(262 days)
The FreeStyle Lite Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger, upper arm and palm; and venous blood. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates or arterial blood.
The FreeStyle Freedom Lite Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger, upper arm and palm; and venous blood. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates or arterial blood.
A chemistry change has been made to the FreeStyle Lite Blood Glucose Test Strip. The modified strip is to be marketed under the brand name. FreeStyle Lite, and is intended for use with the following Blood Glucose Monitoring Systems: FreeStyle Lite Blood Glucose Monitoring System, FreeStyle Freedom Lite Blood Glucose Monitoring System. The meters and other system components contained within these systems have not been modified. Each of the aforementioned blood glucose monitoring systems are comprised of a handheld glucose meter, glucose reagent test strips, a quality control solution, a lancing device, lancets, lancing cap, and labeling for performing a blood glucose test. The intended uses and principles of operation for each of the systems remains the same as previously submitted and cleared for market entry. The systems utilize coulometric biosensor technology to quantitatively measure glucose concentration in whole blood samples. The systems are intended for selfmonitoring of glucose in capillary and venous whole blood. The primary users are persons with diabetes. The systems are meant to aid in diabetes management and for healthcare professionals to aid in monitoring the effectiveness of diabetes control program. The FreeStyle Lite Blood Glucose Test Strip is an electrochemical biosensor that fits into a handheld meter. The blood sample volume is approximately 0.3 microliters (300 nanoliters), which can be obtained from the finger, upper arm, or palm. Test results display in accordance with the blood glucose meter's software algorithm (approximately 5 seconds). The internal volume of the test strip is precisely controlled, and a blood glucose result will not be displayed on the meter unless the internal sample chamber is filled. Once the measurement begins, the glucose is rapidly oxidized by the reagents that are present in the inside of the sample chamber. The electrochemical signal that results from this process depends only on the total amount of glucose present. The reagent chemistry enables electrolysis of glucose in the blood sample. A mediator molecule shuttles electrons rapidly between a glucose-oxidizing enzyme and the working electrode on the strip. The mediator is capable of reacting rapidly with both the electrode and the enzyme, resulting in a rapid reaction time and minimizing the total amount of mediator required. The small mediator load results in high accuracy at the low end of the glucose measurement range.
The provided text describes a 510(k) summary for the FreeStyle Lite Blood Glucose Test Strips, which are part of the FreeStyle Lite and FreeStyle Freedom Lite Blood Glucose Monitoring Systems. The submission is for modifications to the test strip chemistry, materials, appearance, and meter turn-on bar.
Here's an analysis of the requested information based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a tabulated format or provide a direct comparison to "reported device performance." Instead, it describes modifications to existing, cleared devices and indicates that the "intended uses and principles of operation for each of the systems remains the same as previously submitted and cleared for market entry." This implies that the new strips are expected to meet the performance standards of the previously cleared systems.
However, the text indicates the reason for modification and implicitly, the performance benefit:
| Category | Original System Chemistry | Modified System Chemistry (Expected Benefit) |
|---|---|---|
| Chemistry | GDH-PQQ with nPBI mediator | GDH-FAD with MAP mediator |
| Interference | Susceptible to interference from carbohydrates (maltose, lactose, galactose) with GDH-PQQ | Does not show interference in the presence of carbohydrates such as maltose, lactose, and galactose with GDH-FAD (Improved accuracy/reliability in patients consuming these carbohydrates) |
Note: The document does not provide quantitative performance data (e.g., accuracy percentages, bias, precision) for either the original or modified device in this summary. It focuses on the change and its expected benefits regarding carbohydrate interference.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not contain information about the sample size used for any test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data).
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
The provided text does not contain information about the number of experts used to establish ground truth or their qualifications. This type of information is typically associated with studies involving diagnostic image interpretation or complex clinical assessments, not typically for glucose monitor performance data as described here.
4. Adjudication Method for the Test Set
The provided text does not contain information about any adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided text does not describe a multi-reader multi-case (MRMC) comparative effectiveness study. This type of study is more relevant to diagnostic imaging interpretation by human readers.
6. Standalone (Algorithm Only) Performance Study
The text describes an electrochemical biosensor system. The "algorithm" here refers to the software within the meter that interprets the electrochemical signal to display a glucose reading. The entire system (strip + meter) is designed for direct measurement. The text states: "Test results display in accordance with the blood glucose meter's software algorithm (approximately 5 seconds)." While the meter processes the signal algorithmically, the concept of a "standalone algorithm" performance, separate from the physical measurement, isn't directly applicable in the same way it would be for an AI diagnostic imaging algorithm. The performance of the device (strip + meter) is what would be evaluated. The provided text does not present a standalone performance study with specific metrics.
7. Type of Ground Truth Used
The ground truth for blood glucose monitoring systems like this would typically be established by a reference method (e.g., laboratory-grade glucose analyzer, YSI 2300 STAT Plus Glucose & Lactate Analyzer) measuring the glucose concentration in the same blood sample. The provided text does not explicitly state the type of ground truth used, but this is the standard for glucose meter validation.
8. Sample Size for the Training Set
The provided text does not mention a "training set" or its sample size. For traditional medical devices like blood glucose monitors, there isn't typically a "training set" in the machine learning sense. Performance is generally validated through clinical studies and laboratory testing.
9. How Ground Truth for the Training Set Was Established
As there is no mention of a "training set" in the machine learning context, the provided text does not describe how ground truth for a training set was established.
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.