(22 days)
No
The description focuses on the mechanical design and material coating of a centrifugal blood pump, with no mention of AI or ML capabilities.
No.
The device is an extracorporeal blood pump used in cardiopulmonary bypass procedures, which is a life support technique, not a therapeutic device designed to treat a medical condition.
No
Explanation: The device description states it is an "extracorporeal blood pump" used in "cardiopulmonary bypass procedures," indicating it is a therapeutic device for moving blood, not for diagnosing conditions.
No
The device description clearly describes a physical extracorporeal blood pump with a rotating impeller and coated surfaces, 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 states the pump is for "cardiopulmonary bypass procedures" and is an "extracorporeal blood pump." This means it is used outside the body to circulate blood during surgery.
- Device Description: The description reinforces its function as an "extracorporeal blood pump" that moves blood by centrifugal force.
- Lack of Diagnostic Purpose: There is no mention of the device being used to analyze samples (blood, tissue, etc.) to diagnose a condition, monitor a disease, or screen for a health issue. Its purpose is purely mechanical support of blood circulation.
- In Vitro Diagnostic Definition: An IVD is a medical device used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, screening, or treatment. This device does not fit that definition.
Therefore, the Cobe Cardiovascular Revolution Pump with PC Coating is a medical device used for therapeutic support during surgery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The pump is intended for use only with Stöckert Instrumente Centrifugal Pump Consoles in cardiopulmonary bypass procedures for periods of up to six hours. Refer to the console operator's manual for console operating procedures.
The pump has not been qualified through in vitro, in vivo, or clinical studies for long term use (i.e., longer than six hours) as a bridge to transplant, for pending recovery of the natural heart or extracorporeal membrane oxygenation (ECMO).
Product codes
KFM
Device Description
The Cobe Cardiovascular Revolution Pump with PC Coating is an extracorporeal blood pump that is provided sterile, single use only, with non-pyrogenic fluid pathways, and is not to be resterilized by the user. It may be sold as a stand-alone device or as a component of a customized heart/lung pack.
The Revolution Centrifugal Blood Pump with PC Coating utilizes a rotating, vaned impeller design to move blood by centrifugal force. Blood contact surfaces of the PC coated Revolution have been coated with phosphorylcholine to improve blood compatibility, resulting in reduced platelet adhesion on the coated surfaces.
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
In-Vitro laboratory tests were performed to demonstrate that the Revolution Centrifugal Blood Pump with PC Coating described in this submission is substantially equivalent to the Revolution Centrifugal Blood Pump (K011835).
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
SPECIAL 510(K) NOTIFICATION Cobe Cardiovascular Inc. Revolution® Centrifugal Blood Pump with PC Coating
| IX. | 510(k) SUMMARY | MAR 0 6 2003 |
|---|---|---|
| ----- | ---------------- | -------------- |
| SUBMITTER: | COBE Cardiovascular, Inc.
14401 West 65th Way
Arvada, CO 80004 USA |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Charles Copperberg
Senior Manager, Regulatory and Clinical Affairs
Charlie.Copperberg@cobecv.com
Phone: (303) 467-6521
Fax: (303) 467-6525 |
| DATE PREPARED: | February 10, 2003 |
| DEVICE TRADE
NAME: | COBE Cardiovascular Revolution ®
Centrifugal Blood Pump with PC Coating |
| COMMON/USUAL
NAME: | Centrifugal Blood Pump |
| CLASSIFICATION
NAME: | Nonroller-type cardiopulmonary bypass blood pump |
| PREDICATE
DEVICE: | COBE Cardiovascular Revolution Centrifugal Blood Pump
K011835 |
| | Dideco Monolyth Mimesys Hollow Fiber Oxygenator
K004001 |
| | Dideco Avant PH.I.S.I.O. Hollow Fiber Oxygenator
K020351 |
DEVICE DESCRIPTION:
The Cobe Cardiovascular Revolution Pump with PC Coating is an extracorporeal blood pump that is provided sterile, single use only, with non-pyrogenic fluid pathways, and is not to be resterilized by the user. It may be sold as a stand-alone device or as a component of a customized heart/lung pack.
The Revolution Centrifugal Blood Pump with PC Coating utilizes a rotating, vaned impeller design to move blood by centrifugal force. Blood contact surfaces of the PC coated Revolution have been coated with phosphorylcholine to improve blood compatibility, resulting in reduced platelet adhesion on the coated surfaces.
1
SPECIAL 510(K) NOTIFICATION Cobe Cardiovascular Inc. Revolution® Centrifugal Blood Pump with PC Coating
INDICATIONS FOR USE:
The pump is intended for use only with Stöckert Instrumente Centrifugal Pump Consoles in cardiopulmonary bypass procedures for periods of up to six hours. Refer to the console operator's manual for console operating procedures.
The pump has not been qualified through in vitro, in vivo, or clinical studies for long term use (i.e., longer than six hours) as a bridge to transplant, for pending recovery of the natural heart or extracorporeal membrane oxygenation (ECMO).
STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON:
The Revolution Centrifugal Blood Pump with PC coating has the same intended use as the current Revolution Centrifugal Blood Pump. The two devices differ in that the blood contacting surfaces of the Revolution with PC coating have been treated with phosphorylcholine. Otherwise, materials, components, design, sterilization and manufacturing processes for the two devices are the same.
TESTING TO DETERMINE SUBSTANTIAL EQUIVALENCE:
In-Vitro laboratory tests were performed to demonstrate that the Revolution Centrifugal Blood Pump with PC Coating described in this submission is substantially equivalent to the Revolution Centrifugal Blood Pump (K011835).
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 0 6 2003
COBE Cardiovascular, Inc. c/o Mr. Charles Copperberg Senior Manager, Regulatory and Clinical Affairs 14401 West 65" Way Arvada, CO 80004
Re: K030462
Trade Name: COBE Cardiovascular Revolution® Centrifugal Blood Pump with PC Coating. Regulation Number: 21 CFR 870.4360 Regulation Name: Nonroller-type Cardiopulmonary Bypass Blood Pump Regulatory Class: Class III (three) Product Code: KFM Dated: February 11, 2003 Received: February 12, 2003
Dear Mr. Copperberg:
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. Iisting 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Mr. Charles Copperberg.
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); 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. This letter will allow you to begin marketing your device as described in your Section 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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. 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" (21CFR Part 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,
Qelll lll
Bram D. Zuckerman. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications For Use
510(k) Number (if known): K030462
Device Name: COBE Cardiovascular Revolution™ Centrifugal Blood Pump with PC Coating
Indications For Use:
The pump is intended for use only with Stöckert Instrumente Centrifugal Pump Consoles in cardiopulmonary bypass procedures for periods of up to six hours. Refer to the console operator's manual for console operating procedures.
The pump has not been qualified through in vitro, in vivo, or clinical studies for long term use (i.e., longer than six hours) as a bridge to transplant, for pending recovery of the natural heart or extracorporeal membrane oxygenation (ECMO).
PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K030462
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use