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510(k) Data Aggregation
(79 days)
The CONTOUR® NEXT USB 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 CONTOUR® NEXT USB Blood Glucose Monitoring System is indicated for use with fresh capillary whole blood samples drawn from the fingertip and palm only. The CONTOUR® NEXT USB Blood Glucose Monitoring System may be used as an aid to monitor the effectiveness of a diabetes control program and 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 USB Blood Glucose Monitoring System for the quantitative measurement of glucose in whole blood. The Contour® NEXT Controls are for use with the CONTOUR® NEXT USB Blood Glucose Monitoring System to check that the meter and test strips are working properly.
Glucofacts® Deluxe Diabetes Management Software is an over-the-counter software program intended for use by health care professionals and patients with diabetes for viewing and printing reports that display blood sugar readings from Baver's Contour and Breeze families of meters.
The Contour NEXT USB Blood Glucose Monitoring System consists of a small handheld blood glucose meter that is substantially equivalent in look and feel to the predicate system. Contour Next Wireless Blood Glucose Meter, (K110894). The system also consists of dry reagent test strips used for the measurement of glucose in capillary whole blood and includes liquid controls to check the performance of the system.
The chemical principle of the system 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.
The Bayer Contour NEXT USB Blood Glucose Monitoring System was tested and found to meet the system accuracy requirements of ISO 15197:2003 through analytical performance testing and a user performance evaluation.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from ISO 15197:2003 for system accuracy.
System Accuracy - Glucose Concentrations < 75 mg/dL
| Acceptance Criteria (ISO 15197:2003) | Reported Device Performance (Contour NEXT USB) |
|---|---|
| At least 95% of results must be within ± 15 mg/dL of the reference method. | 78 of 78 (100%) of results were within ± 15 mg/dL. |
| (Not explicitly stated as an ISO requirement in the document, but for context) 95% within ± 10 mg/dL | 78 of 78 (100%) of results were within ± 10 mg/dL. |
| (Not explicitly stated as an ISO requirement in the document, but for context) 95% within ± 5 mg/dL | 65 of 78 (83.3%) of results were within ± 5 mg/dL. |
System Accuracy - Glucose Concentrations ≥ 75 mg/dL
| Acceptance Criteria (ISO 15197:2003) | Reported Device Performance (Contour NEXT USB) |
|---|---|
| At least 95% of results must be within ± 20% of the reference method. | 522 of 522 (100%) of results were within ± 20%. |
| (Not explicitly stated as an ISO requirement in the document, but for context) 95% within ± 15% | 522 of 522 (100%) of results were within ± 15%. |
| (Not explicitly stated as an ISO requirement in the document, but for context) 95% within ± 10% | 512 of 522 (98.1%) of results were within ± 10%. |
| (Not explicitly stated as an ISO requirement in the document, but for context) 95% within ± 5% | 390 of 522 (74.7%) of results were within ± 5%. |
Repeatability (Analytical Testing)
| Target Glucose (mg/dL) | Mean Glucose (mg/dL) | Standard Deviation (mg/dL) | Coefficient of Variation (%) |
|---|---|---|---|
| 40 | 47 | 0.8 | 1.8 |
| 80 | 87 | 1.3 | 1.5 |
| 130 | 131 | 1.9 | 1.5 |
| 210 | 211 | 2.8 | 1.3 |
| 330 | 342 | 6.4 | 1.9 |
Intermediate Precision (Analytical Testing with Control Solution)
| Control Level | Mean Glucose (mg/dL) | Standard Deviation (mg/dL) | Coefficient of Variation (%) |
|---|---|---|---|
| Level 1 | 45 | 0.9 | 2.0 |
| Level 2 | 133 | 2.0 | 1.5 |
| Level 3 | 397 | 6.6 | 1.7 |
User Performance Evaluation - Glucose Concentrations < 75 mg/dL (Subject & Professional Fingertip Results)
| Tester | Within ± 5 mg/dL | Within ± 10 mg/dL | Within ± 15 mg/dL |
|---|---|---|---|
| Subject | 8 of 8 (100%) | 8 of 8 (100%) | 8 of 8 (100%) |
| Professional | 8 of 8 (100%) | 8 of 8 (100%) | 8 of 8 (100%) |
User Performance Evaluation - Glucose Concentrations ≥ 75 mg/dL (Subject & Professional Fingertip Results)
| Tester | Within ± 5% | Within ± 10% | Within ± 15% | Within ± 20% |
|---|---|---|---|---|
| Subject | 152 of 196(77.6%) | 188 of 196(95.9%) | 193 of 196(98.5%) | 195 of 196(99.5%) |
| Professional | 151 of 196(77.0%) | 194 of 196(99.0%) | 196 of 196(100%) | 196 of 196(100%) |
2. Sample Size and Data Provenance for Test Set
- Analytical System Accuracy Test Set: The "N" for the regression statistics was 600, indicating 600 samples for the primary system accuracy evaluation. The results are further broken down into <75 mg/dL (78 samples) and ≥75 mg/dL (522 samples). The document does not specify the country of origin or whether the data was retrospective or prospective.
- Repeatability Test Set: 300 venous blood tests per glucose level (40, 80, 130, 210, 330 mg/dL), with 100 tests from each of three lots of test strips.
- Intermediate Precision Test Set: 300 control solution tests per control level (Level 1, Level 2, Level 3), with 100 tests from each of three lots of test strips.
- User Performance Evaluation Test Set: For glucose concentrations <75 mg/dL, 8 samples were tested by both subjects (intended users) and professionals. For glucose concentrations ≥75 mg/dL, 196 samples were tested by both subjects and professionals. The data provenance is not explicitly stated regarding country or retrospective/prospective nature.
3. Number of Experts and Qualifications for Ground Truth
The document does not provide information about the number or qualifications of experts used to establish the ground truth. It refers to a "reference method" for comparison but does not detail how this reference method was implemented or who performed it.
4. Adjudication Method for Test Set
The document does not describe any adjudication method. The comparisons are made against a "reference method."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is reported. The tests focus on device accuracy against a reference method and user performance without comparison to human readers with and without AI assistance.
6. Standalone Algorithm Performance
Yes, the study primarily describes the standalone performance of the device (Contour NEXT USB Blood Glucose Monitoring System). The "System Accuracy" and "Repeatability" sections detail the analytical performance of the device without human-in-the-loop assistance in the measurement process itself, although the "User Performance Evaluation" section involves human users operating the device. The core measurement algorithm's performance is reflected in the accuracy and precision data.
7. Type of Ground Truth Used
The ground truth used is a "reference method" for glucose measurement. The specific nature of this reference method (e.g., a laboratory gold-standard analyzer, a specific clinical assay) is not detailed in the provided text.
8. Sample Size for Training Set
The document does not provide information on the sample size used for a training set. This is typical for a medical device (blood glucose meter) where the fundamental chemical and electrical principles are fixed, and performance is characterized through analytical and clinical validation, rather than a machine learning model that requires a "training set."
9. How Ground Truth for Training Set Was Established
Since no training set is described for a machine learning algorithm, the establishment of ground truth for a training set is not applicable here. The device's underlying principles are based on the reaction of glucose with FAD-GDH enzyme and electrical current measurement.
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