TRILLIUM BIOPUMP PLUS, MODEL BPX80T

K050109 · Medtronic Perfusion Systems · KFM · Feb 11, 2005 · Cardiovascular

Device Facts

• Record ID: K050109
• Device Name: TRILLIUM BIOPUMP PLUS, MODEL BPX80T
• Applicant: Medtronic Perfusion Systems
• Product Code: KFM · Cardiovascular
• Decision Date: Feb 11, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medtronic Trillium® BioPump Plus is indicated for use only with the Medtronic Bio-Console to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g. valvuloplasty, circulatory support during mitral valve reoperation, surgery of vena cava or aorta, liver transplants, etc.)

Device Story

Trillium BioPump Plus is a single-use, disposable centrifugal blood pump. Device functions as the disposable component of a pumping system, electromechanically coupled to a BioConsole. Input: venous blood via inlet port. Operation: smooth rotating cones within a polycarbonate housing accelerate blood via centrifugal force, transferring pressure and velocity to blood; flow rate/pressure controlled by adjusting BioConsole RPM. Output: arterial blood returned to patient. Used in clinical settings (e.g., OR) by perfusionists/clinicians. Device provides circulatory support during bypass or surgical procedures. Benefit: maintains blood flow during extracorporeal circulation.

Clinical Evidence

No clinical data. Substantial equivalence supported by biocompatibility and in vitro bench testing.

Technological Characteristics

Centrifugal blood pump; polycarbonate housing with smooth rotating cones. Blood-contacting surfaces coated with Trillium Biopassive Surface. Single-use, disposable. Electromechanically coupled to external BioConsole for speed control. No new materials or manufacturing processes compared to predicate.

Indications for Use

Indicated for patients requiring extracorporeal circulatory support, including cardiopulmonary bypass or procedures not requiring complete bypass (e.g., valvuloplasty, mitral valve reoperation, vena cava/aorta surgery, liver transplants). Support duration limited to 6 hours.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• BPX80 BioPump Plus (K973011)
• AFFINITY® Hollow Fiber Oxygenator with Trillium® Biopassive Surface (K973760)

Submission Summary (Full Text)

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KOSD109

## SUMMARY OF SAFETY AND EFFECTIVENESS

#### COMPANY AND CONTACT PERSON

Medtronic Perfusion Systems 7611 Northland Drive Minneapolis, MN 55428 [phone] Tel: FAX: [phone]

Preeti Jain, Director, Regulatory/Clinical Affairs

#### DEVICE NAME

Trillium® BioPump Plus

## NAME OF PREDICATED OR LEGALLY MARKETED DEVICE

BPX80 BioPump Plus (K973011) AFFINITY® Hollow Fiber Oxygenator with Trillium® Biopassive Surface (K973760)

#### DESCRIPTION OF DEVICE

The Trillium® BioPump Plus is a centrifugal blood pump which is a single use, disposable, non-pvrogenic device designed to move blood through the extracorporeal circuit by centrifugal forces created by smooth rotating cones. It is the disposable portion of the pumping system and is electromechanically coupled to the BioConsole which is the instrument that monitors and displays the flow and pressure of the blood flow. Venous blood enters the inlet port of the Bio-Pump. The smooth cones rotate in the polycarbonate housing. As the cones rotate, energy in the form of pressure and velocity is transferred from the cones to the blood. The blood is gently accelerated towards the outlet of the pump. The Bio-Pump moves the blood through the circuit at a desired pressure and flow rate by increasing or decreasing the speed of the rotating cones. This is accomplished by adjusting the BioConsole's RPM (revolutions per minute). The arterial blood is returned to the patient from the extracorporeal circuit.

#### STATEMENT OF INTENDED USE

The Medtronic Trillium® BioPump Plus is indicated for use only with the Medtronic Bio-Console to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g. valvuloplasty, circulatory support during mitral valve reoperation, surgery of vena cava or aorta, liver transplants, etc.)

Trillium® BioPump Plus

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## STATEMENT OF INTENDED USE OF PREDICATED/MARKETED DEVICE

The Medtronic BioPump Plus is indicated for use only with the Medtronic Bio-Console to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory pupport for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal circulatory support systems (for periods up to six lhours) not requiring complete cardiopulmonary bypass (e.g. valvuloplasty, circulatory nually having mitral valve reoperation, surgery of vena cava or aorta, liver transplants, etc.)

