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BD PhaSeal Optima Connecting Set (C83-O); BD PhaSeal Optima Spike Set (C180-O)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K250059

by Becton, Dickinson and Company

Identifiers

510(k) Number
K250059 FDA 510(k)
FDA Product Code
ONB FDA 510(k)
Models / Variants
BD PhaSeal™ Optima Connecting Set (C83-O) FDA 510(k)
BD PhaSeal™ Optima Spike Set (C180-O) FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5440 FDA 510(k)
Regulation Number
880.5440 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The BD PhaSeal Optima Connecting Set (C83-O) and Spike Set (C180-O) are closed antineoplastic and hazardous drug reconstitution and transfer systems. These devices are designed to facilitate the safe handling of hazardous drugs by minimizing exposure risks during preparation, transfer, and administration.

These single-use systems are intended for use in general hospital settings and are supplied sterile. The Connecting Set (C83-O) and Spike Set (C180-O) enable a single infusion line for multiple non-hazardous and hazardous drugs, reducing the need for priming multiple lines. They are classified as Class II devices under FDA regulations and have received 510(k) clearance for substantial equivalence. Proper storage and handling are required to maintain sterility and functionality.

Frequently asked questions

Are these systems reusable or designed for single-use only, and how does that affect their safety features?

The BD PhaSeal Optima Connecting Set (C83-O) and Spike Set (C180-O) are explicitly designed for single-use only. This design choice is critical to their safety features, as it minimizes the risk of contamination and cross-infection during hazardous drug handling. Single-use systems also reduce the need for reprocessing, which can introduce additional exposure risks when dealing with antineoplastic or hazardous drugs.

How do these systems help reduce the risk of exposure during drug preparation and administration?

These systems are closed antineoplastic and hazardous drug reconstitution and transfer systems, meaning they maintain a sealed environment during drug handling. This design eliminates the need for manual spiking or connecting lines, which are common sources of aerosolization or splashing—both of which pose significant exposure risks. By enabling a single infusion line for multiple drugs, they also reduce the number of connections and disconnections, further lowering the chance of accidental leaks or spills.

What storage conditions are required to maintain sterility and functionality of these sets?

While the exact storage conditions aren’t detailed in the data, the systems are supplied sterile, so they must be stored in a way that preserves sterility until use. Typically, this means keeping them in their original, sealed packaging away from direct sunlight, extreme temperatures, or contamination sources. Always follow manufacturer guidelines for storage to ensure the integrity of the system’s components, especially since they’re intended for hazardous drug handling where sterility is non-negotiable.

Are there different sizes or models available, and how do they differ in application?

The data does not specify distinct sizes or models beyond the two primary variants: the Connecting Set (C83-O) and the Spike Set (C180-O). The Connecting Set is designed to link infusion lines, while the Spike Set is used to pierce vials or bags for drug transfer. Both are part of the same closed-system platform, ensuring compatibility for seamless integration in hazardous drug preparation workflows. No additional size variations are mentioned, so compatibility should be confirmed with your existing infusion systems.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BD PhaSeal™ Optima Connecting Set C83-O - 515629 | BD, BD PhaSeal™ Optima System, BD PhaSeal™ Optima Connecting Set (C83-O); BD PhaSeal™ Optima Spike Set ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Becton, Dickinson and Company

Sources (1)

  • FDA 510(k) K250059 24 fields · synced Oct 6, 2026