(151 days)
The ACCU-CHEK Aviva Expert System is indicated as an aid in the treatment of Insulin-requiring diabetes. The ACCU-CHEK Aviva Expert System consists of the ACCU-CHEK Aviva Expert Meter, ACCU-CHEK Aviva Plus test strips, ACCU-CHEK Aviva control solutions, and ACCU-CHEK Bolus Advisor. The ACCU-CHEK Aviva Expert System is Intended to facilitate the optimization of glycemic control in patients who are trained in multiple daily insulin injection therapy and are under the supervision of healthcare professionals experienced in managing insulin treated patients.
The ACCU-CHEK Aviva Expert blood glucose monitoring system is intended to be used for the quantitative measurement of giucose in fresh capillary whole blood samples drawn from the fingertips. The ACCU-CHEK Aviva Expert blood glucose monitoring system is intended for selftesting outside the body (in vitro diagnostic use) by people with diabetes. The ACCU-CHEK Aviva Expert blood glucose monitoring system is intended to be used by a single person and should not be shared. The ACCU-CHEK Aviva Expert blood giucose monitoring system should not be used for the diagnosis or screening of diabetes or for neonatal use. Altemative site testing should NOT be used with the ACCU-CHEK Aviva Expert blood glucose monitoring system. The ACCU-CHEK Aviva Expert System is intended for prescription home use only.
The ACCU-CHEK Aviva Expert meter is also indicated for the calculation of an insulin dose or carbohydrate intake based on user-entered data. The ACCU-CHEK Bolus Advisor, as a component of the Accu-Chek Aviva Expert meter, is intended for use in providing insulin dose recommendations in response to blood glucase, health events, and carbohydrate input. The ACCU-CHEK Bolus Advisor is intended to provide direction for insulin adjustment within the scope of a preplanned treatment program from a healthcare professional. Before its use, a physician or healthcare professional must prescribe the ACCU-CHEK Aviva Expert System and provide the patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the ACCU-CHEK Bolus Advisor. Once programmed, a patient must consult with his/her physician or healthcare professional before making any changes to these ACCU-CHEK Bolus Advisor settings.
The ACCU-CHEK Aviva Expert System consists of the following:
- ACCU-CHEK Aviva Expert meter .
- ACCU-CHEK Bolus Advisor (a component of the Aviva Expert meter) .
- . ACCU-CHEK Aviva Plus test strips (K101299)
- ACCU-CHEK Aviva control solutions (K043474) .
The ACCU-CHEK Aviva Expert system is a blood glucose monitoring system that makes use of the ACCU-CHEK Aviva Plus test strips (cleared under K101299) and the ACCU-CHEK Aviva control solutions (cleared under K043474). The industrial design of the ACCU-CHEK Aviva Expert meter is nearly identical to that of the ACCU-CHEK Aviva Combo meter (cleared under kl 11353); the only difference between the two devices is that the ACCU-CHEK Aviva Expert meter does not have Bluetooth wireless capability and therefore cannot be connected to an insulin pump, whereas the ACCU-CHEK Aviva Combo meter does have Bluetooth capability and can be connected to an insulin pump.
The ACCU-CHEK Aviva Expert system provides the user with the ability to measure capillary blood glucose levels when a sample of capillary blood is applied to the test strip. The meter also provides an optional insulin bolus calculator (the ACCU-CHEK Bolus Advisor) designed for use by individuals with diabetes who require insulin. This feature is optional in that a user can simply obtain a blood glucose value through capillary blood testing and does not need to use the insulin bolus calculator portion of the system if it is not desired. The insulin bolus calculator algorithm is identical to the bolus calculator algorithm that was cleared during the Aviva Combo 510(k) submission (K111353). For the ACCU-CHEK Aviva Expert system, this bolus calculator is meant to be used by patients with diabetes on multiple daily insulin injection (MDI) therapy. In order to calculate the appropriate bolus of insulin, the ACCU-CHEK Bolus Advisor takes the measured bG, the target bG, the carbohydrate intake, the insulin-to-carbohydrate ratio, the insulin sensitivity, health events (such as exercise), the time of day, and the active insulin into account. Before using the ACCU-CHEK Aviva Expert system, a physician or healthcare professional must provide the patient-specific target blood glucose, insulinto-carbohydrate ration, and insulin sensitivity parameters.
Here's a detailed breakdown of the acceptance criteria and study information for the ACCU-CHEK Aviva Expert System, based on the provided 510(k) Summary:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for blood glucose monitoring systems typically align with ISO 15197 (or similar standards) for accuracy. The provided document details the accuracy of the device against a reference method. It also outlines precision performance.
| Performance Metric | Acceptance Criteria (Implied by Predicate/General Standards) | Reported Device Performance |
|---|---|---|
| Accuracy (Method Comparison) | ||
| Glucose 95% of results within ±15 mg/dL of laboratory reference (a common standard for this range) | 41/48 (85.4%) within ±5 mg/dL | |
| 48/48 (100%) within ±10 mg/dL | ||
| 48/48 (100%) within ±15 mg/dL | ||
| Glucose ≥ 75 mg/dL | >95% of results within ±15% of laboratory reference (a common standard for this range) | 147/252 (58.3%) within ±5% |
| 222/252 (88.1%) within ±10% | ||
| 246/252 (97.6%) within ±15% | ||
| 250/252 (99.2%) within ±20% | ||
| Precision (Repeatability - Within Lot) | For targets |
§ 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.