(504 days)
The CONTOUR®NEXT EZ blood glucose nonitoring system is an over the counter (OTC) device utilized for self-esting by persons with diabetes at home for the quantiative measurement of glucose in whole patient use only, and should not be shared.
The CONTOUR® NEXT EZ blood glucose monitoring system is indicated for use with fresh fingertip capillary whole blood samples. The clinical utility of this device is to aid in monitoring the effectiveness of your diabetes control program.
The CONTOUR® NEXT EZ blood glucose monitoring system is not intended for use for screening for diabetes mellitus and is not intended for use on neonates.
The 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 EZ 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 EZ 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 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. After a fixed reaction time, the glucose concentration in the sample is calculated and displayed.
Here's a breakdown of the acceptance criteria and study information for the Contour Next EZ Blood Glucose Meter (K130265):
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Contour Next EZ Blood Glucose Monitoring System are based on ISO 15197:2003 standards for accuracy, repeatability, linearity, and intermediate precision. The provided document details the performance of the Contour Plus System as a proxy for the Contour Next EZ system, along with specific additional testing for the modified Contour Next EZ meter.
| Test Type | Acceptance Criteria | Reported Device Performance (Contour Plus System, unless otherwise noted) |
|---|---|---|
| Accuracy (Analytical) | Glucose < 75 mg/dL: - Within ±5 mg/dL (unspecified %) - Within ±10 mg/dL (unspecified %) - Within ±15 mg/dL (unspecified %) Glucose ≥ 75 mg/dL: - Within ±5% (unspecified %) - Within ±10% (unspecified %) - Within ±15% (unspecified %) - Within ±20% (unspecified %) | Glucose < 75 mg/dL (combined lots): - Within ±5 mg/dL: 75 of 78 (96.2%) - Within ±10 mg/dL: 78 of 78 (100%) - Within ±15 mg/dL: 78 of 78 (100%) Glucose ≥ 75 mg/dL (combined lots): - Within ±5%: 454 of 522 (87.0%) - Within ±10%: 519 of 522 (99.4%) - Within ±15%: 522 of 522 (100%) - Within ±20%: 522 of 522 (100%) |
| Accuracy (Clinical Trial) | Glucose < 75 mg/dL: - Within ±5 mg/dL (unspecified %) - Within ±10 mg/dL (unspecified %) - Within ±15 mg/dL (unspecified %) Glucose ≥ 75 mg/dL: - Within ±5% (unspecified %) - Within ±10% (unspecified %) - Within ±15% (unspecified %) - Within ±20% (unspecified %) | Glucose < 75 mg/dL: - Within ±5 mg/dL: 3 of 7 (42.9%) - Within ±10 mg/dL: 4 of 7 (57.1%) - Within ±15 mg/dL: 7 of 7 (100%) Glucose ≥ 75 mg/dL: - Within ±5%: 119 of 209 (56.9%) - Within ±10%: 186 of 209 (89.0%) - Within ±15%: 205 of 209 (98.1%) - Within ±20%: 209 of 209 (100%) |
| Repeatability | Not explicitly stated as a pass/fail criterion in the summary, but data provided for comparison. | Mean, Pooled Standard Deviation, and Coefficient of Variation provided for five glucose levels (e.g., at 42.2 mg/dL, CV was 2.8%; at 323 mg/dL, CV was 1.5%). |
| Linearity | Results within ±10 mg/dL for glucose values < 100 mg/dL and results within ±10% for glucose values ≥ 100 mg/dL. | 100% of results met the acceptance criteria. Additionally, 100% of tests for 0.1 mg/dL and 692 mg/dL samples yielded "LO" and "HI" messages, respectively. Range 10-600 mg/dL covered. |
| Intermediate Precision | Cp values ≥ 0.65. | All results generated Cp values > 1.0, meeting the acceptance criteria. |
| EMC and Electrical Safety | Compliance with IEC 62316-2-6:2005, IEC 61010-1:2001, and IEC 61010-2-101:2002. | Evaluated and found to be compliant. |
| Hematocrit + Temp Study | Bias from YSI < 10 mg/dL (glucose < 100 mg/dL) or < 10% (glucose ≥ 100 mg/dL). | Acceptance criteria met using both current and modified meters. Modified meter showed narrower bias range at low temperatures. |
