(143 days)
The CONTOUR®NEXT EZ blood glucose monitoring system is an over the counter (OTC) device utilized for self-testing by persons with diabetes at home for the quantitative measurement of glucose in whole blood, is for single-patient use only, and should not be shared.
The system is intended for self testing outside the body (in vitro diagnostic use) and is to monitor the effectiveness of diabetes control. The CONTOUR® NEXT EZ blood glucose monitoring system is indicated for use with fresh fingertip capillary whole blood samples.
The CONTOUR® NEXT EZ 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 test strips are for use with the CONTOUR® NEXT EZ blood glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
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.
The provided text describes modifications made to the Contour Next EZ Blood Glucose Monitoring System (K162336) compared to its predicate device (K130265). It outlines the new features and the testing conducted to demonstrate substantial equivalence, but it does not explicitly state specific acceptance criteria or provide detailed study results in numerical form. It describes the type of studies performed and what they aimed to confirm.
However, based on the information provided, I can infer the general acceptance criteria and describe the studies conducted.
Here's an analysis structured around your request:
Acceptance Criteria and Device Performance for Contour Next EZ Blood Glucose Monitoring System (K162336)
The documentation provided focuses on demonstrating substantial equivalence of the modified device (K162336) to its predicate (K130265) by highlighting improved error detection capabilities and confirming that fundamental performance remains unchanged. While explicit numerical acceptance criteria are not detailed, the underlying goal for a blood glucose monitoring system is generally accuracy and reliability, particularly in identifying and preventing erroneous results.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (Inferred) | Reported Device Performance (From Text) |
|---|---|
| Error Detection: Exposed Test Strips | Meets Criteria: The modified meter improved detection of test strips exposed to a chemical that can degrade the mediator and provides an error message instead of a high-biased result. Bench testing confirmed the error check acted as intended for test strips exposed to a reducing agent. |
| Error Detection: Un-mixed Control Solution | Meets Criteria: The modified meter improved detection of un-mixed control test solutions and provides an error message instead of a high-biased result. Bench testing confirmed the error check acted as intended for un-mixed control test solution. Control testing specifically ensured that adequately mixed control solution did not generate error codes. |
| Error Detection: Sample Perturbation During Test | Meets Criteria: The modified meter improved detection of a sample disturbed during the countdown period and provides an error message instead of a biased result. Bench testing confirmed the error check acted as intended for samples disturbed during the test countdown. |
| Equivalency to Predicate (Fundamental Performance) | Meets Criteria: Equivalency testing was conducted to ensure the performance of the modified and predicate meters was not statistically different. The document explicitly states the modified and predicate devices use the same glucose calculation algorithm, same test strips, and same control solutions, and are "substantially equivalent in its intended use, performance, safety and effectiveness." |
| Software Functionality (No False Positives for Errors) | Meets Criteria: Software verification testing was conducted to ensure that no "good results" were classified as errors as a result of the modifications. |
| Data Download Capabilities (Communication Protocol Changes) | Meets Criteria: Improved data download capabilities were added (e.g., max BG records, total BG records, ability to get single or sets of records, ability to set BGTOTAL to zero for internal testing). The risk assessment summary indicates "The communication changes do not have any impact on the user interface or customer blood glucose test results." |
| General performance characteristics (Measuring Range, Sample Volume, HCT Range, etc.) (Implicitly, to be equivalent to predicate specifications) | Meets Criteria: All these characteristics are listed as "Same as Predicate." |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not specify numerical sample sizes for any of the test sets (bench testing, equivalency testing, software verification, control testing).
The data provenance is not explicitly stated (e.g., country of origin). Given the FDA submission, it is assumed to be from studies conducted under US regulatory standards, though the specific location of the study subjects or samples is not mentioned. The studies appear to be prospective insofar as they were designed specifically to evaluate the modifications before market clearance.
