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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 measurement of glucose in whole blood, and is for single-patient use only and should not be shared. The CONTOUR®NEXT 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 Control Solutions are aqueous glucose solutions intended for use in self-testing by people with diabetes as a quality control check.

The CONTOUR®NEXT 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 Blood Glucose Monitoring System consists of a small handheld blood glucose meter that utilizes dry reagent test strips and liquid controls for the measurement of glucose in capillary whole blood by persons with diabetes. The meter together with the test strips and control solutions is referred to as the CONTOUR® NEXT Blood Glucose Monitoring System.

The CONTOUR® NEXT Blood Glucose Monitoring System underwent various verification and validation activities to demonstrate its substantial equivalence to the predicate device. Details regarding acceptance criteria and study results are provided below based on the information extracted:

Acceptance Criteria and Device Performance

• Meter shall not experience permanent damage or present hazard such as excessive temperature or heat due to overvoltage. | - All blood glucose tests attempted while connected to PC generated "Do not Test, Connected" error screen.
• All results maintained correct voltage regulation within limits and did not present temperature hazard near or above the specified limit. |
  | Biocontamination – exposure to blood-borne pathogens via device | - Must meet requirements set forth in IEC 61010-1:2001 (2nd Edition).
• No residual blood or control solution to be observed on any of the meters after cleaning.
• No virus must be detected on any surface after 60s of cleaning with specified wipes. | - Compliance with IEC 61010-1:2001 requirements confirmed via testing by an external lab.
• There was no residual blood or control solution observed on any of the meters after soiling and cleaning.
• The specified disinfectant passed the virus elimination effectiveness test for all tested meter device surfaces. |
  | Material degradation due to cleaning and disinfection | - Plastic parts were not to exhibit any cracking, glazing, discoloration or expansion after being exposed to cleaning agents.
• Metallic parts were to exhibit little or no corrosion (evaluated as low, medium, or high). | - All results for plastic and metallic parts met the specified criteria for each solution tested. |
  | Choking/toxicity dangers from small parts (batteries) | - Reagent insert shall warn users of accidental swallowing of test strip.
• User Guide shall warn users of accidental swallowing of assembly components.
• Assembly components are not required to be unscrewed for any reason.
• Design will utilize a non-ordinary screw and require uncommon tools to remove. | - Test strip insert already warns against swallowing test strips.
• System User Guide warns: "Keep out of reach of children. This kit contains small parts which could cause suffocation if accidentally swallowed." and "Keep batteries away from children. Lithium batteries are poisonous. If swallowed, immediately contact your poison..."
• Device designed so that no hazardous assembly parts are easily accessible to user. |
  | Meter malfunction - incorrect reading or does not function properly | - The accuracy of the test strip driving voltage of the Analog Front End at operating temperature range shall be assessed under various test temperatures.
• The CONTOUR®NEXT meter data port shall withstand multiple cycles (insertions/removals).
• The meter shall perform an electronics self test to verify proper function of the meter electronics. | - All results for each test temperature were within the required mV range set forth in the testing.
• All results for the meter data port were within the specified limits after multiple test strip insertion/removal cycles.
• All software test conditions in validation testing passed acceptance criteria. |
  | Erroneous data transfer from meter to PC | - The CONTOUR®NEXT meter's computer interface shall detect and correct communication errors. | - All software test conditions in validation testing passed acceptance criteria. |
  | User unable to properly use meter or follow its instructions for use | - Product labeling for proper instrument operation shall be validated through customer focus study (summative usability study) for 2 critical tasks: 1) completing initial setup and 2) running a mock blood glucose test and marking the result. | - Completing initial setup task was successful.
• Study subjects successfully completed a mock blood glucose test and marked the reading. |
  | User misinterprets meter readings | - Product labeling for proper instrument operation shall be validated through customer focus study (summative usability study) for 2 critical tasks: 1) completing initial setup and 2) running a mock blood glucose test and marking the result. | - Completing initial setup task was successful.
• Study subjects successfully completed a mock blood glucose test and marked the reading. |
  | User mishandles meter (i.e., drops meter, spills liquid on meter) | - Meter must be designed to withstand drop and show no signs of damage to any components.
• Meter must also be designed to withstand Spill Test after exposure to various test solutions. | - All results withstood the stated Drop test and Spill challenges. |

Study Details

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

   • Biocontamination: "One set of meters were soiled with CONTOUR®NEXT liquid control and another set of meters were soiled with 5 uL of venous blood." "Test meters received contact with an EPA-approved surrogate for a human virus for 24 hours on various test surfaces." The exact number of meters in each set is not specified.
   • Usability Study: The document refers to a "customer focus study (summative usability study)" but does not specify the number of participants.
   • Other tests: For other technical performance tests (e.g., electrical safety, material degradation, meter malfunction, data transfer, drop/spill), the sample size of meters or components tested is not explicitly stated, but the results indicate "All results" for the tested items met criteria.
   • Data Provenance: Not explicitly stated as "country of origin" or "retrospective/prospective." The studies appear to be internal verification and validation tests conducted by the manufacturer as part of the device development and submission process.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The studies described are engineering and usability focused, not involving expert interpretation of medical images or diagnostic results. The "ground truth" for these tests are objective engineering specifications or direct observation of user behavior (for usability).

3. Adjudication method for the test set: Not applicable. The tests performed are objective, involving mechanical stress, electrical measurement, or direct observation of adherence to instructions. There is no mention of a need for adjudication.

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: Not applicable. This device is a blood glucose monitoring system, not an AI-based diagnostic imaging tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself is standalone in terms of its glucose measurement algorithm. The various tests described assess the device's standalone performance across different parameters (electrical, mechanical, software, etc.). The usability studies indirectly evaluate human-in-the-loop performance in terms of whether users can operate the device correctly.

6. The type of ground truth used:

   • Objective Engineering Specifications: For risks like electric shock, material degradation, meter malfunction, erroneous data transfer, and user mishandling, "ground truth" is defined by established engineering standards (e.g., IEC 61010-1:2001, specified mV ranges, withstand limits for drop/spill).
   • Direct Observation/Absence of Failure: For biocontamination, the ground truth is the absence of observed residual blood/control solution or detected virus.
   • Successful Task Completion: For user inability to use the meter or misinterpreting readings, the ground truth is the successful completion of specific tasks by study participants as observed in the usability study.

7. The sample size for the training set: Not applicable based on the provided document. The document describes validation and verification studies for a medical device (blood glucose meter), not an AI algorithm requiring a training set. The device utilizes a "blood glucose measurement algorithm and automatic calibration," but details about the development or training of this algorithm are not provided in this 510(k) summary.

8. How the ground truth for the training set was established: Not applicable, as no training set for an AI algorithm is described.

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