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.q., valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants etc).

Device Description

System - The Levitronix CentriMag® Extracorporeal Blood Pumping System is a fault-tolerant system comprised of four (4) main assemblies which are available separately:

Blood Pump
Remote Motor Drive Unit
Control Console
Ultrasonic Flow Sensor

Blood Pump - The Levitronix CentriMag® Extracorporeal Blood Pump is a sterile, single-use, disposable, non-pulsatile, non-roller pump that utilizes a rotor to impart energy to the blood in an extracorporeal circuit through centrifugal forces. The inlet to the pump runs concentric with the axis of the rotor. The outlet of the pump is perpendicular to the inlet and tangent to the outer diameter. Blood enters the pump housing via the pump's inlet port where it makes contact with the rotor. As the rotor turns, energy in the form of pressure and velocity is transferred from the rotor to the blood. The CentriMag® Extracorporeal Blood Pump moves the blood through the circuit at a desired pressure and flow rate by increasing or decreasing the speed of the rotor. This is accomplished by adjusting the The pump operates from the Levitronix Remote Motor Drive Unit and microprocessor-based console, located outside the sterile field.

Remote Motor Drive Unit - The CentriMag® Motor Drive Unit is positionable on an IV pole/mast or adjacent to the console using an optional utility post. The Motor Drive Unit holds the disposable blood pump and drives the rotor inside the blood pump.

Control Console - The Levitronix CentriMag Console is a microprocessorbased device, which drives and controls the speed of the blood pump in the extracorporeal circuit. The console also provides monitoring of motor speed, fluid flow, and pressure through the use of alphanumeric display, audible alarms and visible alarms.

Ultrasonic Flow Sensor - The Levitronix CentriMag® Extracorporeal Blood Pumping System includes an ultrasonic flow meter.

AI/ML Overview

The provided text outlines the safety and effectiveness of the Levitronix CentriMag® Extracorporeal Blood Pumping System, focusing on its substantial equivalence to predicate devices rather than establishing specific acceptance criteria for a novel device performance. Therefore, a direct table of "acceptance criteria and reported device performance" as typically seen for AI/ML device evaluations is not explicitly present.

However, based on the narrative, the device's performance was evaluated through in-vitro bench testing and compared against established internal performance specifications and the performance of predicate devices. The primary goal was to demonstrate substantial equivalence to existing legally marketed devices.

Here's an attempt to structure the information based on your request, with an understanding that the original document is a traditional 510(k) summary for a non-AI/ML device, focusing on equivalence rather than detailed performance metrics against quantitative acceptance criteria for a new clinical claim:

Acceptance Criteria and Study Details for Levitronix CentriMag® Extracorporeal Blood Pumping System

The Levitronix CentriMag® Extracorporeal Blood Pumping System's acceptance criteria and performance were primarily established through substantial equivalence to predicate devices and adherence to relevant standards and internal specifications, as detailed in the K020271 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a non-AI/ML device demonstrating substantial equivalence, explicit quantitative acceptance criteria with corresponding reported performance metrics are not detailed in the same manner as for novel performance claims. Instead, the "acceptance criteria" are implied by the demonstration of:

Technological Characteristics similar to predicate devices.
Functional Characteristics the same or equivalent to predicate devices.
Safety and Effectiveness not significantly affected compared to predicate devices.
Compliance with relevant standards and guidance documents (e.g., software validation, biocompatibility, sterilization).

Acceptance Criteria Category	Implied Criterion	Reported Device Performance
Overall Equivalence	Substantial equivalence to predicate devices (Bio-Pump, Model BPX-80, and Bio-Console, Model 550) in terms of indications for use, materials, design features, and functional characteristics.	"The Levitronix CentriMag® Extracorporeal Blood Pumping System is believed to be substantially equivalent to the following predicate devices..." and "In-Vitro bench testing demonstrates that when compared to the predicate devices (BPX-80 Bio-Pump), the Levitronix CentriMag® Extracorporeal Blood Pump does not significantly affect safety and effectiveness and is substantially equivalent to other commercially distributed centrifugal blood pumps."
In-Vitro Bench Testing	Performance comparable to predicate devices and Levitronix performance specifications.	"The performance characteristics... were tested and compared with Levitronix performance specifications established for the system and with commercially available predicate devices." No specific quantitative metrics reported in the summary but stated to be comparable.
Software Validation	Validation and verification in accordance with FDA Guidance.	"Software on-board the CentriMag® Console was validated and verified in accordance with the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Biocompatibility	Biocompatibility and non-toxicity for intended use.	"Biocompatibility testing... performed in accordance with FDA Blue Book Memorandum - #395-1 and Biological Evaluation of Medical Devices Guidance - International Standard ISO 10993-1, and in accordance with United States Pharmacopoeia - XXIII." Results: "determined to be biocompatible and non-toxic and, therefore, safe for its intended use."
Sterilization	Sterility Assurance Level (SAL) of 10⁻⁶.	"Sterilization... has been validated to assure a sterility assurance level (SAL) of 10⁻⁶. EtO sterilized... in accordance with... ANSI/AAMI/ISO 11135-1994."
EtO Residuals	Meet specified limits for residual concentrations.	"EtO dissipation curves are used for routine product release to assure EtO sterilized CentriMag® Extracorporeal Blood Pumps meet the limits for residual concentrations of ethylene oxide (<25ppm), ethylene chlorohydrin (<25ppm), and ethylene glycol (<250ppm) as published in ANSI standard Number ANSI/AAMI/ISO 10993-7."
Pyrogens	Less than 0.5 EU/ml.	"Routine Pyrogen Testing is performed using the Limulus Amebocyte Lysate (LAL) method. Product testing and release criteria (less than .5 EU/ml) is in accordance to the December 1987 Guideline..."
Functional Range	Capable of specific flow rate, pressure head, and battery life.	Console capable of "flow rate of up to 9.99 LPM against a maximum pressure head of 600 mmHg." Internal battery "capable of running the pump for a minimum of 60 minutes when fully charged at maximum speed of 5,500 and under nominal load."
Flow Sensor Range	Detect flows 0-9.99 LPM and retrograde flow >40 cc/min.	"The Flow Sensor... can detect flows from 0-9.99 LPM and can detect retrograde flow of >40 cc/min."

