(490 days)
COBE Precision Blood Pump
Not Found
No
The description details a mechanical peristaltic pump with basic electronic controls, and there is no mention of AI, ML, or any related concepts in the intended use, device description, or performance studies.
No.
The device functions as a pump to move fluids in an extracorporeal circuit during cardiopulmonary surgical procedures, which is a supportive role in a medical procedure rather than directly treating a disease or condition.
No
The device is a blood pump used in extracorporeal circuits during cardiopulmonary surgical procedures, which is a therapeutic function, not a diagnostic one. It pumps fluids, it does not analyze or detect medical conditions.
No
The device description explicitly details hardware components such as a pump head, chassis, control cards, power supply, and connectors, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for pumping fluids in an extracorporeal circuit during cardiopulmonary surgical procedures. This is a therapeutic and supportive function performed directly on a patient, not a diagnostic test performed on a sample taken from a patient.
- Device Description: The description details a peristaltic pump that moves fluids through tubing. This mechanism is for fluid delivery and circulation, not for analyzing biological samples to diagnose a condition.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The COBE Century Precision Blood Pump does not fit this description.
N/A
Intended Use / Indications for Use
The COBE Century Perfusion Pump is intended for use in cardiopulmonary surgical procedures requiring pumping of fluids in an extracorporeal circuit for periods up to 6 hours.
Product codes
74 DWB
Device Description
The COBE Century Perfusion Pump is the principal component of the COBE Century Perfusion System. It is a peristaltic-type roller pump that functions by tube-occluding rollers that move along a piece of tubing. As the pump head rotates, the rollers draw fluid through the tubing. Pumped fluids are contained within the tubing and have no contact with the pump. The pump has positive displacement over a wide range of flow rates and delivery pressures.
The COBE Century Perfusion Pump consists of:
- a front panel containing displays and operational switches ●
- a pump head with the roller pump mechanism and shields ●
- a chassis containing control cards, a power supply, and connectors for external ● 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
The COBE Century Perfusion Pump was tested to assure that it met its functional specifications and its user interface specification. It successfully met all specifications at the system test level, where every system requirement was addressed by a corresponding test or tests.
Key Metrics
Not Found
Predicate Device(s)
COBE Precision Blood Pump
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4370 Roller-type cardiopulmonary bypass blood pump.
(a)
Identification. A roller-type cardiopulmonary bypass blood pump is a device that uses a revolving roller mechanism to pump the blood through the cardiopulmonary bypass circuit during bypass surgery.(b)
Classification. Class II (performance standards).
0
JUL | 4 |997
510(k) SUMMARY
| SUBMITTER: | COBE Cardiovascular, Inc.
14401 W. 65th Way
Arvada, CO 80004 |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON:
Phone:
Fax: | Mary L. Armstrong
(303) 467-6521
(303) 467-6525 |
| DATE PREPARED: | March 31, 1997 |
| DEVICE TRADE NAME: | COBE® Century™ Perfusion Pump |
| COMMON NAME: | Peristaltic perfusion blood pump |
| CLASSIFICATION NAME: | Roller-type cardiopulmonary bypass
blood pump and
Cardiopulmonary bypass heart-lung
machine console |
| PREDICATE DEVICE: | COBE Precision Blood Pump |
DEVICE DESCRIPTION:
The COBE Century Perfusion Pump is the principal component of the COBE Century Perfusion System. It is a peristaltic-type roller pump that functions by tube-occluding rollers that move along a piece of tubing. As the pump head rotates, the rollers draw fluid through the tubing. Pumped fluids are contained within the tubing and have no contact with the pump. The pump has positive displacement over a wide range of flow rates and delivery pressures.
The COBE Century Perfusion Pump consists of:
- a front panel containing displays and operational switches ●
- a pump head with the roller pump mechanism and shields ●
- a chassis containing control cards, a power supply, and connectors for external ● devices
COBE® is a registered name of COBE Laboratories, Inc. Century™ is a trademark of COBE Laboratories, Inc.
1
INDICATIONS FOR USE:
The COBE Century Perfusion Pump is intended for use in cardiopulmonary surgical procedures requiring pumping of fluids in an extracorporeal circuit for periods up to 6 hours.
TECHNOLOGICAL CHARACTERISTICS:
The COBE Century Perfusion Pump is a modification of its predicate, the COBE Precision Blood Pump. As such. it retains most of the technological characteristics of its predicate.
