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510(k) Data Aggregation
(312 days)
The COOL Blood Glucose Monitoring System consists of a measuring meter, test strips and control solutions. The COOL Blood Glucose Meter is intended for use with the COOL Blood Glucose Test Strips for the quantitative measurement of glucose in capillary whole blood from the fingertip and the alternate sites such as forearm, palm, thigh and calf. The alternate site testing should be used only during steady-state glucose conditions. The COOL Control Solutions are for use with the COOL Meter and COOL Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
The COOL Blood Glucose Monitoring System is intended for self testing outside the body by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program. The system is intended to be used by a single person and should not be shared. It is not intended for use on neonates and is not for the diagnosis of or screening for diabetes.
The COOL Blood Glucose Monitoring System (BGMS) measures the glucose in whole blood sample by a small electrical current generated in the test strips and sent to the meter for measurement. The system consists of the following devices: COOL Meter (Model GM505MA), COOL Test Strips, COOL Control Solutions for two different glucose concentration ranges (called "Normal" and "Middle" ranges, sold separately), Lancing Device, Lancets, User manual, Quick reference guide and Logbook.
This 510(k) summary (K103396) describes the COOL Blood Glucose Monitoring System, which is substantially equivalent to the predicate CareSens N Blood Glucose Monitoring System (K083468). The modifications in the COOL system are limited to the meter's outer casing design and the test strip's electric connector pattern.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes two performance studies: Repeatability Test (PE-01) and Linearity Study (PE-03). The studies were conducted to verify the proper operation of the modified electric connector of the COOL test strip with the COOL meter.
Repeatability Test (PE-01):
| Interval | Mean Concentration (mg/dL) | Acceptance Criteria | Reported Performance | Met Acceptance Criteria? |
|---|---|---|---|---|
| 1 | 30 to 50 | SD < 7.7 mg/dL | (Not explicitly stated, but reported as "Yes") | Yes |
| 2 | 51 to <100 | SD < 7.7 mg/dL | (Not explicitly stated, but reported as "Yes") | Yes |
| 3 | 111 to 150 | CV < 7.5% | (Not explicitly stated, but reported as "Yes") | Yes |
| 4 | 151 to 250 | CV < 7.5% | (Not explicitly stated, but reported as "Yes") | Yes |
| 5 | 251 to 400 | CV < 7.5% | (Not explicitly stated, but reported as "Yes") | Yes |
| >= 100 | CV < 7.5% | (Not explicitly stated, but reported as "Yes") | Yes |
Linearity Study (PE-03):
| Item | Acceptance Criteria | Reported Performance | Met Acceptance Criteria? |
|---|---|---|---|
| Correlation coefficient (r) | $\ge$ 0.97 | (Not explicitly stated, but reported as "Yes") | Yes |
| Bias: Linear equation | |||
| A (slope) | 0.95 < A < 1.05 | (Not explicitly stated, but reported as "Yes") | Yes |
| B (y-intercept) | -5 < B < 5 | (Not explicitly stated, but reported as "Yes") | Yes |
The document states, "The test results confirmed that the modified electric connector of the strip operated properly with the meter. Thus, COOL BGMS demonstrated satisfactory performance and is suitable for its intended use."
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the repeatability and linearity tests (PE-01 and PE-03).
The data provenance (e.g., country of origin, retrospective or prospective) for these specific tests is not provided. However, the applicant and manufacturer, i-SENS, Inc., are located in Seoul, Korea, implying the studies were likely conducted there.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This section is Not Applicable as the studies described (repeatability and linearity of a blood glucose meter) are analytical performance studies. They involve quantitative measurements against a reference method or known concentrations, not qualitative assessments requiring expert interpretation like in image-based diagnostic systems. Therefore, experts for establishing ground truth in the context of diagnostic interpretation are not relevant here.
4. Adjudication Method for the Test Set
This section is Not Applicable for the same reasons as in point 3. Analytical performance testing does not involve adjudication of expert opinions.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not performed. The submission focuses on the analytical performance of a blood glucose monitoring system, not on diagnostic accuracy involving human readers.
6. Standalone Performance Study
Yes, a standalone (i.e., algorithm only without human-in-the-loop performance) study was done. The repeatability and linearity tests described are standalone analytical performance studies of the device's ability to accurately and precisely measure glucose concentrations.
7. Type of Ground Truth Used
For the repeatability and linearity tests:
- Repeatability: The ground truth would typically be the mean of multiple measurements of a known glucose concentration or a control solution.
- Linearity: The ground truth would be a series of known glucose concentrations (e.g., prepared standards or reference materials) spanning the measuring range of the device.
The document does not explicitly detail the specific reference methods or the exact nature of the "mean concentration (mg/dL)" used, but implicitly, these are based on accurately prepared reference samples.
8. Sample Size for the Training Set
The document describes performance verification studies for a modified version of an existing device. It does not mention a training set, as it is not a machine learning or AI-based product in the context of image analysis requiring a distinct training phase. These are analytical performance studies.
9. How the Ground Truth for the Training Set Was Established
This section is Not Applicable as there is no mention of a training set for machine learning or AI algorithm development in this 510(k) submission. The studies presented are analytical performance tests for a blood glucose monitoring system.
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