(291 days)
The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system during drug preparation and administration, thereby minimizing exposure of individuals, healthcare personnel and the environment to hazardous drugs.
The ChemoCLAVE® Cytotoxic Medication Preparation and Delivery System devices are sterile, single use CSTDs, which prohibit the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system. The Spiros and ChemoClave components comprise the primary components of the ChemoClave CSTD System, which connect to form a closed fluid path for transfer of hazardous medications. The devices which include the ChemoClave component are vial access devices, bag access devices, adapters, and administration sets. The devices which include the mating Spiros component are syringes, adapters, and administration sets. The Spiros and the ChemoClave will each independently self-seal when they are disconnected from one another.
The provided text describes the ChemoCLAVE Cytotoxic Medication Preparation and Delivery System and its substantial equivalence to a predicate device. However, the document does not contain information about the acceptance criteria for an AI/ML powered device, nor does it detail a study that proves a device meets such criteria.
The context of the document is a 510(k) premarket notification for a medical device (ChemoCLAVE Cytotoxic Medication Preparation and Delivery System) that is not an AI/ML powered device. The "acceptance criteria" discussed in the document refer to the performance of this physical medical device in functional and performance tests like microbial ingress testing, emission testing, hazardous drug exposure testing, and sterility validation, to demonstrate substantial equivalence to an existing predicate device.
Therefore, I cannot provide the requested information about acceptance criteria and a study proving an AI/ML powered device meets those criteria based on the given text. The provided text is about a traditional medical device, not an AI/ML system.
§ 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.