(123 days)
Non- pressure rated: The Carefusion NeutraClear™ multi-fuse Extension Set with needle-free connector(s) is for single use only. The extension set can be used for direction, intermittent infusion, continuous infusion, or aspiration.
Pressure rated: The Carefusion NeutraClear™ multi-fuse Extension Set with needle-free connector(s) is for single use only. The extension set can be used for direct infusion, continuous infusion, or aspiration. This set may be used with power injector procedures to a maximum pressure of 325psi at a flow rate of 10mL/s.
Carefusion NeutraClear™ multi-fuse Extension Set with needle-free connector(s) are Extension Sets that are intended for single patient use, including pediatrics and immunocompromised patients, for direct injection, intermittent infusion, continuous infusion or aspiration of drugs, blood or fluids. All Carefusion NeutraClear™ multi-fuse Extension Set with needle-free connector(s) has a Neutraclear connector that is removable or bonded to the extension set tubing. Carefusion NeutraClear™ multi-fuse Extension Set with needle-free connector(s) allows thorough and easy disinfection due to a solid flat smooth surface and eliminates the risk of needle stick injuries. Carefusion NeutraClear™ multi-fuse Extension Set with needle-free connector(s) are sterile single patient devices that can be used for 200 activations and for 7 days. All extension set included are not made from natural rubber latex or DEHP.
The provided document is a 510(k) premarket notification letter from the FDA regarding a medical device, the "Carefusion NeutraClear™ multi-fuse Extension Set with Needle-free Connector(s)". This document outlines the regulatory review and substantial equivalence determination for this device, comparing it to a predicate device.
It IS NOT a study report for an AI/ML powered medical device.
Therefore, I cannot provide the detailed information requested in your prompt regarding acceptance criteria and a study proving a device meets them, especially for an AI/ML device. The document describes a traditional medical device (an IV extension set) and its non-clinical performance testing. It does not mention any AI/ML components, nor does it conduct studies involving human reader performance, ground truth establishment by experts, or training/test sets for AI models.
The "Performance Data" section (Section VI on pages 7 and 8) lists various ISO standards and specific tests that were performed. These are standard tests for the physical and biological properties of IV administration sets, such as:
- Physical performance: Leakage, connection/disconnection cycles, resistance to alcohol/lipids, pressure resistance (325 psi at 10mL/s flow rate), luer connector dimensions and integrity, tensile strength, flow rate.
- Biocompatibility: Cytotoxicity, intracutaneous injection, systemic injection, sensitization, hemolysis, hemocompatibility, pyrogenicity, particulate contamination, endotoxin levels, extractable/leachable agents.
- Sterilization: Validation of ethylene oxide sterilization (bioburden, sterility, EOR/ECH residuals).
- Packaging: Sterility barrier after aging.
- Functional performance: Microbial ingress, shelf life, harsh infusates, priming volume/flow rate.
The conclusion (Section IX on page 9) states: "The results of the non-clinical testing exhibited that Carefusion NeutraClear™ multi-fuse Extension Set with needle-free connector(s) met the acceptance criteria for all functional, microbial ingress, sterility, biocompatibility and other performance criteria, which verify it to be substantially equivalent to the predicate devices."
In summary, this document does not contain the information requested in the prompt because it pertains to a mechanical medical device, not an AI/ML one. It describes standard engineering and biological testing, not clinical performance studies with human readers or AI algorithms.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.