IBC FLOPUMP, MODEL 6000

{0}------------------------------------------------ 3/24/99 Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The characters appear to be a combination of letters and numbers. The string reads 'K983272'. Image /page/0/Picture/2 description: The image shows the letters IBC in a stylized font. The letters are large and bold, and they are arranged in a slightly overlapping manner. Behind the letters, there is a faint image of a world map. The map is divided into sections by lines of longitude and latitude. # 510(k) SUMMARY #### 510(K) SUMMARY # COMPANY NAME AND CONTACT PERSON September 16, 1998 International Biophysics Corporation (IBC) 4020 South Industrial Drive Suite 160 Austin, TX 78744 Tel. (512) 326-3244 Fax (512) 326-3299 H. David Shockley, Jr. President #### DEVICE NAME IBC FloPump Catalog Number 6000 #### COMMON NAME Centrifuqal Blood Pump #### CLASSIFICATION NAME Non-roller type cardiopulmonary bypass blood pump (21 CFR - 870.4360) ## PREDICATE DEVICE OR LEGALLY MARKETED DEVICE Medtronic Bio-Medicus, Inc. - BP-80 Bio-Pump® (K852698) ## INTENDED USE 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). 용 INTERNATIONAL BIOPHYSICS CORPORATION • 4020 S. INDUSTRIAL DRIVE, SUITE 160 • AUSTIN, TEXAS 78744 • 512 326-3299 {1}------------------------------------------------ #### 510(k) SUMMARY 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. $$\mathbb{S} \text{ - } \mathbb{Q}$$ {2}------------------------------------------------ The magnet for coupling the pump head to the pump console in both products is made of Strontium Ferrite and magnetized to 1500 Gauss. The rotor bearings and bearing assembly of both products are the same part number from the same bearing manufacturer. Both products are identical in these respects. The IBC FloPump was in-vitro bench tested for performance evaluation. The IBC FloPump was subjected to a series of flow tests in a side by side comparison with the BioMedicus BioPump. The RPM required to generate specific flow rate and output pressure was measured at one liter intervals from one to seven liters per minute. The data generated was insignificantly different between each IBC FloPump tested, and insignificantly different between the IBC data and the BioMedicus data. The IBC FloPump was also compared to the BioMedicus BioPump for hemolysis. While the IBC data indicates that the IBC FloPump had lower hemolysis than the BioMedicus BioPump, it is the opinion of IBC that the blood trauma is too low in either system to attribute significance to the differences seen. This testing demonstrates the IBC FloPump does not raise any new safety and effectiveness questions, and it is substantially equivalent to the predicate device, BioMedicus Bio-Pump. The IBC FloPump is manufactured at IBC in a Class 100,000 clean room. The Bioburden prior to sterilization is extremely low, meets IBC criteria and comparable to other products manufactured by IBC. The IBC FloPump is labeled non-pyrogenic (less than 0.5 EU/ml) and this is tested and validated by the LAL method. The device will be packaged and sterilized for single use. The IBC FloPump has passed our sterilization validation test, meets the IBC SAL standard, meets the sterilization residue standards in accordance with ISO 10993-7, and the packaging has been validated to maintain sterility for 2 years using accepted accelerated aging methods and microbial challenged. Additionally, the IBC FloPump will be packaged in bulk form and non-sterile for the Custom Perfusion Tube Pack market. The materials used to manufacture the IBC FloPump are biocompatible and non-toxic and, therefore, safe for its intended use in accordance with ISO 10993-1 standard. In addition, these same materials have been used in other IBC products in the same manufacturing process for years. An end user substituting an IBC FloPump for BioMedicus BioPump in his or her perfusion circuit will be unable to distinguish between the two pumps functionally. Performance, functional, and biocompatibility testing demonstrated that there are no new safety and effectiveness questions raised by the IBC FloPump. The IBC FloPump is substantially equivalent to the Medtronic BioMedicus Bio-Pump, BP-80. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three abstract human figures, possibly representing people, in a row. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 2 4 1999 Mr. H. David Shockley, Jr. President International Biophysics Corporation 4020 S. Industrial Drive Suite 160 Austin, TX 78744 K983272 Re : IBC FloPump, Model 6000 III (Three) Regulatory Class: Product Code: 74 KFM Dated: January 11 1999 Received: January 14, 1999 Dear Mr. Shockley: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the maries is substantially equivalent (for the indications for use acvice in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the markeed in Incorrown Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, che reachar rood, brag, and, subject to the general controls enovisions of the Act. The general controls provisions of the provisions of the Act. The general registration, listing of nee instado roquing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in In addition, FDA may publish further regulatory action. announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {4}------------------------------------------------ Page 2 - Mr. H. David Shockley, Jr. This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding a bubstantial equivalence of your device to a legally marketed or subbeantial equivals in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at Gragitosere devices), promo y, for questions on the promotion and advertising of your device, please contact the Office of Also, please note the regulation Compliance at (301) 594-4639. entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your (arch obilities under the Act may be obtained from the Division responsibilitions assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html." Sincerely yours, Thomas J. Callehan Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ # INDICATIONS FOR USE 510(k) Number: ______________________________________________________________________________________________________________________________________________________________________________ Device Name: IBC FloPump Indications for use: 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). . I (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) ______________________________________________________________________________________________________________________________________________________________________________ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Concurrence of CDRH, Office of Device Evaluation (ODE) | | <p>M.</p> | |---------------------|---------------------------------------------------------------| | (Division Sign-Off) | (Division Sign-Off) | | | Division of Cardiovascular, Respiratory, Neurological Devices | | | 3983272 | | Prescription Use (Per 21 CFR 801.109) | <span style="text-decoration: overline;">✓</span> | or | Over-The-Counter-Use | |---------------------------------------|---------------------------------------------------|----|----------------------| |---------------------------------------|---------------------------------------------------|----|----------------------|