(87 days)
The CareSens N POP Blood Glucose Monitoring System consists of a measuring meter, test strips and control solutions. The CareSens N POP Blood Glucose Meter is intended for use with the CareSens N Single Blood Glucose Test Strips for the quantitative measurement of glucose in capillary whole blood from the fingertip and alternative sites such as the forearm, palm, thigh and calf. Alternative site testing should be used only during steady-state blood glucose conditions. The CareSens Control Solutions are for use with the CareSens N POP Meter and CareSens N Single Test Strips to check that the meter and the test strips are working together properly and that the test is performing correctly.
The CareSens N POP Blood Glucose Monitoring System is intended for self testing, in vitro (outside the body) testing at home by people with diabetes 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 or screening of diabetes.
The CareSens N POP Blood Glucose Monitoring System (BGMS) measures the glucose level in whole blood sample by the meter using a small electrical current generated in the test strips. The system consists of the following: the CareSens N POP Meter, CareSens N Single Test Strips, CareSens Control Solutions with two different glucose concentrations ("Control A" and "Control B" ranges, sold separately), Lancing Device, Lancets, User's manual, Quick reference guide and Logbook.
Here's an analysis of the provided text regarding the CareSens N POP Blood Glucose Monitoring System's acceptance criteria and studies:
Understanding the Context:
It's important to note that this document is a 510(k) summary, specifically a "Special 510(k)". This type of submission is for modifications to a legally marketed device that do not significantly alter its fundamental scientific technology or intended use. Therefore, the performance data presented here largely relies on demonstrating that the modified device performs equivalently to the predicate device (CareSens N BGMS), rather than undergoing extensive de novo clinical trials.
Acceptance Criteria and Device Performance
The document explicitly states that the CareSens N POP BGMS has the same fundamental scientific technology, intended use, operating principle, and operating ranges as its predicate device. This implies that the acceptance criteria for performance are primarily based on demonstrating equivalence, with additional validation for newly added features.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Intended Use | Same as predicate: Quantitative measurement of glucose in capillary whole blood for self-testing at home by people with diabetes as an aid in monitoring diabetes control. Not for neonates or diagnosis/screening of diabetes. | "Same" (as predicate device K083468) |
| Enzyme | Glucose Oxidase | "Same" |
| Measurement Principle | Amperometric method | "Same" |
| Test Principle | Electro-chemical reaction | "Same" |
| Sample Type | Capillary whole blood | "Same" |
| Test Time | 5 seconds (as per predicate) | "Same" |
| Sample Volume | Minimum 0.5 µL (as per predicate) | "Same" |
| Test Range | 20 - 600 mg/dL (as per predicate) | "Same" |
| Temperature Range | 50 - 104°F (10 - 40°C) (as per predicate) | "Same" |
| Operating Humidity | 10 - 90% (as per predicate) | "Same" |
| Hematocrit Range | 20 - 60% (as per predicate) | "Same" |
| Power | Two (2) 3.0 V lithium battery (CR2032) (as per predicate) | "Same" |
| Battery Life | 1,000 tests (as per predicate) | "Same" |
| Memory Capacity | Increased to 500 blood glucose values (from 250 in predicate) | 500 blood glucose values |
| Averaging Options | Expanded to 1, 7, 14, 30 and 90 days (from 14 days in predicate) | 1, 7, 14, 30 and 90 days |
| Disinfection Effectiveness | Complete inactivation of live virus (HBV) on materials; no impact on performance or external materials after 5 years simulated use. | CLOROX GERMICIDAL Wipes validated for complete inactivation. 260 pre-cleaning and disinfection cycles (simulating 5 years) had no effect on performance or external materials. |
Key takeaway on acceptance criteria: For most core performance attributes, the acceptance criterion is "demonstrated equivalence" to the predicate device. For new features (memory, averaging options, disinfection), specific validation tests were conducted to confirm proper operation and robustness.
Study Details
The document primarily describes validation testing for the modifications from the predicate device, relying on the predicate's extensive testing for the core functionalities.
2. Sample size used for the test set and the data provenance
- Disinfection Study: 260 samples (meters and lancing devices) for pre-cleaning and disinfection cycles, simulating 5 years of use.
- Other performance characteristics (e.g., accuracy, precision): The document does not explicitly state sample sizes for test sets related to the core glucose measurement performance. It states that the "performance, safety and effectiveness show results similar to the predicate device" because the device uses the same test strips and control solutions, and the fundamental scientific technology is identical. This strongly implies reliance on the predicate device's existing performance data rather than new, large-scale clinical test sets for glucose accuracy.
- Data Provenance: Not specified for any performance testing. Given the manufacturer's location (Seoul, Korea), it's highly probable that any performance testing was conducted in Korea. The disinfection study was performed by an "outside commercial testing service," location not specified.
- Retrospective or Prospective: Not specified. For core performance, it would be largely retrospective (relying on predicate data). For disinfection testing and new feature validation, it would be prospective testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not mentioned. For glucose monitoring systems, the "ground truth" for glucose levels is typically established using a reference laboratory method (e.g., YSI analyzer), not expert consensus. The document does not detail how ground truth was established for any glucose measurement performance.
4. Adjudication method for the test set
- Not applicable/Not mentioned. Adjudication methods are typically used in studies where human readers interpret images or cases. This is a blood glucose monitoring system.
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.
- Not applicable. This device is a blood glucose monitoring system, not an AI-assisted diagnostic imaging or interpretation device that would involve human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. Blood glucose meters operate as standalone devices, providing a quantitative measurement. The performance claims for the "CareSens N POP BGMS" are for the device itself, providing an output "concentration of glucose." There isn't a human-in-the-loop aspect for the core measurement function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For glucose measurement, the ground truth would typically be established by a laboratory reference method (e.g., YSI glucose analyzer), which is the standard for blood glucose monitoring systems. However, the document does not explicitly state this, mostly relying on the equivalence to the predicate where such methods would have been used.
- For the disinfection study, the ground truth was the presence/absence and viability of HBV (Hepatitis B Virus) inoculated on the materials.
8. The sample size for the training set
- Not applicable. This device is a traditional electrochemical blood glucose meter, not an AI/machine learning system that requires a "training set" in the conventional sense. Its algorithm (converting electrical current to glucose concentration) is based on electrochemical principles and calibration, not learned from a training dataset.
9. How the ground truth for the training set was established
- Not applicable (as it's not an AI/ML device with a training set).
§ 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.