(188 days)
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 provided text describes the IBC FloPump centrifugal blood pump and its substantial equivalence to a predicate device. However, it does not explicitly state acceptance criteria in a table format, nor does it detail a study proving the device meets specific acceptance criteria as a standalone performance study would. The information provided is primarily focused on demonstrating substantial equivalence to a previously marketed device (Medtronic Bio-Medicus, Inc. - BP-80 Bio-Pump®).
Based on the provided text, here's an analysis of the information requested:
1. A table of acceptance criteria and the reported device performance
The document does not present acceptance criteria in a table. Instead, it describes comparative performance testing and concludes substantial equivalence. The key performance metrics discussed are:
| Acceptance Criteria (Implied) | Reported Device Performance (IBC FloPump vs. Bio-Medicus Bio-Pump) |
|---|---|
| Flow Rate and Output Pressure (RPM required to generate specific flow rate and output pressure) | Insignificantly different between IBC FloPump and Bio-Medicus Bio-Pump. |
| Hemolysis (Blood trauma) | IBC data indicates lower hemolysis for IBC FloPump, but IBC states the difference is too low in either system to attribute significance. |
| Biocompatibility | Materials are biocompatible and non-toxic, in accordance with ISO 10993-1. Same materials used in other IBC products for years. |
| Sterility | Passed sterilization validation test, meets IBC SAL standard, meets sterilization residue standards (ISO 10993-7), packaging validated for 2 years. |
| Non-pyrogenic | Labeled non-pyrogenic ( |
§ 870.4360 Nonroller-type blood pump.
(a)
Nonroller-type cardiopulmonary and circulatory bypass blood pump —(1)Identification. A nonroller-type cardiopulmonary and circulatory bypass blood pump is a prescription device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:(i) Full or partial cardiopulmonary bypass (
i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
(2)
Classification —Class II (special controls). The special controls for this device are:(i) Non-clinical performance testing must perform as intended over the intended duration of use and demonstrate the following: Operating parameters, dynamic blood damage, heat generation, air entrapment, mechanical integrity, and durability/reliability;
(ii) The patient-contacting components of the device must be demonstrated to be biocompatible;
(iii) Sterility and shelf life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components; and
(iv) Labeling must include information regarding the duration of use, and a detailed summary of the device- and procedure-related complications pertinent to use of the device.
(b)
Nonroller-type temporary ventricular support blood pump —(1)Identification. A nonroller-type temporary ventricular support blood pump is a prescription device that uses any method resulting in blood propulsion to provide the temporary ventricular assistance required for support of the systemic and/or pulmonary circulations during periods when there is ongoing or anticipated hemodynamic instability due to immediately reversible alterations in ventricular myocardial function resulting from mechanical or physiologic causes. Duration of use would be less than 6 hours.(2)
Classification. Class III (premarket approval).(c)
Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with FDA on or before September 8, 2015, for any nonroller-type temporary ventricular support blood pump that was in commercial distribution before May 28, 1976, or that has, on or before September 8, 2015, been found to be substantially equivalent to any nonroller-type temporary ventricular support blood pump that was in commercial distribution before May 28, 1976. Any other nonroller-type temporary ventricular support blood pump shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.