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The BIOPORT System is designed for closed, needle-free access of arterial blood from pressure monitoring catheters. The BIOPORT System is designed for needle-free access of undiluted blood from arterial catheters (typically 16 or 18 Ga.) not longer than 6.4 cm (2 - ½ "). Diluted, heparinized blood is drawn beyond the BIOPORT into the BPS Reservoir Syringe to permit needle-free withdrawal of undiluted blood from the BIOPORT using a blood sampling syringe fitted with the Blunt Cannula Adapter (BPN). After the undijuted sample is drawn, the heparinized, diluted blood in the Reservoir Syringe is reinfused into the patient to reduce fluid loss.

The BIOPORT System is composed of a 3-way stopcock; BIOPORT (a pre-slit latex rubber septum housed in a clear, rigid, plastic housing); a 3 cc Reservoir Syringe with protective dust cover over the plunger shaft to minimize contamination of Syringe contents by dust particles; and high-pressure Extension Tubing. The BIOPORT and stopcock are bonded 12 and 14 inches, respectively, from the distal male Luer lock connector of the pressure monitoring tubing. The 3-cc Luer lock Reservoir Syringe is pre-attached to the 3-way stopcock. The stopcock, BIOPORT, and Reservoir Syringe are located on a rigid plastic support equipped with a Velcro-type fastener for mounting on a patient's arm. A Blunt Cannula Adapter (BPN)- terminating in a female Luer lock connector at one end for attachment to the male Luer of a sampling syringe, and a hollow, blunt plastic cone at the other end for insertion into the pre-slit septum of the BIOPORT- is provided separately to effect needle-free blood access via the BIOPORT.

The Biosensors Embolectomy Catheter is indicated for use in the removal of emboli and thrombi from the arterial system. The catheter should be used only by a physician with surgical skill in the vascular system.

Biosensors International (BI) has developed an embolectomy catheter that is equivalent in design and performance to embolectomy catheters currently marketed by Baxter. BSI's embolectorny catheters are configured as single lumen, balloon-tipped catheters. The catheters vary in length and diameter to accommodate various thrombotic obstruction and vessel lumen sizes. They are supplied in 3, 4, 5, 6, and 7 French diameters, with inflated balloon diameters of 6, 9, 11, 13, and 14 mm, respectively. The catheters are color coded, and have black distance markings at 10 cm intervals (with "0" cm located at the distal catheter tip.) The proximal end of the flexible catheters terminate in a rigid, winged adapter with female luer lock port to permit attachment to a stylet for stiffening the catheter during insertion, or sterile syringe during balloon inflation. The distal end of the catheters terminate in a latex-coated tip immediately distal to the latex balloons. The latex balloons lie flat against the catheters during insertion through the vasculature and lesion, and are inflated with sterile isotonic saline or other appropriate sterile solution during embolectomy procedures. The catheters are supplied with a stainless steel stylet inserted in their lumens. The stylets terminate proximally in a rigid male luer adapter that mates with the female luer of the catheters. The stylets can be used, when appropriate, to add rigidity to the catheters to aid in their insertion.

The BSI BIOTRANS Pressure Monitoring Kits are designed for use with BIOTRANS Sensor Bases. Kits containing integral 3- and 40 cc/hr flush device are designed for use in physiologic pressure measurements where continuous flow is required to maintain catheter patency. The 40 cchr flush devices are included in Kits designed for neonatal applications in conjunction with a properly calibrated fluid delivery purnp.

The BIOTRANS Pressure Monitoring Systems consist of the sterile, single-use BIOTRANS Pressure Monitoring Kits and reusable BIOTRANS Reusable Sensor Bases and Monitor Adapter Cables. The single-use BIOTRANS Pressure Monitoring Kits provide the sterile fluid pathway components that deliver IV solution to maintain catheter patency via the administration set components. transducer dome assembly and extension set, and convey the hemodynamic waveform from the patient's catheter to the reusable sensor (provided separately). The pressure waveform is conveyed to the sensor via two compliant diaphragms which are brought into intimate contact during set up of the device by the end-user. All fluid contact occurs within the sterile single-use kit components.

The BSI BIOTRANS is used to convert hemodynamic pressure waveforms into electrical signals which can be displayed using separate monitoring equipment. As such, its Indications for Use are identical to those for Medex's MX 860 and MX 960. BIOTRANS cables are used to make an electrical connection between the sensor and monitor. Their use is identical to that of cables manufactured by Utah Medical Products, Inc. The BSI BIOTRANS Sensor Base is used to convert hemodynamic pressure waveforms via a piezoresistive bridge circuit into electrical signals which can be displayed using separate monitoring equipment.

The BIOTRANS Pressure Monitoring System consists of the sterile, single-use BIOTRANS Pressure Monitoring Kit (subject of a separate 510k) and BIOTRANS Reusable Sensor Base and Monitor Adapter Cables. The Base consists of a rugged silicon-based piezoresistive pressure sensor mounted on a rigid plastic support. A standard Wheatstone Bridge circuit etched into the sensor is used to detect pressure changes applied to the sensor and convert them to electronic signals for display on standard monitoring equipment. The sensor is electrically isolated from the patient by a dielectric gel and two elastomeric diaphragms. The physiologic pressure waveform is conveyed from the patient catheter via a fluid-filled pathway to the single-use dome diaphragm. The dome diaphragm is mechanically coupled to the reusable pressure sensor diaphragm for pressure monitoring. The diaphragms make intimate contact during use permitting transfer of the pressure waveform to the transducer, with fluid contact occurring on the patient side of the disposable dome diaphragm. A 25 cm (10") Sensor cable permanently wired to the sensor transmits the electronic signal from the transducer to the patient monitor via the appropriate Monitor Adapter Cable. The integral Sensor cables terminate in 5 different electrical adapters compatible with 5 common brands of Monitor Cables (Utah Medical, Baxter International, Medex, Abbott, and Ohmeda.) Monitor Adapter Cables designed for specific use with all major monitor suppliers are available from BSI. The Base features built-in organizer/mounting systems compatible with standard manifold clamps for pole-mount applications.