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510(k) Data Aggregation
(172 days)
FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System
Libre 2 Sensor users:
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.
Libre 2 Plus Sensor users:
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.
Libre 3 Sensor users:
The FreeStyle Libre 3 Continuous Glucose Monitoring System is a real time continuous glucose monitoring (CGM) device with alarms capability indicated for the management of diabetes in persons age 4 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated.
The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time.
The System is also intended to autonomously communicate with digitally connected devices. The System can be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions.
Libre 3 Plus Sensor users:
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 subject FSL3 System consists of a sensor (the FreeStyle Libre 3 Sensor (FSL3 Sensor) or FreeStyle Libre 3 Plus Sensor (FSL3 Plus Sensor)) and a primary display device (the FreeStyle Libre 3 Reader (FSL3 Reader) or the FreeStyle Libre App (FSL App) [iOS and Android] downloaded to a compatible phone). The FSL3 Reader and the FSL App do not interact with each other.
The subject FSL2 System consists of a sensor (the FreeStyle Libre 2 Sensor (FSL2 Sensor) or FreeStyle Libre 2 Plus Sensor (FSL2 Plus Sensor)) and a primary display device (the FreeStyle Libre 2 Reader (FSL2 Reader) or the FSL App (iOS and Android) downloaded to a compatible phone). The FSL2 Reader and FSL 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.
This document is a 510(k) summary from Abbott Diabetes Care Inc. regarding their FreeStyle Libre 3 Continuous Glucose Monitoring System and FreeStyle Libre 2 Flash Glucose Monitoring System. It outlines the device details, indications for use, comparison to predicate devices, and a summary of performance testing.
Acceptance Criteria and Study Proving Device Meets Criteria
The provided text focuses on the substantial equivalence of the new FreeStyle Libre 2 Plus and 3 Plus sensors and updated app features to their predicate devices, rather than establishing new acceptance criteria for the entire system's glucose monitoring accuracy. The document states that clinical performance and human factors were "established in the predicate device (K223435) and are not affected by the introduction of the FSL App in this 510(k)." This implies that the glucose accuracy and user interface performance metrics (e.g., MARD, % in Zones A+B, usability outcomes) for the core glucose monitoring function were previously accepted for the predicate devices and are assumed to hold true for the current submission due to the nature of the changes being primarily related to sensor life, age ranges, and app features.
Therefore, the acceptance criteria and performance data discussed below are extrapolated from the types of performance studies conducted to demonstrate substantial equivalence for the modifications presented in this 510(k), particularly regarding safety and compatibility, and from the implied reliance on the predicate device's established clinical performance.
Please note: This response does not contain specific quantitative acceptance criteria or precise performance metrics for glucose accuracy (e.g., MARD values) as these details are explicitly referred to as having been established in the predicate device (K223435) and are not re-evaluated in this submission. The focus of this 510(k) is on the changes from the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of this 510(k) (modifications to existing systems), the presented "acceptance criteria" are derived from the tests conducted to demonstrate that the changes do not adversely affect safety and effectiveness.
