(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.
§ 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.