(156 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 gluosse 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 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 meter remains unchanged.
The CONTOUR® NEXT Blood Glucose 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 Blood Glucose Test Strips are to be used with an over the counter (OTC) device utilized by lay-users with diabetes in home settings for the measurement of glucose in whole blood. There is no change in either intended use or indications for use. CONTOUR® NEXT Blood Glucose Test Strips remain the same.
The modification discussed in this Special 510K consists of the following:
- Replacing the current CONTOUR NEXT Blood Glucose test strips in the CONTOUR NEXT ONE Blood Glucose Monitoring System packaging from CONTOUR NEXT glucose Test strips in a bottle to CONTOUR NEXT glucose test strips in foiled packaging ("Foiled Strips"). The Foiled Strips were cleared under K191286 for a retail box package. This new, alternative packaging configuration consists of the Foiled Strips (without a retail box) placed in a wallet with the other system components.
- Replacing the current CONTOUR NEXT ONE color, booklet User Guide with a black and white pamphlet User Guide. In addition, some format and minor content labeling changes to the User Guide and Quick Reference Guide have occurred with this transformation. Please see Volume 012 for proposed labeling changes.
- Replacing the current CONTOUR NEXT ONE Blood Glucose Monitoring System packaging with a smaller outer carton.
This modification represents an alternative labeling and packaging configuration.
The provided text is a 510(k) Summary for the CONTOUR® NEXT ONE Blood Glucose Monitoring System. This document describes modifications made to an existing device (predicate device K191286) and seeks to demonstrate substantial equivalence to the predicate.
Here's an analysis of the acceptance criteria and study information, based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or a detailed table of device performance results against specific criteria. It broadly states that "Verification and validation testing against well-established methods showed that the CONTOUR® NEXT ONE Blood Glucose Monitoring System, with the proposed changes outlined herein, performed as intended and met the system specifications."
The core of this 510(k) is about packaging and labeling changes, not fundamental performance changes of the blood glucose measurement technology itself. The performance of the underlying blood glucose test strips (CONTOUR® NEXT Blood Glucose Test Strips) is implicitly covered by their prior clearance (K191286) and the statement "CONTOUR® NEXT Blood Glucose Test Strips remain the same."
The key performance assessment mentioned is:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Usability of the new "black and white pamphlet User Guide" | "Usability testing on the proposed black and white pamphlet User Guide was conducted to ensure that the CONTOUR® NEXT ONE Blood Glucose Monitoring System was easy to use by typical customers." (No specific metrics or pass/fail thresholds are provided in this summary.) |
| Overall performance of the system with proposed changes | "performed as intended and met the system specifications." (General statement, no specific metrics provided in this summary.) |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size for the usability test set(s) or the provenance (country of origin, retrospective/prospective) of the data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. The usability testing likely involved "typical customers" (lay users with diabetes), not necessarily experts in establishing a ground truth for a medical device's performance, but rather experts in using the device.
4. Adjudication method for the test set
This information is not provided.
5. 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
An MRMC study is not relevant here as the device is a Blood Glucose Monitoring System, not an imaging device with human readers or AI assistance in interpretation. The context is self-testing for glucose levels.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable. The device measures glucose (an "algorithm" in itself to convert electrical signals to glucose values), and the performance of this measurement system is covered by prior clearances. The current submission focuses on packaging and labeling updates.
7. The type of ground truth used
For the usability testing, the "ground truth" would be the ability of typical users to correctly and safely operate the device following the new pamphlet guide. This is typically assessed through observational studies, task completion success rates, and user feedback. No specific "ground truth" method (like pathology or outcomes data) is described in this summary.
For the measurement accuracy of the blood glucose system itself, the ground truth would typically be established against a laboratory reference method (e.g., YSI analyzer). However, this submission relies on the established performance of the CONTOUR® NEXT Test Strips and meter from the predicate device (K191286), rather than presenting new accuracy data for the measurement component.
8. The sample size for the training set
This information is not provided and is not applicable for a traditional ML/AI "training set" as this is not an AI/ML device per se. If "training set" refers to samples used for initial development and validation of the (non-AI) blood glucose measurement algorithm, that data would have been part of the predicate device's submission and is not detailed here.
9. How the ground truth for the training set was established
Not applicable as this is not an AI/ML device. For the predicate device, the ground truth for the glucose measurement accuracy would have been established against a laboratory reference method.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 11, 2021
Ascensia Diabetes Care Stacie Geffner-Atiya Principal Regulatory Affairs Associate 100 Summit Lake Drive Valhalla, New York 10595
Re: K210687
Trade/Device Name: CONTOUR® NEXT ONE Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW Dated: March 9, 2021 Received: March 10, 2021
Dear Stacie Geffner-Atiya:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Marianela Perez-Torres, Ph.D. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210687
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 gluosse 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)
| Research Use Only. Not for use in diagnostic procedures. | |
|---|---|
| In Vitro Diagnostic. For use in diagnostic procedures. |
| | 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 "A" shape in purple, with a blue teardrop shape next to it. Below the shapes, the word "ASCENSIA" is written in a bold font, with the words "Diabetes Care" written in a smaller font underneath.
