The Levitronix CentriMag Primary and Back-Up Consoles are 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 Description

The CentriMag Primary 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, system options, and menus. Operator adjustable alarms and parameters are accessible via the system menus.

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.

AI/ML Overview

This document pertains to a 510(k) submission for the Levitronix CentriMag Primary Console and Back-Up Console. It specifically states that the submission is for a "labeling change" and that this change "did not require any performance characteristics testing."

Therefore, the document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria as typically understood for new device submissions or modifications requiring performance validation.

Here's why the requested information cannot be extracted from this document:

No Acceptance Criteria or Performance Data: The document explicitly states: "The proposed labeling change did not require any performance characteristics testing." This means no new tests were conducted to establish performance or acceptance criteria for this particular submission.
Substantial Equivalence to Predicate Device: The entire premise of this 510(k) is based on demonstrating substantial equivalence to previously cleared predicate devices (K083340 and K090004). This implies that the performance characteristics (and thus, presumably, acceptance criteria met by those predicate devices) are considered already established.
No Study Conducted: Since no performance testing was required or conducted for this submission, there is no study to describe in terms of sample size, data provenance, ground truth, expert involvement, or MRMC analysis.

In summary, the provided document does not contain the information requested because the 510(k) submission described is for a labeling change that did not necessitate new performance testing or the establishment of new acceptance criteria.

Summary

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i093832

Attachment 3 - 510(k) Summary

510(k) Summary for Levitronix CentriMag Primary 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.

A. Application Information:	JAN 1 3 2010
Date Prepared:	December 11, 2009
Submitter's Name & Address:	Levitronix LLC45 First AvenueWaltham, MA 02451
Contact Person:	Susan K. HamannRegulatory Affairs ManagerPh: (781) 466-6553Fax: (781) 622-5090e-mail: shamann@levitronix.com
B. Device Information:
Trade or Proprietary Name:	Levitronix CentriMag® Primary ConsoleLevitronix CentriMag® Back-Up Console
Common or Usual Name:	Cardiopulmonary Bypass PumpConsole
Classification Name:	Class II, DWA, 21 CFR - 870.4380Control, Pump Speed, CardiopulmonaryBypass
Performance Standard:	Performance standards do not currentlyexist for these devices. Noneestablished under section 514 of theFood, Drug and Cosmetic Act.

C. Predicate Devices:

Levitronix CentriMag Primary Console - 510(k) (K083340) Levitronix CentriMag Back-Up Console - 510(k) (K090004)

Levitronix LLC

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D. Device Description

E. Intended Use

The Levitronix CentriMag Primary and Back-Up Consoles are indicated for use with the Levitronix CentriMag Extracorporeal Blood Pumping System. The Levitronix CentrilMag 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).

ய் Technological Characteristics

CentriMag Primary Console has technological The Levitronix characteristics identical to the predicate device.

The Levitronix CentriMag Primary 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.

The CentriMag Primary Console uses single phase AC power and is capable of a flow rate of up to 9.9 LPM. Each Primary Console contains a

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rechargeable internal battery that is capable of maintaining Primary Console functionality in the event of a loss of AC Power.

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

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 mmHg when used with the CentriMag Blood Pump. In addition 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 Primary and Back-Up Consoles have indications for use which are substantially equivalent to the predicate devices. are composed of the same or equivalent materials as the predicate devices. have equivalent design features as the predicate devices, and have functional characteristics which are the same or equivalent to those of the predicate devices. Due to the equivalency of indications for use, materials of composition, design features, and functional characteristics, the devices raises no new safety or effectiveness issues.

H. Summary of Performance Data

The proposed labeling change did not require any performance characteristics testing.

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

JAN 1 3 2010

Levitronix LLC c/o Ms. Susan K. Hamann 45 First Avenue Waltham, MA 02451

Re: K093832

Trade/Device Name: CentriMag Primary Console and Back-Up Console Regulation Number: 21 CFR 870.4380 Regulation Name: Cardiopulmonary Bypass Pump Speed Control Regulatory Class: II Product Code: DWA Dated: December 11, 2009 Received: December 14, 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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

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Page 2 -- Ms. Susan K. Hamann

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

R. Vohrer

Sram 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):	K093832

Device Name:

CentriMag® Primary and Back-Up Consoles

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dune R. belmer

(Division Sian-Oif) Division of Cardiovascular Devices

510(k) Number K0

Page 1 of 1

Levitronix LLC

Special 610(k): Labeling Change Consolidated CentriMag® Primary Console and Back-Up Console Operating Manuals

Regulation Number and Section

§ 870.4380 Cardiopulmonary bypass pump speed control.

(a)
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.(b)
Classification. Class II (performance standards).