CARDIOVENTION CORX IOS-200 SYSTEM, MODEL IOS-200

K032068 · Cardiovention, Inc. · DTR · Aug 22, 2003 · Cardiovascular

Device Facts

• Record ID: K032068
• Device Name: CARDIOVENTION CORX IOS-200 SYSTEM, MODEL IOS-200
• Applicant: Cardiovention, Inc.
• Product Code: DTR · Cardiovascular
• Decision Date: Aug 22, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4240
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CardioVention CORx System is intended to be used in surgical procedures requiring extracorporeal hemodynamic and gas-exchange support. The device contains a thermal regulating system. 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. The CORx System is intended for use with the Medtronic Bio-Medicus Bio-Console and the CardioVention PowerBase Console.

Device Story

Cardiopulmonary bypass system comprising oxygenator, non-roller blood pump, heat exchanger, and blood circuit defoamer. Used in surgical settings for extracorporeal hemodynamic and gas-exchange support. Operates with Medtronic Bio-Medicus Bio-Console or CardioVention PowerBase Console. Provides thermal regulation during bypass. Supports blood flow up to 6 L/min for up to 6 hours. Intended for use by trained surgical personnel.

Clinical Evidence

Bench testing only. In-vitro testing results demonstrate the system is safe and effective for its intended function.

Technological Characteristics

System includes oxygenator, non-roller blood pump, heat exchanger, and defoamer. Designed for integration with external consoles (Medtronic Bio-Medicus or CardioVention PowerBase). Supports flow rates up to 6 L/min and durations up to 6 hours. Thermal regulation integrated.

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 heat exchanger is a device, consisting of a heat exchange system used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device.

Predicate Devices

• CardioVention CORx System (K012325)

Reference Devices

• Medtronic Bio-Medicus Bio-Console
• CardioVention PowerBase Console

Submission Summary (Full Text)

{0}------------------------------------------------

## 510(k) Summary

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: July 2, 2003

K032068 510(k) number:

### Applicant Information:

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

| Contact Person: | Tessa Yamut, Director of RA/QA |
|-----------------|--------------------------------|
| Phone Number: | [phone] |
| Fax Number: | [phone] |

#### Device Information:

| Classification: | Class III |
|-----------------|-----------|
|-----------------|-----------|

CardioVention CORx IOS-200 System Trade Name:

- The CORx IOS-200 System is a cardiopulmonary Classification Name: bypass system consisting of an oxygenator (870.4350), a non-roller-type cardiopulmonary bypass blood pump (870.4360), a heat exchanger (870.4240) and a blood circuit defoamer (870.4230)
#### Equivalent Device:

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

#### Intended Use:

The CardioVention CORx System is intended to be used in surgical procedures requiring extracorporeal hemodynamic and gas-exchange support. The device contains a thermal regulating system. 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. The CORx System is intended for use with the Medtronic Bio-Medicus Bio-Console and the CardioVention PowerBase Console.

{1}------------------------------------------------

1632068

# Test Results:

Results of in-vitro testing demonstrate that the CardioVention CORx IOS-200 System is safe and effective for its intended function.

### Summary:

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

{2}------------------------------------------------

AUG 2 2 2003

Public Health Service

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: K032068

CardioVention CORx IOS-200 System Regulation Number: 21 CFR 870.4240, 870.4350, 870, 4360, 870.4230 Regulation Name: Cardiopulmonary bypass (CPB) heat exchanger, CPB oxygenator, nonroller type CPB blood pump, CPB defoamer Regulatory Class: Class II (two) Product Code: DTR, DTZ, DTP, KFM Dated: July 2, 2003 Received: July 3, 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, 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 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 – 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,

Ashley B. Boone

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

Enclosure

{4}------------------------------------------------

### Indication for Use Statement

K032068 510(k) Number (if known): __________

CardioVention CORx IOS-200 System Device Name:

Indications for Use:

The CardioVention CORx System is intended to be used in surgical procedures requiring extracorporeal hemodynamic and gas-exchange support. The device contains a thermal requlating system. 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. The CORx System is intended for use with the Medtronic Bio-Medicus Bio-Console and the CardioVention PowerBase Console.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109)

OR

Over-the Counter Use

Ashley B. Barnum

diovascular Devices

510(k) Number K632068

(Optional Format 1-2-96)