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TEVADAPTOR® is a Closed System Drug Transfer Device (CSTD) that mechanically prohibits the release of the drug 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.

The TEVADAPTOR® Closed Drug Reconstitution and Transfer System is a system of components that allows the safe reconstitution of liquid or pre-dissolved powder drugs into infusion bags, flexible bottles or syringes. Single, partial or multiple vials can be used for each infusion solution container. The TEVADAPTOR® Closed Drug Reconstitution and Transfer System prevents contamination of the user or the environment by the drug through the use of elastomeric seals and an active carbon filter. Sterility of the drug in the vial is maintained because any air entering the vial during pressure equalization enters through of a hydrophobic acrylic copolymer membrane with a pore size of 0.2 micron. The components of the previously cleared TEVADAPTOR® system are: - . Vial Adaptor 20 mm with 13 mm Vial Converter - . Vial Adaptor 28 mm - . Syringe Adaptor - Spike Port Adaptor . - . Connecting Set - . Luer Lock Adaptor - . Syringe Adaptor Lock Each of the above component parts is available separately. The purpose of this 510(k) is to add an additional component to the TEVADAPTOR® system already cleared for sale in the US, the description of which is: - New component: TEVADAPTOR® Catheter Adaptor The Catheter Adaptor provides closed system protection and disconnection of the fluid path between the Syringe Adaptor of the TEVADAPTOR® system and a bladder catheter (not supplied), while allowing safe administration of cytotoxic drugs to the bladder. The Catheter Adaptor connects to the TEVADAPTOR® Syringe Adaptor, the short length of polymeric tubing of the adaptor is connected to the adaptor main body, which in turn is connected to the universal bladder catheter connector. A vented cap is supplied over the universal connector. The universal bladder catheter connector connects to a bladder catheter (not supplied).

TEVADAPTOR is a Closed System Drug Transfer Device (CSTD) that mechanically prohibits the release of the drug 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.

The TEVADAPTOR® Closed Drug Reconstitution and Transfer System is a system of components that allows the reconstitution of liquid or pre-dissolved powder drugs into infusion bags, flexible bottles or syringes. Single, partial or multiple vials can be used for each infusion solution container. The TEVADAPTOR® Closed Drug Reconstitution and Transfer System prevents contamination of the user or the environment by the drug through the use of elastomeric seals and an active carbon filter. Sterility of the drug in the vial is maintained because any air entering the vial during pressure equalization enters through of a hydrophobic acrylic copolymer membrane with a pore size of 0.2 micron. The purpose of this Special 510(k) is to add an additional design of one of the components, the TEVADAPTOR® Syringe Adaptor Lock. The Syringe Adaptor (SA) Lock is one component of the system which is intended for connection to a standard Luer lock syringe. A non-latex elastomer protector covers the liquid dispensing needle tip. A clamp mechanism reversibly connects the Syringe Adaptor Lock to ther components of the TEVADAPTOR® system. The TEVADAPTOR® Syringe Adaptor Lock includes a stainless steel needle that is shielded at all times during preparation, use and disposal. The Syringe Adaptor Lock is supplied with a cap. Disconnection of a syringe is not possible with the Syringe Adaptor Lock, because of a design change from the syringe adaptor that introduces a two-component distal hub. One of these components attaches, and rotates within the second component, together with the syringe, if disconnection is attempted. The components of the TEVADAPTOR® system available separately are: - Vial Adaptor 20 mm with 13 mm Vial Converter - Vial Adaptor 28 mm - Syringe Adaptor - Syringe Adaptor Lock - Spike Port Adaptor - Connecting Set - Luer Lock Adaptor

TEVADAPTOR® is a Closed System Drug Transfer Device (CSTD) that mechanically prohibits the release of the drug 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.

The TEVADAPTOR® Closed Drug Reconstitution and Transfer System, developed by Teva Medical, is a closed system to be used by pharmacists or other healthcare professionals to prepare drugs, including cytotoxic drugs, for infusion, injection, or instillation. The TEVADAPTOR® Closed Drug Reconstitution and Transfer System is a system of components that allow the safe reconstitution of liquid or pre-dissolved powder drugs into infusion bags, flexible bottles or syringes. Single, partial or multiple vials can be used for each infusion solution container. The TEVADAPTOR® Closed Drug Reconstitution and Transfer System prevents contamination of the user or the environment by the drug through the use of elastomeric seals and an active carbon filter. Sterility of the drug in the vial is maintained because any air entering the vial during pressure equalization enters through of a hydrophobic acrylic copolymer membrane with a pore size of 0.2 micron. The components of the TEVADAPTOR® system are: - Vial Adaptor 20 mm with 13 mm Vial Converter - Vial Adaptor 28 mm - Syringe Adaptor - Spike Port Adaptor - Connecting Set - Luer Lock Adaptor Each of the above component parts is sold separately.

The I.V. Administration Set is a single use, sterile I.V. set for administration of drugs and/ or fluids from a container to a patient vascular system.

