CARDIOVENTION POWERBASE CONSOLE, MODEL PBC-100

K021694 · Cardiovention, Inc. · DTQ · Jan 8, 2003 · Cardiovascular

Device Facts

• Record ID: K021694
• Device Name: CARDIOVENTION POWERBASE CONSOLE, MODEL PBC-100
• Applicant: Cardiovention, Inc.
• Product Code: DTQ · Cardiovascular
• Decision Date: Jan 8, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4220
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CardioVention PowerBase™ Console is a cardiopulmonary bypass flow control device, which is intended to be used with the CORx System in surgical procedures requiring extracorporeal hemodynamic and gas exchange support. The device is indicated for use in procedures requiring a maximum blood flow rate of six liters/minute and lasting for up to six hours.

Device Story

CardioVention PowerBase™ Console is a cardiopulmonary bypass flow control device; used with CORx System for extracorporeal hemodynamic and gas exchange support. Operates as a console to control blood flow during surgery; maximum flow rate 6 L/min; duration up to 6 hours. Used in surgical settings; operated by trained medical professionals. Provides flow control to support patient hemodynamics during bypass; benefits patient by maintaining circulation and gas exchange during procedures.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including functional acceptance testing, ship testing, and software verification and validation.

Technological Characteristics

Cardiopulmonary bypass console; flow control device. Designed for integration with CORx System. Includes software for system operation. Class II device (21 CFR 870.4220).

Indications for Use

Indicated for patients undergoing surgical procedures requiring extracorporeal hemodynamic and gas exchange support, specifically for procedures requiring a maximum blood flow rate of 6 L/min and duration up to 6 hours.

Regulatory Classification

Identification

A cardiopulmonary bypass heart-lung machine console is a device that consists of a control panel and the electrical power and control circuitry for a heart-lung machine. The console is designed to interface with the basic units used in a gas exchange system, including the pumps, oxygenator, and heat exchanger.

Predicate Devices

• Bio-medicus Bio-Console (K936091)
• Stockert Centrifugal Pump (K011838)
• RotaFlow Centrifugal Pump System (K991864)

Submission Summary (Full Text)

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This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Date Prepared: May 16, 2002

510(k) number: K021694

JAN 0 8 2003

# l. Applicant Information:

CardioVention, Inc. 3045 Stender Way Santa Clara, CA 95054

Contact Person: Tessa Yamut Phone Number: [phone] Fax Number: [phone]

### II. Device Information:

Classification: Class II Trade Name: CardioVention PowerBase™ Console Classification Name: Cardiopulmonary Bypass Console (21 CFR 870.4220)

### lll. Equivalent Device:

The subject device is substantially equivalent in intended use and/or method of operation to the following:

| Name: | Bio-medicus Bio-Console |
|---------------|----------------------------------|
| Manufacturer: | Medtronic |
| Status: | Post-enactment |
| 510(k) # | K936091 |
| Name: | Stockert Centrifugal Pump |
| Manufacturer: | Stockert Instrumente GmbH |
| Status: | Post-enactment |
| 510(k) # | K011838 |
| Name: | RotaFlow Centrifugal Pump System |
| Manufacturer: | Jostra Medizintechnik AG |
| Status: | Post-enactment |
| 510(k) # | K991864 |

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## IV. Intended Use:

The CardioVention PowerBase™ Console is a cardiopulmonary bypass flow control device, which is intended to be used with the CORx System in surgical procedures requiring extracorporeal hemodynamic and gas exchange support. The device is indicated for use in procedures requiring a maximum blood flow rate of six liters/minute and lasting for up to six hours.

## V. Performance Testing Results:

Testing submitted in this premarket notification consists of functional acceptance testing, ship testing, and software verification and validation.

### VI. Technological Characteristics and Substantial Equivalence:

The CardioVention PowerBase™ Console claims equivalence to cited predicate devices based on equivalence in indications for use, operational characteristics, and technological characteristics.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 0 8 2003

CardioVention, Inc. c/o Ms. Tessa Yamut Director of Quality Assurance/Regulatory Affairs 3045 Stender Way Santa Clara, CA 95054

Re: K021694

Trade Name: CardioVention PowerBase™ Console Regulation Number: 21 CFR 870.4220 Regulation Name: CPB Heart Lung Machine Console Regulatory Class: Class II (two) Product Code: DTQ Dated: December 4, 2002 Received: December 6, 2002

Dear Ms. Yamut:

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 A.ct. 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.

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Page 2 - Ms. Tessa Yamut

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 you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

W. NQ. G. Tuth
Bram D. Zuckerman, M.D.

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

Enclosure

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510(k) Number (if known): k_OZ1694

Device Name: CardioVention PowerBase™ Console

Indications for Use:

The CardioVention PowerBase™ Console is a cardiopulmonary bypass flow control device, which is intended to be used with the CORx System in surgical procedures requiring extracorporeal hemodynamic and gas exchange support. The device is indicated for use in procedures requiring a maximum blood flow rate of six liters/minute and lasting for up to six hours.

**Prescription Use**
(Per 21 CFR 801.109)

Kalen Tu

510(k) Numb

CardioVention, Inc.

CONFIDENTIAL