(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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Bayer HealthCare Diabetes Care
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JUN - 2- 8 2012,
K121087 510(k) Summary
According to the requirements of 21 CFR 807.92, the following information is being submitted in sufficient detail to provide an understanding of the basis for a determination of substantial equivalence.
- Submitter
Roger Sonnenburg Bayer Healthcare Diabetes Care 430 S. Beiger St. Mishawaka, IN 46544 Telephone: 574-256-3441 Date prepared: June 26, 2012
- Device name:
Trade name: Contour NEXT USB Blood Glucose Monitoring System Meter: Contour NEXT USB Blood Glucose Meter Strips: Contour NEXT Blood Glucose Test Strips
Controls: Contour NEXT Control Solution
Classification name: NBW, Blood Glucose Test System, Overthe-Counter (21 CFR § 862.1345); LFR, Glucose Dehydrogenase; JJX, Single Analyte Controls
-
Predicate device:
-
Device description: Contour NEXT LINK Wireless Glucose Monitoring System (K110894)
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.
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Baver HealthCare Diabetes Care
Image /page/1/Picture/1 description: The image shows the Bayer company logo. The logo is a circle with the word "BAYER" written in a cross shape. The letters are bolded and outlined. The logo is black and white.
- Intended Use
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 overthe-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 Bayer's Contour and Breeze families of meters.
Data demonstrating substantial equivalence
The Contour NEXT USB Blood Glucose Monitoring System was tested in accordance with ISO 15197:2003. Analytical performance testing included system accuracy, repeatability, intermediate precision and linearity testing. A user performance evaluation assessed accuracy of results and usability of the device in the hands of intended users. The data demonstrates that the system is substantially equivalent to the predicate device.
System Accuracy
The following tables show that the device met the system accuracy requirement as spelled out in ISO 15097:2003, using three lots of test strips.
System Accuracy results for glucose concentrations <75 mg/dL Number and percent of glucose results within stated limits of the reference method.
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Bayer HealthCare Diabetes Care
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| Within ± 5 mg/dL | Within ± 10 mg/dL | Within ± 15 mg/dL |
|---|---|---|
| 65 of 78 (83.3%) | 78 of 78 (100%) | 78 of 78 (100%) |
System Accuracy results for glucose concentrations ≥75 mg/dL Number and percent of glucose results within stated limits of the reference method.
| Within ± 5% | Within ± 10% | Within ± 15% | Within ± 20% |
|---|---|---|---|
| 390 of 522 (74.7%) | 512 of 522 (98.1%) | 522 of 522 (100%) | 522 of 522 (100%) |
Regression Statistics
The table below shows that the Contour NEXT USB system compares well with the glucose reference system.
Least Squares Regression Statistics
| Proportional weighting: Syx = k * reference | ||||
|---|---|---|---|---|
| --------------------------------------------- | -- | -- | -- | -- |
| Regression Equation | $y = 0.96(x) + 2.1$ |
|---|---|
| 95% Confidence Interval of Slope | 0.960 ± 0.005 (0.955 to 0.965) |
| 95% Confidence Interval of Intercept | 2.087 ± 0.398 (1.690 to 2.485) |
| r² | 0.9957 |
| Syx | 3.62% |
| N | 600 |
Repeatability
300 venous blood tests per level (100 tests with each of three lots of test strips)
| Target Glucose(mg/dL) | Mean Glucose(mg/dL) | Standard Deviation(mg/dL) | Coefficient ofVariation (%) |
|---|---|---|---|
| 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
300 Control Solution tests per level (100 tests with each of three lots of test strips)
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| Control Level | Mean Glucose(mg/dL) | Standard Deviation(mg/dL) | Coefficient ofVariation (%) |
|---|---|---|---|
| Level 1 | 45 | 0.9 | 2.0 |
| Level 2 | 133 | 2.0 | 1.5 |
| Level 3 | 397 | 6.6 | 1.7 |
User Performance Evaluation
Subject and Professional Fingertip Results for Glucose Concentration <75 mg/dL
| 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%) |
Subject and Professional Fingertip Results for Glucose Concentration ≥75 mg/dL
| 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%) |
Design verification and validation testing confirmed that the performance, safety and effectiveness of the Contour NEXT USB Blood Glucose Monitoring System is equivalent or better than the predicate device.
Conclusion
The Contour NEXT USB Blood Glucose Monitoring System is substantially equivalent in its intended use, performance, safety and effectiveness to the predicate device, Contour NEXT LINK Wireless Blood Glucose Monitoring System.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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10903 New Hampshire Avenue Silver Spring, MD 20993
Bayer HealthCare LLC, Diabetes Care c/o Roger Sonnenburg 430 South Beiger St. Mishawaka, IN 46544
JUN 28 2012
Re: K121087
Trade Name: Contour NEXT USB Blood Glucose Monitoring System; Glucofacts® Deluxe Diabetes Management Software
.
Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Codes: LFR, NBW, JJX, JQP Dated: May 30, 2012 Received: June 1, 2012
Dear Mr. Sonnenburg:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). .
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance ...
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm
Sincerely yours,
Signature
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number K12XXXX: 〈〈ソノし087
Device Name: CONTOUR® NEXT USB Blood Glucose Monitoring System
Indications for Use:
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.
Prescription Use x (21 CFR Part 801 Subpart D) Over the Counter Use X (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
And/Or
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K121087
§ 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.