Through software and hardware modifications, the pump has an improved user interface and an improved overspeed protection circuit. Updating of the user interface involved replacing most of the rotary switches with membrane switches, replacing the front panel that holds the switches, and providing additional displays. Improving the overspeed protection circuit involved increasing overspeed sensitivity at low speeds, adding a fixed, maximum speed limit, and implementing a safety function which detects a component failure in the speed setpoint circuitry.
The COBE Century Perfusion Pump and its predicate are equipped with universal tubing clamps, which allow the pumps to accommodate a wide range of tubing sizes and types with a minimum of hardware changes. For non-continuous pumping applications only. polyvinylchloride (PVC) tubing of 1/8 inch to 1/4 inch inside diameter (ID) by 1/16 inch wall minimum can be accommodated. For continuous pumping, PVC tubing of 1/4 inch (ID) by 3/32 inch wall to 5/8 inch ID by 1/8 inch wall can be accommodated. For continuous and noncontinuous pumping, silicone rubber tubing with 3/16 inch ID by 1/16 inch wall to 5/8 inch ID by 1/8 inch wall can be accommodated.
Flow rate (Liters Per Minute) through the pumps is based on pump speed (Revolutions Per Minute) and tubing ID. Flow rates can range from .01 LPM (3/16 inch ID and 1 RPM) to over 10 LPM (for larger sizes of tubing and higher speeds). For some sizes of tubing, two segments of tubing can be placed in the pump head at the same time.
The COBE Century Perfusion Pump is not-nor is it intended to be-interchangeable with its predecessor, the COBE Precision Blood Pump. However, the COBE Century Perfusion Pump and its predicate device are each compatible with certain other devices: 1) The COBE Century Perfusion Pump can be run in master/slave mode with another COBE Century Perfusion Pump. Similarly, the COBE Precision Blood Pump can be run in master/slave mode with another COBE Precision Blood Pump. 2) The COBE Century Perfusion Pump can be operated in conjunction with the COBE Computerized Perfusion Controller (CPC). Similarly, the COBE Precision Blood Pump can be operated in conjunction with the COBE Computerized Perfusion Controller (CPC). The CPC can be used to pressure-limit either pump, volumetrically control either pump, and/or pulse either pump. 3) The COBE Century
2
Perfusion Pump can be used with the COBE Air Emboli Protection System (AEPS). Similarly, the COBE Precision Blood Pump can be used with the COBE Air Emboli Protection System (AEPS). The AEPS is designed to provide protection against air embolism during cardiopulmonary bypass surgery by stopping the pump if specific conditions are sensed.
NONCLINICAL TEST RESULTS:
The COBE Century Perfusion Pump was tested to assure that it met its functional specifications and its user interface specification. It successfully met all specifications at the system test level, where every system requirement was addressed by a corresponding test or tests.
CLINICAL TEST RESULTS:
No clinical testing was performed.
CONCLUSIONS:
The COBE Century Perfusion Pump is a modification of the COBE Precision Blood Pump. Through hardware and software modifications, the Century Perfusion Pump has an improved user interface and an improved overspeed protection circuit. The COBE Century Perfusion Pump is substantially equivalent to the COBE Precision Blood Pump.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 image of an eagle with three human profiles incorporated into its design.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Mary L. Armstrong Requlatory Affairs Manager COBE Cardiovascular, Inc. 14401 W. 65th Way Arvada, Colorado 80004-3599
JUL 1 4 1997
K960974 Re : COBE® Century™ Perfusion Pump Requlatory Class: II (Two) Product Code: 74 DWB Dated: April 11, 1997 Received: April 14, 1997
Dear Ms. Armstrong:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
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 requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (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 requlatory action. In addition, FDA may publish further 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.
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Page 2 - Ms. Mary L. Armstrong
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results 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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
PG. 10/16
Indications For Use 2.
960974 510(k) Number (If known):_____________________________________________________________________________________________________________________________________________________
COBE® CenturyTM Precision Blood Pump Device Name: '` i
Indications For Use:
The COBE Century™ Precision Blood Pump is intended for use in cardiopulmonary surgical procedures requiring pumping of fluids in an extracorporeal circuit for periods up to 6 hours.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
- Bele E. Cooper G
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K960974
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________