(9 days)
No
The summary describes a mechanical blood pump and its coating, with no mention of AI or ML in its function or control.
Yes
The device is used to pump blood through an extracorporeal bypass circuit for circulatory support, which is a therapeutic intervention.
No
The device description clearly states its purpose is to pump blood through an extracorporeal bypass circuit for circulatory support, not to diagnose medical conditions.
No
The device description clearly details a physical blood pump with mechanical components (rotating cone, impeller fins, pivot bearing) and a biocompatible coating, indicating it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used to pump blood through an extracorporeal circuit during surgical procedures (cardiopulmonary bypass, valvuloplasty, etc.). This is a therapeutic and supportive function, not a diagnostic one.
- Device Description: The description focuses on the mechanical function of pumping blood and the coating to improve biocompatibility. There is no mention of analyzing blood or other biological samples to provide diagnostic information.
- Lack of Diagnostic Elements: The text does not mention any components or functions related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health status. The Affinity™ CP Centrifugal Blood Pump with Balance™ Biosurface does not perform this function. It is a medical device used to support a patient's circulation during surgery.
N/A
Intended Use / Indications for Use
The Affinity™ CP Centrifugal Blood Pump with Balance™ Biosurface is used to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to 6 hours).
It is also indicated for use in extracorporeal support systems (for periods up to 6 hours) not requiring complete cardiopulmonary bypass (e.g. valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants).
The Affinity™ CP Centrifugal Blood Pump with Balance™ Biosurface is driven by the External Drive Motor or the Emergency Handcrank.
Product codes
KFM
Device Description
The Affinity™ CP Centrifugal Blood Pump with Balance™ Biosurface is intended to be used in medical procedures requiring extracorporeal circulation circuits. Functionality and intended use of the coated pump are the same as those for the uncoated pump. The pump is designed to move blood by centrifugal force generated by a combination of a smooth rotating cone and low-profile impeller fins. Energy is transferred from the pump in the form of pressure and velocity as the blood is driven toward the outlet port of the pump. The pump utilizes a pivot bearing design on a dual ceramic pivot.
The Affinity CP Centrifugal Blood Pump with Balance Biosurface is coated with a nonleaching biocompatible surface to reduce platelet activation and adhesion and preserve platelet function.
As with the uncoated Affinity CP pump the Affinity CP Centrifugal Blood Pump with Balance Biosurface is driven by the External Drive Motor or the Emergency Handcrank (K100631). There have been no changes to these accessory devices.
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)
Verification and validation testing has demonstrated that the Affinity CP Centrifugal Blood Pump with Balance Biosurface is substantially equivalent to the predicates. Performance testing included: flow rates, heat generation, maximum differential pressure, maximum rotational speed, noise generation, duration of performance, hydraulic performance, pivot bearing wear, prime volume, sterilization, biocompatibility, hemolysis, bioactivity, coating leaching and coverage.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
JUN 2 3 2011
Summary of Safety and Effectiveness 5
I. General Information:
Submitter's Name and Address:
Contact Person:
Date of Summary:
Proprietary Name of Device:
Common/Usual Name:
Classification Name:
Classification:
Product Code:
Predicate Device:
Medtronic, Inc. Medtronic Perfusion Systems 8200 Coral Sea Street NE Mounds View, MN 55112
Lisa Stone Principal Regulatory Affairs Specialist Tel: 763-514-9866 Fax: 763-367-8360 Email: lisa.j.stone@medtronic.com
June 13, 2011
Affinity™ CP Centrifugal Blood Pump with Balance™ Biosurface (model BBAP40)
Centrifugal Blood Pump
Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Class III, 21 CFR 870.4360
KFM
Affinity™ CP Centrifugal Blood Pump Model AP40 (K100631)
Affinity Pixie™ Arterial Filter with Balance™ Biosurface Model BB4014 (K100646)
II. Device Description:
The Affinity™ CP Centrifugal Blood Pump with Balance™ Biosurface is intended to be used in medical procedures requiring extracorporeal circulation circuits. Functionality and intended use of the coated pump are the same as those for the
Special 510k: Centritugal Blood Pump Balance Medtronic Confidential
1 - 14
1
uncoated pump. The pump is designed to move blood by centrifugal force generated by a combination of a smooth rotating cone and low-profile impeller fins. Energy is transferred from the pump in the form of pressure and velocity as the blood is driven toward the outlet port of the pump. The pump utilizes a pivot bearing design on a dual ceramic pivot.
The Affinity CP Centrifugal Blood Pump with Balance Biosurface is coated with a nonleaching biocompatible surface to reduce platelet activation and adhesion and preserve platelet function.
As with the uncoated Affinity CP pump the Affinity CP Centrifugal Blood Pump with Balance Biosurface is driven by the External Drive Motor or the Emergency Handcrank (K100631). There have been no changes to these accessory devices.
III. Intended Use:
The AFFINITY CP Centrifugal Blood Pump with Balance Biosurface is used to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to 6 hours).
It is also indicated for use in extracorporeal support systems (for periods up to 6 hours) not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants).
The AFFINITY CP Centrifugal Blood Pump with Balance Biosurface is driven by the External Drive Motor or the Emergency Handcrank.
IV. Comparison to Predicate Devices:
The Affinity CP Centrifugal Blood Pump with Balance Biosurface is substantially equivalent to the predicate uncoated Affinity CP Centrifugal Blood Pump, in that its intended use and design are exactly the same. The only difference is the addition of Balance Biosurface to the blood contacting surfaces of the pump. The Balance Biosurface is exactly the same as that used on the Affinity Pixie Arterial Filter with Balance Biosurface.
V. Summary of Performance Data:
Verification and validation testing has demonstrated that the Affinity CP Centrifugal Blood Pump with Balance Biosurface is substantially equivalent to the predicates. Performance testing included: flow rates, heat generation.
2
maximum differential pressure, maximum rotational speed, noise generation, duration of performance, hydraulic performance, pivot bearing wear, prime volume, sterilization, biocompatibility, hemolysis, bioactivity, coating leaching and coverage.
VI. Conclusion:
Based on the accumulated technical information, intended use, verification tests and performance data provided, the Affinity CP Centrifugal Blood Pump with Balance Biosurface is substantially equivalent to the currently marketed predicate devices.
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" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract shapes resembling human figures or waves, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 2 3 2011
Medtronic, Inc. c/o Ms. Lisa Stone Principal Regulatory Affairs Specialist 8200 Coral Sea Street NE Mounds View, MN 55112
Re: K111657
Trade/Device Name: Affinity™ CP Centrifugal Blood Pump with Balance™ Biosurface (Model BBAP40) Regulation Number: 21 CFR 870.4360 Regulation Name: Non-roller type cardiopulmonary bypass blood pump Regulatory Class: Class III Product Code: KFM Dated: June 13, 2011 Received: June 14, 2011
Dear Ms. Stone:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
4
Page 2 - Ms. Lisa Stone
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events} (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D.
Bram D Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
1 Statement of Indications for Use
510(k) Number: K111657
Affinity™ CP Centrifugal Blood Pump with Balance™ Biosurface (model BBAP40)
Indications for use:
The Affinity™ CP Centrifugal Blood Pump with Balance™ Biosurface is used to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to 6 hours).
It is also indicated for use in extracorporeal support systems (for periods up to 6 hours) not requiring complete cardiopulmonary bypass (e.g. valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants).
The Affinity™ CP Centrifugal Blood Pump with Balance™ Biosurface is driven by the External Drive Motor or the Emergency Handcrank.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter-Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sian-Off) Division of Cardiovascular Devices 510(k) Number