| Hematocrit Dependency | Bias from YSI < 10 mg/dL (glucose < 100 mg/dL) or < 10% (glucose ≥ 100 mg/dL). | Acceptance criteria met. |
| Temperature Dependency | Bias from YSI < 10 mg/dL (glucose < 100 mg/dL) or < 10% (glucose ≥ 100 mg/dL). | Acceptance criteria met. |
| Temp and Humidity Comb. | ±10 mg/dL or ±10% of the reference method. | Results met acceptance criteria. |
| Sample Re-application (Lab) | 95% of results fall within ±15 mg/dL (glucose < 100 mg/dL) or within 15% (glucose ≥ 100 mg/dL) of the reference assay. | When severely under-filled: both current and modified meters met criteria. When moderately under-filled: current meter generated E2 error (100%), modified meter generated accurate results meeting criteria. |
| Sample Re-application (Lay User) | ISO 15197:2013 accuracy criteria (implied to be within ±15mg/dL or ±15% of the YSI reference for glucose levels, as per stated performance). | Lay users trained to underfill: 100% of results following re-application met ISO 15197:2013 accuracy criteria (within 15% of YSI reference). R&D lay user studies (58 instances): 98% of data met ISO 15197:2013 accuracy criteria (within ±15mg/dL or ±15% of YSI reference). |
| Moisture Damaged Test Strips | Increased detection of damaged test strips compared to predicate device. | Modified Contour Next EZ meters were capable of detecting damaged test strips more frequently than the current Contour Next EZ meter and generated an E11 error code. |
2. Sample Size Used for the Test Set and Data Provenance
- Much of the analytical testing (Accuracy, Repeatability, Linearity, Intermediate Precision, EMC, Electrical Safety) was performed using the Contour Plus Blood Glucose Monitoring System and test strips, which is stated to be representative.
- Analytical Accuracy:
- Glucose < 75 mg/dL: Three lots of test strips, with 26 measurements per lot. Total: 78 unique measurements.
- Glucose ≥ 75 mg/dL: Three lots of test strips, with 174 measurements per lot. Total: 522 unique measurements.
- Repeatability: Not explicitly stated, but data is given for 5 glucose levels across 3 lots of test strips.
- Linearity: Blood glucose samples ranged from 0.1 mg/dL to 692 mg/dL. No specific number of samples is given, but it implies a range of concentrations were tested.
- Intermediate Precision: 300 control tests (using three lots of test strips and three levels of control solution).
- Clinical Trial (Accuracy): 220 persons with diabetes were enrolled.
- Glucose < 75 mg/dL: 7 instances (across the 220 subjects).
- Glucose ≥ 75 mg/dL: 209 instances (across the 220 subjects).
- Hematocrit and Temperature Combination Study: Not explicitly quantified, but performed with "Three glucose concentrations and four hematocrit levels... at temperatures of 5, 10, 22, 35, 40 and 45℃."
- Hematocrit Dependency Study: Not explicitly quantified, but performed with "Four glucose concentrations and five hematocrit levels."
- Temperature Dependency Study: Not explicitly quantified, but performed with "Three glucose concentrations were tested at temperatures of 5, 10, 15 and 22°C."
- Temperature and Humidity Combination Study: Not explicitly quantified, but tested across 5 different environmental conditions.
- Blood Sample Re-application (Lab Personnel): Not explicitly quantified, but involved "inoculated with blood to simulate severely under-filled and moderately under-filled conditions."
- Blood Sample Re-application (Lay Users):
- Feasibility Study: Not explicitly quantified, but lay users were "trained to underfill the test strips."
- R&D Lay User Studies: 58 instances of under-filled test strips from multiple studies.
- Error Detection of Moisture Damaged Test Strips: Not explicitly quantified, but test strips "stressed by leaving the bottles open for 23 days inside a 30°C80% RH environmental chamber."
