COBE REVOLUTION

K011835 · Cobe Cardiovascular, Inc. · KFM · Feb 12, 2002 · Cardiovascular

Device Facts

• Record ID: K011835
• Device Name: COBE REVOLUTION
• Applicant: Cobe Cardiovascular, Inc.
• Product Code: KFM · Cardiovascular
• Decision Date: Feb 12, 2002
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.4360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The COBE® REVOLUTION™ Centrifugal Blood Pump is intended to be used with a Stöckert Instrumente GmbH Centrifugal Pump console in cardiopulmonary bypass procedures for periods of up to six hours. The pump has not been qualified through in vitro, in vivo, or clinical studies for long term use (i.e., as a bridge to transplant, for pending recovery of the natural heart, or extracorporeal membrane oxygenation (ECMO) procedures.

Device Story

Extracorporeal blood pump; utilizes rotating vaned impeller design to move blood via centrifugal force. Device consists of pump housing with 3/8" inlet/outlet ports and internal vaned impeller molded onto steel shaft. Multi-pole magnet enclosed within housing couples with external Stockert Instrumente GmbH Centrifugal Pump console drive unit. Rotation of magnet drives impeller. Used in cardiopulmonary bypass procedures; operated by clinical staff. Provides mechanical circulatory support for up to six hours. Sterile, single-use device.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Rotating vaned impeller; magnetic coupling to external console; 3/8" inlet/outlet ports; 57 ml priming volume; 8 L/min max flow; 800 mm Hg max pressure. Sterilized via Ethylene Oxide. Non-pyrogenic fluid pathway.

Indications for Use

Indicated for use in cardiopulmonary bypass procedures for up to six hours. Not indicated for long-term use, bridge to transplant, recovery of the natural heart, or ECMO.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Medtronic BP-80 BioPump® Centrifugal Blood Pump (K852698)

Submission Summary (Full Text)

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## FEB 1 2 2002

K011835

## 510(k) Summary

| SUBMITTER: | COBE Cardiovascular, Inc.<br>14401 W. 65th Way<br>Arvada, CO 80004 |
|----------------------|---------------------------------------------------------------------|
| CONTACT PERSON: | Lynne Leonard<br>Phone: [phone]<br>Fax: [phone] |
| DATE PREPARED: | June 1, 2001 |
| DEVICE TRADE NAME: | COBE® Revolution™ Centrifugal Blood Pump |
| COMMON/USUAL NAME: | Centrifugal Blood Pump |
| CLASSIFICATION NAME: | Non-roller type cardiopulmonary bypass blood pump (21 CFR 870.4360) |
| PREDICATE DEVICE: | Medtronic BP-80 BioPump® Centrifugal Blood Pump (K852698) |

#### DEVICE DESCRIPTION:

The COBE® Revolution™ Centrifugal Blood Pump is an extracorporeal blood pump that utilizes a rotating vaned impeller design to move blood by centrifugal force. The device is provided sterile with a nonpyrogenic fluid pathway, and is for single use only. It is indicated for use with a Stockert Instrumente GmbH Centrifugal Pump console in cardiopulmonary bypass procedures for periods of up to six hours. The device has not been qualified for longterm use (greater than six hours) as a bridge to transplant, for pending recovery of the natural heart or extracorporeal membrane oxygenation (ECMO).

The Revolution Pump consists of a rotating vaned impeller within a pump housing. The pump housing has two components, a top and bottom case, and features a central, single-barbed, 3/8" inlet port and tangential, double-barbed, 3/8" outlet port. The vaned impeller is molded onto a steel shaft that supports it at its axis of rotation, with the shaft rotating on a bearing at each end. The device contains a multi-pole magnet that is fully enclosed within the magnet housing and thus does not contact the blood pathway. The magnet is designed to magnetically couple with the pump drive unit of the Stockert Instrumente GmbH Centrifygal Pump console. Rotation of the magnet causes the impeller to rotate and pump blood via centrifugal force.

#### STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON

The Revolution Pump is substantially equivalent to the currently marketed Medtronic BP-80 BioPump® Centrifugal Blood Pump (K852698) in intended use and operating principle.

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#### Substantial Equivalence Table

| Parameter | COBE Revolution Pump | Medtronic BP-80 |
|-----------------------------|-------------------------|-------------------------|
| Priming Volume | 57 ml | 80 ml |
| Maximum Blood Flow Rate | 8 liters/minute | Not specified |
| Maximum Operating Pressure | 800 mm Hg | 900 mm Hg |
| Impeller Design | Rotating vaned impeller | Vaneless rotating cones |
| Bearing Design | No seals | Sealed bearings |
| Motor Interface | Magnetic coupling | Magnetic coupling |
| Inlet/Outlet Port Diameters | 3/8 inch | 3/8 inch |
| Sterilization Method | Ethylene Oxide | Gamma Radiation |

In-vitro test data demonstrate that the COBE® Revolution™ Centrifugal Blood Pump is substantially equivalent to the Medtronic BP-80 BioPump® Centrifugal Blood Pump.

:

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# FEB 1 2 2002

Ms. Lynne Leonard Sf. Regulatory Affairs Manager COBE Cardiovascular, Inc. 14401 W. 65th Way Arvada, CO 80004-3599

Re: K011835

Trade Name: COBE Revolution Centrifugal Blood Pump Regulation Number: 21 CFR 870.4360 Regulation Name: Nonroller-type cardiopulmonary bypass blood pump Regulatory Class: Class II (two) Product Code: KFM Dated: February 4, 2002 Received: February 5, 2002

Dear Ms. Leonard:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becasing to (1) for device is substantially equivalent (for the indications for referented in the enclosure) to legally marketed predicate devices marketed in interstate commerce ass suited in also encreated of the Medical Device Amendments, or to devices that prior to thay 20, 1970, also cordance 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 therefore, maintons 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 (PMA), it rr your device to such additional controls. Existing major regulations affecting your device can be may or beyott to carrent 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 that Federal statutes and regulations administered by other Federal agencies. You must comply with all + each statutes and 155 met 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.

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Page 2 - Ms. Lynne Leonard

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin maxioning of substantial equivalence of your device to a legally prematication: "The PDF Intently of cation 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 IT you desire specific active for you invitro diagnostic devices), please contact the Office of additionally 21 CT N Furt 607.10 for questions on the promotion and advertising of Compliance at [phone]. Timber of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division Other general information on your and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Rella Till

Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications For Use

510(k) Number (If known): K011835

COBE® REVOLUTION™ Centrifugal Blood Pump Device Name:

Indications For Use:

The COBE® REVOLUTION" Centrifugal Blood Pump is intended to be used with a Stöckert The CODE REVOLOTION - Ocharitagal Droob - asprocedures for periods of up to six hours.

The pump has not been qualified through in vitro, in vivo, or clinical studies for long term use (i.e., I he pullip has not boon qualified in registed to transplant, for pending recovery of the natural heart, or extracorporeal membrane oxygenation (ECMO) procedures.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K011835

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ___________