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ALTAPORE is an implant intended to fill bony voids or gaps of the skeletal system i.e., extremities and pelvis. ALTAPORE can be used in combination with autograft as a bone graft extender in the extremities and pelvis. ALTAPORE can be used in combination with autogenous bone marrow aspirate in the extremities and pelvis. These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. ALTAPORE resorbs and is replaced with bone during the healing process.

ALTAPORE is a bioactive and osteoconductive silicate-substituted calcium phosphate bone void filler. The interconnected and open porous structure of the silicate-substituted calcium phosphate phase of ALTAPORE is similar to human cancellous bone and is intended to support bone growth with macroand micro- porosity. ALTAPORE is composed solely of elements that exist naturally in normal bone (Ca, P, O, H, Si). ALTAPORE is supplied in a sterile applicator and contains ALTAPORE microgranules, sized 1-2 mm, 80-85% total porosity, suspended in an absorbable aqueous gel carrier. ALTAPORE docs not set in-situ following implantation. ALTAPORE is available in 1.5ml, 2.5ml, 5ml, 10ml, and 20ml configurations. AI,TAPORE is designed for use as a standalone bone graft substitute or as an autograft extender. While not necessary. the product can be mixed with Bone Marrow Aspirate (BMA) or autologous bone at the discretion of the surgeon. ALTAPORE is bioactive based on in vitro studies that show it forms a surface apatite-layer when submerged in simulated body fluid that contains the same ion concentrations as human blood plasma. This apatite layer provides scaffolding onto which the patient's new bone will grow allowing complete repair of the defect. ALTAPORE is osteoconductive based on in vivo animal studies that show it achieves bony healing in a critical defect model as confirmed with radiographic, histolopatholgical, histomorphometric, and mechanical analyses. ALTAPORE undcrgocs ccll-mediated remodeling and is replaced by natural bone.

The Baxter Neutral Luer Activated Device is intended for single patient use with a vascular access device for the administration of drugs and solutions without needles, thus eliminating the potential for needle-stick injuries during use. This device is an in-line injection site which can be connected to standard male Luer adapters (e.g., syringes or sets) for the continuous or intermittent fluid administration or the withdrawal of fluids. This device may be used with low pressure power injectors.

The proposed devices, which are the subject of this Special 510(k) Premarket Notification. consist of a power injectable extension set without the One-Link Needle-free IV connector, extension set codes with the One-Link Needle-free IV connector bonded to the rest of the set, standard bore power injectable extension sets, and a power injectable extension set with a one piece male Luer. They are single use disposable devices intended for use with a vascular access device for the withdrawal of fluids and/or the continuous or intermittent administration of fluids.

To administer fluids from a container into the patient's vascular system through a vascular access device.

The proposed devices, which are the subject of this Special 510(k) Premarket Notification, consist of a stand-alone stopcock, stopcock manifold gangs, Intravenous (I.V.) administration sets with stopcock(s), and I.V. extension sets with stopcock(s). They are single use disposable devices intended for use for continuous or intermittent fluid administration or withdrawal of fluids. These devices are the same as the current marketed devices, previously cleared under 510(k) premarket notifications K962581 (cleared August 28, 1996), K961225 (cleared June 21, 1996) and K022895 (Elcam Plastic, cleared October 18, 2002). The stand-alone stopcock is an in-line access site and can be connected to male Luer adapters (e.g., syringes or sets) to allow needleless access to the fluid or vascular path. It is used to control the fluid flow pathway by rotating the flow control handle. The stopcock manifold gangs consist of individual stopcocks assembled in series through common Luer fittings to form a manifold or gang. These pre-assembled stopcock gangs provide multiple access sites into a common fluid path for the administration of drugs and solutions. The Luer connectors on either end of the stopcock gang allow connection to an administration or extension set for fluid administration through an indwelling intravascular catheter. The I.V. administration sets with stopcock(s) (i.e. solution sets, secondary medication sets, Continu-Flo sets) are used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. They contain the stopcock(s) that can be used for the administration of secondary medication. The I.V. extension sets with stopcock(s) are used for the administration and withdrawal of fluids. They consist of the stopcock connected to the extension set. Currently, Baxter uses three stopcock designs in the stopcock system. The basis for this premarket notification is the standardization to one stopcock design. No new materials of construction are being introduced into Baxter's stopcock system as part of this change. This change does not impact the intended use or the fundamental scientific technology of the device. The product labels are also being updated to add the indications for use statement of the device and clarify their use to comply with Baxter's labeling standards.