Data Provenance: The document does not explicitly state the country of origin for the data. Given the "Bayer Healthcare LLC" submitter, it is likely that parts of the studies, especially regulatory submissions, involve US-based data or adherence to international standards globally. The studies appear to be prospective in nature, as they involve active testing and clinical trials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The ground truth for all glucose measurements was established using a YSI reference method. This is a laboratory-based, highly accurate method for measuring glucose, often considered the gold standard in such studies. The number and qualifications of experts performing the YSI reference measurements are not specified in the document, but it's implied to be performed by qualified laboratory personnel.
4. Adjudication Method for the Test Set
There is no mention of an adjudication method for the test set. Given that the ground truth is established by a YSI reference method, which is an objective measurement, an adjudication process involving human reviewers for interpretation of results is generally not applicable in this context. The comparison is directly between the device reading and the YSI reference.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC comparative effectiveness study was done in the conventional sense (i.e., comparing human readers' performance with and without AI assistance). This device is a blood glucose meter, and the primary assessment is its analytical accuracy against a reference standard, not its impact on human interpretation of images or other subjective data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance was done. All the analytical accuracy, repeatability, linearity, intermediate precision, and various environmental/interference studies (hematocrit, temperature, humidity) reflect the standalone performance of the device (system/algorithm). The clinical trial also evaluates the system's accuracy "in the hands of intended users," which still primarily assesses the device's output against the ground truth, rather than human diagnostic performance. The "Blood Sample Re-application (Lab)" and "Error Detection of Moisture Damaged Test Strips" studies directly test the algorithmic improvements implemented in the modified device.
7. The Type of Ground Truth Used
The primary ground truth used for glucose measurements throughout the studies is the YSI reference method. This is an objective, laboratory-based measurement of glucose concentration, considered a highly accurate standard.
8. The Sample Size for the Training Set
The document does not provide information on the sample size used for a training set. This is typical for a 510(k) submission for a blood glucose meter where the device's underlying chemistry and algorithms are often developed and validated over time, with the submission focusing on performance testing for the final product and its modifications, rather than detailing the initial machine learning model training (if any complex machine learning was even involved, which is less common for these types of electrochemical devices). The modifications described (glucose calculation algorithm, improved blood detection, error detection for damaged strips) would likely have been developed and refined using internal data before the formal validation studies presented here.
9. How the Ground Truth for the Training Set Was Established
As no training set is explicitly mentioned or detailed, the method for establishing its ground truth is not provided in the document.
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JUN 2 3 2014
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510(k) Summary
Date prepared: May 20, 2014
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.
| 1) Submitter | Jennifer Gregory Regulatory Affairs Specialist Bayer Healthcare LLC 430 South Beiger Street Mishawaka, IN 46544 Telephone: (574) 256-3447 Fax: (574) 256-3519 |
|---|---|
| 2) Device name: | Trade name: Contour® Next EZ Blood Glucose Meter Common name: Blood Glucose Meter Classification name: Blood Glucose Test System, Over- the-Counter, 75 NBW (21 CFR § 862.1345) |
| 3) Predicate device: | Contour Next EZ Blood Glucose Meter (Reference: Contour Next EZ Blood Glucose Monitoring System (K111268)) |
| 4) Device description: | The Contour Next EZ 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 EZ 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 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 |
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is proportional to the glucose in the sample. After a fixed reaction time, the glucose concentration in the sample is calculated and displayed.
The Contour Next EZ blood qlucose monitoring system is 5) Intended Use: an over the counter (OTC) device utilized for self-testing bv persons with diabetes at home for the quantitative measurement of glucose in whole blood, is for singlepatient use only, and should not be shared. The Contour Next EZ blood glucose monitoring system is indicated for use with fresh fingertip capillary whole blood samples. The clinical utility of this device is to aid in monitoring the effectiveness of your diabetes control program. The Contour Next EZ blood glucose monitoring system is not intended for use for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. The 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.
