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The TidalPort-AP™ Implantable Apheresis Vascular Access Port is indicated for therapies requiring repeated access to the vascular system. The port system can be used for long-term therapeutic apheresis, withdrawal of blood, and infusion of medications, I.V. fluids, parenteral nutrition solutions, blood, and blood products. The TidalPort-AP™ Implantable Apheresis Vascular Access Port is indicated for power injection of contrast media. For power injection of contrast media, the maximium recommended infusion rate is 5 mL/s.

The TidalPort-AP™ has one port size (Standard) and one catheter size (9.6F Polyurethane). It is designed to provide repeated access to the vascular system without the need for repeated venipuncture or the daily care of an external catheter. The TidalPort-APTM is available as a standard profile totally implantable, titanium port-based design and is accessed perpendicularly to the skin like a typical, conventional access port. For the purpose of apheresis, high-flow procedures, it is accessed with using the FDA Cleared 16G or 18G high-flow, non-coring needle Tidal High-Flow Non-coring Needle (K151341). The TidalPort-APTM can also be used for routine vascular access infusion or withdrawal using Huber point needle. For power injection infusion procedures, the subject device can be accessed with a power injection rated needle to create a power-injectable system. The design of the TidalPort-AP™ utilizes a spherical reservoir and an elongated radius contoured septum to achieve the design purpose of creating a port with a smaller reservoir and less clearance volume. The TidalPort-APTM comes with a number of kit components to aid in the implantation procedure and/or access of the device once implanted. The TidalPort-AP™ and necessary kit components are provided sterile (EtO). The overall implanted port system consists of three primary components: the titanium port body with a silicone septum, an attachable radiopaque polyurethane catheter, and a catheter lock which secures the catheter to the port body stem. Once implanted, the method of accessing the subject TidalPort-APTM device is the exact same as the predicate TidalPort™ device. After the implanted device has been identified and access is prepped per institutional policy, the user palpates the uniquely shaped port. Once the port is palpated, providing the location of the septum, the 16G or 18G high-flow needle (K151341) is inserted into the reservoir for apheresis procedure use. After the reservoir floor is reached, the stylet is unlocked and pulled back slightly, and the needle is once again advanced forward until contacting the reservoir floor again. The stylet is then completely removed, leaving the hollow cannula with luer lock fitting in place. After stylet removal, the cannula is attached to the appropriate extension set and secured for the necessary infusion or withdrawal procedure.

The Tidal High-Flow Non-coring Needle is intended for the access of totally implantable vascular access ports (VAPs) to administer I.V. fluids, infusions drugs, and other fluids, and for the administration of blood products, and/or withdrawal of blood as part of the therapy regimen

The 16Ga and 18Ga Tidal High-Flow Non-coring Needles are an extension of our 19, 20, and 22 gauge non-coring (Huber) Needle line used to access our line of totally implantable access devices. These large gauge non-coring needles incorporate a stylet to render them non-coring. The needle is made from 304 series stainless steel and the hubs are molded from K-Resin and LDPE. All materials are certified USP Class VI and are the exact same materials used to manufacture the products approved under K863721 and K111101. The needles are a disposable product that will be packaged sterile and non-pyrogenic in a single use peel pouch. ETO sterilization will be used. The sterilization will be done in-house using a validated sterilization procedure that is identical to the sterilization method used in previous 510(k) clearances.

The SportPort™ is indicated for use when the patient requires the following: repeated access to the vascular system for injections, infusion of drugs, administration of blood or blood products, and/or withdrawal of blood as part of the therapy regimen. When used with a power injectable needle infusion set, the SportPort™ is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s with a 19 or 20 gauge non-coring power injectable needle and 2 ml/s with a 22-gauge non-coring power injectable needle.

