Search Results

The LifeChoice Oxygen Concentrator is used on a prescriptive basis by patients who are diagnosed as requiring supplemental oxygen. This oxygen concentrator will provide supplemental, high concentration oxygen to these patients. It is not life supporting nor life sustaining. It may be used continuously in a home, institution or travel environment. The LifeChoice is also portable.

The IBC LifeChoice Oxygen Concentrator is a prescription use device for patients needing supplemental high concentration oxygen. The LifeChoice is not intended to be life sustaining or to be life supporting. The LifeChoice provides approximately 90% oxygen to the patients on a demand flow basis at an equivalent rate of 1.0 liter per minute to 3.0 liters per minute in increments of 1.0 liter per minute. The LifeChoice is a portable device which may be used continuously in a home, institution or travel environment. The LifeChoice uses molecular sieve pressure swing adsorption technology.

The International Biophysics Corporation Laser Peel system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology.

The International Biophysics Corporation Laser Peel System is an Er:YAG laser producing emission at a wavelength of 2940 nm. The laser consist of two interconnected sections: The cabinet which houses the power supply, the cooling system and the electronics, and; the umbilical cables and the hand piece, which houses the laser.

The IBC VRV is indicated for use as an intracardiac suction control valve for left ventricular venting during cardiopulmonary bypass surgery (up to six hours).

The IBC VRV Valve is a single use, disposable, vacuum and pressure relief, check valve that is intended for use during open-heart surgery for left ventricular venting. It is sometimes commonly referred to as a suction control valve for left ventricular venting. The device is designed for use in a suction line and must be used in accordance with the operating parameters of that blood recovery line. The fully assembled IBC VRV Valve is geometrically similar and clinically the same to the Omni Model RLV-2100"B" VRV valve, which is the predicate device for purposes of this 510(k) submission. The operating principles of the two devices are identical. The differences between the IBC VRV and the predicate device are found in the material selection and specific dimensions of the component parts neither of which effects safety or effectiveness of the product. The first of these differences is the choice of polymer for molding the plastic components. The main flow through body of the IBC VRV is made of polycarbonate and the Omni RLV-2100"B" is made of ABS. The polycarbonate is clear, has higher impact resistance, greater tensile and compression strength and superior chemical. Upon review of the predicate device, we found the inability to see the interior of the device made it difficult for the user to identify the vacuum relief point. The use of polycarbonate eliminated that problem. Secondly, the straight duck bill check valve in the predicate device represents a substantial resistance to flow which contributes significantly to hemolysis. The unique curved design of the duckbill check valve in the IBC VRV substantially reduces flow resistance and hemolysis.

The IBC FloGard is indicated for use for the prevention of retrograde flow when used with centrifugal pumps during cardiopulmonary bypass surgery (up to six hours).

The IBC FloGard is a single-use, disposable, check valve intended for use for the prevention of retrograde flow in the arterial line when used with centrifugal pumps during open-heart surgery. The device is designed for use in the main arterial line when centrifugal pumps are used. The fully assembled IBC FloGard Valve is geometrically similar to the Quest RetroGuard valve, which is the predicate device for purposes of this 510(k) submission. The operating principles of the two devices are identical. The differences between the IBC VRV and the predicate device are found in the material selection, specific dimensions of the component parts and the type of check valve used. The first of these differences is the choice of polymer for molding the plastic components. The main flow through body of the IBC VRV is made of polycarbonate and the Quest RetroGuard is made of clear ABS. The polycarbonate is clearer, has higher impact resistance, greater tensile and compression strength and superior chemical resistance. Secondly, the straight duck bill check valve in the predicate device, Quest RetroGuard, required an oversized body to accommodate clinical flow rates without a substantial resistance to flow. The bi-leaflet design of the check valve in the IBC FloGard valve substantially reduces the size of the flow through housing without increasing resistance to flow. This geometry substantially lowered prime volume and hemolysis.

The Cardiotomy Vent Valve is indicated for use to maintain a low level of vacuum in cardiotomy reservoirs.

The IBC Vent Valve is a single use, disposable, vacuum relief valve that is intended for use to maintain a low level of vacuum in reservoirs. The valve is closed until the vacuum reaches a pre-determined value in the reservoir and operates best when the pump runs at a very slow rate. The fully assembled IBC Vent Valve is basically identical to the American Omni Vent Valve, which is the predicate device for purposes of this 510(k) submission. The operating principles, performance and indications for use of the two devices are the same. The IBC Vent Valve is manufactured in a Class 100,000 clean room. The device will be packaged and sterilized for single use. Additionally, the IBC Vent Valve will be packaged in bulk form and non-sterile for the Custom Perfusion Pack market. The materials used to manufacture the IBC Vent Valve are non-toxic and meet current ISO biocompatible tripartite standards using the FDA matrix. A perfusionist substituting an IBC Vent Valve for an American Omni Vent Valve with his or her cardiotomy reservoir will be unable to distinguish between the two valves functionally.

The IBC FloPump centrifugal blood pump is indicated for use only with the Medicus Bio-Console® to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). The IBC FloPump centrifugal blood pump is indicated for use and is compatible with all models of the Medicus Bio-Medicus Bio-Consoles to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours).