Data demonstrating substantial equivalence
The Contour Next EZ Blood Glucose Meter consists of a small handheld blood glucose meter that is substantially equivalent to the predicate device, the Contour Next EZ Blood Glucose Monitoring System (K111268). The modified device uses dry reagent test strips for the measurement of glucose in capillary whole blood by persons with diabetes and liquid controls to check the performance of the system. The same Contour Next test strips and control solutions are used by both the modified and predicate device.
A detailed comparison of the characteristics featured between the modified and predicate devices is provided in the tables below:
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Modified Device (Contour Next EZ meter)
Image /page/2/Picture/3 description: The image shows a Contour NEXT EZ blood glucose meter. The meter's display shows a reading of 93 mg/dL, with the date as 10/13 and the time as 12:24 PM. The meter also has buttons for navigation and a Bayer logo at the bottom.
Predicate Device (Contour Next EZ meter)
Image /page/2/Picture/5 description: The image shows a Contour NEXT blood glucose meter. The display shows a reading of 93 mg/dL. The date is 10/13 and the time is 12:24 PM.
| Summary of the Technological Characteristics of the Modified Device Compared toPredicate | |||
|---|---|---|---|
| SIMILARITIES to Predicate | |||
| Characteristic | PredicateContour Next EZ(K111268) | Contour Next EZ(Modified Device) | |
| Test Strip | Contour Next Test Strips | Same as Predicate | |
| Control Solution | Contour Next Control Solution(Level 1 and 2) | Same as Predicate | |
| Detection Method | Amperometric | Same as Predicate | |
| Measuring Range | 20-600 mg/dL | Same as Predicate | |
| Sample Volume | 0.6 µL, minimum | Same as Predicate | |
| Countdown time displayed | 5 Seconds | Same as Predicate | |
| Illuminated Strip Port | No | Same as Predicate | |
| Operational Buttons | 2 button choice selection andmenu/power button | Same as Predicate | |
| Battery Type | Two 3-volt lithium batteries(DL2032 or CR2032) | Same as Predicate | |
| Operating Temperature Range | 41°-113° F | Same as Predicate | |
| Operating Humidity Range | 10-93% RH | Same as Predicate | |
| Sound | A beep sounds when the meter | Same as Predicate | |
| SIMILARITIES to Predicate | |||
| Predicate | Contour Next EZ(Modified Device) | ||
| Characteristic | Contour Next EZ(K111268) | ||
| is turnedon, a test strip is inserted,when a test strip isfilled with blood, or when a testresult appears on thedisplay. Two beeps soundwhen the meter turns off or toindicate an error.You will hear twenty beepswhen a programmed remindersounds. | |||
| Meter life | 5 Years | Same as Predicate | |
| Validated Product Used forCleaning and Disinfection | Clorox Germicidal wipes | Same as Predicate | |
| Test Reminder | Yes | Same as Predicate | |
| Calibration/Coding | Autocoding (no coding forusers) | Same as Predicate | |
| Display (technology) | Segmented (LCD),Alphanumeric characters &Icons | Same as Predicate | |
| Display Visibility | Daylight only | Same as Predicate | |
| Error Message Displays | No, but error codes andsymbols are displayed andtheir meanings are provided inthe system's User Guide | Same as Predicate | |
| Communication Link toComputer | Via serial to USB cable | Same as Predicate | |
| Test Results in Memory | 480 Results | Same as Predicate | |
| Meter Materials | Case Top/Bottom: ABSButtons: AS | Same as Predicate | |
| Before and After MealMarkers | Yes, when used in advancedsetting | Same as Predicate |
BAYER CONFIDENTIAL
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| DIFFERENCES from Predicate | |||
|---|---|---|---|
| Predicate | Contour Next EZ | ||
| Characteristic | Contour Next EZ (K111268) | (Modified Device) | Risk Assessment Summary |
| GlucoseCalculationAlgorithm thatensuresconsistentperformance atlow temperatures(<15°C) | No | Yes | No additional risk as a result ofthe modification. The risk ofslightly biased results prior tothe modification was low. Themodification provides a morerobust mathematical calculationslightly enhancing accuracy. |
