An Integrated Continuous Glucose Monitoring (Icgm) System is a real-time device designed for continuous glucose monitoring in individuals with diabetes. It comprises a subcutaneous sensor, transmitter, and compatible receiver for displaying readings. The sensor incorporates Dexamethasone Acetate, a corticosteroid that reduces inflammation and enhances accuracy by mitigating immune responses that may impact sensor performance and longevity.

Intended Use of Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate

Integrated Continuous Glucose Monitoring System (iCGM) is a medical device designed to continuously measure glucose levels in bodily fluids and transmit the data to digitally connected devices, like automated insulin dosing systems, for managing glycemic control; essentially, a continuous glucose monitors with advanced connectivity features.

Intended Use

The system is intended to provide real-time glucose readings, offering users continuous insight into their blood sugar levels. It also delivers glucose trend information, helping individuals track fluctuations and patterns over time. Additionally, the system features alerts for detecting and predicting episodes of hypoglycemia (low blood glucose) and hyperglycemia (high blood glucose), enabling timely intervention and better diabetes management.

Device Description

An integrated continuous glucose monitoring system (iCGM) with sensor containing dexamethasone acetate is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time. iCGM systems are designed to reliably and securely transmit glucose measurement data to digitally connected devices, including automated insulin dosing systems, and are intended to be used alone or in conjunction with these digitally connected medical devices for the purpose of managing a disease or condition related to glycemic control. The dexamethasone acetate coating is intended to reduce inflammation at the sensor insertion site.

The device consists of a glucose sensor, transmitter, and receiver, integrated with software for glucose calculation and interpretation. It measures glucose levels in interstitial fluid within the subcutaneous tissue, ensuring continuous monitoring.

The iCGM system provides real-time glucose monitoring with continuous data transmission for effective diabetes management. Its Dexamethasone Acetate-enhanced sensor improves accuracy and longevity by reducing immune response. The system supports wireless data transfer to compatible devices and offers customizable alerts for glucose fluctuations, along with trend tracking for proactive decision-making.

• Chemical interference testing
• MRI exposure testing
• Ultrasound exposure testing
• Adhesion testing
• Insertion tool verification testing
• Software verification and validation
• Sterility and shelf life
• Cybersecurity risk
• Electromagnetic Compatibility
• Electrical, Mechanical and Thermal performance characteristics
• Particulate test

Clinical Testing

No Guidance available for 510k submission

Testing should comply with ISO 10993 standards, considering the type, duration, and frequency of patient contact.

• Cytotoxicity
• Sensitization
• Irritation
• Systemic Toxicity (Material Mediated Pyrogen)
• Sub chronic Toxicity and Implantation
• Chronic Toxicity and Implantation
• Genotoxicity/Carcinogenicity (Bacterial Reverse Mutation)
• Genotoxicity/Carcinogenicity (Mouse Lymphoma)
• Chemical Characterization