(252 days)
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.
CONTOUR® NEXT ONE Blood Glucose Monitoring System is a blood glucose meter with Bluetooth Low Energy technology built in so that the meter can communicate wirelessly to a mobile smart device. The meter uses the CONTOUR NEXT test strips and CONTOUR NEXT control solution. It utilizes a similar algorithm to the one used in the CONTOUR NEXT USB blood glucose meter, but this algorithm has been enhanced for even better accuracy. The meter has a 7-segment display and icons in the display to aid the user with the features of the meter. It uses two replaceable CR2032 coin cell batteries. The associated CONTOUR Diabetes app is compatible with Apple iOS operating system and the Android operating system. The app communicates with the CONTOUR® NEXT ONE blood glucose meter using Bluetooth Low Energy wireless technology. Blood glucose test results are automatically sent to the mobile device for viewing and editing, and settings on the meter can be modified using the app.
The provided document is a 510(k) summary for the Contour Next ONE Blood Glucose Monitoring System. It outlines the device description, intended use, and a comparison to a predicate device (Contour Next USB Blood Glucose Monitoring System). While it mentions "Clinical trials and bench testing showed that the Contour Next One Blood Glucose Monitoring System performed as intended and met the system specifications," it does not provide detailed acceptance criteria or study results for accuracy, which would typically include metrics like bias, precision, or agreement rates against a reference method. It also does not discuss sample sizes, ground truth establishment, or expert involvement in a manner relevant to the accuracy of the blood glucose measurements.
Therefore, many of the requested details cannot be extracted from this document as they are not present.
Here's what can be extracted:
-
A table of acceptance criteria and the reported device performance
This information is not provided in the document. The document states "Clinical trials and bench testing showed that the Contour Next One Blood Glucose Monitoring System performed as intended and met the system specifications," but it doesn't give specific numerical acceptance criteria (e.g., % of results within ±X mg/dL of reference) or the precise performance values achieved against those criteria. -
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. For blood glucose monitoring systems, the "ground truth" is typically a laboratory reference method, not an expert panel. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. Adjudication methods are typically used for subjective assessments (e.g., image interpretation), not for quantitative measurements like blood glucose. -
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable and not provided. MRMC studies are related to interpretive tasks often involving medical imaging, not blood glucose meters where the device provides a direct numerical reading. There is no "AI assistance" for human readers in this context. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The device itself (Blood Glucose Monitoring System) is a standalone measurement tool. The document states, "Clinical trials and bench testing showed that the Contour Next One Blood Glucose Monitoring System performed as intended and met the system specifications." This implies standalone performance was evaluated, but details of the study are not provided. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document does not explicitly state the type of ground truth used for accuracy studies. For blood glucose meters, the standard ground truth is typically a validated laboratory reference method (e.g., YSI analyzer) measuring plasma glucose. -
The sample size for the training set
This information is not provided in the document. While the document mentions the algorithm was "enhanced for even better accuracy," it does not discuss training sets or how the algorithm was developed in detail. -
How the ground truth for the training set was established
This information is not provided in the document.
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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 (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) 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 Regulatory Affairs Manager Ascensia Diabetes Care 430 South Beiger Street Mishawaka, IN 46544 Telephone: (574) 256-3447 |
|---|---|
| 2) Device name: | Trade name: CONTOUR® NEXT ONE Blood Glucose Monitoring System K160682 Common name: Blood Glucose Meter and app Classification name: 75 NBW; Glucose Test System, OTC, 75 LFR; Glucose Dehydrogenase |
| 3) Predicate device: | CONTOUR® NEXT USB Blood Glucose Monitoring System (K150942) |
| 4) Device description: | CONTOUR® NEXT ONE Blood Glucose Monitoring System is a blood glucose meter with Bluetooth Low Energy technology built in so that the meter can communicate wirelessly to a mobile smart device. The meter uses the CONTOUR NEXT test strips and CONTOUR NEXT control solution. It utilizes a similar algorithm to the one used in the CONTOUR NEXT USB blood glucose meter, but this algorithm has been enhanced for even better accuracy. The meter has a 7- segment display and icons in the display to aid the user with the features of the meter. It uses two replaceable CR2032 coin cell batteries. The associated CONTOUR Diabetes app is compatible with Apple iOS operating system and the Android operating system. The app communicates with the CONTOUR® NEXT ONE blood glucose meter using Bluetooth Low Energy wireless technology. Blood glucose test results are automatically sent to the mobile device for viewing and editing, and settings on the meter can be modified using the app. |
| 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(Predicate device) | CONTOUR NEXT ONE |
|---|---|---|
| Test strip | CONTOUR® NEXT Teststrips | Same as predicate |
| Test strip chemistry | FAD-GDH (MLB as themediator) | 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(Predicate device) | CONTOUR NEXT ONE |
|---|---|---|
| Meal markers | Yes | Same as predicate |
| Automatic calibration | Yes | Same as predicate |
| Meal markers | Pre-meal, post-meal,fasting and no mark | Same as predicate |
| Enhanced error detection fortest strips exposed to areducing agent | Yes | Same as predicate |
| Enhanced error detection forcontrol solution not mixed | Yes | Same as predicate |
| Enhanced error detection forperturbed 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(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(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).
§ 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.