(24 days)
Not Found
No
The device description focuses on mechanical and electromechanical principles for blood pumping, with no mention of AI or ML technologies for control, monitoring, or analysis. The control mechanism described is adjusting RPM based on desired flow and pressure, which is a standard feedback loop, not AI/ML.
Yes
The device is used to pump blood through an extracorporeal bypass circuit for circulatory support during medical procedures, which is a therapeutic intervention.
No
The device description clearly states its function is to "pump blood through the extracorporeal bypass circuit" for circulatory support, and the Intended Use/Indications for Use section details its role in moving blood during extracorporeal bypass. There is no mention of the device analyzing biological data, making diagnoses, or providing diagnostic information.
No
The device description clearly describes a physical, disposable centrifugal blood pump with rotating cones and a polycarbonate housing, which is a hardware component. It also mentions being electromechanically coupled to a BioConsole instrument, another hardware component.
Based on the provided information, the Medtronic Trillium™ BioPump Plus is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to pump blood through an extracorporeal bypass circuit for cardiopulmonary bypass and other circulatory support procedures. This is a direct intervention on the patient's blood circulation, not a diagnostic test performed on a sample outside the body.
- Device Description: The device is a centrifugal blood pump designed to move blood through a circuit. It is part of a system that supports the patient's circulation during surgery.
- Lack of Diagnostic Activity: There is no mention of analyzing blood components, detecting biomarkers, or providing diagnostic information based on a sample. The device's function is purely mechanical – to move blood.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or screening purposes. The Trillium™ BioPump Plus does not fit this description.
N/A
Intended Use / 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 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.)
Product codes
KFM
Device Description
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.
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
KOSD109
SUMMARY OF SAFETY AND EFFECTIVENESS
COMPANY AND CONTACT PERSON
Medtronic Perfusion Systems 7611 Northland Drive Minneapolis, MN 55428 (763) 391-9533 Tel: FAX: (763) 391-9603
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
1
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.
2
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.
.
3
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.
4
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 (301) 594-4646. Additionally, for questions on the contact the Office of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
5
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