| Category | Specific Test/Feature | Acceptance Criteria (Implied/Stated) | Reported Device Performance/Conclusion |
|---|---|---|---|
| Software | Software Verification and Validation | Compliant with IEC 62304 and FDA Guidance "Content of Premarket Submissions for Device Software Functions" (June 14, 2023) and "Multiple Function Device Products: Policy and Considerations" (July 29, 2020). | Results of executed protocols met the acceptance criteria and therefore support that the system software is acceptable for its intended use. |
| Cybersecurity | Cybersecurity Risk Management | Compliant with FDA guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions'' (September 27, 2023). Appropriate risk mitigation for identified threats and vulnerabilities. | Risk assessment performed, appropriate risk mitigation controls implemented and tested. |
| Bench Testing | Removal of CT/MRI Contraindications, X-ray Caution | Functionality testing acceptance criteria met for sensor performance after exposure to CT, MRI (MR conditional), and X-ray. | The test results showed all functionality testing acceptance criteria was met. (Previous mechanical, electrical, and functional testing established in the predicate device are not affected). |
| App Feature: Auto-Display (FSL2) | Automatic display of glucose results without user-initiated scan. | Functionality: Glucose data automatically displays via BLE without user scan, while NFC scan option remains. | Functionality confirmed. (Users may still perform NFC scan as an option, consistent with predicate FSL2 App behavior.) |
| App Feature: Alarms Escalation | Incremental volume increase for alarms (High, Low, Urgent Low, Signal Loss). | Volume increases incrementally over 30 seconds until maximum volume, equal to predicate device alarm volume. | Functionality confirmed: Alarms increase volume over 30 seconds to the maximum level of predicate device alarms. |
| Core Glucose Monitoring Performance | Clinical Performance (e.g., Accuracy) | Established in predicate device K223435. (No new evaluation specified in this 510(k) summary for these aspects). | Established in the predicate device (K223437) and not affected by the introduction of the FSL App in this 510(k). (This implies that the existing performance data from K223435 is deemed sufficient for these modified devices). |
| Human Factors | Usability and User Interface (new features) | Established in predicate device K223435. (No new evaluation specified in this 510(k) summary for these aspects beyond software V&V). | Established in the predicate device (K223437) and not affected by the introduction of the FSL App in this 510(k). (The app navigation change to "Bottom bar navigation menu" from "Side panel navigation", and the "App Stopped Alarm" for Android were likely part of software V&V and user acceptance testing, implied by overall software V&V acceptance). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide specific sample sizes for the detailed technical tests (Software V&V, Cybersecurity, Bench Testing for CT/MRI/X-ray). These types of tests typically involve controlled laboratory environments rather than human subject test sets in the traditional sense for clinical performance.
For the core clinical performance (glucose accuracy, etc.), the document explicitly states these characteristics were "established in the predicate device (K223435) and are not affected." Therefore, any sample size for these fundamental performance aspects would refer to those used in the studies for the predicate device, which are not detailed in this 510(k) summary.
Data Provenance: The document does not specify the country of origin for any testing data. The nature of the tests (Software V&V, Cybersecurity, Bench Testing) suggests they are likely conducted in a controlled environment, potentially in-house or by a certified testing facility. The "retrospective or prospective" nature is not specified, but these are typically prospective tests conducted as part of the development and verification process.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information (number of experts, qualifications, and ground truth establishment) is typically relevant for clinical studies involving expert adjudication (e.g., for diagnostic imaging devices). Given that the 510(k) summary indicates clinical performance was "established in the predicate device" and that the current submission primarily addresses technical and software improvements/modifications, there's no mention of a new clinical study involving multiple experts to establish ground truth for this specific submission.
For the bench testing related to CT/MRI/X-ray compatibility, ground truth would be established by physical measurements and functional checks against engineering specifications, not by human experts.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies, particularly for diagnostic accuracy where multiple human readers interpret data. As explained above, this 510(k) focuses on technical and software changes, and refers back to the predicate device for clinical performance. Therefore, no information on an adjudication method for a test set is provided or expected in this context.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done, and it is not typically relevant for a CGM device. MRMC studies are primarily conducted for diagnostic imaging devices to assess how AI assistance impacts human reader performance (e.g., radiologists interpreting scans). CGM devices provide quantitative glucose measurements, and their performance is evaluated directly against a reference method (e.g., laboratory glucose measurements), not through human reader interpretation of complex images or cases.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, for the core glucose algorithm, a standalone performance evaluation is inherent to a CGM device. The document explicitly states:
- Glucose Algorithm: "ADC Glucose Algorithm"
- Location of Glucose Algorithm: "FSL2 System: Receiver", "FSL3 System: Sensor"
This implies that the algorithm processes the sensor's raw electrical signals to calculate a glucose value and trend independently. The clinical performance of this algorithm (e.g., MARD against a reference method) would have been part of the studies for the predicate device (K223435). This 510(k) does not present new data for this, but rather relies on the predicate's established performance, stating that ADC (Abbott Diabetes Care) Glucose Algorithm is the "Same" for the subject device.