## STATEMENT OF TECHNOLOGICAL CHARACTERISTICS COMPARISON

Information regarding technological characteristics comparison is provided in the following section, "Determination of Substantial Equivalence".

### DETERMINATION OF SUBSTANTIAL EQUIVALENCE

This "SPECIAL 510(k)" is being submitted for a modification to the BioPump Plus. The modification to the currently marketed centrifugal pump is to coat the blood contact surfaces with Trillium.

The Trillium™ BioPump Plus is being compared to the following marketed devices:

- BPX80 BioPump Plus Centrifugal Blood Pump (K973011) .
- AFFINITY® Hollow Fiber Oxygenator with Trillium® Biopassive Surface (K973760) .

The Trillium®BioPump Plus has the same indications statement and intended uses as the presently marketed BioPump Plus.

The Trillium® BioPump Plus has "no new technological characteristics (e.g., materials and manufacturing processes)" from the currently marketed centrifugal pumps. The technological characteristic is solely the coating material of the blood pathway:

- Trillium® .
The technological characteristic of the Trillium® BioSurface is common to other medical devices (hollow fiber oxygenators) currently in commercial distribution as follows:

- AFFINITY® Hollow Fiber Oxygenator with Trillium® BioSurface (K973760) .
This technological characteristic "could affect the safety and effectiveness of the device". However, these "technological characteristics do not raise new types of safety or effectiveness questions". In addition, "there are acceptable scientific methods which exist for assessing effects of these new technological characteristics".

"Performance data to assess the effects of these new technological characteristics" has been performed. These "performance data demonstrate" that the Trillium® BioPump Plus is substantially equivalent to other marketed extracorporeal cardiopulmonary bypass devices.

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The biocompatibility and in vitro bench testing demonstrated that when compared to the predicate devices, the Trillium®BioPump Plus does not significantly affect safety and effectiveness and is substantially equivalent to other commercially distributed extracorporeal cardiopulmonary devices.

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Image /page/3/Picture/2 description: The image is a logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a bird with outstretched wings.

FEB 1 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medtronic Perfusion Systems c/o Mr. Preeti Jain Director, Regulatory/Clinical Affairs 7611 Northland Drive N Minneapolis, MN 55428-1088

K050109 Re:

Trillium™ BioPump Plus Regulation Number: 21 CFR 870.4370 Regulation Name: Cardiopulmonary Bypass Non-Roller type blood pump Regulatory Class: Class III (three) Product Code: KFM Dated: January 14, 2005 Received: January 18, 2005

Dear Mr. Jain:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We nave reviewed your Section >10(x) premainer is substantially equivalent (for the indications ferenced above and nave determined the are are are are and and marketed in interstate for use stated in the encrosule for regars manatt date of the Medical Device Amendments, or to commerce prior to May 26, 1776, the enating with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Costnetic Act (Act) that do not require appear al controls provisions of the Act. The You may, therefore, market me actives, policements for annual registration, listing of general controls provisions of the rist labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) the existing major regulations affecting your device can may be subject to such additional controlior Linesting of Parts 800 to 898. In addition, FDA may be found in the Ood or reasis concerning your device in the Federal Register.

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Page 2 - Mr. Preeti Jain

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oc actived that i Drimination that your device complies with other requirements of the Act that I DA has made a actor regulations administered by other Federal agencies. You must or any I carated and the Act's requirements, including, but not limited to: registration and listing (21 Comply with an the 11et 0704 and manufacturing practice requirements as set CI K rat 6077, moonling (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provention as described in your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally premaint in the motions 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), please 11 you desire specific of Compliance at [phone]. Additionally, for questions on the contact the Office of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to (2017) 27 1055. 1100, pressed and 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Duna R. Vochner

Image /page/4/Picture/5 description: The image shows what appears to be a signature. The signature is composed of curved lines and strokes, forming a unique and stylized design. The overall impression is that of a handwritten mark, possibly representing a person's name or initials.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): Ko 5 010 9

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The Medtronic Trillium™ BioPump Plus is indicated for use only with the Medtronic Bio-Console to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary byrass (up to six hours). It is also indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g. valvuloplasty, circulatory support during mitral valve reoperation, surgery of vena cava or aorta, liver transplants, etc.)

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

oning R. Jackine

Ovision Sign-Off) n ision of Cardiovascula

510(K) Number_KoS 0 Lo 9