The I.V. Administration Set is single use, sterile, non-pyrogenic device used to administer intravenous solutions and/or drugs solutions from a container to a patient's vascular system. The I.V Administration set is comprised of various generic components which are broadly used through the industry such as: Spike, Y-site, tubing, clamp, needless injection site, 'twist-off' and Luer connection. The purpose of this Special 510(k) is to add the following two new designs of IV Administration Sets to the one already cleared for sale in the US under K121269: - TEVADAPTOR Connecting Set with ULTRASITE Injection Site - TEVADAPTOR Spike Port Adaptor with ULTRASITE Injection Site All components used in the two new Administration Sets were used in the predicate device cleared under K121269, except for two, which are identical to components cleared under K071741.

The I.V. Administration Set is a single use, sterile I.V. set for administration of drugs and/ or fluids from a container to a patient vascular system.

The I.V. Administration Set is single use, sterile, non-pyrogenic device used to administer intravenous solutions and/or drugs solutions from a container to a patient's vascular system. This device is not made with natural rubber latex. The I.V Administration set is comprised of various generic components which are broadly used through the industry such as: Spike, drip chamber, Y-site, tubing, flow regulator, clamp, needless injection site and luer connection. The set may include two unique components: 1. Spike: The Spike is intended for connection to the spike port of an infusion bag. In cases when a drug needs to be introduced, a septum enables connection to the Tevadaptor™ Syringe Adaptor for withdrawal of diluents or introduction of drug. 2. ULTRASITE In Injection site (cleared under 510(k) No. K031923). The Ultrasite Valve is a needle-free, cap less positive displacement valve to be use in place of needles for the administration of fluids. The ULTRASITE™ Valve may be accessed with standard male luer connectors and requires no special accessories devices. The Ultrasite device eliminates the use of needles to access the set during IV administration and aids in the prevention of needle stick injuries. Teva Medical Migada Plant offers both standard and custom sets with tubing of various lengths to meet customer requirements and specifications.

The TEVADAPTOR™, Closed Drug Reconstitution and Transfer System is a closed system to be used by pharmacists or other healthcare professionals to prepare drugs, including cytotoxic drugs, for intravenous infusion or injection.

The device comprises of the following components: - Vial Adaptor System with 13 mm Vial converter - Syringe Adaptor System - Connecting Set - Spike Port Adaptor - Luer Lock Adaptor The Vial Adaptor System is intended to fit over vials with 20mm caps. A converter accessory enables the use of the Vial Adaptor System with a 13 mm cap vial. A special venting mechanism ensures automatic, sterile, pressure equalization within the vial, preventing drug particle and aerosol escape into the environment. The Vial Adaptor is also effective when used with Radionuclide drugs. A special charcoal layer within the venting system prevents also drug vapor from escaping, ensuring the system is closed to all toxic species. The air entering the vial is sterile due to this combination of filters. An elastomeric, nonlatex septum is designed for connection of the Syringe Adaptor System for introduction or withdrawal of liquid. The interface for connecting with the Syringe Adaptor is designed so that it can be easily cleaned and disinfected when required. The Syringe Adaptor System is intended for connection to a standard luer lock syringe. A special non-latex elastomer protector covers the liquid dispensing needle tip. A clamp mechanism reversibly connects the Syringe Adaptor System to the other components. The design incorporates a Passive-Needle protection that eliminates chances of needle-stick injuries. The Spike Port Adaptor is intended for connection to the spike port of an infusion bag. A non- latex septum enables connection to the Syringe Adaptor System for withdrawal of diluents or introduction of drug. Capped short tubing enables connection of the drug containing bag to a delivery set in the hospital ward. The Connecting set is similar to the Spike Port Adaptor, except for a female luer lock connection at the distal end. The Luer Lock Adaptor enables the connection of the Syringe Adaptor System to an intravenous infusion line for direct drug injection.

The TEVADAPTOR™, Drug Reconstitution and Transfer System is a contained system to be used by pharmacists or other healthcare professionals to prepare drugs, including cytotoxic drugs, for intravenous infusion or injection.

The device comprises of the following components: - Vial Adaptor System with 13 mm Vial converter - Syringe Adaptor System - Infusion Bag Adaptor - -I Connector The Vial Adaptor System is intended to fit over vials with 20mm caps. A converter accessory enables the use of the Vial Adaptor System with a 13 mm cap vial. A special venting mechanism ensures automatic. sterile, pressure equalization within the vial, preventing drug particle escape into the environment. An elastomeric, non-latex septum is designed for connection of the Syringe Adaptor System for introduction or withdrawal of liquid. The Syringe Adaptor System is intended for connection to a standard luer lock svringe. A special non-latex elastomer protector covers the liquid dispensing needle tip. A clamp mechanism reversibly connects the Syringe Adaptor System to the other components. The Infusion Bag Adaptor is intended for connection to the spike port of an infusion bag. A non- latex septum enables connection to the Syringe Adaptor System for withdrawal of diluents or introduction of drug. A capped short tubing enables connection of the drug containing bag to a delivery set in the hospital ward. An injection accessory enables the connection of the Syringe Adaptor System to an intravenous infusion line for direct drug injection.