K Number

Device Name

IBC FLOPUMP, MODEL 6000

Manufacturer

INTERNATIONAL BIOPHYSICS CORP.

Date Cleared

1999-03-24

(188 days)

Product Code

KFM

Regulation Number

870.4360

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). 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).

Device Description

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K852698

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on mechanical and hydraulic principles, with no mention of AI or ML.

Therapeutic

Yes
The device is indicated for pumping blood through an extracorporeal bypass circuit for circulatory support, which is a therapeutic intervention.

Diagnostic

The device is a centrifugal blood pump used for extracorporeal circulatory support during open-heart surgery, which involves pumping blood, not diagnosing conditions.

SaMD (Software as a Medical Device)

The device description clearly states that the IBC FloPump is a physical, single-use, disposable centrifugal blood pump with mechanical components (rotor, housing, magnet, shaft, bearings). It is a hardware device intended to pump blood.

IVD (In Vitro Diagnostic)

Based on the provided text, the IBC FloPump centrifugal blood pump is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use is to "pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours)." This describes a device used in vivo (within the body's circulatory system during surgery) to support circulation, not a device used in vitro (outside the body) to examine specimens for diagnostic purposes.
Device Description: The description details the mechanical components and how the device physically pumps blood. It does not mention any components or processes related to analyzing biological samples or providing diagnostic information.
Performance Studies: The performance studies focus on flow rate, output pressure, and hemolysis (blood trauma), which are relevant to the mechanical function of a blood pump used in a surgical setting, not to diagnostic accuracy.

IVD devices are typically used to examine specimens such as blood, urine, or tissue to diagnose diseases, monitor conditions, or screen for health issues. The IBC FloPump's function is purely mechanical support of blood circulation during surgery.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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).

Product codes

74 KFM

Device Description

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 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K852698

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

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

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INTERNATIONAL BIOPHYSICS CORPORATION • 4020 S. INDUSTRIAL DRIVE, SUITE 160 • AUSTIN, TEXAS 78744 • 512 326-3299

510(k) SUMMARY

$$\mathbb{S} \text{ - } \mathbb{Q}$$

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.

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.

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

INDICATIONS FOR USE

510(k) Number:

Device Name: IBC FloPump

Indications for use:

. I

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

	M.
(Division Sign-Off)	(Division Sign-Off)
	Division of Cardiovascular, Respiratory, Neurological Devices
	3983272

Prescription Use (Per 21 CFR 801.109)	✓	or	Over-The-Counter-Use
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