(129 days)
The Contour Next blood glucose monitoring system is an over-the-counter (OTC) device utilized by persons with diabetes in home settings for the quantitative measurement of glucose in whole blood, and 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 be used as an aid to monitor the effectiveness of diabetes control.
The Contour Next blood glucose monitoring system is indicated for use with fresh capillary whole blood samples drawn from the fingertip and palm only. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly).
The system consists of a Contour Next blood glucose meter. Contour Next control solutions.
Contour Next test strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples.
The Contour Next blood glucose monitoring system is not intended for the diagnosis or screening for diabetes mellitus and is not intended for use on neonates.
The Contour Next Link Wireless Blood Glucose Monitoring System is an over the counter (OTC) device utilized by persons with diabetes in home settings for the quantitative measurement of glucose in whole blood, and is for singlepatient use only and should not be shared. The System is intended for self-testing outside the body (in vitro diagnostic use) and is to be used as an aid to monitor the effectiveness of diabetes control.
The Contour Next Link Wireless Blood Glucose Monitoring System is indicated for use with fresh capillary whole blood samples drawn from the fingertip and palm only. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly).
Contour Next Test Strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples.
The Contour Next Link Wireless Blood Glucose Monitoring System is intended to transmit glucose values to Medtronic MiniMed Paradigm Insulin Pumps or Medtronic MiniMed Paradigm REAL-Time Revel Insulin Pumps or Medtronic MiniMed 530G Insulin Pumps and facilitate transfer of information to Medtronic MiniMed Carelink Therapy Management Software through use of radio frequency communication.
The Contour Next Link Wireless Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.
Contour Next Link Wireless Blood Glucose Meter:
The Contour Next Link Wireless 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 Link Wireless Blood Glucose Monitoring System.
The System also contains radio frequency (RF) functions for sending blood glucose results to compatible Medtronic MiniMed insulin pumps. The RF function can also serve as a pass through for data being transmitted from Medtronic MiniMed insulin pumps to Medtronic's MiniMed PC-based data manaqement software.
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 qlucose 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.
Contour Next Blood Glucose Meter:
The Contour Next 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 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 qlucose 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.
Ascensia Diabetes Care US Inc. developed the Contour Next Link Wireless Blood Glucose Monitoring System and Contour Next Blood Glucose Monitoring System. The acceptance criteria and supporting studies are described below:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with numerical targets. However, based on the provided information, the acceptance criteria implicitly involve the proper functioning of new error detection features and comparable performance to predicate devices. The reported device performance indicates that these criteria were met.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Improved detection of test strips exposed to degrading chemicals. | The error check improves the ability of the modified meter to detect exposed test strips and provide an error message instead of a high biased result. |
| Improved detection of un-mixed control solution. | The error check improves the ability of the modified meter to detect un-mixed control test solutions and provide an error message instead of a high biased result. |
| Improved detection of sample 'perturbation' during a test. | The error check improves the ability of the modified meter to detect a sample that is disturbed during the countdown period and provide an error message instead of a biased result. |
| Software verification: No good results classified as errors due to modifications. | Software verification testing was conducted to ensure that no good results were classified as errors as a result of the modifications. |
| Equivalency testing: Performance not statistically different from predicate devices. | Equivalency testing was conducted to ensure the performance of the modified and predicate meters was not statistically different. |
| Internal user study: Blood glucose result accuracy not impacted by modifications (Contour Next Link Wireless). | An internal user study was conducted to ensure the modifications did not impact the blood glucose result accuracy of the Contour Next Link Wireless system. |
2. Sample Size Used for the Test Set and Data Provenance
The document indicates that studies were performed, but does not specify the sample sizes used for the test sets in any of the described performance evaluations (bench testing, software verification, equivalency testing, internal user study).
The data provenance is not explicitly stated regarding country of origin or whether the data was retrospective or prospective. It can be inferred that the internal user study and bench testing were prospective studies conducted by Ascensia Diabetes Care US Inc., likely within the US, given the FDA submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the test sets. For blood glucose monitoring systems, ground truth is typically established using a laboratory reference method (e.g., YSI analyzer) rather than expert consensus on subjective interpretation.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set. Given the nature of blood glucose measurement, where accuracy is assessed against a laboratory reference standard, a traditional adjudication method for subjective interpretations (like 2+1 or 3+1) would not be applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The document describes an "internal user study" for the Contour Next Link Wireless system to ensure accuracy, but this is distinct from an MRMC study comparing human readers with and without AI assistance. The device is a standalone blood glucose meter and does not involve AI assistance for human readers in interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The primary evaluations described are effectively standalone performance studies of the device's algorithm and hardware. Bench testing, software verification testing, and equivalency testing assess the device's inherent performance characteristics, including the new error detection algorithms ("improved detection"). The "internal user study" assesses accuracy when used by individuals, but the core performance criteria focus on the device's ability to accurately measure glucose and detect errors independently.
7. Type of Ground Truth Used
The ground truth used for such blood glucose monitoring systems is typically established using a laboratory reference method, such as a YSI glucose analyzer, which provides a highly accurate and precise measurement of glucose concentration. While not explicitly stated, this is the standard practice for validating blood glucose meters. The document mentions "blood glucose result accuracy," reinforcing the use of an objective, high-precision reference.
8. Sample Size for the Training Set
The document does not specify the sample size for any training set. As the device involves improvements to existing algorithms (e.g., error detection), it's possible that data was used for refining these algorithms, but no details are provided about this "training" data.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how ground truth for any potential 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.