Description

The AP201 - Sapphire Infusion Set by Q Core Medical is a specialized medical device designed for seamless integration with the Sapphire Infusion System. This disposable, single-patient-use intravenous (IV) administration set is crafted to deliver fluids efficiently from a container to a patient's vascular system. Its versatility allows it to administer not only standard fluids but also blood products and epidural fluids, making it an essential tool for various medical settings.

Key Features

• Compatibility: Exclusively designed for use with the Sapphire Infusion System, ensuring precise and controlled fluid delivery.
• Components: Equipped with essential components such as a male and female luer adapter, piercing pin connector, Sapphire cassette, tubing, flow control device, filter, and more.
• Advanced Features: Includes an injection site assembly, check valve, pressure activated valve (PAV), and blood chamber, enhancing its functionality and reliability.

Material and Safety

Constructed from materials that adhere to ISO 10993 standards, the infusion set ensures biocompatibility, addressing factors like hemocompatibility, cytotoxicity, sensitization, and more. This rigorous compliance guarantees minimal risk of adverse reactions, providing peace of mind to healthcare providers and patients alike.

Performance Testing

The AP201 - Sapphire Infusion Set undergoes extensive performance and safety testing, including:

• Particulate contamination
• Leakage prevention
• Tensile strength
• Coring resistance
• Flow regulator function

These tests align with ISO standards, ensuring the device meets high-quality benchmarks. The set also boasts accurate flow rate regulation when used with the Sapphire Infusion System and maintains a Sterility Assurance Level of 10^-6.

Regulatory Compliance

Classified as a Class II medical device accessory under 21 CFR 880.5725, this infusion set aligns with regulatory requirements, with design and material aspects previously cleared through 510(k) submissions. Its functional equivalence to predicate devices underscores its reliability and effectiveness in fulfilling its intended medical purposes.

The AP201 - Sapphire Infusion Set stands as a trustworthy component in medical fluid administration, embodying Q Core Medical's commitment to quality and innovation in healthcare solutions.