1. Product Overview
(1) Product structure and composition
This product consists of a blood glucose meter host (buttons, display, test strip slot, battery, circuit board, Bluetooth module) and software (release version: v4.).4) Composition.
(2) Scope of application of the product
This product is used to quantify blood glucose concentrations in venous blood, arterial blood, neonatal whole blood, and fresh capillary whole blood taken from the fingers. It is used for clinical blood glucose testing of medical staff and self-blood glucose monitoring of diabetic patients. Testing of venous, arterial, and newborn blood is restricted to health care providers. This system is used to assist in monitoring the effect of blood glucose control, and is not suitable for the diagnosis and screening of diabetes, nor is it suitable for the detection of umbilical cord blood samples in newborn infants. This product wirelessly transmits blood glucose values to a compatible insulin pump that supports Bluetooth wireless technology through Bluetooth Low Energy communication technology, and is used for the calibration of the continuous glucose monitoring module in a compatible insulin pump, using a Medtronic MiniMed insulin pump, model: MiniMed 670G BLE.
(3) Model specifications
accu-chek guide link [model: 114]
(4) Working principle
This product is based on the principle of electrochemistry and is used in conjunction with the ACCU-Chek Guide blood glucose test strip, which is suitable for in vitro diagnosis and self-detection of blood glucose in diabetic patients.
2. Overview of preclinical studies
(1) Product performance research
The applicant has carried out the relevant performance verification of the blood glucose meter and the detection system. The main performance of the declared product includes measurement repeatability, system accuracy, and quality control substance detectionand requirements for instrument functionality, network security, electrical safety, electromagnetic compatibility, etc. The applicant submitted the product technical requirements and product test report for the above performance, and the test results were consistent with the product technical requirements.
For the combined use of the declared product with blood glucose test strips, the applicant submitted a performance evaluation report on accuracy, repeatability, linearity, measurement range, etc. For the purpose of the declared product to wirelessly transmit blood glucose values to a compatible insulin pump, the applicant submitted a test and verification report of the Bluetooth Low Energy (BLE) communication function, which verified that the BLE transmission function met the design requirements.
(2) Product expiration date and packaging
This product has a 5-year shelf life under normal use conditions. The applicant determines the duration of use by calculating the frequency of use. The applicant submitted research data on the duration of use.
The applicant provided packaging design verification materials, and verified that the integrity of the packaging met the design requirements by conducting pre-packaging evaluation, environmental testing, vibration testing, drop testing and other tests according to the corresponding international standards.
(3) Software research
The software security level of this product is severity, and the release version of the blood glucose meter software is 44. The full version number is 44.2。The applicant submitted the corresponding level of software description document and software version naming rule statement, which confirmed that the software design and development process of the product was standardized and controllable, and the comprehensive remaining risks were acceptable.
The applicant submitted a network security description document to prove that the existing network security risks of the product are controllable, and a network security emergency response plan has been established.
(4) Security indicators for active devices
The product meets the requirements of the following mandatory standards:
gb 4793.1-2007 Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 1: General Requirements
gb 4793.9-2007 "Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use – Part 9: Special Requirements for Automatic and Semi-Automatic Equipment for Laboratory Analytical and Other Purposes".
YY 0648-2008 "Safety of Electrical Equipment for Measurement, Control and Laboratory Use.
Requirements Part 2-101: In Vitro Diagnostic (IVD) Medical Devices
(5) Others
Under normal use conditions, for the quantitative detection of blood glucose concentration in fresh capillary whole blood, the declared product belongs to the "Catalogue of Medical Devices Exempt from Clinical Evaluation", and compared with the approved domestic registered products of the same variety, the declared product and the product of the same variety are equivalent in terms of testing-related performance and intended use.
3. Overview of clinical evaluation
The applicant is targeting the declared product for use in the minimed insulin pump (model:
minimed 670g BLE), and the clinical trial pathway was selected for clinical evaluation. The clinical trial is carried out jointly with the supporting insulin pump.
