CONTOUR NEXT ONE Blood Glucose Monitoring System

K160682 · Ascensia Diabetes Care · NBW · Nov 17, 2016 · Clinical Chemistry

Device Facts

• Record ID: K160682
• Device Name: CONTOUR NEXT ONE Blood Glucose Monitoring System
• Applicant: Ascensia Diabetes Care
• Product Code: NBW · Clinical Chemistry
• Decision Date: Nov 17, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Contour® Next ONE blood glucose monitoring system is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips or palm. The Contour® Next ONE blood glucose monitoring system is intended to be used by a single person and should not be shared. The Contour® Next ONE blood glucose monitoring system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program. The Contour® Next ONE blood glucose monitoring system should not be used for the diagnosis of or screening for diabetes or for neonatal use. Alternative site testing (palm) should be done only during steady state times (when glucose is not changing rapidly). The Contour® Next test strips are for use with the Contour® Next ONE blood glucose meter to quantitatively measure glucose in fresh capillary whole blood drawn from the fingertips or palm. The system is intended for in vitro diagnostic use only.

Device Story

Blood glucose monitoring system; measures glucose in fresh capillary whole blood via test strips; utilizes FAD-GDH chemistry; multi-pulse voltage pattern. Device includes meter with Bluetooth Low Energy (BLE) for wireless data transmission to mobile app (iOS/Android). Meter features LCD display, illuminated strip port (color-coded target indicators), and physical buttons. Used by patients at home for self-monitoring; data automatically syncs to app for viewing/editing. Enhances diabetes management by providing real-time glucose readings and trend tracking. Replaces rechargeable battery with CR2032 coin cells; increases sample re-application time to 60 seconds.

Clinical Evidence

Bench testing included precision, linearity (20-600 mg/dL), analytical specificity, altitude, hematocrit, and environmental robustness. Clinical performance evaluated via lay-user studies (n=372) for fingerstick and palm testing compared to YSI 2300 reference. Fingerstick results: 100% within ±15% for ≥75 mg/dL. Palm results: 98.6% within ±20% for ≥75 mg/dL. No clinical sensitivity/specificity data required for this device type.

Technological Characteristics

Blood glucose meter using FAD-GDH electrochemical sensing. Connectivity: Bluetooth Low Energy (BLE) to mobile devices, Micro-USB for PC. Power: 2x CR2032 coin cell batteries. Display: LCD with 7-segments and icons. Features illuminated strip port for target range indication. Algorithm: Modified regression equations based on predicate.

Indications for Use

Indicated for people with diabetes for quantitative self-testing of glucose in fresh capillary whole blood from fingertips or palm to monitor diabetes control program effectiveness. Not for diabetes diagnosis, screening, or neonatal use. Alternative site testing (palm) restricted to steady-state glucose conditions.

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 USB Blood Glucose Monitoring System (K150942)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. 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 image of three human profiles facing to the right, with flowing lines connecting them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 17, 2016

ASCENSIA DIABETES CARE JENNIFER GREGORY REGULATORY AFFAIRS MANAGER 430 S. BEIGER ST. MISHAWAKA IN 46544

Re: K160682

Trade/Device Name: Contour Next ONE Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, LFR Dated: November 4, 2016 Received: November 7, 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 [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

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# Indications for Use

510(k) Number (if known) K160682

#### Device Name

Contour Next ONE Blood Glucose Monitoring System

#### Indications for Use (Describe)

The Contour® Next ONE Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips or palm. The Contour® Next ONE Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The Contour® Next ONE Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program.

The Contour® Next ONE Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. Alternative site testing (palm) should be done only during steady state times (when glucose is not changing rapidly). The Contour® Next test strips are for use with the Contour® Next ONE blood glucose meter to quantitatively measure glucose in fresh capillary whole blood drawn from the fingertips or palm.

The system is intended for in vitro diagnostic use only.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

| Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Ascensia Diabetes Care. The logo features a stylized letter "A" formed by a purple triangle on the left and a blue teardrop shape on the right. Below the symbol, the word "ASCENSIA" is written in a sans-serif font, with the words "Diabetes Care" in a smaller font size underneath.

## 510(k) Summary

Date prepared: November 10, 2016

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 <p>Regulatory Affairs Manager</p> <p>Ascensia Diabetes Care</p> <p>430 South Beiger Street</p> <p>Mishawaka, IN 46544</p> <p>Telephone: [phone]</p> |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2) Device name: | Trade name: CONTOUR® NEXT ONE Blood Glucose <p>Monitoring System K160682</p> <p>Common name: Blood Glucose Meter and app</p> <p>Classification name: 75 NBW; Glucose Test System, OTC,</p> <p>75 LFR; Glucose Dehydrogenase</p> |
| 3) Predicate device: | CONTOUR® NEXT USB Blood Glucose Monitoring <p>System (K150942)</p> |
| 4) Device description: | CONTOUR® NEXT ONE Blood Glucose Monitoring <p>System is a blood glucose meter with Bluetooth Low</p> <p>Energy technology built in so that the meter can</p> <p>communicate wirelessly to a mobile smart device. The</p> <p>meter uses the CONTOUR NEXT test strips and</p> <p>CONTOUR NEXT control solution. It utilizes a similar</p> <p>algorithm to the one used in the CONTOUR NEXT USB</p> <p>blood glucose meter, but this algorithm has been</p> <p>enhanced for even better accuracy. The meter has a 7-</p> <p>segment display and icons in the display to aid the user</p> <p>with the features of the meter. It uses two replaceable</p> <p>CR2032 coin cell batteries. The associated CONTOUR</p> <p>Diabetes app is compatible with Apple iOS operating</p> <p>system and the Android operating system. The app</p> <p>communicates with the CONTOUR® NEXT ONE blood</p> <p>glucose meter using Bluetooth Low Energy wireless</p> <p>technology. Blood glucose test results are automatically</p> <p>sent to the mobile device for viewing and editing, and</p> <p>settings on the meter can be modified using the app.</p> |
| 5) Intended Use: | The Contour® Next ONE Blood Glucose Monitoring |