The Buretrol Solution Sets are intended for use in the administration of fluids from a container into the patient's vascular system through a vascular access device.

The Buretrol Solution Sets are sterile, single use disposable devices indicated for use in the administration of fluids from a container into the patient's vascular system through a vascular access device. The sets contain a burette chamber which can be used to mix supplementary medication in a measured amount of diluent from the main container. The sets can be adjusted for either metered volume solution administration (intermittent) or continuous solution administration. The sets can be converted from intermittent to continuous administration by closing the air vent at the top of the burette and allowing continuous infusion from the main container. There are different configurations of the burette, based on presence of and differences in valve type.

For the administration of fluids from a container to the patient through a vascular access device. The Interlink Lever Lock Cannula is indicated to function exclusively with the Interlink Injection Site as a fluid path injection device.

The proposed devices, which are the subject of this Special 510(k) Premarket Notification, consist of the Interlink Lever Lock Cannula, Interlink Solution Sets, Interlink Secondary Medication Sets, and Interlink CONTINU-FLO Sets. They are single use disposable devices intended for use with a vascular device for continuous or intermittent fluid administration. These devices are the same as the current marketed devices, previously cleared under 510(k) premarket notifications K883638 (cleared on September 23, 1988), K925126 (cleared on June 18, 1993), and K940697 (cleared on August 30, 1994). The Interlink Lever Lock Cannula is intended to function exclusively with the Interlink Injection Site as a fluid path injection device. It has a female Luer that allows the connection of a svringe or the distal end of an Interlink Secondary Medication Set to an Interlink injection site of an Interlink solution set or an Interlink CONTINU-FLO set. The Interlink Solution Sets, Interlink Secondary Medication Sets, and Interlink CONTINU-FLO Sets are used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. They can be used for gravity or pump infusion of I.V. fluids. Interlink CONTINU-FLO Sets contain the Interlink Injection Site that can be used for the administration of secondary medication. They also contain a check valve which prevents blackflow of solution from the secondary medication container into the primary container during the administration of secondary medication. Interlink Secondary Medication Sets are used in conjunction with Interlink CONTINU-FLO sets to administer intermittent fluids to the patient. The basis for this premarket notification is a modification to the Interlink Lever Lock Cannula, which is an integral part of the Interlink System. The modification consists of replacing the solvent carrier used in the silicone lubrication process of the Interlink Lever Lock Cannula. The product labels are also being updated to add the indications for use statement of the device and clarify their use to comply with Baxter's labeling standards.

Intended for the subcutaneous infusion of fluid medicines.

FlowEase [Subcutaneous] Infusion Set is a single use disposable device intended for the subcutaneous infusion of fluid medicines. The FlowEase [Subcutaneous] Infusion Set consists of a copolyester blend Female ISO 594-2 Luer Lock Connector attached to a 24 inch length of non-DEHP PVC Tubing that is connected to a non-DEHP PVC Hub with wings. The Hub holds a 24-Gauge thin wall AISI 304 stainless steel Needle with a 90° bend at the distal end. A medical grade UV-curable acrylated urethane Adhesive is placed on the outside bend of the needle to secure it within the Hub. The FlowEase [Subcutaneous] Infusion Set also includes a HDPE Bantam Slide Clamp used to start and stop fluid flow. The needle is supplied covered with an LDPE Needle Protector, and the Female Luer Lock Connector is covered with an ABS Male ISO 594-2 Luer Lock Cap. The FlowEase [Subcutaneous] Infusion Set will be marketed with a 24-Gauge thin wall needle that will be available in three needle lengths: 6 mm, 9 mm, and 12 mm. Each set will be packaged with a commercially available dressing, used to hold the device in place on the patient. The FlowEase [Subcutaneous] Infusion Set is provided Gamma sterilized and non-pyrogenic. Each Set is packaged individually in a medical grade thermoformed copolyester tray with a Tyvek® lid, labeled according to needle size.

