LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLES

K090004 · Levitronix, LLC · DWA · Jan 15, 2009 · Cardiovascular

Device Facts

• Record ID: K090004
• Device Name: LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLES
• Applicant: Levitronix, LLC
• Product Code: DWA · Cardiovascular
• Decision Date: Jan 15, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4380
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Levitronix CentriMag Back-Up Console is indicated for use with the Levitronix CentriMag Extracorporeal Blood Pumping System. The Levitronix CentriMag Extracorporeal Blood Pumping System is indicated to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants etc).

Device Story

Microprocessor-based console for CentriMag Extracorporeal Blood Pumping System; monitors system sensors; generates motor control signals; provides alarm functions; displays data on alphanumeric screen. Operates on single-phase AC power with internal non-rechargeable, field-replaceable battery backup. Controls motor and pump to achieve flow rates up to 9.9 LPM at 600 mmHg pressure head. Used in clinical settings for circulatory support; provides real-time monitoring and alarm feedback to clinicians to ensure system stability during bypass procedures.

Clinical Evidence

Bench testing only; performance compared against established Levitronix specifications and the predicate device.

Technological Characteristics

Microprocessor-based control unit; single-phase AC power; internal non-rechargeable field-replaceable battery; alphanumeric display; motor control and sensor monitoring circuitry.

Indications for Use

Indicated for patients requiring extracorporeal circulatory support via the CentriMag Extracorporeal Blood Pumping System for up to six hours, including cardiopulmonary bypass and procedures not requiring complete bypass (e.g., valvuloplasty, mitral valve reoperation, vena cava/aorta surgery, liver transplants).

Regulatory Classification

Identification

A cardiopulmonary bypass pump speed control is a device used that incorporates an electrical system or a mechanical system, or both, and is used to control the speed of blood pumps used in cardiopulmonary bypass surgery.

Predicate Devices

• Levitronix CentriMag Back-Up Console Software Version 1.01 (K051209)

Submission Summary (Full Text)

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Attachment 3 - 510(k) Summary

JAN 1 5 2009

# 510(k) Summary for Levitronix CentriMag Back-Up Console

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title 21 of the Code of Federal Regulations, Part 807, and in particular §807.92.

#### Application Information: A.

Date Prepared:

Submitter's Name & Address:

Contact Person:

December 30, 2008

Levitronix LLC 45 First Avenue Waltham, MA 02451

Susan K. Hamann Regulatory Affairs Manager [phone] Ph: [phone] Fax: e-mail: [e-mail]

#### B. Device Information:

Trade or Proprietary Name:

Common or Usual Name:

Classification Name:

Performance Standard:

Levitronix CentriMag® Back-Up Console

Cardiopulmonary Bypass Pump Console

Class II, DWA, 21 CFR - 870.4380 Control, Pump Speed, Cardiopulmonary Bypass

Performance standards do not currently exist for these devices. None established under section 514 of the Food, Drug and Cosmetic Act.

#### ். Predicate Device:

Levitronix CentriMag Back-Up Console Software Version 1.01 - 510(k) (K051209)

Levitronix LLC

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#### D. Device Description

The CentriMag Back-Up Console is a microprocessor-based device. The microprocessor generates the primary Motor control signal, monitors system sensors, generates front display outputs, and provides alarm functions. The microprocessor acquires the sensor data for use in generating operator displays and alarms. An alphanumeric screen is used to display monitored data.

#### E. Intended Use

The Levitronix CentriMag Back-Up Console is indicated for use with the Levitronix CentriMag Extracorporeal Blood Pumping System. The Levitronix CentriMag Extracorporeal Blood Pumping System is indicated to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants etc).

#### F. Technological Characteristics

The Levitronix CentriMag Back-Up Console has technological characteristics similar to the predicate device.

The CentriMag Back-Up Console is a microprocessor-based device. The microprocessor generates the primary Motor control signal, monitors system sensors, generates front display outputs, and provides alarm functions. The microprocessor acquires the sensor data for use in generating operator displays and alarms. An alphanumeric screen is used to display monitored data.

Identical to the predicate device, the Back-Up Console uses single phase AC power and is capable of controlling the Motor and Pump to produce a flow rate of up to 9.9 LPM at maximum pressure head of 600 mmHq when used with the CentriMag Blood Pump. Each Back-Up Console contains a non-rechargeable, field replaceable internal battery that is capable of powering the Back-Up Console in the event of a loss of AC Power.

#### G. Comparison to Predicate Device

The Levitronix CentriMag Back-Up Console has indications for use which is substantially equivalent to the predicate device, is composed of the same or equivalent materials as the predicate device, has equivalent

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design features as the predicate device, and has functional characteristics which are the same or equivalent to those of the predicate device. Due to the equivalency of indications for use, materials of composition, design features, and functional characteristics, the device raises no new safety or effectiveness issues.

#### H. Summary of Performance Data

The performance characteristics of the Levitronix CentriMag Back-Up Console were tested and compared with Levitronix performance specifications established for the device and with the commercially available predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 5 2009

Levitronix LLC c/o Susan Hamann Regulatory Affairs Manager 45 First Avenue Waltham, MA 02451

K090004 Re:

> Levitronix CentriMag Backup Console Regulation Number: 21 CFR 870.4380 Regulation Name: Cardiopulmonary Bypass Pump Speed Control Regulatory Class: Class II Product Code: DWA Dated: December 30, 2008 Received: January 2, 2009

Dear Ms. Hamann:

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.

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Page 2 - Ms. Susan Hamann

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.html.

Sincerely vours.

D. Wuhner

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

Enclosure

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## Attachment 1 - Indications for Use Statement

| Applicant: | Levitronix LLC |
|---------------------------|-------------------------------------------------------------------------|
| 510(k) Number (if known): | K090004 |
| Device Name: | CentriMag ^® Back-Up Console (with V2. Application Software) |

### Indications for Use:

The Levitronix CentriMag Back-Up Console is indicated for use with the Levitronix CentriMag Extracorporeal Blood Pumping System. The Levitronix CentriMag Extracorporeal Blood Pumping System is indicated to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants etc).

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duma R. V. Hines

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_Ko90004

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Levitronix LLC