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The Nutricair enteral ENFit adapter: ENFit male - stepped/Christmas tree connector is a disposable, sterile medical device intended to be used as an adapter between ENFit connections and funnel connections, used in enteral nutrition. A doctor, a nurse or the adult laypersons can do enteral feeding. The target population is adults.

The Nutricair™ enteral ENFit adapter: ENFit male – stepped/Christmas tree connector is sterile single use device. The adapter presents a ENFit connection in ABS at one extremity and a notched connection (in ABS) at the other extremity. The device has also a female ENFit cap in PEHD attached to the adapter with a link. This device incorporates a male ENFit connection to enteral access device with a female ENFit connector that is compliant to ISO 80369-3. It is provided with a sterility protector.

The ENFit Adaptor is intended for connecting an enteral giving set with an ENFit connector to an enteral catheter with funnel.

To facilitate the interconnection between newly-released feeding sets, which are equipped with female ENFit connectors, and the funnel feeding ports of previously-designed enteral feeding tubes, the proposed device is designed with the mating component of an ENFit female connector, designed and tested in accordance with ISO 80369-3 and ISO 80369-20, at one of its ends, and the mating component of a non-ISO 80369-1 compliant funnel feeding port, a stepped tip connector, at its other end. It can prevent an interruption or delay in patient care by allowing fitment of enteral feeding sets with ISO 80369-3 compliant ENFit female connectors to existing enteral feeding tubes with non-ISO 80369-1 compliant end connectors, referred to as "funnel feeding ports" which are still available for use in healthcare setting. The proposed device is sterile or non-sterile device is sterilized by ethylene oxide to achieve a SAL 10- and supplied in sterility maintenance package which maintain the sterility of the device during the shelf life 5 years. No DEHP, BPA and Natural Rubber Latex are added in the device.

The enteral specific transition connectors are intended to facilitate enteral specific connections between ISO 80369-3 compliant connectors and non-ISO 80369-3 compliant legacy enteral connectors.

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The Cedic F 00126 ENFit to Reverse Luer Transition Connector is intended to connect an enteral female ENFit giving set to the "g" port of the AbbVie PEG-J enteral male Luer catheter. The Cedic F 00128 Luer to ENFit Transition Connector is intended to connect the AbbVie Duopa Medication Cassette Reservoir delivery system to an enteral male ENFit catheter.

The Cedic Enteral ENFit Transition Connectors are designed to facilitate enteral specific connections between ISO 80369-3 compliant connectors and non ISO 80369-1 compliant legacy enteral connectors. This submission describes the Cedic ENFit to Reverse Luer Transition Connector and the Cedic Luer to ENFit Transition Connector. These Cedic ENFit Transition Connectors are intended for prescription use only. The two transition connectors introduced by means of this submission are intended only for use with specific products commercialized in the US by Abbvie Inc., North Chicago, IL 60064-1802, USA, these being the AbbVie PEG-J enteral male Luer catheter (cleared under K142816) and the AbbVie Duopa Medication Cassette Reservoir (details available in DMF 26089) respectively.

The Nutrisafe 2 – ENFit adaptor is indicated for enteral use only. It enables the connection between an administration set equipped with a female ENFit connector at its distal end and a Nutrisafe 2 feeding tube equipped with a male Nutrisafe 2 connector at its proximal end.

The Nutrisafe 2 – ENFit adaptor is indicated for enteral use only. It enables the connection between an administration set equipped with a female ENFit connector at its distal end and a Nutrisafe 2 feeding tube equipped with a male Nutrisafe 2 connector at its proximal end. Vygon has not previously submitted any 510(k)s for the subject device.

The Medline ENFit Transition Connecting an enteral feeding set with an ENFit connector to a gastronomy tube with funnel. The Medline ENFit G-Tube Connector is intended for connecting an enteral feeding set equipped with a stepped enteral distal end to a gastronomy tube equipped with an ENFit connector.

