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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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