(259 days)
The CONTOUR® PLUS BLUE Blood Glucose Monitoring System consists of the CONTOUR® PLUS BLUE meter, the CONTOUR® PLUS blood glucose test strips and the Contour® Diabetes app.
The CONTOUR® PLUS BLUE Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips. The CONTOUR® PLUS BLUE Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The CONTOUR® PLUS BLUE 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® PLUS BLUE Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. The CONTOUR® PLUS blood glucose test strips are for use with the CONTOUR® PLUS BLUE meter to quantitatively measure glucose in fresh capillary whole blood drawn from the fingertips.
The system is intended for in vitro diagnostic use only.
CONTOUR® PLUS BLUE Blood Glucose Monitoring System is a blood glucose monitoring system with Bluetooth Low Energy technology built in so that the meter can communicate wirelessly to smart phones and tablets. The meter uses the CONTOUR® PLUS blood glucose test strips and CONTOUR® PLUS control solution. The meter can be connected to the Contour® Diabetes app. It utilizes a similar algorithm as the one used in the CONTOUR® NEXT GEN Blood Glucose Monitoring System. It uses two replaceable coin cell batteries. The meter's shape is a traditional oval form factor and it includes an on-screen arrow that points to the color indicating if a glucose result is above, within, or below target range.
This document describes the CONTOUR® PLUS BLUE Blood Glucose Monitoring System, a medical device for quantitative measurement of glucose in fresh capillary whole blood. The submission aims to demonstrate substantial equivalence to a predicate device (CONTOUR® NEXT GEN Blood Glucose Monitoring System (K193407)).
Here's an analysis of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text generally states that the device "met the system specifications" and "performed as intended." However, it does not provide specific numerical acceptance criteria or detailed performance data in a tabular format as requested. Therefore, the table below provides what can be inferred from the text, but lacks the specific quantitative details typically found in such a table.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Bench Testing | The CONTOUR® PLUS BLUE Blood Glucose Monitoring System performed as intended and met the system specifications. |
| Usability Testing | The CONTOUR® PLUS BLUE Blood Glucose Monitoring System was easy to use by typical customers. |
| Clinical Testing | The CONTOUR® PLUS BLUE Blood Glucose Monitoring System performed as intended and met the system specifications. |
Important Note: The current document lacks the detailed numerical acceptance criteria (e.g., specific accuracy ranges, precision limits, interference limits) and the corresponding measured performance data. For a complete answer, this information would be required from a more detailed study report.
2. Sample Size and Data Provenance
The document states that "clinical testing showed that the CONTOUR® PLUS BLUE Blood Glucose Monitoring System performed as intended and met the system specifications." However, it does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the study).
3. Number of Experts and Qualifications for Ground Truth
The document does not provide any information regarding the number of experts used to establish the ground truth for the test set or their qualifications. This information is typically relevant for studies involving human interpretation (e.g., interpretation of medical images), which is not directly applicable to a blood glucose monitoring system that provides a quantitative reading. The "ground truth" for a device measuring glucose would likely be a highly accurate laboratory reference method.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method. This is usually relevant in studies where multiple human readers or experts are involved in assessing data, and their disagreements need to be resolved. For a blood glucose monitoring system, the "adjudication" would refer to the process by which the reference method's result is established, which is typically a standardized laboratory procedure rather than expert consensus on interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable to a blood glucose monitoring system. This type of study evaluates the effect of AI assistance on human reader performance, typically in diagnostic imaging. The CONTOUR® PLUS BLUE system directly measures glucose and provides a reading, without human interpretation in the same way an imaging study would require. Therefore, no such study was performed or needed.
6. Standalone Performance (Algorithm Only)
The document focuses on the overall system performance, which includes the meter, test strips, and app. It states that the system "met the system specifications." While the device uses "a similar algorithm as the one used in the CONTOUR® NEXT GEN Blood Glucose Monitoring System," the document does not provide separate standalone (algorithm-only) performance data. The performance described encompasses the integrated device.
7. Type of Ground Truth Used
While not explicitly stated, for a blood glucose monitoring system, the ground truth is typically established using a highly accurate laboratory reference method for glucose measurement (e.g., a YSI analyzer, or a certified clinical laboratory method). This is the gold standard against which the device's measurements are compared. The document states "clinical testing showed that the CONTOUR® PLUS BLUE Blood Glucose Monitoring System performed as intended and met the system specifications," implying comparison to a reference.
8. Sample Size for the Training Set
The document does not provide any information about the sample size for the training set. The device utilizes "a similar algorithm as the one used in the CONTOUR® NEXT GEN Blood Glucose Monitoring System," which suggests that the core algorithm may have been trained previously, and this submission focuses on validating the integrated system.
9. How Ground Truth for Training Set Was Established
The document does not provide any information on how the ground truth for the training set was established. Given it states the algorithm is "similar" to a previously approved device, it's possible the training data and ground truth protocols for the original algorithm are foundational, but the specific details are not present in this submission summary. As with the test set, it would expectedly involve comparison to 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.