3. Number of Experts and Qualifications for Ground Truth
The document does not provide any information regarding the use of experts, their number, or qualifications for establishing ground truth. The nature of the device (blood glucose monitor) generally relies on laboratory reference methods (e.g., YSI glucose analyzer) for ground truth, rather than expert interpretation of images or clinical data.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method (e.g., 2+1, 3+1). This is typical for objective diagnostic devices like blood glucose monitors where results are compared directly against a reference method, rather than subjective interpretations needing consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done or mentioned. This type of study is not applicable to a blood glucose monitoring system, which provides objective numerical results and does not involve human readers interpreting cases (like radiology or pathology). The assessment is about the device's accuracy compared to a reference standard or its predicate.
6. Standalone (Algorithm Only) Performance
The studies described, particularly "Equivalency testing" and "Control testing," assess the device's performance directly, implying a standalone performance assessment. The device's modifications are primarily related to error detection algorithms and communication protocols, which are inherent to the algorithm and system's standalone operation. The comparison is between the modified device and the predicate device's performance, which itself is a standalone measurement.
7. Type of Ground Truth Used
While not explicitly named, the ground truth for blood glucose monitoring systems like this is typically established using laboratory reference methods, such as a YSI glucose analyzer, which are considered highly accurate. The phrase "equivalency testing was conducted to ensure the performance of the modified and predicate meters was not statistically different" implies comparison against a reliable standard.
8. Sample Size for the Training Set
The document does not provide any information about a specific "training set" or its sample size. For an electrochemical blood glucose meter, the "training" (calibration) is typically done during manufacturing using known glucose concentrations and the system's inherent design, rather than a machine learning training set in the conventional sense. The "Contour Next Test Strips are for use with the Contour Next EZ blood glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips," indicating that the system is pre-calibrated to the strips.
9. How Ground Truth for the Training Set Was Established
As no specific "training set" in the machine learning sense is described, the method for establishing its ground truth is not applicable or mentioned. The device operates based on a determined chemical reaction and electrical current measurement, where the relationship between current and glucose concentration is established through engineering and chemical principles, likely validated against laboratory reference methods during the device's development and manufacturing calibration process.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
ASCENSIA DIABETES CARE US INC. JENNIFER GREGORY PRINCIPAL REGULATORY AFFAIRS SPECIALIST 430 SOUTH BEIGER STREET MISHAWAKA IN 46544
January 12, 2017
Re: K162336
Trade/Device Name: Contour Next EZ Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, LFR Dated: August 19, 2016 Received: August 22, 2016
Dear 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 does 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'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); good manufacturing practice requirements as set forth in the quality systems (QS) 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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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/Resourcesfor You/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/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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Katherine Serrano -S
For : Courtney H. Lias, Ph.D. 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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Indications for Use
510(k) Number (if known) K162336
Device Name
Contour Next EZ Blood Glucose Monitoring System
Indications for Use (Describe)
The CONTOUR®NEXT EZ blood glucose monitoring system is an over the counter (OTC) device utilized for self-testing by persons with diabetes at home for the quantitative measurement of glucose in whole blood, is for single-patient use only, and should not be shared.
The system is intended for self testing outside the body (in vitro diagnostic use) and is to monitor the effectiveness of diabetes control. The CONTOUR® NEXT EZ blood glucose monitoring system is indicated for use with fresh fingertip capillary whole blood samples.
The CONTOUR® NEXT EZ 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 test strips are for use with the CONTOUR® NEXT EZ blood glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image is a logo for Ascensia Diabetes Care. The logo features a purple triangle shape next to a blue teardrop shape. Below the shapes, the word "ASCENSIA" is written in a sans-serif font, and below that, the words "Diabetes Care" are written in a smaller font.
