The Levitronix CentriMag Primary 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 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.

AI/ML Overview

This document is a 510(k) summary for a medical device called the "Levitronix CentriMag Primary Console". It describes the device, its intended use, and its comparison to a predicate device to demonstrate substantial equivalence. However, it does not contain acceptance criteria for device performance or a study demonstrating the device meets those criteria in the way typically expected for an AI/software device that makes diagnostic or interpretive claims.

This device is a cardiopulmonary bypass pump console, which is hardware that controls a blood pumping system. The 510(k) is primarily focused on demonstrating that a new version of the console, specifically with "Software Version 3.00", is substantially equivalent to a previously cleared version (Software Version 2.02).

Therefore, I cannot extract the requested information as it is not present in the provided text. The questions posed relate to the evaluation of AI or diagnostic software, which this device is not.

Here's why the requested information isn't applicable or available in this document:

Acceptance Criteria for Performance: For a mechanical device like this, acceptance criteria would typically involve engineering specifications (e.g., flow rate accuracy, pressure monitoring accuracy, alarm response times, battery life). These are not detailed in a way that can be presented in a performance table as if it were a diagnostic AI. The document only generally states: "The performance characteristics of the Levitronix CentriMag Primary Console were tested and compared with Levitronix performance specifications established for the device and with the commercially available predicate device." No specific performance metrics or their achieved values are reported in this summary.
Study Proving Acceptance Criteria: The "study" mentioned is a comparison to a predicate device and internal performance specifications. This is not a study in the sense of a clinical trial or performance evaluation using a test set with ground truth as would be done for an AI algorithm.
Sample Size for Test Set/Data Provenance/Experts/Adjudication/MRMC/Standalone/Ground Truth (for test set)/Training Set/Ground Truth (for training set): These are all concepts related to the validation of AI or diagnostic algorithms using clinical data. This document describes a medical device (a pump console) that does not make diagnostic interpretations or use AI in the way implied by these questions. The software mentioned (V3.00 Application Software) is for controlling the pump, monitoring sensors, and displaying data, not for making diagnostic decisions based on patient data.

In summary, the provided text is a regulatory submission for a hardware medical device with embedded software for control, not a diagnostic or AI-driven system. Therefore, the questions are largely not applicable to the content provided.

Summary

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KOr3340

NOV 2 6 2008 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:

Date Prepared:	November 11, 2008
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
Device Information:
Trade or Proprietary Name:	Levitronix CentriMag® Primary 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. None

C. Predicate Device:

Levitronix CentriMag Console Software Version 2.02 – 510(k) (K081221)

established under section 514 of the Food, Drug and Cosmetic Act.

в.

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D. Device Description

ட். Intended Use

ட Technological Characteristics

Levitronix CentriMag Primary Console has technological The characteristics similar 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 displav 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 rechargeable internal battery that is capable of maintaining Primary Console functionality in the event of a loss of AC Power,

G. Comparison to Predicate Device

The Levitronix CentriMag Primary 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 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

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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 Primary Console were tested and compared with Levitronix performance specifications established for the device and with the commercially available predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 6 2008

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

K083340 Levitronix CentriMag Primary Console Regulation Number: 21 CFR 870.4380 Regulation Name: Cardiopulmonary Bypass Pump Speed Control Regulatory Class: Class II Product Code: DWA Dated: November 11, 2008 Received: November 12, 2008

Dear Ms. Hamann:

Re:

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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

uma R. Vachus

A 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):	K083340
Device Name:	CentriMag Primary Console (with V3.00 Application Software)

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)

R. Vmmmm

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_k o83340

Page 1 of 1

Levitronix LLC

Special 510(k): Device Modification CentriMag® Primary Console

Page 25 of 138

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).