| Improved blooddetectionalgorithm to allowblood re-application whensensor is eitherseverely under-filled (less thanhalf-full) ormoderatelyunder-filled (morethan half-full) | No | Yes | No additional risk as a result ofthe modification. Prior to themodification, the potentialexisted for customerdissatisfaction as underfill errors(E2) were still possible due tothe limited range ofperformance. The modificationshould lead to improvedcustomer satisfaction sinceresults are provided instead ofan error code. |
| Error detectionalgorithm todetect test stripsthat have beendamaged byexposure toexcessivemoisture | No | Yes | No additional risk as a result ofthe modification. Prior to themodification, there is a low riskof the customer receiving biasedresults when test strips havebeen damaged by exposure toexcessive moisture as a resultof severe mishandling. Themodification allows the meter tomore frequently detect damagedtest strips. |
The Contour Next EZ Blood Glucose Monitoring System was evaluated according to ISO 15197:2003 using the Contour Plus Blood Glucose Monitoring · System. Analytical testing included system accuracy, repeatability, linearity and intermediate precision. EMC and electrical safety of the Contour Next EZ meter was also evaluated using the Contour Plus meter.
The performance and usability of the Contour Next EZ Blood Glucose Monitoring System (including second chance sampling for under-filled test strips) was tested in the hands of intended users using the Contour Plus Blood Glucose Monitoring System.
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Additional testing was performed using the modified Contour Next EZ meter to evaluate combined hematocrit and temperature effect, hematocrit effect, temperature effect, temperature and humidity combination effect, sample reapplication for under-filled test strips and error detection for test strips that have been exposed to excessive moisture.
Sample volume and analytical specificity were established in K111268. Altitude testing was also included in K111268.
A summary of the test data is provided below:
Accuracy
The accuracy of the Contour Plus System was evaluated according to ISO 15197:2003 using three lots of Contour Plus test strips.
Results for glucose concentrations < 75 mg/dL:
| Lot # | Within ± 5 mq/dL | Within ± 10 mg/dL | Within ± 15 mq/dL |
|---|---|---|---|
| 2DGHC01 | 26 of 26 (100%) | 26 of 26 (100%) | 26 of 26 (100%) |
| 2DGHC02 | 25 of 26 (96.2%) | 26 of 26 (100%) | 26 of 26 (100% |
| 2DGHC03 | 24 of 26 (92.3%) | 26 of 26 (100%) | 26 of 26 (100%) |
| combined | 75 of 78 (96.2%) | 78 of 78 (100%) | 78 of 78 (100%) |
Results for glucose concentrations ≥ 75 mg/dL:
| Lot # | Within ± 5 % | Within ± 10 % | Within ± 15 % | Within ± 20% |
|---|---|---|---|---|
| 2DGHC01 | 152 of 174(87.4%) | 173 of 174(99.4%) | 174 of 174(100%) | 174 of 174(100%) |
| 2DGHC02 | 149 of 174(85.6%) | 173 of 174(99.4%) | 174 of 174(100%) | 174 of 174(100%) |
| 2DGHC03 | 153 of 174(87.9%) | 173 of 174(99.4%) | 174 of 174(100%) | 174 of 174(100%) |
| combined | 454 of 522(87.0%) | 519 of 522(99.4%) | 522 of 522(100%) | 522 of 522(100%) |
Repeatability
The repeatability of the Contour Plus System was evaluated according to ISO 15197 using three lots of Contour Plus test strips across five glucose levels. The results are as follows:
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| ReferenceGlucose, mg/dL | Mean, mg/dL | Pooled StandardDeviation | Coefficient ofVariation, % |
|---|---|---|---|
| 42.2 | 44.7 | 1.3 | 2.8 |
| 79 | 84.6 | 2.1 | 2.5 |
| 126.4 | 130.6 | 1.9 | 1.5 |
| 201.3 | 210.0 | 2.8 | 1.3 |
| 323 | 333.2 | 4.8 | 1.5 |
Linearity
A linearity study was performed to demonstrate the analytical range of the Contour Plus assay (10-600 mg/dL). Note: the claimed range for the Contour Next EZ meter will be 20-600 mg/dL. The blood glucose samples that were tested ranged from 0.1 mg/dL to 692 mg/dL.