7. The Type of Ground Truth Used
For Continuous Glucose Monitoring (CGM) devices, the ground truth for establishing accuracy is typically obtained from laboratory reference methods for blood glucose concentration, such as:
- YSI analysis (Yellow Springs Instrument): This is a widely accepted laboratory reference method for measuring glucose in blood or plasma samples.
While not explicitly stated in this 510(k) summary for the ground truth method, it is the standard for CGM accuracy studies which would have been performed for the predicate device to which this submission refers for clinical performance.
8. The Sample Size for the Training Set
The document does not provide a sample size for the training set of the glucose algorithm. This information would typically be detailed in the original predicate device's submission which established the clinical performance. The current 510(k) refers to the "ADC Glucose Algorithm" as being the same as the predicate, indicating no retraining or significant algorithm changes that would necessitate reporting new training data.
9. How the Ground Truth for the Training Set was Established
Similar to the sample size, the specifics of how the ground truth was established for the training set would have been detailed in the original submission for the predicate device. For CGM algorithms, this involves comparing the sensor's raw electrical signals to paired blood glucose values obtained from a highly accurate laboratory reference method (like YSI), collected over time from a cohort of study participants under various glycemic conditions. This establishes the true glucose concentration against which the algorithm learns to convert sensor signals into accurate glucose readings.
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(150 days)
FreeStyle Libre 3 Continuous Glucose Monitoring System; 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.
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.
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(200 days)
FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous 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.
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 2 Flash Glucose Monitoring System (with modified Sensor tail), hereinafter also referred to as 'modified FSL2 System' and FreeStyle Libre 3 Continuous Glucose Monitoring System (with modified Sensor tail), hereinafter also referred to as 'modified FSL3 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 Systems also provide configurable alarms designed to warn the user of Low Glucose or Signal Loss. The user may make treatment decisions based in part on the Sensor glucose results provided by the Systems require a prescription and are intended for home use.
The FreeStyle Libre 2 System consists of the FreeStyle Libre 2 Sensor and either the FreeStyle Libre 2 Reader or the FreeStyle Libre 2 App downloaded to a compatible smartphone as a primary display device. The FreeStyle Libre 3 System consists of the FreeStyle Libre 3 Sensor and the FreeStyle Libre 3 App downloaded to a compatible smartphone as a primary display device.
Both the FreeStyle Libre 2 and FreeStyle Libre 3 Systems are compatible with the Libre Data Sharing API cleared in K223537. The display device of the connected FreeStyle Libre 2 or FreeStyle Libre 3 Systems, which directly receives the data from the Sensor, continues to serve as a primary display device for the glucose data and alarms.
The Abbott FreeStyle Libre 2 Flash Glucose Monitoring System and FreeStyle Libre 3 Continuous Glucose Monitoring System sought clearance for modified sensor tails to reduce vitamin C interference, extend sensor wear to 15 days, and enable compatibility with automated insulin dosing (AID) systems.
Here's an analysis of the acceptance criteria and supporting studies:
1. Table of Acceptance Criteria & Reported Device Performance:
The document doesn't explicitly list a table of "acceptance criteria" with specific numeric targets for device performance. Instead, it states that the devices meet the iCGM special controls for clinical performance set forth in 21 CFR 862.1355. This regulation broadly outlines requirements for accuracy, reliability, and safety of integrated Continuous Glucose Monitoring systems.
