(277 days)
Arisure® is a Closed System Drug Transfer Device (CSTD) that mechanically prohibits the release of drugs in vapor, aerosol or liquid form during preparation and administration, and prevents the introduction of microbial and airborne contaminants into the drug or fluid path, allowing the system to minimize exposure of individuals, healthcare personnel, and the environment to hazardous drugs.
Arisure® Closed System Drug Transfer Device (CSTD) uses three primary components to prevent the escape of drug and ingress of microbes: Closed Vial Adapter, Closed Male Luer, and Dry Spike. The Closed Vial Adapter attaches to the drug vial allowing access to the vial contents while preventing vial pressurization by capturing displaced vapor and allowing filtered air into the vial. The Dry Spike attaches to an IV container allowing drug to be injected into the container while a separate port accepts the spike of an administration set. The Closed Male Luer syringe adapter provides a means of closed fluid transfer from the drug vial to the IV container. The Closed Male Luer was designed specifically to access the needle-free valve (neutral valve) on the Closed Vial Adapter and Dry Spike. The fluid path of the Closed Vial Adapter, Dry Spike, and Closed Male Luer is normally closed, opening only when the Closed Male Luer is connected to the neutral valve.
The Yukon Medical, LLC Arisure Closed System Drug Transfer Device (CSTD) (K201422) demonstrates substantial equivalence to its predicate device (TEVADAPTOR® Closed Drug Reconstitution and Transfer System, K141448) based on a comprehensive set of non-clinical performance data.
1. Acceptance Criteria and Reported Device Performance:
The document provides a table of various tests conducted to support the substantial equivalence of the Arisure CSTD. The reported device performance is indicated by its compliance with the specified standards or by direct statements of outcome (e.g., "Non-pyrogenic," "Single use"). Where acceptance criteria are implicitly stated through comparison with standards, the device is reported to have met these. Explicit performance metrics are provided for certain aspects.
| Test Name | Acceptance Criteria (Implicit/Explicit from provided text) | Reported Device Performance |
|---|---|---|
| Cytotoxicity | ISO 10993-5 compliant | Met |
| Hemocompatibility | ISO 10993-4 compliant | Met |
| Sensitization | ISO 10993-10 compliant | Met |
| Systemic Toxicity (Acute) | ISO 10993-11 compliant | Met |
| Irritation | ISO 10993-10 compliant | Met |
| Material-Mediated Pyrogenicity | ISO 10993-11 compliant | Met |
| LAL Endotoxin | ANSI/AAMI ST72:2002, USP 24 compliant | Met |
| Luer Access | ISO 594-2 compliant | Met |
| Liquid Leakage (back pressure) | ISO 594-2 compliant | Met |
| Liquid Leakage (connected pressure) | ISO 594-2 compliant | Met |
| Ease of Assembly | ISO 594-2 compliant | Met |
| Resistance to Overriding | ISO 594-2 compliant | Met |
| Stress Cracking | ISO 594-2 compliant | Met |
| Separation Force | ISO 594-2 compliant | Met |
| Gloved Hands | Usable with nitrile gloved hands | Usable with nitrile gloved hands |
| Valve Removal Torque and Bond Strength | >4.5 in-lbs | Met (>4.5 in-lbs) |
| Vial Pressure | (Not explicitly stated in provided document, but implicitly met for CSTD function) | Met |
| Attachment Force | 4.5 in-lbs", " |
§ 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.