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

Here's a breakdown of the acceptance criteria and study information for the Levitronix CentriMag Primary Console, based on the provided text:

It's important to note that the provided text is a 510(k) summary for a medical device and not a detailed clinical study report. Therefore, some information, particularly regarding specific statistical metrics and study designs common in AI/diagnostic device evaluations, is not present. This submission focuses on substantial equivalence to a predicate device for regulatory clearance.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Specifications)	Reported Device Performance (Summary)
Not explicitly detailed in the provided text. The document refers to "Levitronix performance specifications established for the device."	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. The document states that the device has "functional characteristics which are the same or equivalent to those of the predicate device."
Functional characteristics of the predicate device (K020271, K053630).	The CentriMag Primary Console operates as a microprocessor-based system for motor control, sensor monitoring, display outputs, and alarm functions. It acquires sensor data for display and alarms. It uses single-phase AC power and has a flow rate capability of up to 9.9 LPM. It includes a rechargeable internal battery.
Safety and effectiveness (implied by 510(k) process).	The conclusion is that the device "raises no new safety or effectiveness issues" due to its equivalency with the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated. The document refers to "performance characteristics... were tested," but doesn't provide the number of tests, units, or specific data points.
Data Provenance: Not explicitly stated. Given the nature of a 510(k) for a hardware console, the testing likely involved in-house engineering and laboratory validation, rather than patient data in the typical sense of a diagnostic or therapeutic device. The "comparison with the commercially available predicate device" suggests comparative bench testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided and is generally not applicable in the context of a 510(k) for a medical device console like the CentriMag, which is a hardware system for pumping blood rather than an AI/diagnostic tool requiring expert labeling of data. The "ground truth" would be the expected functional output and safety parameters confirmed by engineering specifications and testing.

4. Adjudication Method for the Test Set

Not applicable. This typically refers to resolving discrepancies in expert labeling for ground truth in diagnostic tests. For a device like the CentriMag Console, "adjudication" would refer to engineering and quality control procedures for discrepancy resolution during testing, which are part of standard quality management systems but not detailed in this 510(k) summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No. An MRMC study is not applicable here. The Levitronix CentriMag Primary Console is a cardiopulmonary bypass pump console, not an AI or diagnostic imaging device that assists human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This question is not applicable as the device is a hardware console for extracorporeal blood pumping, not an algorithm. Its operation inherently involves human interaction for setup, monitoring, and control. The "microprocessor-based" nature implies internal algorithmic control, but not as a standalone algorithm in the context of typical AI device evaluation.

7. The Type of Ground Truth Used

Engineering Specifications and Predicate Device Performance: The "ground truth" for this device's performance would be against established engineering performance specifications (e.g., flow rate accuracy, alarm functionality, motor control stability) and the known, acceptable performance of the predicate CentriMag Console. Safety and functional reliability are key "truths" established through testing against these benchmarks.

8. The Sample Size for the Training Set

Not applicable. The CentriMag Primary Console is a hardware device (with embedded software) for blood pumping, not a machine learning or AI model that requires a "training set" in the conventional sense. Its "training" would be analogous to the design, development, and validation of its hardware and software components.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As established in point 8, there isn't a "training set" in the context of an AI model for this device. The "ground truth" for its development would be derived from medical and engineering requirements for safely and effectively performing cardiopulmonary bypass, informed by existing medical practice and the performance of previous or similar devices.

Summary

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K081221

Attachment 3 - 510(k) Summary

JUN 1 9 2008

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:	April 29, 2008
Submitter's Name & Address:	Levitronix LLC45 First AvenueWaltham, MA 02451
Contact Person:	Farzad ParsaieV.P., RA/QAPh: (781) 622-5075Fax: (781) 622-5090e-mail: fparsaie@levitronix.com

B. 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. Noneestablished under section 514 of theFood, Drug and Cosmetic Act.

C. Predicate Device:

Levitronix CentriMag Console (K020271) Levitronix CentriMag Console Software Version 2.00 - special 510(k) (K053630)

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Device Description D.

ய் Intended Use

Technological Characteristics ட்

The Levitronix CentriMag Primary Console has technological 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 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 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

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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.

Summary of Performance Data H.

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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Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.

JUN 1 9 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Levitronix LLC. c/o Farzad Parsaie Vice President, Regulatory Affairs and Quality Assurance 45 First Avenue Waltham, MA 02451

Re: K081221

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: April 29, 2008 Received: April 30, 2008

Dear Mr. Parsaie:

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 - Mr. Farzad Parsaie

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 (CDRI'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 Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding 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 yours,

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):	K081221
Device Name:	CentriMag ® Primary Console (with v2.02 Application Software onboard)

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)

vision Sign-Offi

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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).