However, based on the provided text, we can infer some key performance objectives and the reported outcome:
| Acceptance Criteria (Inferred from Changes & Regulations) | Reported Device Performance |
|---|---|
| Accuracy across measuring range (15-day wear) | The clinical study demonstrated that the subject devices meet the iCGM special controls for clinical performance. Specific accuracy metrics (e.g., MARD) are not provided in this summary but would be part of the full submission. |
| Reduced Vitamin C Interference | An additional clinical study evaluated the effects of high doses of vitamin C, and the results showed the devices met iCGM special controls. Labeling was updated to reflect Vitamin C interference at doses >1000 mg/day (improved from >500 mg/day for the predicate). |
| Extended Sensor Wear Duration (from 14 to 15 days) | The subject devices (modified FreeStyle Libre 2 and 3 Sensors) are designed for a 15-day wear duration, and performance was evaluated throughout this duration in the clinical study. |
| Compatibility with Automated Insulin Dosing (AID) systems | Interoperability testing and an interoperability communication plan were provided to ensure secure and reliable data transfer with digitally connected devices, including AID systems. |
| Software Functionality and Safety | Software regression testing was conducted in accordance with established specifications and IEC 62304. Results met acceptance criteria. |
| Non-clinical Performance | Non-clinical performance testing was conducted as per internal design control process requirements, and results met acceptance criteria. |
| Known Performance of Unaffected Aspects | Sterilization, biocompatibility, shelf life stability, packaging integrity/shipping integrity, mechanical engineering, electrical safety and electromagnetic compatibility, and human factors were established in predicate/reference devices and are not affected. Cybersecurity for FSL3 also relies on existing data. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The clinical study evaluated performance in adult (18 years and older) and pediatric (2 to 17 years) participants with diabetes. Specific numbers of participants within these age groups are not provided in this summary.
- Data Provenance: The document does not specify the country of origin. It indicates the studies were clinical studies, implying a prospective nature.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document mentions that the clinical study evaluated performance with respect to reference venous plasma sample YSI measurements.
- Ground Truth Providers: YSI measurements are obtained from laboratory instruments, which are considered the gold standard for glucose measurement. The "experts" involved would be trained lab technicians and medical professionals responsible for collecting and processing blood samples and operating the YSI instrumentation.
- Qualifications: Not explicitly stated, but they would be certified laboratory personnel and healthcare providers responsible for patient care and sample collection within a clinical study setting.
4. Adjudication Method for the Test Set:
Not applicable. The ground truth was established by YSI laboratory measurements, not subjective expert review or adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A Human-in-the-loop or MRMC study is not applicable for this device type (Continuous Glucose Monitoring System). The device provides continuous glucose values, and its performance is assessed against a laboratory reference, not human interpretation of images or other data that would involve multiple readers.
6. Standalone Performance:
Yes, the studies described are primarily focused on the standalone performance of the algorithm (as embedded in the device) in measuring glucose levels against a reference method (YSI venous plasma samples). The "clinical study" directly assesses how well the device's sensor and algorithm perform without direct human intervention in the glucose reading process itself, other than the placement and use of the device by participants.
7. Type of Ground Truth Used:
The ground truth used was venous plasma sample YSI measurements. This is a highly accurate and accepted laboratory reference method for glucose concentration.
8. Sample Size for the Training Set:
The document does not specify the sample size for the training set used for the device's glucose algorithm. It mentions that the "ADC Glucose Algorithm established for the predicate device" is used, implying that the core algorithm was developed and trained previously, and this submission focuses on modifications and re-validation.
9. How the Ground Truth for the Training Set Was Established:
The document does not specify how the ground truth for the training set of the ADC Glucose Algorithm was established. However, given that the clinical performance evaluation uses venous plasma YSI measurements as ground truth, it is highly probable that similar high-accuracy reference methods would have been employed during the development and training of the original algorithm.
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(322 days)
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 4 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated.
The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time.
The System is also intended to autonomously communicate with digitally connected devices. The System can be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions.
