(143 days)
The CONTOUR®NEXT EZ blood glucose monitoring system is an over the counter (OTC) device utilized for self-testing by persons with diabetes at home for the quantitative measurement of glucose in whole blood, is for single-patient use only, and should not be shared.
The system is intended for self testing outside the body (in vitro diagnostic use) and is to monitor the effectiveness of diabetes control. The CONTOUR® NEXT EZ blood glucose monitoring system is indicated for use with fresh fingertip capillary whole blood samples.
The CONTOUR® NEXT EZ blood glucose monitoring system is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.
The CONTOUR® NEXT test strips are for use with the CONTOUR® NEXT EZ blood glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
The Contour Next EZ Blood Glucose Meter consists of a small handheld blood glucose meter that utilizes dry reagent test strips for the measurement of glucose in capillary whole blood by persons with diabetes. Liquid control solution is used to check the performance of the system. The meter, together with the test strips and control solutions, is referred to as the Contour Next EZ Blood Glucose Monitoring System.
The chemical principle utilized for both the predicate and modified devices is based on measurement of electrical current caused by the reaction of glucose in the blood with chemicals on the reagent strip. The blood sample is drawn into the tip of the reagent strip through capillary action. Glucose in the sample reacts with FAD glucose dehydrogenase (FAD-GDH) enzyme on the reagent strip. The electrons generated by this reaction are shuttled to an electrode by a mediator chemical, producing a current that is proportional to the glucose in the sample. After a fixed reaction time, the glucose concentration in the sample is calculated and displayed.
The provided text describes modifications made to the Contour Next EZ Blood Glucose Monitoring System (K162336) compared to its predicate device (K130265). It outlines the new features and the testing conducted to demonstrate substantial equivalence, but it does not explicitly state specific acceptance criteria or provide detailed study results in numerical form. It describes the type of studies performed and what they aimed to confirm.
However, based on the information provided, I can infer the general acceptance criteria and describe the studies conducted.
Here's an analysis structured around your request:
Acceptance Criteria and Device Performance for Contour Next EZ Blood Glucose Monitoring System (K162336)
The documentation provided focuses on demonstrating substantial equivalence of the modified device (K162336) to its predicate (K130265) by highlighting improved error detection capabilities and confirming that fundamental performance remains unchanged. While explicit numerical acceptance criteria are not detailed, the underlying goal for a blood glucose monitoring system is generally accuracy and reliability, particularly in identifying and preventing erroneous results.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (Inferred) | Reported Device Performance (From Text) |
|---|---|
| Error Detection: Exposed Test Strips | Meets Criteria: The modified meter improved detection of test strips exposed to a chemical that can degrade the mediator and provides an error message instead of a high-biased result. Bench testing confirmed the error check acted as intended for test strips exposed to a reducing agent. |
| Error Detection: Un-mixed Control Solution | Meets Criteria: The modified meter improved detection of un-mixed control test solutions and provides an error message instead of a high-biased result. Bench testing confirmed the error check acted as intended for un-mixed control test solution. Control testing specifically ensured that adequately mixed control solution did not generate error codes. |
| Error Detection: Sample Perturbation During Test | Meets Criteria: The modified meter improved detection of a sample disturbed during the countdown period and provides an error message instead of a biased result. Bench testing confirmed the error check acted as intended for samples disturbed during the test countdown. |
| Equivalency to Predicate (Fundamental Performance) | Meets Criteria: Equivalency testing was conducted to ensure the performance of the modified and predicate meters was not statistically different. The document explicitly states the modified and predicate devices use the same glucose calculation algorithm, same test strips, and same control solutions, and are "substantially equivalent in its intended use, performance, safety and effectiveness." |
| Software Functionality (No False Positives for Errors) | Meets Criteria: Software verification testing was conducted to ensure that no "good results" were classified as errors as a result of the modifications. |
| Data Download Capabilities (Communication Protocol Changes) | Meets Criteria: Improved data download capabilities were added (e.g., max BG records, total BG records, ability to get single or sets of records, ability to set BGTOTAL to zero for internal testing). The risk assessment summary indicates "The communication changes do not have any impact on the user interface or customer blood glucose test results." |
| General performance characteristics (Measuring Range, Sample Volume, HCT Range, etc.) (Implicitly, to be equivalent to predicate specifications) | Meets Criteria: All these characteristics are listed as "Same as Predicate." |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not specify numerical sample sizes for any of the test sets (bench testing, equivalency testing, software verification, control testing).
The data provenance is not explicitly stated (e.g., country of origin). Given the FDA submission, it is assumed to be from studies conducted under US regulatory standards, though the specific location of the study subjects or samples is not mentioned. The studies appear to be prospective insofar as they were designed specifically to evaluate the modifications before market clearance.
3. Number of Experts and Qualifications for Ground Truth
The document does not provide any information regarding the use of experts, their number, or qualifications for establishing ground truth. The nature of the device (blood glucose monitor) generally relies on laboratory reference methods (e.g., YSI glucose analyzer) for ground truth, rather than expert interpretation of images or clinical data.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method (e.g., 2+1, 3+1). This is typical for objective diagnostic devices like blood glucose monitors where results are compared directly against a reference method, rather than subjective interpretations needing consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done or mentioned. This type of study is not applicable to a blood glucose monitoring system, which provides objective numerical results and does not involve human readers interpreting cases (like radiology or pathology). The assessment is about the device's accuracy compared to a reference standard or its predicate.
6. Standalone (Algorithm Only) Performance
The studies described, particularly "Equivalency testing" and "Control testing," assess the device's performance directly, implying a standalone performance assessment. The device's modifications are primarily related to error detection algorithms and communication protocols, which are inherent to the algorithm and system's standalone operation. The comparison is between the modified device and the predicate device's performance, which itself is a standalone measurement.
7. Type of Ground Truth Used
While not explicitly named, the ground truth for blood glucose monitoring systems like this is typically established using laboratory reference methods, such as a YSI glucose analyzer, which are considered highly accurate. The phrase "equivalency testing was conducted to ensure the performance of the modified and predicate meters was not statistically different" implies comparison against a reliable standard.
8. Sample Size for the Training Set
The document does not provide any information about a specific "training set" or its sample size. For an electrochemical blood glucose meter, the "training" (calibration) is typically done during manufacturing using known glucose concentrations and the system's inherent design, rather than a machine learning training set in the conventional sense. The "Contour Next Test Strips are for use with the Contour Next EZ blood glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips," indicating that the system is pre-calibrated to the strips.
9. How Ground Truth for the Training Set Was Established
As no specific "training set" in the machine learning sense is described, the method for establishing its ground truth is not applicable or mentioned. The device operates based on a determined chemical reaction and electrical current measurement, where the relationship between current and glucose concentration is established through engineering and chemical principles, likely validated against laboratory reference methods during the device's development and manufacturing calibration process.
§ 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.