Contour Next EZ Blood Glucose Monitoring System

K162336 · Ascensia Diabetes Care U.S., Inc. · NBW · Jan 12, 2017 · Clinical Chemistry

Device Facts

• Record ID: K162336
• Device Name: Contour Next EZ Blood Glucose Monitoring System
• Applicant: Ascensia Diabetes Care U.S., Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jan 12, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Contour Next EZ Blood Glucose Monitoring System is intended for single-patient use only.

Device Story

Handheld blood glucose meter; uses dry reagent test strips; measures glucose in capillary whole blood via amperometric detection. User applies blood to strip; FAD-GDH enzyme reaction generates current proportional to glucose concentration; meter calculates and displays result. Used by patients with diabetes at home for monitoring glucose control. Includes error detection for degraded test strips, un-mixed control solutions, and sample perturbation. Data can be downloaded via serial-to-USB cable to external management systems. Benefits include improved accuracy through error checking and reliable monitoring of diabetes management.

Clinical Evidence

Bench testing only. Verification and validation activities performed based on risk analysis to confirm that modifications (error detection for strip degradation, control solution, and sample perturbation) function as intended without impacting fundamental technology.

Technological Characteristics

Blood glucose meter; electrochemical sensing principle. Modifications include firmware-based error condition checks and communication protocol updates ('Q Token'). Device materials validated for 520 cleaning/disinfection cycles (260 cleaning, 260 disinfection) using Clorox Germicidal Wipes. Standalone operation with data management system connectivity.

Indications for Use

Indicated for single-patient use for the quantitative measurement of glucose in capillary whole blood as an aid in monitoring the effectiveness of diabetes control programs.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Contour Next EZ Blood Glucose Monitoring System (K130265)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other, with flowing lines extending from the bottom profile.

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.

{1}------------------------------------------------

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 [phone] or [phone] 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 [phone] or [phone] 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

{2}------------------------------------------------

## 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) | |
|--------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| <label><input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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 Gregory<br>Regulatory Affairs Manager<br>Ascensia Diabetes Care US Inc.<br>430 South Beiger Street<br>Mishawaka, IN 46544<br>Telephone: [phone]<br>Fax: [phone] |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2) Device name: | Trade name: Contour® Next EZ Blood Glucose Monitoring System<br>K162336<br>Common name: Blood Glucose Test System<br>Classification: Class II<br>Classification name: Blood Glucose Test System, Over-the-Counter,<br>75 NBW and Glucose Dehydrogenase, 75 LFR (21 CFR § 862.1345) |
| 3) Predicate device: | Contour Next EZ Blood Glucose Monitoring System (K130265)) |
| 4) Device<br>description: | The Contour Next EZ Blood Glucose Meter consists of a small<br>handheld blood glucose meter that utilizes dry reagent test strips for<br>the measurement of glucose in capillary whole blood by persons with<br>diabetes. Liquid control solution is used to check the performance<br>of the system. The meter, together with the test strips and control<br>solutions, is referred to as the Contour Next EZ Blood Glucose<br>Monitoring System.<br>The chemical principle utilized for both the predicate and modified<br>devices is based on measurement of electrical current caused by the<br>reaction of glucose in the blood with chemicals on the reagent strip.<br>The blood sample is drawn into the tip of the reagent strip through<br>capillary action. Glucose in the sample reacts with FAD glucose<br>dehydrogenase (FAD-GDH) enzyme on the reagent strip. The<br>electrons generated by this reaction are shuttled to an electrode by<br>a mediator chemical, producing a current that is proportional to the<br>glucose in the sample. After a fixed reaction time, the glucose<br>concentration in the sample is calculated and displayed. |
| 5) Intended Use: | The CONTOUR®NEXT EZ blood glucose monitoring system is an over<br>the counter (OTC) device utilized for self-testing by persons with<br>diabetes at home for the quantitative measurement of glucose in<br>whole blood, is for single-patient use only, and should not be shared.<br>The system is intended for self-testing outside the body (in vitro |

{4}------------------------------------------------

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.

{5}------------------------------------------------

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 to<br>Predicate | | |
|----------------------------------------------------------------------------------------------|--------------------------------------------------------|------------------------------------------------|
| 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<br>(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 and<br>menu/power button | Same as Predicate |
| Battery Type | Two 3-volt lithium batteries<br>(DL2032 or CR2032) | Same as Predicate |
| Operating Temperature<br>Range | 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 for<br>Cleaning and Disinfection | Clorox Germicidal wipes | Same as Predicate |
| Before and After Meal<br>Markers | Yes, when used in advanced<br>setting | Same as Predicate |
| Calibration/Coding | Autocoding (no coding for<br>users) | Same as Predicate |
| Display (technology) | Segmented (LCD),<br>Alphanumeric characters &<br>lcons | Same as Predicate |
| Display Visibility | Daylight only | Same as Predicate |
| Communication Link to<br>Computer | Via serial to USB cable | Same as Predicate |
| Summary of the Technological Characteristics of the Modified Device Compared to<br>Predicate | | |
| SIMILARITIES to Predicate | | |
| Characteristic | Predicate<br>Contour Next EZ(K130265) | Contour Next EZ (K162336)<br>(Modified Device) |
| Test Results in Memory | 480 Test Results | Same as Predicate |
| Meter Materials | Case Top/Bottom: ABS<br>Buttons: AS | Same as Predicate |

{6}------------------------------------------------

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.

{7}------------------------------------------------

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 | Predicate<br>Contour Next EZ<br>(K130265) | Contour Next EZ<br>(K162336)<br>(Modified Device) | Risk Assessment Summary |
| Improved detection of test strips that<br>may have been exposed to a chemical<br>that can degrade the mediator | No | Yes | The error check improves the ability of the<br>modified meter to detect exposed test strips<br>and provide an error message instead of a high<br>biased result. |
| Improved detection of un-mixed<br>control solution | No | Yes | The error check improves the ability of the<br>modified meter to detect un-mixed control test<br>solutions and provide an error message instead<br>of a high biased result. |
| Improved detection of sample<br>perturbation' during a test | No | Yes | The error check improves the ability of the<br>modified meter to detect a sample that is<br>disturbed during the countdown period and<br>provide an error message instead of a biased<br>result. |
| Improved data down load capabilities<br>of the meter due to the addition of<br>specific information parameters to the<br>communication protocol:<br>a) The maximum number of blood<br>glucose (BG) records that the meter<br>can store (BGMAX)<br>b) The total number of BG records that<br>have ever been stored in meter<br>(BGTOTAL)<br>c) Get a single BG record or set of<br>records when requested from an | No | Yes | The communication changes do not have any<br>impact on the user interface or customer blood<br>glucose test results. |
| DIFFERENCES from Predicate | | | |
| Characteristic | Predicate<br>Contour Next EZ<br>(K130265) | Contour Next EZ<br>(K162336)<br>(Modified Device) | Risk Assessment Summary |
| external application (such as a data<br>management system)<br>d) Get the actual number (total) BG<br>records that the meter currently has<br>stored when requested from an<br>external application (such as a data<br>management system)<br>e) Ability to set BGTOTAL to zero (this<br>feature is only used for internal<br>testing) | | | |

{8}------------------------------------------------

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.

{9}------------------------------------------------

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.