The internal acceptance criteria for accuracy was results within ± 10mg/dL for glucose values < 100mg/dL and results within ±10% for glucose values ≥ 100mg/dL. 100% of results met the acceptance critieria
For the samples tested at 0.1 and 692 mg/dL, 100% of the tests yielded "LO" and "HI" messages as expected since those values are outside of the claimed range.
Intermediate Precision
300 control tests were performed using three lots of Contour Plus test strips and three levels of Contour Plus control solution. The internal acceptance criteria was Cp values ≥ 0.65. All results generated Cp values > 1.0, so the acceptance criteria was met.
EMC and Electrical Safety
The Contour Plus meter was evaluated and found to be compliant with applicable sections of IEC 62316-2-6:2005, IEC 61010-1:2001 and IEC 61010-2-101:2002
Clinical Trial
The accuracy of the Contour Plus System was evaluated in the hands of intended users according to ISO 15197:2003 using three lots of Contour Plus test strips. A total of 220 persons with diabetes were enrolled as subjects in the trial, which was conducted at two sites. The subjects ranged in age from 26 to 86 with a mean age of 60.
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Results for glucose concentrations < 75 mg/dL:
| Within ± 5 mg/dL | Within ± 10 mg/dL | Within ± 15 mg/dL |
|---|---|---|
| 3 of 7 (42.9%) | 4 of 7 (57.1%) | 7 of 7 (100%) |
Results for glucose concentrations ≥ 75 mg/dL:
| Within ± 5 % | Within ± 10 % | Within ± 15 % | Within ± 20% |
|---|---|---|---|
| 119 of 209 (56.9%) | 186 of 209 (89.0%) | 205 of 209 (98.1%) | 209 of 209 (100%) |
Blood Sample Re-application (Second Chance Sampling)
During the clinical trial, there were instances where users did not apply a sufficient blood sample to the Contour Plus test strip and were prompted by the Contour Plus meter to add more blood. In some cases, the attempt to apply more blood did not yield a blood glucose result and an expected E2 error was received. In the other cases, a blood glucose result was received after the additional blood sample was applied within the time allowed.
Hematocrit and Temperature Combination Study
Testing was performed using the current CONTOUR®NEXT EZ meter (K111268) and the modified Contour Next EZ meter. Three glucose concentrations and four hematocrit levels were tested at temperatures of 5, 10, 22, 35, 40 and 45℃. Acceptance criteria was met using both software versions (Bias from YSI should be less than 10 mg/dL at glucose levels below 100 mg/dL and less than 10% at higher glucose levels) However, the range of bias obtained at different hematocrits at 5 and 10°C was narrower with the modified CONTOUR®NEXT EZ meter than with the current CONTOUR®NEXT EZ meter.
Hematocrit Dependency Study
Additional testing was performed using the modified Contour Next EZ meter. Four glucose concentrations and five hematocrit levels were tested. The acceptance criteria, that bias from YSI should be less than 10 mg/dL at glucose levels below 100 mg/dL and less than 10% at higher glucose levels, was met.
Temperature Dependency Study
Testing was performed using the modified Contour Next EZ meter. Three glucose concentrations were tested at temperatures of 5, 10, 15 and 22°C. The acceptance criteria, that bias from the YSI should be less than 10 mg/dL at
BAYER CONFIDENTIAL
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glucose levels below 100 mg/dL and less than 10% at higher glucose levels, was met.
Temperature and Humidity Combination Study
The following conditions were tested using the modified Contour Next EZ meter at glucose reference levels of 20, 80, 120, 350 and 550 mg/dL:
- 5°C, 10%RH (corner) .
- 5°C, 93%RH (corner) .
- 25°C, 50%RH (center) .
