(109 days)
Not Found
No
The summary describes a mechanical centrifugal blood pump and its associated drive systems. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
Yes
The device is used to pump blood through an extracorporeal bypass circuit for extracorporeal circulatory support, which is a medical intervention aimed at treating a patient's condition by supporting their circulation, thus qualifying it as a therapeutic device.
No
The device is a centrifugal blood pump used to move blood through an extracorporeal bypass circuit. Its function is to circulate blood, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly states it is a sterile, single-use centrifugal blood pump, which is a physical hardware component. It also mentions being driven by an External Drive Motor and Emergency Handcrank, which are also hardware.
Based on the provided text, the AFFINITY™ CP Centrifugal Blood Pump is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used to "pump blood through the extracorporeal bypass circuit" and for "extracorporeal circulatory support." This describes a device that interacts directly with the patient's blood outside the body for therapeutic or supportive purposes.
- Device Description: The description details a mechanical pump designed to move blood. It mentions components like an impeller, housing, and ports for blood flow. This aligns with a medical device used for circulation support, not for analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances within those samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
In summary, the AFFINITY™ CP Centrifugal Blood Pump is a device used for mechanical support of blood circulation during medical procedures, which falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AFFINITYTM CP Centrifugal Blood Pump 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 AFFINITYTM CP Centrifugal Blood Pump is driven by the External Drive Motor or the Emergency Handcrank.
Product codes (comma separated list FDA assigned to the subject device)
KFM, DWA
Device Description
The Medtronic AFFINITY CP Centrifugal Blood Pump is a sterile, single-use centrifugal blood pump. It is a non-invasive, nonpyrogenic device designed to move blood through the extracorporeal circuit by centrifugal force. The pump is the disposable portion of the pumping system and it is electromagnetically coupled to an instrument that monitors and displays the flow and pressure of the blood. Blood enters the inlet port of the pump, where a cone with impeller blades within the pump housing rotates and the blood is gently accelerated towards the outlet of the pump.
The AFFINITY CP Centrifugal Blood Pump can be driven through magnetic coupling by the following two devices:
- External Drive Motor (Model 560A) a
- . Emergency Handcrank (Model HC150A)
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 and its associated drive systems are safe and effective. The blood pump is more efficient, as evidenced by less heat generation, and less damaging to red blood cells, as evidenced by reduced hemolysis. Other validation tests included: maximum pressure generation, flow rates, pivot bearing wear, maximum speed, port strength, magnetic coupling force, biocompatibility, noise generation and prime volume. Validation testing under simulated conditions of use with expert users also demonstrated the effectiveness of the AFFINITY CP Centrifugal Blood Pump.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Summary of Safety and Effectiveness
I. Applicant Information:
JUN 2 2 2010
| Date Prepared: | June 21, 2010 |
|---|---|
| Submitter: | Medtronic, Inc. |
| Medtronic Perfusion Systems | |
| Address: | 7611 Northland Drive |
| Minneapolis, MN 55428 | |
| Establishment | |
| Registration No.: | 2184009 (owner operator number 2112641) |
| Contact Person: | Sue Fidler, Regulatory Affairs Manager |
| Medtronic, Inc. | |
| 8200 Coral Sea Street NE | |
| Mounds View, MN 55112 | |
| Telephone Number: | |
| Fax Number: | (763) 514-9839 |
| (763) 367-8360 |
II. Device Information:
.
| Trade Name: | Medtronic AFFINITYTM CP Centrifugal Blood Pump (Model
AP40); Medtronic External Drive Motor (Model 560A); Medtronic
Emergency Handcrank (Model HC150A) |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | AFFINITYTM Cardiopulmonary Centrifugal Blood Pump; External
Drive Motor; Emergency Handcrank |
| Classification Name: | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type;
Cardiovascular bypass pump speed control |
| Classification: | Class III, 21 CFR 870.4360; Class II, 21 CFR 870.4380 |
| Product Code: | KFM; DWA |
| Predicate Devices: | Medtronic Bio-Medicus® Bio-Pump (BPX-80) Centrifugal Pump
(K973011); Medtronic External Drive Motor (Model 540T)
(K936091); Emergency Handcrank (Model H150) (K926357) |
1
Predicate Device Intended Uses:
The BPX-80 centrifugal blood pump is indicated for use only with the Medtronic Bio-Console pump speed controller 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 support systems (for periods up to six 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 External Drive Motor and Emergency Handcrank are intended for use with the Bio-Console System and Bio-Pump Centrifugal Blood Pump. The Bio-Console System is a centrifugal blood pumping system intended for use as an extracorporeal centrifugal blood pumping system during cardiopulmonary bypass procedures.