510k Summary: K210687
Date prepared: August 11, 2021
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 | Stacie Geffner-AtiyaPrincipal Regulatory Affairs SpecialistAscensia Diabetes Care100 Summit Lake DriveValhalla, NY 10595 |
|---|---|
| 2) Device name: | Trade name: CONTOUR® NEXT ONE Blood GlucoseMonitoring SystemCommon name: Glucose Test SystemClassification name: NBW; Glucose Test System, OTC(21 C.F.R. Section 862.1345) |
| 3) PredicateDevice: | CONTOUR® NEXT ONE (K191286) |
| 4) DeviceDescription: | CONTOUR® NEXT ONE Blood Glucose Monitoring Systemis a blood glucose meter with Bluetooth Low Energytechnology built in so that the meter can communicatewirelessly to a mobile smart device. The meter has a 7-segment display and icons in the display to aid the user withthe features of the meter. It uses two replaceable CR2032coin cell batteries. The associated CONTOUR Diabetes appis compatible with Apple iOS operating system and theAndroid operating system. The app communicates with theCONTOUR® NEXT ONE blood glucose meter using BluetoothLow Energy wireless technology. Blood glucose test resultsare automatically sent to the mobile device for viewing andediting, and settings on the meter can be modified using theapp. The meter remains unchanged. |
| The CONTOUR® NEXT Blood Glucose Test Strips are |
al e intended for self-testing by persons with diabetes for the
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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 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 font.
quantitative measurement of glucose in whole blood samples from 20 to 600 mg/dL. The CONTOUR® NEXT Blood Glucose Test Strips are to be used with an over the counter (OTC) device utilized by lay-users with diabetes in home settings for the measurement of glucose in whole blood. There is no change in either intended use or indications for use. CONTOUR® NEXT Blood Glucose Test Strips remain the same.
The modification discussed in this Special 510K consists of the following:
-
- Replacing the current CONTOUR NEXT Blood Glucose test strips in the CONTOUR NEXT ONE Blood Glucose Monitoring System packaging from CONTOUR NEXT glucose Test strips in a bottle to CONTOUR NEXT glucose test strips in foiled packaging ("Foiled Strips"). The Foiled Strips were cleared under K191286 for a retail box package. This new, alternative packaging configuration consists of the Foiled Strips (without a retail box) placed in a wallet with the other system components.
-
- Replacing the current CONTOUR NEXT ONE color, booklet User Guide with a black and white pamphlet User Guide. In addition, some format and minor content labeling changes to the User Guide and Quick Reference Guide have occurred with this transformation. Please see Volume 012 for proposed labeling changes.
-
- Replacing the current CONTOUR NEXT ONE Blood Glucose Monitoring System packaging with a smaller outer carton.
This modification represents an alternative labeling and packaging configuration.
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Image /page/5/Picture/0 description: The image contains the logo for Ascensia Diabetes Care. The logo features a stylized letter "A" in purple next to a blue water droplet. Below the graphic are the words "ASCENSIA" and "Diabetes Care" in a smaller font size.
- Intended The CONTOUR® NEXT ONE Blood Glucose Monitoring System is Use(s): 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 selftesting 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 time (when glucose is not changing rapidly).
The CONTOUR® NEXT Blood Glucose 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.
| Predicate Device | Subject Device | |
|---|---|---|
| PRODUCT NAME | CONTOUR® NEXT ONE BloodGlucose Monitoring System(K191286) | CONTOUR NEXT ONE BloodGlucose Monitoring System |
| CHARACTERISTICS | ||
| Meter | CONTOUR® NEXT OneMeter | Same as predicate |
| Test strip | CONTOUR® NEXT TestStrips | Same as predicate |
| CONTOUR® NEXTONE Blood GlucoseMonitoring SystemPackagingConfiguration | CONTOUR® NEXT BloodGlucose Test Strips indesiccated-lined bottle orCONTOUR® NEXT BloodGlucose Test Strips indesiccated-lined foil pouch | CONTOUR® NEXT BloodGlucose Test Strips indesiccated-lined foil pouch,place in a wallet, included inthe Contour Next One |
A detailed comparison of the modified device and predicate device is provided below:
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Image /page/6/Picture/0 description: The image shows the logo for Ascensia Diabetes Care. The logo features a purple triangle 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.
| Predicate Device | Subject Device | |
|---|---|---|
| PRODUCT NAME | CONTOUR® NEXT ONE BloodGlucose Monitoring System(K191286) | CONTOUR NEXT ONE BloodGlucose Monitoring System |
| sold separately in retailpackaging. | Blood Glucose MonitoringSystem Packaging. | |
| CONTOUR® NEXTONE Blood GlucoseMonitoring SystemOuter Carton Box | Carton Box Dimensions:12.065 x 6.985 x 16.670 cm | Carton Box Dimensions:11.50 x 5.00 x 16.50 cm |
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Image /page/7/Picture/0 description: The image shows the logo for Ascensia Diabetes Care. The logo features a stylized "A" formed by a purple triangle and a blue teardrop shape. Below the symbol, 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.
| Predicate Device | Subject Device | |
|---|---|---|
| PRODUCT NAME | CONTOUR® NEXT ONE BloodGlucose Monitoring System(K191286) | CONTOUR NEXT ONE BloodGlucose Monitoring System |
| CHARACTERISTICS | ||
| CONTOUR NEXT ONEBlood GlucoseMonitoring System UserGuide | Color Booklet Format | Folded black and whitepamphlet, along with someformat and minor contentlabeling changes haveoccurred with thistransformation |
Summary of Performance testing
Verification and validation testing against well-established methods showed that the CONTOUR® NEXT ONE Blood Glucose Monitoring System, with the proposed changes outlined herein, performed as intended and met the system specifications.
Usability testing on the proposed black and white pamphlet User Guide was conducted to ensure that the CONTOUR® NEXT ONE Blood Glucose Monitoring System was easy to use by typical customers.
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 CONTOUR® NEXT ONE Blood Glucose Monitoring System (K191286).
§ 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.