(99 days)
The KIRO Set is a sterile, single-use disposable ancillary device used with the peristaltic pumps in the KIRO Oncology pharmacy compounding device for the transfer of fluids into sterile powder drug vials for reconstitution of intravenous drugs or into sterile medication containers for intravenous drug administration.
The KIRO Set is a disposable sterile, single-use fluid transfer tubing set medical device that when placed in one of the double channel peristaltic pumps integrated in the KIRO Oncology pharmacy compounding device, the KIRO Set allows the accurate and fast transfer of sterile fluids from a large source container into a drug vial for the reconstitution of lyophilized drugs (powder), or into a final medication container from which an intravenous medication will be administered. Sterile fluids delivered can be saline (0.9% sodium chloride), 5% alucose, Water for Injection (WFI) or any aqueous diluent which is adequate for the dilution of drugs into the right concentration for intravenous administration.
The KIRO Set is comprised of medical grade silicone tubing with a central double tubing channel pathway for use in the KIRO Oncology peristaltic pump. The KIRO Set includes a filtered vented bag spike for connection to source containers on one end and a male luer lock connector on the outlet end for connection to a dosing spike to allow for dosing into vials for reconstitution or direct connection to final medication containers such as infusion bags, cassettes or elastomeric pump reservoirs.
The device is intended to be used inside the KIRO Oncology compounding area, which is an ISO5 environment for the compounding of sterile medications.
The device is provided sterile and is intended for single-use.
The KIRO Set is not intended to be used for direct patient contact.
This document is a 510(k) Pre-market Notification for a medical device called the "KIRO Set." It evaluates the substantial equivalence of the KIRO Set to a legally marketed predicate device (Sets Gri-Fill 3.0, K050339) and a reference device (Baxa Tubing Set, K872743).
Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature | Acceptance Criteria (from Predicate/Reference) | Reported Device Performance (KIRO Set) |
|---|---|---|
| Intended Use | Fluid transfer in preparation of final medication containers or syringes, and reconstitution of drug vials in hospital pharmacies when used with the GRI-FILL 3.0/Repeater Pump pharmacy compounding devices. | Fluid transfer in the preparation of final medication containers and the reconstitution of drug vials in hospital pharmacies when used with the KIRO Oncology pharmacy compounding device. (This is presented as being substantially equivalent, implying it meets the same functional intention.) |
| Use | Single Use | Single Use |
| Sterility | Sterile; Non-pyrogenic fluid pathway | Sterile; Non-pyrogenic fluid pathway |
| Biocompatibility | Not known (for predicate/reference) | Per ISO 10993-1:2010 for prolonged duration, indirect blood path contacting device. Testing results: Passed Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute systemic toxicity, Material-mediated pyrogenicity, Hemocompatibility (Hemolysis Indirect and Hemolysis Direct), Pyrogen testing. |
| Acceptable Fluids | Not to be used with lipids (predicate); No limitations (reference) | Saline (0.9% sodium chloride), 5% glucose, WFI or any aqueous diluent which is adequate for the dilution of drugs into the right concentration for intravenous administration. |
| Closed system (fluid not in contact with any reusable part of the compounding device) | YES | YES |
| Dose Range | 2.0 ml to 3000 ml (predicate); Minimum dispensing volume of 0.2 ml (reference) | 0.5 ml to 200 ml |
| Accuracy (Doses into vials) |
§ 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.