510(k) Summary
Date prepared: January 4, 2017
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 GregoryRegulatory Affairs ManagerAscensia Diabetes Care US Inc.430 South Beiger StreetMishawaka, IN 46544Telephone: (574) 256-3447Fax: (574) 256-3519 |
|---|---|
| 2) Device name: | Trade name: Contour® Next EZ Blood Glucose Monitoring SystemK162336Common name: Blood Glucose Test SystemClassification: Class IIClassification name: Blood Glucose Test System, Over-the-Counter,75 NBW and Glucose Dehydrogenase, 75 LFR (21 CFR § 862.1345) |
| 3) Predicate device: | Contour Next EZ Blood Glucose Monitoring System (K130265)) |
| 4) Devicedescription: | The Contour Next EZ Blood Glucose Meter consists of a smallhandheld blood glucose meter that utilizes dry reagent test strips forthe measurement of glucose in capillary whole blood by persons withdiabetes. Liquid control solution is used to check the performanceof the system. The meter, together with the test strips and controlsolutions, is referred to as the Contour Next EZ Blood GlucoseMonitoring System.The chemical principle utilized for both the predicate and modifieddevices is based on measurement of electrical current caused by thereaction of glucose in the blood with chemicals on the reagent strip.The blood sample is drawn into the tip of the reagent strip throughcapillary action. Glucose in the sample reacts with FAD glucosedehydrogenase (FAD-GDH) enzyme on the reagent strip. Theelectrons generated by this reaction are shuttled to an electrode bya mediator chemical, producing a current that is proportional to theglucose in the sample. After a fixed reaction time, the glucoseconcentration in the sample is calculated and displayed. |
| 5) Intended Use: | The CONTOUR®NEXT EZ blood glucose monitoring system is an overthe counter (OTC) device utilized for self-testing by persons withdiabetes at home for the quantitative measurement of glucose inwhole blood, is for single-patient use only, and should not be shared.The system is intended for self-testing outside the body (in vitro |
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Image /page/4/Picture/0 description: The image is a logo for Ascensia Diabetes Care. The logo features a purple triangle with a light blue teardrop shape attached to the right side. Below the shape, the word "ASCENSIA" is written in a bold, sans-serif font, and below that, the words "Diabetes Care" are written in a smaller, less bold font.
diagnostic use) and is to be used as an aid to monitor the effectiveness of diabetes control. The CONTOUR® NEXT EZ blood qlucose monitoring system is indicated for use with fresh fingertip capillary whole blood samples.
The CONTOUR® NEXT EZ blood alucose 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 test strips are for use with the CONTOUR® NEXT EZ blood glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
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 Meter (K130265). The modified and predicate devices use the same qlucose calculation algorithm. Both devices also use dry reagent test strips for the measurement of glucose in capillary whole blood by persons with diabetes and liguid controls to check the performance of the system. The same Contour Next test strips and Contour Next control solutions are used by both the modified and predicate devices.
A detailed comparison of the characteristics featured between the modified and predicate devices is provided in the tables on the following pages:
Modified Device (Contour Next EZ meter)
Image /page/4/Picture/8 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 memory recall.
Predicate Device (Contour Next EZ meter)
Image /page/4/Picture/10 description: The image shows a Contour NEXT EZ blood glucose meter. The meter displays a reading of 93 mg/dL, along with the date 10/13 and time 12:24 PM. The device has a gray and white design with a display screen and buttons for navigation and settings. The Bayer logo is visible at the bottom of the meter.
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Image /page/5/Picture/0 description: The image contains the logo for Ascensia Diabetes Care. The logo features a purple triangle shape next to a blue teardrop shape. Below the shapes, the word "ASCENSIA" is written in a bold font, and below that, the words "Diabetes Care" are written in a smaller, less bold font.
| Summary of the Technological Characteristics of the Modified Device Compared toPredicate | ||
|---|---|---|
| SIMILARITIES to Predicate | ||
| Predicate | Contour Next EZ (K162336) | |
| Characteristic | Contour Next EZ(K130265) | (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 | Same as Predicate |
| Countdown time displayed | 5 Seconds | 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 TemperatureRange | 41°-113° F | Same as Predicate |
| Operating Humidity Range | 10-93% RH | Same as Predicate |
| Hematocrit Range | 15%-65% | Same as Predicate |
| Meter life | 5 Years | Same as Predicate |
| Validated Product Used forCleaning and Disinfection | Clorox Germicidal wipes | Same as Predicate |
| Before and After MealMarkers | Yes, when used in advancedsetting | Same as Predicate |
| Calibration/Coding | Autocoding (no coding forusers) | Same as Predicate |
| Display (technology) | Segmented (LCD),Alphanumeric characters &lcons | Same as Predicate |
| Display Visibility | Daylight only | Same as Predicate |
| Communication Link toComputer | Via serial to USB cable | Same as Predicate |
| Summary of the Technological Characteristics of the Modified Device Compared toPredicate | ||
| SIMILARITIES to Predicate | ||
| Characteristic | PredicateContour Next EZ(K130265) | Contour Next EZ (K162336)(Modified Device) |
| Test Results in Memory | 480 Test Results | Same as Predicate |
| Meter Materials | Case Top/Bottom: ABSButtons: AS | Same as Predicate |
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Image /page/6/Picture/0 description: The image contains the logo for Ascensia Diabetes Care. The logo features a purple triangle shape next to a blue teardrop shape. Below the shapes, the text "ASCENSIA" is written in a larger font, and "Diabetes Care" is written in a smaller font.