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Image /page/4/Picture/0 description: The image shows the logo for Ascensia Diabetes Care. The logo features a stylized letter "A" in purple, next to a blue teardrop shape. Below the shapes, the word "ASCENSIA" is written in a dark purple sans-serif font, with the words "Diabetes Care" written in a smaller font below it.

System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips or palm. The Contour® Next ONE Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The Contour® Next ONE Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program.

The Contour® Next ONE Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. Alternative site testing (palm) should be done only during steady state times (when glucose is not changing rapidly). The Contour® Next test strips are for use with the Contour® Next ONE blood glucose meter to quantitatively measure qlucose in fresh capillary whole blood drawn from the fingertips or palm.

The system is intended for in vitro diagnostic use only.

# Data demonstrating substantial equivalence

A detailed comparison of the modified device and predicate device is provided in the tables below:

| Feature | CONTOUR NEXT USB<br>(Predicate device) | CONTOUR NEXT ONE |
|-------------------------|----------------------------------------|-------------------|
| Test strip | CONTOUR® NEXT Test<br>strips | Same as predicate |
| Test strip chemistry | FAD-GDH (MLB as the<br>mediator) | Same as predicate |
| Blood sample volume | 0.6µL | Same as predicate |
| Test count-down time | 5 seconds | Same as predicate |
| Applied voltage pattern | Multi-pulse | Same as predicate |
| Glucose range | 20-600 mg/dL | Same as predicate |
| Controls | CONTOUR® NEXT Control | Same as predicate |
| Control solution ranges | Level 1 and 2 | Same as predicate |

# Table of Similarities between CONTOUR® NEXT ONE to CONTOUR® NEXT USB (K150942):

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Image /page/5/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 incorporated into the design. Below the symbol, the word "ASCENSIA" is written in a sans-serif font, followed by the words "Diabetes Care" in a smaller font size.

| Feature | CONTOUR NEXT USB<br>(Predicate device) | CONTOUR NEXT ONE |
|----------------------------------------------------------------------------|---------------------------------------------|-------------------|
| Meal markers | Yes | Same as predicate |
| Automatic calibration | Yes | Same as predicate |
| Meal markers | Pre-meal, post-meal,<br>fasting and no mark | Same as predicate |
| Enhanced error detection for<br>test strips exposed to a<br>reducing agent | Yes | Same as predicate |
| Enhanced error detection for<br>control solution not mixed | Yes | Same as predicate |
| Enhanced error detection for<br>perturbed test strips | Yes | 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 word "ASCENSIA" is written in purple, and below that, the words "Diabetes Care" are written in a smaller font.

## Table of Differences between CONTOUR NEXT ONE and CONTOUR NEXT USB (K150942):

| Feature | CONTOUR NEXT USB<br>(Predicate device) | CONTOUR NEXT ONE |
|----------------------------------------|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Algorithm | Multiple regression equations | Modified terms in the equations for improved accuracy |
| Wireless technology | No wireless communication | Bluetooth Low Energy to smart phones and tablets |
| PC connection | USB port | Micro-USB port |
| Display | Graphical OLED with text | LCD with 7-segments and icons |
| Color Indicator for Above/Below Target | Color display | Illuminated Strip Port, with colors indicating glucose result<br>(red=below target, yellow=above target, green=in target) |
| Buttons | 4 | 1 center button with up/down rocker button |
| Sample re-application capability | 30-second re-application time | 60-second re-application time |
| Battery type | Lithium Polymer rechargeable | CR 2032 |
| Test memory | 2000 results | 800 results |

Image /page/6/Picture/3 description: The image shows a Contour NEXT USB blood glucose meter. The meter has a digital display showing a reading of 93, along with the time 1:33 PM and the date 11/10. The display also indicates that the reading was taken before a meal. The meter has a sleek, modern design with a silver and black color scheme.

Image /page/6/Picture/4 description: The image shows a Contour Next One blood glucose meter. The meter displays a reading of 93 mg/dL, with the time 9:41 AM and date 3/8/15. The meter is black and has a sleek, modern design. The Contour Next One is a popular blood glucose meter used by people with diabetes to monitor their blood sugar levels.

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Image /page/7/Picture/0 description: The image is a 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 dark purple sans-serif font, and below that, the words "Diabetes Care" are written in a smaller, lighter purple font.

### Summary of Performance testing

Clinical trials and bench testing showed that the Contour Next One Blood Glucose Monitoring System performed as intended and met the system specifications.

Usability testing was conducted to ensure that the Contour Next One Blood Glucose Monitoring System was easy to use by typical customers. Usability testing was also done on the app to ensure that the app could be linked to the meter, that the applicable meter parameters could be set up, that data could be successfully transmitted from the meter to the app, and that the features of the app were easy to use and understand.

## Conclusions from Performance Evaluations

Based on the outcome of the performance testing conducted, the modified Contour Next One Blood Glucose Monitoring System is substantially equivalent to the predicate Contour Next USB Blood Glucose Monitoring System (K150942).