Device Description: The Medtronic AFFINITY CP Centrifugal Blood Pump is a sterile, single-use centrifugal blood pump. It is a non-invasive, nonpyrogenic device designed to move blood through the extracorporeal circuit by centrifugal force. The pump is the disposable portion of the pumping system and it is electromagnetically coupled to an instrument that monitors and displays the flow and pressure of the blood. Blood enters the inlet port of the pump, where a cone with impeller blades within the pump housing rotates and the blood is gently accelerated towards the outlet of the pump.
The AFFINITY CP Centrifugal Blood Pump can be driven through magnetic coupling by the following two devices:
- External Drive Motor (Model 560A) a
- . Emergency Handcrank (Model HC150A)
The AFFINITY™ CP Centrifugal Blood Pump is used to pump Intended Use: 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 (eg, valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants). "
2
The AFFINITY™ CP Centrifugal Blood Pump is driven by the External Drive Motor or the Emergency Handcrank.
Contraindications: The AFFINITY CP Centrifugal Blood Pump is contraindicated as a cardiotomy suction device. Comparison to Predicate Device: The AFFINITY CP Centrifugal Blood Pump is substantially equivalent to the predicate device, in that its intended use is the same, and the basic design is the same, with a magnetic coupling to an external motor that drives the rotating cones. Both pump drives are controlled with Medtronic controllers. The new pump includes the following improvements: The bearing heat generation is reduced due to a ceramic pivot system. -Priming volume is reduced by 50%, to a volume of 40 mL. Hemolysis is reduced compared to the predicate device. -The External Drive Motor and Emergency Handcrank are substantially equivalent to the predicate devices, in that their intended uses are the same and the basic design is the same. Necessary design changes were made to allow for compatibility with the AFFINITY CP Centrifugal Blood Pump: dimensional changes and rotational direction. Test Data: Verification and validation testing has demonstrated that the AFFINITY CP Centrifugal Blood Pump and its associated drive systems are safe and effective. The blood pump is more efficient, as evidenced by less heat generation, and less damaging to red blood cells, as evidenced by reduced hemolysis. Other validation tests included: maximum pressure generation, flow rates, pivot bearing wear, maximum speed, port strength, magnetic coupling force, biocompatibility, noise generation and prime volume. Validation testing under simulated conditions of use with expert users also demonstrated the effectiveness of the AFFINITY CP Centrifugal Blood Pump. Based on the accumulated technical information, intended use, Summary: laboratory verification tests and performance data provided, the AFFINITY CP Centrifugal Blood Pump and its associated drive systems are substantially equivalent to the currently marketed predicate devices.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" written around it.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
JUN 2 2 2010
Medtronic, Inc. c/o Ms. Susan C. Fidler 8200 Coral Sea Street NE Mounds View, MN 55112
Re: K100631
Trade/Device Name: Medtronic AFFINITY™ CP Centrifugal Blood Pump (Model AP40); Medtronic External Drive Motor (Model 560A); Medtronic Emergency Handcrank (Model HC150A)
Regulation Number: 21 CFR 870.4360
Regulation Name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Regulatory Class: III Product Code: KFM, DWA Dated: May 24, 2010 Received: May 25, 2010 /_
Dear Ms. Fidler:
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.
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
4
Page 2 - Ms. Susan C. Fidler
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.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Statement of Indications for Use
510(k) Number: K100631
Medtronic AFFINITY™ CP Centrifugal Blood Pump (Model AP40); Medtronic External Drive Motor (Model 560A); Medtronic Emergency Handcrank (Model HC150A)
Indications for use:
The AFFINITY™ CP Centrifugal Blood Pump 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 is driven by the External Drive Motor or the Emergency Handcrank.
Prescription Use (Part 21 CFR 801 Subpart D) OR
Over-The-Counter-Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
rrence of operative of Device
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K100631
6/22/2