The FreeStyle Libre 3 Continuous Glucose Monitoring System (herein referred to as the 'FreeStyle Libre 3 System' or 'System') is an integrated continuous glucose monitoring system (iCGM) that provides real time continuous glucose measurements every minute to provide glucose levels, trends, and alarms. The System requires a prescription and is intended for home use. The System consists of the following components: a Sensor which transmits via Bluetooth Low Energy (BLE), and a mobile application, FreeStyle Libre 3 App, downloaded to a compatible smartphone running iOS operating system. The FreeStyle Libre 3 System provides the user with real-time glucose measurements (glucose values) accompanied by trend information (glucose arrows) and historical glucose information (glucose graph). The user may make treatment decisions based in part on the Sensor glucose results provided by the System. The System also provides fixed and configurable alarms designed to warn the user of Low Glucose, High Glucose, or Signal Loss.
Here's a breakdown of the acceptance criteria and study information for the FreeStyle Libre 3 Continuous Glucose Monitoring System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't provide a specific table of numerical acceptance criteria for clinical performance (like MARD values with defined thresholds). Instead, it states that the device "met the iCGM special controls requirements per 21 CFR 862.1355." However, it does list several performance characteristics that were "confirmed to support substantial equivalence," implying that specific acceptance criteria were met for each. Without the actual criteria for each, here's a general table based on the information provided:
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Sterility | Sterility Assurance Level (SAL) of 10^-6 | Achieved SAL of 10^-6 with minimum sterilization dose of 25 kGy (established by VDmax25 method described in ISO 11137-2). |
| Shelf-Life & Packaging | Seal integrity, user accessibility, and device functionality met | Attributes related to seal integrity, user accessibility, & device functionality (including sterile barrier system integrity) met acceptance criteria after subjecting units to worst-case sealing, sterilization, shipping, storage, handling, and transit challenges. |
| Electrical Safety | Compliance to IEC 60601-1, IEC 60601-1-6, IEC 60601-1-11 | Demonstrated compliance to IEC 60601-1: 2005(r)2012, IEC 60601-1-6:2010+A1:2013, and IEC 60601-1-11:2015. |
| Electromagnetic | Withstand EMI and emissions (IEC 60601-1-2, CISPR 11) | Verified system withstands EMI and emissions in compliance with IEC 60601-1-2 and IEC CISPR 11. Wireless coexistence testing confirmed functionality within acceptable limits in presence of common radiating electronic devices (FDA Guidance, AAMI TIR69, ANSI C63.27). Complied with FCC Part 15.225, Part 15.247, and FAA Advisory Circular RTCA DO-160. |
| Mechanical Engineering | Mechanical, electrical, and functional testing met | Test results showed mechanical, electrical, and functional testing all met acceptance criteria at system and component level. |
| Biocompatibility | Compliance with ISO 10993-1 and FDA Guidance | Evaluation and testing performed in accordance with ISO10993-1 and FDA Guidance. |
| Software V&V | Met established specifications and IEC 62304 | Results of executed protocols met acceptance criteria, supporting the System's embedded software is acceptable for intended use (in accordance with IEC 62304 and FDA Guidance). |
| Cybersecurity | Analysis of confidentiality, integrity, availability, risk mgmt. | Provided cybersecurity risk management documentation (analysis of confidentiality, integrity, availability for data, info, & software per FDA Draft Guidance). Risk assessment performed for identified threats/vulnerabilities, and appropriate risk mitigation controls implemented/tested. |
| Clinical performance | Met iCGM special controls requirements per 21 CFR 862.1355 | A bridging clinical study demonstrated comparability of performance to the predicate FreeStyle Libre 2 System, and the combined System accuracy of the FreeStyle Libre 3 and FreeStyle Libre 2 System met the iCGM special controls. |
| Human Factors | Met usability requirements for intended use (ANSI/AAMI/IEC 62366) | Risk analysis of design and user interface (in accordance with ANSI/AAMI/IEC 62366, IEC 60601-1-6, and FDA Guidance) demonstrated design changes met usability requirements. |
| Interoperability | Alignment with FDA Guidance "Design Considerations..." | Incorporated an approach for interoperability developed in alignment with FDA Guidance. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions "a bridging clinical study" but does not explicitly state the number of subjects or data points used in this study.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). The phrasing "bridging clinical study" generally implies a prospective study designed to bridge results from a previous study or device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For glucose monitoring systems, ground truth is typically established using a highly accurate reference method (e.g., YSI glucose analyzer) rather than expert consensus on images.
