(237 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 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 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.
This 510(k) summary describes the FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App), focusing on the addition of an Android application to the existing system. The document states that the Android app utilizes the identical algorithm and implements the same wireless interfaces with the sensor as the previously cleared Reader and iOS app. Therefore, no additional clinical data was used in this 510(k) to support a determination of substantial equivalence for clinical performance. The original clinical performance data was established in predicate devices K193371 and K211102.
Since this 510(k) relies on the clinical performance data established in prior submissions (K193371 and K211102) and explicitly states that no new clinical performance data was generated for this specific submission (K210943) regarding the Android App, the detailed acceptance criteria and study information for clinical accuracy are not directly present within this provided text for K210943. The document focuses on non-clinical performance testing for the Android app.
However, based on the information provided regarding the non-clinical performance of the Android App within this specific 510(k) (K210943):
Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Software Verification and Validation | Results of executed protocols met the acceptance criteria, supporting that the Android App software is acceptable for its intended use. (Conducted in accordance with IEC 62304 and FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," May 11, 2005.) |
| Human Factors | Results demonstrated that the System met usability requirements. (Conducted in accordance with ANSI/AAMI/IEC 62366, IEC 60601-1-6, and FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices," dated February 3, 2016.) |
| Wireless Coexistence | Test results showed the System could tolerate interference generated by tested RF interfering devices and still meet the target performance criteria. (Consistent with AAMI TIR69 and ANSI C63.27, including in-band interference sources and other expected wireless interference sources from the intended use environment.) |
| Cybersecurity | Appropriate risk mitigation controls have been implemented and tested. (Risk management documentation includes analysis of confidentiality, integrity, and availability for data, information, and software, with risk assessment and mitigation for identified threats and vulnerabilities.) |
| Electrical Safety and Electromagnetic Compatibility (EMC) | 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.) |
Due to the nature of this 510(k) being primarily for the addition of the Android app, the following information regarding clinical performance criteria, sample sizes, expert involvement, and ground truth would have been established in the predicate device studies (K193371 and K211102) and are not detailed in this document (K210943):
- Sample size used for the test set and the data provenance: Not specified in K210943, as clinical data was referenced from predicate devices. For iCGM, clinical studies typically involve a significant number of participants (e.g., hundreds) across varied demographics to assess accuracy across the glycemic range. Data provenance would likely be from multi-center prospective clinical trials conducted in various regions.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in K210943. In iCGM clinical trials, ground truth is usually established by highly precise laboratory reference methods (e.g., YSI glucose analyzer) rather than expert consensus on device readings.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for iCGM clinical accuracy studies where the "ground truth" is typically a laboratory reference method.
- 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: Not applicable for iCGM clinical accuracy studies as described. The device provides direct glucose values, not interpretations requiring human reader assistance in the same way as imaging diagnostics. It replaces blood glucose testing for treatment decisions.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, the core accuracy of the algorithm is evaluated in a standalone manner against laboratory reference values in the predicate device studies. The FreeStyle Libre 2 System itself, including the sensor and its algorithm, performs autonomously to produce glucose readings.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For iCGM devices, the gold standard ground truth for accuracy studies is typically laboratory reference methods, such as those performed by a YSI glucose analyzer, which measures glucose concentration in blood plasma.
- The sample size for the training set: Not specified in K210943. Training data for the glucose algorithm would have been part of the original development and validation of the FreeStyle Libre 2 system (K193371 and K211102), and would involve a large, diverse dataset of sensor readings and corresponding reference glucose values.
- How the ground truth for the training set was established: Not specified in K210943. Similar to the test set, the ground truth for training would have been established using highly accurate laboratory reference methods (e.g., YSI analyzer) from blood samples collected concurrently with sensor readings.
§ 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.