The I.V. extension set with a 0.22 micron air venting filter is indicated for the administration of fluid to a patient's vascular system and for the removal of air and particulate matter.

The MICRO-VOLUME Extension Set product line consists of sterile, single use disposable devices indicated for the administration of fluid to a patient's vascular system and for the removal of air and particulate matter. These intravascular administration sets provide a clinician the ability to increase the distance between the patient and the fluid administration source. The overall set configuration consists of a female Luer connector, non-DEHP microbore tubing, a 0.22 micron hydrophilic filter, and a male Luer lock connector at the distal end of the set. The filter housing also contains a 0.1 micron hydrophobic filter which vents air to the atmosphere. The MICRO-VOLUME Extension Set with a 0.22 micron filter is designed to remove air and particulate matter and has a maximum pressure of 45 psi (2241 kPa). The product is sterile and non-pyrogenic.

Additive Cap is indicated for use on the medication port of VIAFLEX and AVIVA containers to provide visual evidence that medication has been added.

The subject of this submission is an Additive Cap which will be indicated for use on the medication port of VIAFLEX and AVIVA containers to provide visual evidence that medication has been added. The material and design of the cap are not changing. The proposed Additive Cap will continue to be non-fluid path and non-sterile. The only change is a label modification to expand the indications for use statement to identify compatibility with an additional I.V. container (AVIVA). The device is marketed as a stand-alone device and is packaged in bulk.

The HomeChoice/HomeChoice Pro Automated Personal Cycler peritoneal dialysis system is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.

The HomeChoice/HomeChoice PRO Automated Personal Cycler is used for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis therapy. The HomeChoice/HomeChoice PRO cycler automates peritoneal dialysis by heating the dialysis solution, pumping the solution to and from the patient, controlling dwell times, accounting for volumes of the solution according to a physician prescribed therapy and recording the ultrafiltration volume produced by the therapy.

The IV extension tubing kits provide the user with a "ready-to-use" set up for the administration and withdrawal of fluids avoiding the need to acquire/assemble components from various manufacturers. The kits are indicated for one-time use. The IV extension tubing set is indicated for use with a vascular access device for administration and withdrawal of fluids. The Vital-Hold catheter stabilization device and the foam tape strips are indicated to provide a method for catheter securement. The APLICARE skin prep pad is indicated to prepare the skin prior to application of a dressing or bandage.

The intravenous extension tubing kits will consist of an intravenous extension tubing set, a Vital-Hold catheter stabilization device, two foam tape strips and an APLICARE skin protectant prep pad. The intravenous extension sets may contain any of Baxter's cleared access ports (e.g., Interlink Injection Site, Clearlink Luer Activated Valve or V-Link Luer Activated Valve). The IV extension tubing set is used with a vascular access device for administration and withdrawal of fluids. The Vital-Hold catheter stabilization device is used to help anchor medical intravenous tubes and lines requiring mechanical stability while installed on the skin surface of a patient. The two foam tape strips with release liners are used to assist with line stabilization. The APLICARE skin protectant prep pad is a sterile pad saturated in skin prep solution. The prep solution prepares the skin prior to application of a dressing or bandage. When dry, the prep agent leaves a thin polymer film on the skin surface providing a clean surface for adhesion and a barrier to the natural body oils that can affect adhesion. The IV extension tubing set, the Vital-Hold catheter stabilization device, the two foam tape strips and the APLICARE skin protectant prep pad will be integrated into one sterile unit blister package to provide the user with a "ready-to-use" set up avoiding the need to acquire/assemble components from various manufacturers)