In an effort to mitigate the risk of misconnections associated with enteral feeding devices, manufacturers have recently began to adopt a uniform connector for enteral devices, called an ENFit connector, which is based upon the ISO 80369 series of standards and is in accordance with FDA Final Guidance for Industry: Safety Considerations to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications (February 11, 2015). This uniform ENFit connector provides a locking feature that signals the appropriate connection to stay in place. In addition, the ENFit connector features a female mating component end for enteral feeding sets and a male mating component end for gastronomy feeding tubes, which allows for the interconnection of these devices. However, it will take time for enteral devices with this uniform ENFit connector to become widely available and fully adopted across healthcare settings, as existing enteral devices with previouslydesigned "legacy" connectors, which are not compliant with ISO 80369-1, still remain in inventory. Therefore, to prevent an interruption or delay in patient care when an enteral device with an AAMI/CN3:2014 (PS) compliant ENFit connector must be connected to an existing enteral device with a non-AAMI/ANSI/ISO 80369-1 compliant connector, a temporary need has emerged for an adapter that can facilitate connection between enteral devices with these incompatible end connectors. The Medline ENFit Transition Connector and the Medline ENFit G-Tube Connector address this temporary need and facilitate enteral-specific connections between AAMI/CN3:2014 (PS) compliant enteral connectors and non-AAMI/ANSI/ISO 80369-1 compliant connectors to ensure that patient enteral feeding is not impeded when an enteral feeding device with an AAMI/CN3:2014 (PS) compliant ENFit connector must be connected to a previously-designed, existing enteral feeding device with a non-AAMI/ANSI/ISO 80369-1 compliant end connector. The Medline ENFit Transition Connector and the Medline ENFit G-Tube Connector, which are described in further detail below, allow specific connections between enteral feeding devices with AAMI/CN3:2014 (PS) compliant ENFit connectors (also known as "PGLock" connectors) and enteral feeding devices with non-AAMI/ANSI/ISO 80369-1 compliant, legacy connectors that are still available for use in healthcare settings. To facilitate this connection, the Medline ENFit Transition Connector and the Medline ENFit G-Tube Connector are both designed with the mating component of an AAMI/CN3:2014 (PS)-compliant ENFit connector at one end and the mating component of a previously-used, legacy connector at its other end. Specifically, the two designs of ENFit transition adapters that are within the scope of this 510(k) Premarket Notification submission are: 1.) The Medline ENFit Transition Connector The Medline ENFit Transition Connector allows fitment of newly-released enteral feeding sets with AAMI/ CN3:2014 (PS) compliant ENFit connectors to existing gastronomy tubes with non-AAMI/ ANSI/ISO 80369-1 compliant end connectors, referred to as "funnel feeding ports," which are still available for use in healthcare settings. Specifically, to facilitate the interconnection between newlyreleased feeding sets, which are equipped with female ENFit connectors, and the funnel feeding ports of previously-designed gastronomy tubes, this adapter provides the mating component of an ENFit female connector, designed and tested in accordance with AAMI/ CN3:2014 (PS) and AAMI/CN20:2014 (PS), at one of its ends, and the mating component of a non-AAMI/ANSV/ISO 80369-1 compliant funnel feeding port, a stepped Distal Tip connector, at its other end. 2.) The Medline ENFit G-Tube Connector The Medline ENFit G-Tube Connector allows fitment of newly-released gastronomy tubes (or "Gtubes") with AAMI/CN3:2014 (PS) compliant ENFit connectors to previously-designed enteral feeding sets with non-AAMI/ANSI/ISO 80369-1 compliant connectors, which still may be available for use in healthcare settings. To facilitate the compatibility between gastronomy tubes with ENFit male connectors and the stepped Distal Tip connector of existing enteral feeding sets, the Medline ENFit G-Tube Connector provides the mating component of an ENFit male connector, designed and tested based upon AAMI/ CN3:2014 (PS) and AAMI/CN20:2014 (PS), at one of its ends, and the mating component of a stepped Distal Tip connector, a funnel feeding port, at its other end.

