(256 days)
The Healthpro TM Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh. The Healthpro 114 Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared.
The Healthpro 104 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 to monitor the effectiveness of diabetes control. The Healthpro™ Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
The Healthpro104 test strips are for use with the Healthpro " meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh.
The Healthpro 114 control solutions are for use with the Healthprome meter and test strips to check that the meter and test strips are working together properly and that the test as a quality control checks to verify the accuracy of blood glucose test results.
The Healthpro " Blood Glucose Monitoring System consists of the meter, test strips and control solutions (low, normal and high levels), a lancing device and sterile lancets (sold separately; accessory). The blood glucose test system is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood sample by means of an electrical current produced in the test strip and sent to the meter for measurement.
Here's a summary of the acceptance criteria and study information for the Healthpro™ Blood Glucose Monitoring System, based on the provided 510(k) summary (K113192):
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary states that the device was "performed in accordance with ISO 15197:2003" and "passed all of the tests based on pre-determined Pass/Fail criteria." However, it does not explicitly list the specific acceptance criteria (e.g., accuracy percentages for different glucose ranges) required by ISO 15197:2003, nor does it provide a detailed breakdown of the reported device performance against those specific criteria. It only offers a general statement of compliance.
Therefore, the table below reflects what can be extracted.
| Acceptance Criteria Category | Specific Acceptance Criteria (Not explicitly stated in provided document) | Reported Device Performance |
|---|---|---|
| System Accuracy | ISO 15197:2003 compliance (specific accuracy % thresholds for different glucose levels, as per ISO standard) | Device passed all tests based on pre-determined Pass/Fail criteria related to system accuracy |
| User Performance | (Specific criteria related to ease of use, user error rates, etc., as per ISO 15197:2003) | Device passed all tests based on pre-determined Pass/Fail criteria related to user performance |
| Alternative-Site Blood Glucose Measurement | (Specific criteria for agreement between alternative site and fingertip samples, as per ISO 15197:2003) | Device passed all tests based on pre-determined Pass/Fail criteria related to alternative-site measurement |
| Non-clinical Performance | (Specific criteria related to functionality, reliability, etc.) | Device passed all tests based on pre-determined Pass/Fail criteria related to non-clinical performance |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set (number of patients, number of blood samples).
The origin of the data is not explicitly stated as country of origin, nor is it explicitly stated whether the study was retrospective or prospective. Given the nature of a clinical performance evaluation, it is highly likely to be prospective, but this is not confirmed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not provide information on the number of experts used to establish the ground truth for the test set, nor their qualifications.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is more common for diagnostic imaging AI, where human readers interpret cases with and without AI assistance. For a blood glucose monitoring system, the focus is on the accuracy of the device itself compared to a reference method, not on human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance study was done. The "system accuracy" and "alternative-site blood glucose measurement" evaluations described are inherently standalone assessments of the device's accuracy in measuring glucose concentrations. The device itself (meter and test strip) is the "algorithm only" in this context, as it directly provides a quantitative measurement without human intervention in the result generation.
7. The Type of Ground Truth Used
The ground truth used for blood glucose monitoring systems is typically established by comparing the device's readings to those from a laboratory reference method (e.g., YSI analyzer) which is considered highly accurate. While the document mentions "clinical performance evaluation," it does not explicitly name the reference method. For system accuracy studies on blood glucose meters, the ground truth is almost invariably a laboratory analyzer.
8. The Sample Size for the Training Set
The document does not mention a training set or its sample size. For traditional medical devices like blood glucose meters, there isn't a "training set" in the same way there would be for an AI/machine learning algorithm that needs to learn patterns from data. The performance is assessed based on the device's inherent chemical and electrical mechanisms as designed by the manufacturer, not from a trained model.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned (see point 8), this information is not applicable.
§ 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.