MODIFICATION TO CARDIOVENTION POWERBASE CONSOLE, MODEL PCB-100

K030141 · Cardiovention, Inc. · DTQ · Feb 26, 2003 · Cardiovascular

Device Facts

• Record ID: K030141
• Device Name: MODIFICATION TO CARDIOVENTION POWERBASE CONSOLE, MODEL PCB-100
• Applicant: Cardiovention, Inc.
• Product Code: DTQ · Cardiovascular
• Decision Date: Feb 26, 2003
• Decision: SESE
• Submission Type: Special
• 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 functions as cardiopulmonary bypass flow control device; used in conjunction with CORx System. Provides extracorporeal hemodynamic and gas exchange support during surgical procedures. Operates in clinical/surgical settings; managed by trained medical professionals. Device regulates blood flow during bypass; supports patient hemodynamics. Benefits include maintenance of circulation and gas exchange during cardiac or related surgeries. Output used by surgical team to monitor and control bypass parameters.

Clinical Evidence

No clinical data. Evidence based on in-vitro and software testing.

Technological Characteristics

Cardiopulmonary bypass heart-lung machine console. Class II device. Flow control functionality. Software-controlled operation.

Indications for Use

Indicated for patients undergoing surgical procedures requiring extracorporeal hemodynamic and gas exchange support, with 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

• CardioVention PowerBase™ Console (K021694)
• CardioVention CORx System (K012325)

Submission Summary (Full Text)

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## 510 (k) Summarv

FEB 2 6 2003

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: January 14, 2003

510(k) number: _______________________________________________________________________________________________________________________________________________________________

### Applicant Information:

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

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

### Device Information:

| Classification: | Class II |
|----------------------|---------------------------------------------------|
| Trade Name: | CardioVention PowerBaseTM Console |
| Classification Name: | Cardiopulmonary Bypass Heart-Lung Machine Console |
| | (21 CFR 870.4220) |

#### Equivalent Device:

The subject device is substantially equivalent in intended use and/or method of operation to the CardioVention PowerBase™ Console [K021694] and the CardioVention CORx System [K012325].

#### 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.

#### Test Results:

Results of in-vitro and software testing demonstrate that CardioVention PowerBase™ Console is safe and effective for its intended function.

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### Summary:

Based on the intended use, product performance and software information provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed and unmodified predicate device.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

FEB 2 6 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

CardioVention, Inc. c/o Ms. Tessa Yamut Director, RA/QA 3045 Stender Way Santa Clara, CA 95054

Re: K030141

Trade Name: CardioVention PowerBaseTM Console Regulation Number: 21 CFR 870.4220 Regulation Name: Cardiopulmonary Bypass Heart-Lung Machine Console Regulatory Class: Class II (two) Product Code: DTQ Dated: February 6, 2003 Received: February 7, 2003

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 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.

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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]. 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 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,

KATHLEEN

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

Enclosure

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# Indication for Use Statement

KO30141 510(k) Number (if known): ________

CardioVention PowerBase™ Console Device Name:

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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|------------------------------------|--------|
| Division of Cardiovascular Devices | |
| 510(k) Number | K0314/ |

| Prescription Use | OR | Over-the Counter Use |
|----------------------|----|----------------------|
| (Per 21 CFR 801.109) | | |

(Optional Format 1-2-96)