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Image /page/7/Picture/0 description: The image shows the logo for Ascensia Diabetes Care. The logo features a purple triangle on the left and a blue teardrop shape on the right. Below the shapes, the word "ASCENSIA" is written in a sans-serif font, and below that, the words "Diabetes Care" are written in a smaller font.
| DIFFERENCES from Predicate | |||
|---|---|---|---|
| Characteristic | PredicateContour Next EZ(K130265) | Contour Next EZ(K162336)(Modified Device) | Risk Assessment Summary |
| Improved detection of test strips thatmay have been exposed to a chemicalthat can degrade the mediator | No | Yes | The error check improves the ability of themodified meter to detect exposed test stripsand provide an error message instead of a highbiased result. |
| Improved detection of un-mixedcontrol solution | No | Yes | The error check improves the ability of themodified meter to detect un-mixed control testsolutions and provide an error message insteadof a high biased result. |
| Improved detection of sampleperturbation' during a test | No | Yes | The error check improves the ability of themodified meter to detect a sample that isdisturbed during the countdown period andprovide an error message instead of a biasedresult. |
| Improved data down load capabilitiesof the meter due to the addition ofspecific information parameters to thecommunication protocol:a) The maximum number of bloodglucose (BG) records that the metercan store (BGMAX)b) The total number of BG records thathave ever been stored in meter(BGTOTAL)c) Get a single BG record or set ofrecords when requested from an | No | Yes | The communication changes do not have anyimpact on the user interface or customer bloodglucose test results. |
| DIFFERENCES from Predicate | |||
| Characteristic | PredicateContour Next EZ(K130265) | Contour Next EZ(K162336)(Modified Device) | Risk Assessment Summary |
| external application (such as a datamanagement system)d) Get the actual number (total) BGrecords that the meter currently hasstored when requested from anexternal application (such as a datamanagement system)e) Ability to set BGTOTAL to zero (thisfeature is only used for internaltesting) |
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Image /page/8/Picture/0 description: The image shows the logo for Ascensia Diabetes Care. The logo features a stylized letter "A" in purple, with a blue teardrop shape next to it. Below the shapes, the word "ASCENSIA" is written in a sans-serif font, with the words "Diabetes Care" written in a smaller font below it.
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Image /page/9/Picture/0 description: The image shows the logo for Ascensia Diabetes Care. The logo features a stylized "A" shape in purple, with a blue teardrop shape attached to the right side of the "A". Below the shape is the word "ASCENSIA" in a sans-serif font, and below that is the phrase "Diabetes Care" in a smaller font.
Summary of Performance testing
Bench testing was conducted to ensure that the error checks acted as intended and qave error messages for:
- Test strips that had been exposed to a reducing agent
- Un-mixed control test solution
- Samples that had been disturbed during the test countdown
Equivalency testing was conducted to ensure the performance of the modified and predicate meters was not statistically different.
Software verification testing was conducted to ensure that no qood results were classified as errors as a result of the modifications.
Control testing was conducted to ensure that adequately mixed control solution did not generate error codes.
Conclusions from Performance Evaluations
The Contour Next EZ Blood Glucose Monitoring System is substantially equivalent in its intended use, performance, safety and effectiveness to the predicate Contour Next EZ Blood Glucose Monitoring System (K130265) based on the performance of the modified Contour Next EZ Blood Glucose Monitoring System.
§ 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.