle Libre 3 Continuous Glucose Monitoring System 5.5.1
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. During Sensor application, the sensor tail is inserted below the surface of the skin through the guidance of a needle. The needle is retracted back into the applicator after insertion, and the Sensor remains attached to the skin with a medical grade adhesive. The Sensor continuously measures glucose concentration in interstitial fluid and has a 15-day memory capacity. The Sensor is factory calibrated, does not require fingerstick calibration, and can be worn for up to 15 days.
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Image /page/7/Picture/0 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a blue stylized "a" on the left, followed by the text "Abbott" in bold black font on the top line and "Diabetes Care" in a smaller, regular black font on the bottom line. The logo is clean and professional, conveying a sense of trust and reliability.
FreeStyle Libre 3 App (iOS and Android)
- When downloaded to a compatible smartphone, the FreeStyle Libre 3 App uses Near Field Communication (NFC) to start new Sensors and BLE communication to display glucose data and issue alarms based on the measurements calculated by the Sensor. As a mobile application, the FreeStyle Libre 3 App allows connectivity with cloud-based applications. The FreeStyle Libre 3 App is distributed using the 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 Reader
- The FreeStyle Libre 3 Reader is a small handheld device that is powered by a lithium-● ion rechargeable battery and uses NFC communication to start new Sensors and BLE communication to display glucose data and issue alarms that notify the user to scan his/her sensor when glucose values pass a high or low glucose threshold. The Reader also has a built-in strip port with blood glucose functionality (that is intended to work with the FreeStyle Precision Neo Blood Glucose test strips, cleared under K171941), and a user interface that includes event logging features.
5.5.2 FreeStyle Libre 2 Flash Glucose Monitoring System
FreeStyle Libre 2 Sensor
- The Sensor is single use, disposable, and powered by a silver oxide battery. The Sensor is provided as two secondary components, Sensor Applicator and Sensor Pack (electron beam sterilized device) which are used to assemble and apply the Sensor to the back of the user's arm. During Sensor application, the sensor tail is inserted below the surface of the skin through the guidance of a needle. The needle is retracted back into the applicator after insertion, and the Sensor remains attached to the skin with a medical grade adhesive. The Sensor continuously measures glucose concentration in interstitial fluid and has an 8-hour memory capacity. The Sensor is factory calibrated, does not require fingerstick calibration, and can be worn for up to 15 days.
FreeStyle Libre 2 App (iOS and Android)
-
When downloaded to a compatible smartphone, the FreeStyle Libre 2 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 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 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.
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Image /page/8/Picture/0 description: The image shows the Abbott Diabetes Care logo. The logo consists of a blue abstract shape on the left, followed by the text "Abbott" in bold black font on the top right. Below "Abbott" is the text "Diabetes Care" in a regular black font. The logo is clean and professional, representing the company's brand identity.
5.6 Substantial Equivalence
The similarities and differences between the subject and the predicate devices are highlighted in the tables below.
| Similarities | ||
|---|---|---|
| Subject Device: FreeStyle Libre 3 Continuous Glucose | ||
| Monitoring System | Predicate Device: FreeStyle Libre 3 | |
| Continuous Glucose Monitoring System | ||
| (K222447) | ||
| 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 | ||
| 2 and older. It is intended to replace blood glucose testing for | ||
| diabetes treatment decisions, unless otherwise indicated. | ||
| The System also detects trends and tracks patterns and aids in the | ||
| detection of episodes of hyperglycemia and hypoglycemia, | ||
| facilitating both acute and long-term therapy adjustments. | ||
| Interpretation of the System readings should be based on the | ||
| glucose trends and several sequential readings over time. | ||
| The System is also intended to autonomously communicate with | ||
| digitally connected devices, including automated insulin dosing | ||
| (AID) systems. The System can be used alone or in conjunction | ||
| with these digitally connected devices for the purpose of managing | ||
| diabetes. | Same | |
| Intended Use Population | Persons with diabetes age 2 and older | Same |
| Device Type | Integrated CGM | Same |
| Compatible operating systems | ||
| and hardware platform for | ||
| App | App is compatible with iOS and Apple smartphone; Android | |
| operating system (OS) and Android-enabled smartphones. | Same | |
| Principle of Operation | Amperometric measurement of current proportional to glucose | |
| concentration in interstitial fluid via glucose oxidase chemical | ||
| reaction | Same | |
| Similarities | ||
| Subject Device: FreeStyle Libre 3 Continuous Glucose | ||
| Monitoring System | Predicate Device: FreeStyle Libre 3 | |
| Continuous Glucose Monitoring System | ||
| (K222447) | ||
| Test Range | 40 to 400 mg/dL | Same |
| Clinical Application | Management of diabetes mellitus | 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 | Near Field Communication (NFC) | Same |
| Wireless communications | ||
| protocol | NFC: 13.56 MHz RFID | |
| Bluetooth Low Energy (BLE) | Same | |
| Method of Data Transfer | ||
| from Sensor | Bluetooth Low Energy (BLE). Data automatically transfers without | |
| user initiated scan (streaming data). | Same | |
| BLE Communication Range | 33 feet unobstructed | Same |
| Sensor Glucose Algorithm | ADC Glucose Algorithm established for the predicate device | Same |
| Location of glucose algorithm | Sensor | Same |
| Glucose Reading Update | ||
| Interval | Every 1 minute | Same |
| Glucose History | Graph and other reports can be used to view logged data | Same |
| Glucose Trend Arrows | ↑, > +2 mg/dL/min | |
| ↗, +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 | ||
| ↓, |