(150 days)
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.
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.
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.
1. A table of acceptance criteria and the reported device performance:
The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed table of clinical acceptance criteria and specific numerical performance. However, it does state that "System accuracy was demonstrated to meet the iCGM special controls requirements per 21 CFR 862.1355." This regulation for Integrated Continuous Glucose Monitoring Systems outlines performance standards.
Based on the document, the following aspects were evaluated:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Accuracy (Clinical) | Met iCGM special controls requirements per 21 CFR 862.1355. |
| Sterility | Sterility Assurance Level (SAL) of 10^-6 achieved with minimum sterilization dose of 25 kGy, established by VDmax25 method and ISO 11137-1/11137-2. |
| Shelf-Life, Packaging Integrity, Shipping | Seal integrity, user accessibility, and device functionality met acceptance criteria after worst-case testing. |
| Electrical Safety | Compliant with IEC 60601-1: 2005(r)2012, IEC 60601-1-6:2010+A1:2013, and IEC 60601-1-11:2015. |
| Electromagnetic Compatibility (EMC) | Compliant with IEC 60601-1-2 and IEC CISPR 11. Wireless coexistence testing confirmed functionality within acceptable limits in presence of common radiating electronic devices (AAMI TIR69, ANSI C63.27, FDA Guidance). Compliant with FCC Regulations Part 15.225 and Part 15.247, and FAA Advisory Circular RTCA DO-160. |
| Mechanical Engineering | Met acceptance criteria for mechanical, electrical, and functional testing at system level and for individual Sensor Applicator components. |
| Biocompatibility | Demonstrated biocompatibility per ISO10993-1 and FDA Guidance "Use of International Standard ISO 10993-1." |
| Software Verification and Validation | Met acceptance criteria for executed protocols per IEC 62304 and FDA Guidance "Content of Premarket Submissions for Software Contained in Medical Devices." |
| Cybersecurity | Cybersecurity risk management documentation analyzed confidentiality, integrity, and availability of data, information, and software. Appropriate risk mitigation controls implemented and tested per October 2014 FDA Guidance. |
| Human Factors | Risk analysis demonstrated design changes met usability requirements per ANSI/AAMI/IEC 62366, IEC 60601-1-6, and FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices." |
| Interoperability | Incorporated an approach for interoperability in alignment with FDA Guidance "Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices." |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample size for clinical test sets. For the "Clinical Performance" section, it only mentions that "System accuracy was demonstrated to meet the iCGM special controls requirements per 21 CFR 862.1355." This often implies a clinical trial or study, but specific numbers are not provided in this 510(k) summary. The provenance of the data (country of origin, retrospective/prospective) is also not detailed in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. For glucose monitoring systems, "ground truth" is typically established by laboratory reference methods (e.g., YSI glucose analyzer) rather than expert human interpretation.
4. Adjudication method for the test set:
This information is not provided in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable to the FreeStyle Libre Continuous Glucose Monitoring System. This device is a standalone diagnostic tool that provides glucose readings directly to the user (or digitally connected devices), not a system designed to assist human readers in interpreting medical images or data. Therefore, an MRMC study comparing human reader improvement with/without AI assistance would not be conducted for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, the device is inherently designed to operate in a standalone manner (algorithm only) to provide glucose readings. The "Clinical Performance" section implicitly refers to this standalone performance when stating "System accuracy was demonstrated to meet the iCGM special controls requirements per 21 CFR 862.1355." The FSL3 System's glucose algorithm resides in the Sensor, and for FSL2, it resides in the Receiver (App or Reader), generating glucose values without human real-time intervention for each reading.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For Continuous Glucose Monitoring (CGM) systems, the ground truth for accuracy studies is typically established by laboratory reference methods, such as those using a YSI glucose analyzer, which provides highly accurate and precise blood glucose measurements. While not explicitly stated in this summary, this is standard practice for CGM device validation.
8. The sample size for the training set:
The document does not provide information about the training set size. This 510(k) summary focuses on the substantial equivalence and performance of the final device, not the specifics of its development or algorithm training.
9. How the ground truth for the training set was established:
This information is not provided in the document. Similar to the test set, it would typically involve comparison to highly accurate laboratory reference methods.
§ 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.