The IBC FloPump is a single use, disposable centrifugal blood pump that is intended for use during open-heart surgery. The device is designed for and limited to use with the BioMedicus BioPump Console and must be used in accordance with the operating parameters of that device. Directions for Use are included with the IBC FloPump and are the same as the BioMedicus Bio-Pump. The fully assembled IBC FloPump head is a geometric duplicate of the BioMedicus BioPump. The IBC FloPump device is composed of a conical rotor mounted on two ball bearings on the shaft within a generally conical shaped housing. The rotor contains a sealed Strontium Ferrite ring shaped magnet. The magnet is magnetized to 1500 gauss through its thickness every 60 degrees in an alternating north-south and south-north configuration. This enables the rotor to magnetically couple to a similarly configured magnet in the BioMedicus BioPump Console such that the rotor in the IBC FloPump rotates with the magnet in the console. The rotor has two generally conical shaped components attached in close proximity to the magnet housing such that blood contained in the housing forms two generally conical flow paths. The inlet to the housing is in the top center of the housing and the outlet is located on the lower side of the housing tangent to the outer diameter of the rotor. This geometry is identical to the geometry of the predicate device, the BP80 BioMedicus BioPump Pump Head. In use, the rotor subassembly is spun within the housing subassembly by means of the magnetic coupling to the BioMedicus BioPump Console. The blood enters the inlet by gravity and fills the housing such that the two conical flow paths are fully primed. Due to the high surface area to volume ratio of the flow paths, the cohesive force between the blood and rotor members causes the blood to spin. The blood is thereby gently accelerated to about the same angular velocity as the rotor. The resultant centrifugal force causes the blood to move in a direction tangent to the outer diameter of the rotor. The outlet from the housing is centered on the lower edge of the conical flow channels of the rotor and tangent to the outside diameter of the rotor. This dynamic energy provides the pumping power without the use of rotor vanes. The dynamics of the IBC FloPump are identical to the dynamics of the BioMedicus BioPump. There are two technological characteristic differences between the IBC FloPump and the predicate device, the original BioMedicus BioPump. The first of these differences is the choice of polymer for molding the plastic components. The IBC FloPump plastic components are made of clear polycarbonate and the BioMedicus BioPump plastic components are made of acrylic. The polycarbonate has greater clarity and a higher impact resistance. Upon review of the predicate device, the warning to avoid contact with isopropyl alcohol was noted. The use of polycarbonate eliminated that problem. Also, polycarbonate is widely used in a large number of cardiovascular medical devices, and specifically two other brands of centrifugal blood pumps that are currently marketed. Secondly, the main shaft of the IBC FloPump is insert molded into the base of the pump assembly and the BioMedicus BioPump has a main shaft, that is assembled using various rubber seals and formed metal components held together with threads and a nut. The insert-molded shaft eliminates leakage by eliminating the potential leak path, assembly tolerances and stress points from the load-bearing portion of the assembly. This method of insert molding the shaft base has been used on another marketed centrifugal pump brand for years. These two minor technological differences do not raise any new questions concerning the safety and effectiveness of the device.

The Accuflo™ Electromagnetic Flow System is intended for use in the monitoring of the extracorporeal cardiopulmonary bypass circuit blood flow rate during open heart surgery. The device will function in circuits utilizing centrifugal pump heads as well as circuits utilizing roller pumps. There are no other intended uses for the device. The equivalent device, the Bioprobe, is primarily used with centrifugal pumps.

The Accuflo™ Electromagnetic Flow Monitoring System is composed of three (3) components, a monitor display unit, a transducer and a sterile flow-through probe.

The IBC Cardiac Suction Wand is intended for use by a Cardiac Surgeon during open heart surgery for the collection of blood and other fluids from the sterile surgical field for filtering and return to the patient via the Cardiotomy line. It is also intended for use by surgeons for the removal of waste fluids from the surgical field.

The IBC Cardiac Suction Wand is a single use, sterile, disposable surgical instrument intended for the collection of blood and other fluids from the surgical field for return the cardiotomy system during open heart surgery.

The IBC CMO2 Flow Through Cuvette is a single piece, single use, disposable component intended for use with the Bentley OxySat Monitor as a direct substitute for the Bentley OTC Flow Through Cuvette.

The IBC CMO2 Flow Through Cuvette is a single piece, single use, disposable component intended for use with the Bentley OxySat Monitor as a direct substitute for the Bentley OTC Flow Through Cuvette. It is sold sterile and pyrogen free in a Tyvek peel pouch. It is constructed of a single piece of injection molded polycarbonate.

The IBC Gas Cell component was developed for use with the CDI Model 300 Blood Gas Monitoring System manufactured by 3M. The IBC Gas Cell Component may be substituted for the CDI Gas Cell Component in the construction of Extracorporeal Custom Tubing Packs either by the manufacturer of such packs or by the end user to modify his or her pack as needed.

The IBC Gas Cell component was developed for use with the CDI Model 300 Blood Gas Monitoring System manufactured by 3M. The final geometry of the IEC Gas Cell component is identical to the final geometry of the 3M Gas Cell component, and both are fabricated from the same plastic materials. The functional properties of the Gas Cells are determined by the final assembly geometry and the materials employed in construction, especially the two membrane materials. The final geometry of the IBC and CDI components are identical. Using chemical analysis, electron microscopy and information in the public domain, the membranes were sourced from the same supplier used by 3M. The device employs three photochemical sensors to measure pO2, pCO2, and pH. Additionally, there is a thermo-electronic sensor for the direct measurement of temperature.