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1. The Beeline system is intended for continuous and/or intermittent infusion of medication for general infusion use, including antibiotic delivery, chemotherapy and pain management. The Beeline system is indicated for intravenous, intra-arterial, enteral, subcutaneous, percutaneous and epidural infusion of medications or fluids requiring continuous and/or intermittent delivery at controlled infusion rates. The Beeline system is suitable for use as an ambulatory device and is intended for use in the hospital, home environment, and alternative care sites. 2. The Beeline system is intended to provide continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. The Beeline system is also intended for patientcontrolled infusion using the integrated bolus device. 3. The Beeline system is intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or close proximity to nerves when compared with narcotic only pain management.

The Beeline device consists of a spring-pressurized medication reservoir with a flowratecontrolling administration set. A spring applies force against a piston, pressurizing the medication. The administration set includes a flow restrictor component with controlled internal diameter and length. The flow rate at which medication is dispensed from the system is a function of the pressure applied to the medication and the dimensions of the flow restrictor component. The medication may be dispensed from the system continuously and/or intermittently. The size of the reservoir and the amount of flow restriction are determined to yield a variety of product codes with differing infusion volumes and flow rates. The physician prescribes for a patient a flow rate and reservoir size based on the individual patient needs. Administration sets may incorporate a bolus feature, which may be used alone or in conjunction with basal (continuous) or KVO (very low) flow. The bolus device consists of a dosage reservoir that is filled when activated manually. After the bolus device has been activated, the bolus volume is infused at a controlled flow rate. The bolus device is integrated into the administration set and allows patient-controlled administration of medication as needed. A procedure kit option provides various components that facilitate setup and use of the Beeline system. The Beeline system is intended for single patient use.

The Accufuser and Accufuser Plus systems are intended for general infusion use. Routes of infusion include intravenous, percutaneous, subcutaneous, intra-arterial and epidural, and into the intra-operative (soft tissue/body cavity) site. The Accufuser Plus is also intended for patient-controlled infusion using the integrated bolus button. General infusion uses include pain management for preoperative, perioperative, and postoperative surgery. The Accufuser and Accufuser Plus systems are also intended for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural or percutaneous. The Accufuser/Accufuser Plus system is suitable for use as an ambulatory device and is intended for use in the hospital, home environment or alternative care sites.

This submission is intended to notify the Food and Drug Administration that McKinley, Inc. intends to market a modification to an existing device (K023098) called the Accufuser/Accufuser Plus system. The modification to the existing device is the addition of procedure kits containing different accessories. Standard Procedure Kits will have an optional multi-port catheter with a longer fenestrated length for wetting a larger area. The current kits have a standard epidural catheter with a small number of fenestrations over a short length. Standard Procedure Kits will have an optional fixed-hub catheter. The current kits have catheters that utilize a Tuohy-Borst adapter or alligator clip-style adapter. Standard Procedure Kits will have an optional break-away introducer needle, allowing use of a fixed-hub catheter. The current kits have a non-break-away introducer needle that requires use of a catheter with separate connector (i.e., Tuohy-Borst or alligator clip style adapter). Standard Procedure Kits will have an optional fill port cover, inhibiting access to the fill port once the cover is attached.

The Beeline system is indicated for intravenous, intra-arterial, enteral, subcutaneous and epidural infusion of medications or fluids requiring continuous delivery at controlled infusion rates. The Beeline system is also intended to provide continuous infusion of a local anesthetic directly into the intraoperative site for postoperative pain management.

The Beeline device consists of a spring-pressurized, syringe-like medication reservoir with a flowrate-controlling administration set. Medication is held between the barrel and piston of the infuser. A spring applies force against the piston, pressurizing the medication. The administration set includes a flow restrictor component with controlled internal diameter and length. The flow rate at which medication is dispensed from the system is a function of the pressure applied to the medication and the dimensions of the flow restrictor component. The size of the reservoir and the amount of flow restriction are varied during manufacturing to yield a variety of product codes with differing infusion volumes and flowrates. A procedure kit provides various components that facilitate setup and use of the Beeline system. Examples of kit components include items such as a prep tray, sterile drape, transfer syringe, medication/chart labels, catheter & introducer, dressing, tape, gauze, prep pads/wipes, carrying case, etc. Multiple kit product codes are made, with the contents varied as applicable for the particular procedure. The Beeline system is intended for single patient use.

The pump is indicated for intravenous, subcutaneous, arterial, enteral, and epidural infusion of antibiotics, analgesics, chemotherapeutic agents and other medications or fluids requiring precisely-controlled infusion rates.

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The McKinley SP is indicated for intravenous, intra-arterial, enteral, subcutaneous and epidural infusion of medications or fluids requiring continuous delivery at controlled infusion rates. The McKinley SP is also intended to provide continuous infusion of a local anaesthetic directly into the intraoperative site for postoperative pain management.

McKinley SP Disposable Infusion Pump

The OutBound DIP is indicated for intravenous, intra-arterial, subcutaneous, and The OutBound DIP is indicated for inturvenede, may will with the world in the successions of the controlled infusion rates. The OutBound pump is also intended to provide continuous infusion of a local The Outbound pump is also intracperative site for postoperative pain management.

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The McKinley OUTBOUND-2 is indicated for patients requiring intravenous, interarterial, subcutaneous, or enteral administration of medication. It is convenient for use by ambulatory patients.

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