The clinical trial of the declared product is to evaluate the safety, effectiveness and usability of the hybrid closed-loop (HCL) system jointly carried out with insulin pump in adult and adolescent subjects with type 1 diabetes in the Chinese population. The trial was designed as a prospective, multi-center, single-group target value method. In the course of the clinical trial, the subjects detected the blood glucose level in capillary whole blood through the declared product, and the test results were transmitted to the insulin pump blood glucose monitoring module through Bluetooth, and the test data was used for the calibration of the insulin pump blood glucose monitoring module. The clinical trial is divided into an introductory period (14 days) and an in-study period (30 days). The main evaluation index is % of the time in the target range, 39 mmolL< sg <10 mmol, estimated overall mean change in time within the target range from the lead-in period to the study period, and compared using a simple superiority paired test, with a significance level of 0025 (unilateral). Secondary evaluation measures include time in the range of hypoglycemia (% of SG) of SG < 39 mmol/l、3.3 mmol l and 30 mmol/l;Time in the hyperglycemic range (% of SG): SG > 10 mmolL, 139 mmol l and 194 mmol/l;Glucose change SG standard deviation (SD) and glucose coefficient of variation (CV);Change in total daily insulin dose (TDD) and body weight from baseline to end of study;Time taken in automatic mode (HCL) compared to time taken in manual mode (open loop);By hba1c range.
5-8%, >8%), stratified time within the target range (% of SG) 39 mmolL< SG<10 mmolL, time in the range of hypoglycemia (% of SGsg) SG< 39 mmol/l、3.3 mmol l and 54 30 mmol, hyperglycemia Time in the range (% of SG): SG > 10 mmolL, 139 mmol l and 194 mmol/l。
Safety indicators include adverse events, incidence of severe hypoglycemia, incidence of severe hyperglycemia, incidence of diabetic pain acidosis, etc.
The study enrolled 74 participants, and the ratio of adolescents (14-17 years) to ** who completed the study period was approximately 1:5. Fifty-seven patients were included in the protocol-compliant analysis set.
The results of the clinical trial showed that the study was within the target range (39 mmol L-10 mmol) The average percentage of glucose readings increased by the sensor (5.).6%);Below the average percentage decrease in sensor glucose readings within the target range (-2.).5%);The standard deviation of sensor glucose decreased (-4.) during the study9%);The coefficient of variation of sensor glucose decreased during the study (-3.).7%);The average percentage of sensor glucose readings within the target range increased during the study period for each subject in the baseline HbA1c range during the stratified analysis;In subjects with baseline HbA1c < 7%, an increase of 17%;At baseline, HbA1c is between 7<75% of the participants, an increase of 47%;At baseline, HbA1c is between 7Between 5-8% of subjects, there was an increase of 75% of participants with baseline HbA1C > 8%, an increase of 161%。
No serious adverse events, serious device adverse events, serious hypoglycemic events, unexpected device adverse reactions (UADEs), and diabetic ketoacidosis were reported. Three cases of severe hyperglycemia occurred during the trial, two of which were related to the study device.
In summary, the clinical trial was able to confirm that the product was used for the calibration of the continuous glucose monitoring module in the minimed insulin pump (model: minimed 670g BLE), and the clinical evaluation data met the review requirements.
Fourth, the product income risk determination
(1) Benefit assessment
The main benefits of the declared products are: for the quantitative detection of blood glucose concentrations in venous blood, arterial blood, neonatal whole blood and fresh capillary whole blood taken from the fingers. It is used for clinical blood glucose testing of medical staff and self-glucose monitoring of diabetic patients°ACCU-CHEK Guide Link blood glucose monitoring system wirelessly transmits blood glucose values to a compatible minimed insulin pump that supports Bluetooth wireless technology through Bluetooth low energy communication technology, and is used for the calibration of the continuous glucose monitoring module in the compatible minimed insulin pump.
(2) Risk assessment
The main clinical risks of this product include: the risk of incorrect blood glucose display results (high or low). The product deviates from the blood glucose value under some unexpected circumstances, such as improper operation by the user, use of expired test strips, etc. Protective measures such as adding descriptions of instruction manuals, setting machine feedback sounds, and displaying operation instructions on the display screen are alleviated.
(3) Determination of benefits-risks
To sum up, the applicant has taken risk control measures for the current known and possible risks, and after analysis, the user uses the product in accordance with the instruction manual, and the product can achieve the expected performance under normal use conditions. After comprehensive evaluation, at the current level of cognition, it is believed that the benefits brought by the launch of the product outweigh the risks, and the comprehensive residual risks are acceptable.