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
- No MRMC study was mentioned. The FreeStyle Libre 3 is a Continuous Glucose Monitoring (CGM) system, which provides direct glucose readings to the user, not an AI system that assists human "readers" in interpreting diagnostic images or data where MRMC studies are typically performed. The device is intended to replace blood glucose testing for treatment decisions, not to aid human interpretation of complex medical cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, a standalone performance assessment was done. The document states, "The subject device calculates glucose information identically to the predicate device, and the combined System accuracy of the FreeStyle Libre 3 System and FreeStyle Libre 2 System met the iCGM special controls requirements per 21 CFR 862.1355." This refers to the accuracy of the algorithm itself in determining glucose values from the sensor data. The "clinical performance" testing directly assesses the device's accuracy without human intervention influencing the glucose measurement.
7. The Type of Ground Truth Used
- Reference Glucose Methods: While not explicitly named, for CGM devices, the standard ground truth for clinical accuracy studies is typically venous blood samples analyzed by a laboratory reference method, such as a YSI glucose analyzer. The document states accuracy was demonstrated, which implies comparison to such a reference.
8. The Sample Size for the Training Set
- Not provided. The document describes a "bridging clinical study" for performance validation but does not detail the size of any training sets used for algorithm development. It does state that the "Sensor Glucose Algorithm established for the predicate device" is the same, implying the algorithm's core might have been trained previously for the FreeStyle Libre 2.
9. How the Ground Truth for the Training Set was Established
- Not provided. Given that the subject device uses the "ADC Glucose Algorithm established for the predicate device," the ground truth establishment for any original training would have likely involved comparisons to laboratory reference glucose measurements in clinical studies. However, details of such a training process or ground truth for a training set are not in this document.
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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 4 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated.
The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time.
The System is also intended to autonomously communicate with digitally connected devices. The System can be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions.
The FreeStyle Libre 3 Continuous Glucose Monitoring System (herein referred to as the 'FreeStyle Libre 3 System' or 'System') is an integrated continuous glucose monitoring system (iCGM) that provides real time continuous glucose measurements every minute to provide glucose levels, trends, and alarms. The System requires a prescription and is intended for home use. The System consists of the following components: a Sensor which transmits via Bluetooth Low Energy (BLE), and a mobile application, FreeStyle Libre 3 App, downloaded to a compatible smartphone running on Android operating system. The FreeStyle Libre 3 System provides the user with real-time glucose measurements (glucose values) accompanied by trend information (glucose arrows) and historical glucose information (glucose graph). The user may make treatment decisions based in part on the Sensor glucose results provided by the System. The System also provides fixed and configurable alarms designed to warn the user of Low Glucose, High Glucose, or Signal Loss.
The document details the FreeStyle Libre 3 Continuous Glucose Monitoring System and its performance testing to support substantial equivalence to its predicate device, the FreeStyle Libre 2 Flash Glucose Monitoring System.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that a bridging clinical study was conducted, and the "combined System accuracy of the FreeStyle Libre 3 System and FreeStyle Libre 2 System met the iCGM special controls requirements per 21 CFR 862.1355." However, specific numerical acceptance criteria (e.g., MARD percentage, accuracy at different glucose ranges) and the exact reported performance of the FreeStyle Libre 3 System are not explicitly listed in a detailed table within the provided text segments. Instead, a general statement of meeting the iCGM special controls is given.
