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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.

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.

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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 measurement of glucose in whole blood, and is for single-patient use only and should not be shared. 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.

Contour NEXT Test Strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples from 20 to 600 mg/dL.

The Contour NEXT LINK Wireless Blood Glucose Monitoring System is intended to be used to transmit glucose values to Medtronic MiniMed Paradigm Insulin Pumps or Medtronic MiniMed Paradigm REAL-Time Revel Insulin Pumps or Medtronic MiniMed Paradigm REAL-TIME Insulin Pumps or Medtronic MiniMed 530G Insulin Pumps or Guardian REAL-TIME Monitor 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.

The Contour® NEXT LINK Wireless Blood Glucose Monitoring System consists of a blood glucose meter, dry test strips and liquid controls to be used for the measurement of glucose in capillary whole blood by persons with diabetes. The System has the same automatic calibration as the predicate device. Blood glucose results are displayed on the meter window and stored in the meter's memory. The System also contains radio frequency (RF) functions for sending BGM 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 management software.

This 510(k) summary (K122370) describes Bayer Healthcare's Contour® NEXT LINK Wireless Blood Glucose Monitoring System. The submission is to add the Medtronic MiniMed 530G insulin pump to the list of compatible devices in the Indications for Use, meaning the device itself (the blood glucose meter) remains essentially the same as the predicate (K110894).

Therefore, the performance of the updated device is considered substantially equivalent to the predicate device. The submission explicitly states: "The performance of the Contour NEXT LINK Wireless Blood Glucose Monitoring System is substantially equivalent to the performance of the previously cleared Contour NEXT LINK Wireless Blood Glucose Monitoring System (K110894)." This implies that the acceptance criteria and performance data for the predicate device are referenced.

Acceptance Criteria and Reported Device Performance:

The document refers to a PMA submission (P120010) for verification reports on the performance of the Contour NEXT Link Wireless Blood Glucose Meter with the Medtronic MiniMed 530G Insulin Pump. Without access to P120010, the specific acceptance criteria and detailed performance of the device cannot be explicitly extracted from this 510(k) summary. However, for blood glucose meters, typical acceptance criteria would involve accuracy standards (e.g., ISO 15197 for clinical accuracy) which define the permissible deviation of meter readings from laboratory reference values within certain error grids (e.g., Consensus Error Grid or Clarke Error Grid).

Given the statement of substantial equivalence, the device is expected to meet the same performance criteria as the predicate device (K110894).

Study Information (Based on the provided 510(k) summary and inferring from BGM regulatory practices):

1. Sample size used for the test set and the data provenance:

   • The 510(k) summary does not explicitly state the sample size for the test set. It refers to "VERIFICATION AND VALIDATION DATA" in PMA submission P120010.
   • Data provenance: Not specified in this 510(k) document. Typically, accuracy studies for blood glucose meters involve prospective clinical studies with human subjects.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable in the conventional sense for a blood glucose meter accuracy study. The "ground truth" for blood glucose measurements is established by a laboratory reference method (e.g., YSI 2300 STAT PLUS Glucose & Lactate Analyzer), not by expert consensus. This method is operated by trained laboratory personnel, not "experts" in the context of medical imaging or diagnosis.

3. Adjudication method for the test set:

   • Not applicable. Blood glucose meter accuracy studies compare meter readings directly against a highly accurate laboratory reference method, not against an adjudicated ground truth from multiple observers.

4. 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, a MRMC study was not done. This is a blood glucose meter, an in-vitro diagnostic device, not an AI-assisted diagnostic imaging device.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Yes, the accuracy studies for blood glucose meters fundamentally assess the standalone performance of the device (meter + test strip) against a laboratory reference. The user interaction is typically part of human factors validation, ensuring correct operation, but the core accuracy is an "algorithm only" measurement.

6. The type of ground truth used:

   • Laboratory Reference Method: For blood glucose meters, the ground truth is established by a highly accurate and precise laboratory reference instrument, such as a YSI glucose analyzer, which measures glucose concentrations in blood samples.

7. The sample size for the training set:

   • This is not relevant for a blood glucose meter in the context of this 510(k). The device uses a "Multi-pulse algorithm" which is established during the device's original development (likely for K110894) and does not typically involve additional "training sets" in the AI/machine learning sense for each submission unless the algorithm itself is being changed, which it isn't here. This submission is for compatibility with a new insulin pump, not a new algorithm.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no mention of a "training set" in the context of this 510(k) for the reasons mentioned above. The algorithm's parameters would have been set based on extensive testing and calibration during its initial development, using blood samples with known glucose concentrations verified by a laboratory reference.

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