- 45°C, 10%RH (corner) .
- 45°C, 93%RH (corner) .
The results met the acceptance criteria of ± 10 mg/dL or ± 10 % of the reference method
Blood Sample Re-application (or Second Chance Sampling)
Re-application study conducted by lab personnel:
The improved ability of the modified Contour Next EZ meter to detect under-filled test strips was tested using the current Contour Next EZ meter (K111268) and the modified meter (K130265). The Contour Next test strips were inoculated with blood to simulate severely under-filled and moderately under-filled conditions. After the initial inoculation, additional sample was applied to the test strips. The acceptance criteria was that 95% of results fall within ±15 mg/dL (for glucose results < 100 mg/dL) or within 15% (for glucose results ≥ 100 mg/dL) of the reference assay when the test strips were partially filled.
When the test strips were severely under-filled, the results generated by both versions of the Contour Next EZ meter met the acceptance criteria. When the test strips were moderately under-filled, the current Contour Next EZ meter generated an E2 error code 100% of the time, while the modified meter qenerated accurate results that met the acceptance criteria.
Re-application study done by lay users:
A study was conducted with lay users to investigate the feasibility of a proposed protocol that would increase the likelihood that patients would obtain an underfilled test strip during testing. Lay users were trained to underfill the test strips in order to generate the sample re-application prompt. The results after the sample re-application met the ISO 15197:2013 accuracy criteria with 100% of the results falling within 15% of the YSI reference glucose, indicating the method is feasible.
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Lay User Re-application Data:
Data was collected from five R&D lay user studies. In these studies, there were 58 instances of under-filled test strips. The ISO 15197:2013 accuracy criteria were met with 98% of the data falling within the ±15mg/dL or ±15% of the YSI reference glucose.
Error Detection of Moisture Damaged Test Strips
Contour Next test strips were stressed by leaving the bottles open for 23 days inside a 30°C80% RH environmental chamber. This evaluation simulated severe mishandling of the test strips. After 23 days, the test strips from the open bottles (and closed bottles as a control) were tested at three glucose levels using current Contour Next EZ meters (K111268) and the modified Contour Next EZ meters (K130265). The modified Contour Next EZ meters were capable of detecting damaged test strips more frequently than the current Contour Next EZ meter and generated an E11 error code.
Conclusions from Nonclinical and Clinical Evaluations
The Contour Next EZ Blood Glucose Meter is substantially equivalent in its intended use, performance, safety and effectiveness to the predicate Contour Next EZ Blood Glucose Meter (K111268) based on the performance of the Contour Plus and Contour Next EZ Blood Glucose Monitoring Systems.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
BAYER HEALTHCARE LLC JENNIFER GREGORY 430 SOUTH BEIGER STREET MISHAWAKA, IN 46544
June 23,2014
Re: K130265
Trade/Device Name: CONTOUR® NEXT EZ Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Glucose Test System Regulation Name: Glucose Test System Regulatory Class: II Product Code: NBW, LFR Dated: May 19, 2014 Received: June 13, 2014
Dear Ms. Jennifer Gregory:
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. Please note: CDRH docs not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading,
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA is 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): good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
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Page 2-Ms. McKinnies
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resources/orYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to
http://www.fda.gov/MedicalDevices/Safetw/ReportalProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Katherine Serrano -S
For : Courtney H. Lias
Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K130265
Device Name
CONTOUR®NEXT EZ Blood Glucose Monitoring System
Indications for Use (Describe)
The CONTOUR®NEXT EZ blood glucose nonitoring system is an over the counter (OTC) device utilized for self-esting by persons with diabetes at home for the quantiative measurement of glucose in whole patient use only, and should not be shared.
The CONTOUR® NEXT EZ blood glucose monitoring system is indicated for use with fresh fingertip capillary whole blood samples. The clinical utility of this device is to aid in monitoring the effectiveness of your diabetes control program.
The CONTOUR® NEXT EZ blood glucose monitoring system is not intended for use for screening for diabetes mellitus and is not intended for use on neonates.
The 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.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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§ 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.