The devices are to be used by or on the order of a physician. The SportPort™ line of ports has a body/septum retainer made of either commercially pure grade 2 titanium or medical grade polysulfone and has a body/septum chamber with a silicone rubber septum designed for repeated needle puncturing. The SportPort™ comes in a standard design to enable regular use as an infusion/withdrawal port and has high-pressure injection capability to aid to the delivery of large volumes or special fluids such as contrast media. The shape of the base plate of the port body is triangular and is compatible with most imaging systems. The top of the port (septum retainer) has a raised triangle to secure the septum in place during high-pressure use and to enable palpable or image system identification. The port has six (6) elongated holes for suture fixation to the deep fascia tissue during implantation. The fixation is required to prevent migration or flipping of the port. A catheter comes with the port and is inserted into the vascular system. The catheter is assembled to the port and fed into a venous vessel and fed down into the vascular system. The catheter is radiopaque to enable visualization for proper placement. The kit provided to aid in insertion of the catheter and placement of the port may include items like needles, sheaths, vein picks, guidewires, straighteners, and dilators. Likewise, the cut down kit for port placement may contain most infusion sets with Lucent Non-Coring needles, straight pointed Huber needles, blunt needles, and syringes along with the port and catheter. The Norfolk Medical SportPort™ family of ports provides a simple method for the delivery of volumes of medications, fluids and special fluids like chemotherapy agents via a chamber leading to a catheter and opening into a large vessel in the body. The catheter is inserted into a large vessel that ideally terminates in the superior vena cava/high right atrial junction. The port is surgically implanted subcutaneously in the soft tissue near the clavicle on the patient's right upper chest wall. Medications, fluids, nutritional liquids or chemotherapy agents can then be administered as necessary. The ports are intended for long-term placement. The Norfolk Medical SportPort™ family of Vascular Access Devices is a group of ports and catheter sets with infusion and withdrawal capabilities via a port and an access catheter to the large vessels in the vascular system. These ports must be properly attached to a catheter during a procedure. When used with a legally marketed power capable needle infusion set, the SportPort™ is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/sec with a 19 or 20 gauge needle and 2ml/sec with a 22 gauge needle set.

The NorPort CT PC Family of Implanted Vascular Access Devices is indicated for use when the patient requires repeated access to the vascular system for injections, infusion drugs, administration of blood or blood products, and/or withdrawal of blood as part of the therapy regimen. The NorPort CT PC Port is indicated for power injection of contrast media. For rne ron ection of contrast media, the maximum recommended infusion rate is 5 power injection of contained on coring power injectable needle and 2 ml/s with a 22-gauge non-coring power injectable needle. The Lucent Non-Coring needle Infusion Set is intended for the administration of fluids and drugs as well as blood sampling through implanted vascular ports. When used with the NorPort CT·PC Family of Implanted Vascular Access Devices, the Lucent Non-Coring Needle Infusion Set is also indicated for power injection of contrast media into the central venous system.

The Norfolk Medical NorPort CT-PC Port is composed of a port reservoir with an attachable catheter system. The Port reservoir consists of a titanium or polysulfone chamber with a silicone septum and an outlet pin (510 (k)#102385). The silicone septum is designed to allow multiple needle puncturing while maintaining the leak-tight integrity. The NorPort CT·PC comes in standard design to enable regular use as an infusion/withdrawal port and has high-pressure injection capability to aid in the delivery of large volumes of specialty fluids such as contrast media. The NorPort CT·PC is triangular shaped with a recessed septum ring. The body port has a "CT" symbol machine etched on the bottom end to enable easy recognition of the port with most imaging systems. The port has 3 holes for suture fixation to the tissue. A catheter comes with the port and is inserted in the vascular system. The catheter is usually inserted into a venous vessel and fed down into the superior vena cava. The placement of the catheter is checked by radiographic technique. The catheter is radiopaque to enable visualization for placement. The kit provided to aid in insertion of the catheter and placement of the port may include introducer items like needles, sheathes, vein picks, guidewires, straighteners, and dilators. Likewise the, "cut-down", kit for port placement may contain tunnelers, infusion sets with 90 degree Huber point needles, and syringes along with the port and catheter. The Lucent Non-Coring Needle Infusion Set is similar to the following predicate devices: Smiths Medical Gripper Plus Power P.A.C Needle (510 (k)# 070116), the Angiodynamics Lifeguard CT Safety Infusion Set (510 (k)#072375), the Bard the rater of the Safety Infusion Set (510 (k)# 082306), and the MEDCOMP CT Injectable Safety Huber Needle (510 (k)# 080544). The Lucent Non-coring and the predicated devices are supplied sterile and non-pyrogenic and are intended for the administration into or withdrawal of fluids from the Norfolk Medical line of implanted ports. When a "Power Injectable" NorPort CT-PC Port is used, the Lucent Non-coring and the predicate devices are indicated for power injection of contrast media.

The NorPort Family of Implanted Vascular Access Devices is indicated for use when the patient requires repeated access to the vascular system for injections, infusion drugs, administration of blood or blood products, and/or withdrawal of blood as part of the therapy regimen.

Our device is composed of a port reservoir with an attachable catheter system. The Port reservoir consists of a titanium (510 (k)# 871192) or polysulfone (510 (k)# 840788) chamber with a silicone septum and an outlet section. The silicone septum is designed to allow multiple needle puncturing while maintaining the leak-tight integrity. The port comes in two different sizes to accommodate different body frames. The catheter that is attached to the port is long enough to be inserted in the superior vena cava/right atrium junction to allow for fluid infusion into the heart and large blood vessels. The NorPort will also be available as part of an implantable kit. The kit contains all the tools needed to aid in catheter placement, insertion and port implantation.