The AMT Enteral Transition Adapters are intended to facilitate enteral specific connections between AAMI/CN3(PS) compliant connectors and non ISO 80369-1 compliant legacy enteral connectors.

New standard ISO-80369-1 is pushing feeding tube manufacturers to transition current extension set designs to incorporate enteral only connectors. Most enteral feeding devices currently on the market utilize luer slip or catheter tip connectors to connect enteral giving sets and syringes to enteral receiving sets. Standard luer slip and catheter tip connectors raise risk levels for patients as devices outside of the enteral market use similar connections, including IVs. Therefore, the ISO/IEC 80369 series was developed to help reduce the possibility of misconnections across different medical fields. The FDA recently cleared an updated AMT enteral extension set in 510(k) K142989. This extension set remains identical to our previously marketed device, but includes Enfit connectors. However, launching a enteral extension sets with Enfit connectors will not be simultaneous across all manufacturers and distributors. Therefore, transition adapters are necessary for a limited time. As the new Enfit connectors are not backwards compatible with current luer and bolus connections currently used for enteral products, AMT has designed several transition adapter configurations to help users make the switch to the new connections. AMT estimates that there will be a time of at least a year and possibly up to three years where users and distributors will still have access to enteral devices with luer / bolus connectors. The transition adapters AMT has designed in this 510(k) will allow users to use their old giving/receiving sets until the market is flushed of old inventory. The AMT Enteral Transition Adapters come in 5 configurations and are made up of 5 separate components. The five configurations include: • Male Enfit to Male Luer Adapter • Female Enfit to Female Luer Adapter • Female Enfit to Y-Port (Bolus/Luer) Adapter • Female Enfit to Bolus Adapter • Male Enfit to Christmas-tree Adapter These 5 transition adapter configurations will allow AMT to offer users with options for all of the common enteral connectors currently on the market. All components and materials have been previously cleared in 510(k)s for similar use. It is planned to include these transition adapters kitted with enteral devices previously cleared through the 510(k) process, as well as selling the adapters as stand-alone items.

The Cedic Oral/Luer Enteral ENFit Transition Connector for is intended for connecting a male oral tip syringe or a male Luer slip tip syringe to an enteral giving set or enteral catheter with an ENFit medication port.

The Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port is a transition connector intended for connecting a male oral tip syringe or a male Luer slip tip syringe to an enteral giving set or enteral catheter with an ENFit medication port. This connector is available with and without end cap. It operates by providing a means of interconnecting incompatible enteral feeding device end fittings together. The PGLock end of the connector is designed in compliance with ISO 80369-1:2010 and ISO/IEC AAMI/CN3 (PS):2014. It is manufactured by injection molding from ABS HF 380.

The Cedic Enteral Distal End ENFit Transition Connector is intended for connecting an enteral giving set with an ENFit connector to an enteral catheter with funnel. The Cedic Enteral ENFit Transition Connector for Medication Port is intended for connecting a male oral tip syringe to an enteral giving set or enteral catheter with an ENFit medication port. The Cedic Enteral Funnel ENFit Transition Connector is intended for connecting an enteral giving set equipped with a stepped enteral distal end to an enteral catheter equipped with an ENFit connector.

Cedic Srl has designed three transition connectors that will allow specific connections between PGLock end connectors being used on new devices to some of the previously used end connectors that may still be in use in healthcare or home settings. The three transition connectors are: - . Enteral Distal End ENFit Transition Connector, for connecting an enteral giving set with an ENFit connector to an enteral catheter with funnel. Available with and without end cap. - . Enteral ENFit Transition Connector for Medication Port, for connecting a male oral tip syringe to an enteral giving set or enteral catheter with an ENFit medication port. Available with and without end cap. - . Enteral Funnel ENFit Transition Connector, for connecting an enteral giving set equipped with a stepped enteral distal end to an enteral catheter equipped with an ENFit connector. Available with and without end cap. All three Cedic ENFit Transition Connectors are intended for prescription use only.