(904 days)
The Closed System Transfer Device (CSTD) for preparation, reconstitution, compounding and administration of drugs, including antineoplastic and hazardous drugs. This closed system mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills and also prevents microbial ingress.
The Closed System Transfer Device is a sterile, single use, Closed System drug Transfer Device (CSTD) for preparation, reconstitution, compounding and administration of antineoplastic and hazardous drugs. The Closed System Transfer Device consists of a piston syringe set (Dispensing Connector), an adaptor to the medication vial (Vial Adaptor), an adaptor for the IV bag for injection (Spike Adaptor), and Infusion Set.
The provided text is a 510(k) summary for a medical device (Closed System Transfer Device, CSTD) and focuses on demonstrating substantial equivalence to a predicate device. It does not describe an AI/ML-based device or a study involving human readers or ground truth established by experts. Therefore, I cannot extract the information required to populate the fields related to acceptance criteria and the study proving an AI/ML device meets them.
The text discusses:
- Device Name: Closed System Transfer Device (CSTD)
- Indications for Use: Preparation, reconstitution, compounding, and administration of drugs (including antineoplastic and hazardous drugs), minimizing individual and environmental exposure to drug vapor, aerosols, and spills, and preventing microbial ingress.
- Predicate Device: Equashield Closed System Drug Transfer Device (CSTD) (K170706)
- Non-Clinical Testing: A series of tests conducted to verify compliance with various ISO standards (e.g., ISO 594-1, ISO 7886-1, ISO 22413) and biocompatibility testing (e.g., Acute Systemic Toxicity, Cytotoxicity, Hemolysis, Skin Sensitization).
- No Clinical Study: The document explicitly states "No clinical study is included in this submission."
Given this content, I am unable to provide information on:
- A table of acceptance criteria and reported device performance for an AI/ML model.
- Sample size and data provenance for an AI/ML test set.
- Number and qualifications of experts for AI/ML ground truth.
- Adjudication method for an AI/ML test set.
- MRMC study effects for AI assistance.
- Standalone AI algorithm performance.
- Type of ground truth (expert consensus, pathology, outcomes data) for AI/ML.
- Sample size for the AI/ML training set.
- How ground truth for the AI/ML training set was established.
§ 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.