To fill this, we must infer that the implicit acceptance criteria are those defined by the iCGM special controls (21 CFR 862.1355) for integrated continuous glucose monitoring systems. These typically include accuracy metrics like MARD (Mean Absolute Relative Difference) against a reference method, as well as performance across different glucose ranges (hypoglycemic, euglycemic, hyperglycemic). Without the actual study report, we cannot provide specific numbers for the FreeStyle Libre 3's performance or exact acceptance criteria.
General Interpretation of iCGM Special Controls (Implicit Acceptance Criteria):
iCGM special controls generally require demonstration of:
- Accuracy: Sufficient accuracy across the glucose range (e.g., MARD values below a certain threshold when compared to a laboratory reference).
- Safety: Acceptable safety profile with minimal adverse events.
- Performance in various conditions: Performance evaluated across different patient populations, wear sites, and duration of use.
- Alarm performance: Accuracy and reliability of hypoglycemia and hyperglycemia alarms.
- Interoperability: Functionality with digitally connected devices.
2. Sample Size Used for the Test Set and Data Provenance
The document states: "ADC conducted a bridging clinical study to demonstrate comparability of the performance of the FreeStyle Libre 3 System to the predicate FreeStyle Libre 2 System, cleared under K210943."
- Sample Size for Test Set: Not explicitly stated in the provided text.
- Data Provenance: Not explicitly stated in the provided text (e.g., country of origin, retrospective or prospective). It is implied to be prospective as it's a clinical study for FDA clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the text. For CGM devices, the "ground truth" (reference glucose values) is typically established using a highly accurate laboratory reference method (e.g., YSI glucose analyzer) on blood samples, not expert consensus interpreting images or clinical cases. Therefore, the concept of "experts establishing ground truth" in the way it applies to image interpretation is not directly applicable here. The ground truth would be the laboratory-measured glucose values.
4. Adjudication Method for the Test Set
The concept of an "adjudication method" (like 2+1 or 3+1) is primarily relevant for studies where multiple human readers interpret data (e.g., radiology images) and a consensus or tie-breaking mechanism is needed for the ground truth. For a CGM device, the ground truth is established by a quantitative, objective measurement (laboratory blood glucose). Therefore, an adjudication method in this context is not applicable/not mentioned as it's not a reader study.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The FreeStyle Libre 3 is a standalone device that measures glucose; it does not involve human readers interpreting its output in a diagnostic context that would warrant an MRMC study. The "comparative effectiveness" mentioned refers to its performance against a predicate device and standard laboratory methods, not a comparison of human reader performance with and without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, a standalone study was done. The entire premise of the submission is to demonstrate the performance of the FreeStyle Libre 3 System as a standalone integrated continuous glucose monitoring device. The bridging clinical study, designed to show "comparability of the performance of the FreeStyle Libre 3 System to the predicate FreeStyle Libre 2 System," inherently evaluates the algorithm's performance without direct human intervention in the glucose measurement and calculation process. The FreeStyle Libre 3 delivers "real-time continuous glucose measurements every minute" and its "System accuracy" was evaluated.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for a CGM device is typically a highly accurate laboratory reference method (e.g., YSI glucose analyzer) performed on venous blood samples taken concurrently with the CGM readings. While not explicitly stated, this is the standard for CGM accuracy studies.
8. The Sample Size for the Training Set
The document mentions that the "Sensor Glucose Algorithm established for the predicate device" is the same for the FreeStyle Libre 3. It also states that the FreeStyle Libre 3 contains a "software algorithm for conversion of the raw glucose measurements from the Sensor to calculate glucose results." This implies the algorithm was developed and trained prior to this submission, likely using data from previous FreeStyle Libre sensor generations.
The sample size for the training set is not provided in this document.
9. How the Ground Truth for the Training Set was Established
Given that the "Sensor Glucose Algorithm" is the same as the predicate device, it can be inferred that the ground truth for training this algorithm was established similarly to the predicate device's clearance. This would typically involve pairing sensor readings with laboratory reference blood glucose measurements (e.g., YSI) taken from human subjects during previous clinical studies. The specific details of how this ground truth was established for the training set are not provided in the given text.
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