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

Test Set Description: The primary "test set" was the Levitronix CentriMag® Extracorporeal Blood Pumping System itself, and its performance was evaluated through in-vitro bench testing.
Sample Size: The document does not specify the number of devices or experimental replicates used in the in-vitro bench testing.
Data Provenance: The testing was conducted internally by Levitronix, LLC. The provenance of the predicate device performance data used for comparison is not specified (e.g., publicly available specifications, internal testing of predicate devices). The data is retrospective in the sense that it evaluates the manufactured device against existing standards and predicate devices. No human patient data (prospective or retrospective) was used for performance evaluation as "Clinical testing was not performed on this system."

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

Ground Truth Establishment: This concept is not applicable in the context of this 510(k) submission. The "ground truth" for device performance (e.g., flow rate accuracy, pressure resistance, biocompatibility) is established by physically testing the device against defined engineering specifications, industry standards (e.g., ISO, USP, FDA guidance), and the known performance of predicate devices. It does not involve expert consensus on medical findings.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. Performance testing for this type of device (e.g., durability, flow rates, pressure resistance, biocompatibility) is measured objectively and quantitatively against specifications, not through expert review and adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No. This study is not relevant as the device is a medical pump system, not an AI-based diagnostic or assistive technology for human readers.

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

Standalone Performance: Not applicable in the context of AI/ML algorithms. The "standalone performance" of the device refers to its physical and functional operation (e.g., pumping blood, monitoring flow, maintaining pressure) as an electromechanical system, which was evaluated through in-vitro bench testing. The console itself is microprocessor-based and governs the pump's operation.

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" for the various performance aspects (e.g., safety, effectiveness, biocompatibility, sterilization, functional ranges) consists of:
- Engineering Specifications: Internal performance specifications established by Levitronix.
- Regulatory Standards: Compliance with FDA guidance (e.g., software validation, biocompatibility), international and national standards (e.g., ISO 10993-1, ISO 11135-1994, ISO 10993-7, ANSI/AIMI, USP XXIII), and FDA guidelines for residuals and pyrogens.
- Predicate Device Performance: The established operating characteristics and safety profiles of the legally marketed predicate devices (Medtronic Bio-Pump, Model BPX-80 and Medtronic Bio-Console, Model 550) serve as a benchmark for equivalence.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This device is not an AI/ML system that requires a "training set" in the computational sense. Its design and operational parameters are based on established engineering principles, fluid dynamics, and medical device regulations.

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

Ground Truth for Training Set Establishment: Not applicable, as there is no training set for an AI/ML algorithm involved. The "ground truth" for the device's design and manufacturing (analogous to a training process for an AI) is implicitly established through decades of engineering best practices for similar medical devices, adherence to quality systems (e.g., 21 CFR Part 820 Good Manufacturing Practice requirements), and the foundational knowledge of cardiovascular support systems.

Summary

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Summary of Safety & Effectiveness

510(k) Summary

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:

July 15, 2002 Date Prepared: Submitter's Name & Address: Levitronix, LLC 85 First Avenue Waltham, MA 02451 Farzad Parsaie Contact Person: V.P., RA/QA (781) 622-5075 Ph: Fax: (781) 622-5090 e-mail: fparsaie@pharosllc.com

B. Device Information:

Trade or Proprietary Name:

Common or Usual Name:

Classification Name(s):

Levitronix CentriMag® Extracorporeal Blood Pumping System

Centrifuqal Blood Pump Cardiopulmonary Bypass Pump Console

Class III. KFM. 21 CFR - 870.4360 Pump, Blood, Cardiopulmonary Bypass, Non-roller type

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

Note: Non-roller type blood pumps have been classified as Class III devices by the Cardiovascular Devices Panel (Product Code 74KFM). A petition for reclassification of this type of device from Class III to Class II has been approved by the panel, but the final rule has not been promulgated yet.

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Performance Standard:

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

C. Predicate Devices:

The Levitronix CentriMage Extracorporeal Blood Pumping System is believed to be substantially equivalent to the following predicate devices currently in interstate commerce with respect to comparable features, materials of construction and intended use:

Predicate Device - Centrifugal Blood Pump
Device Name	Manufacturer	510(k) No
Bio-Pump, Model BPX-80	Medtronic	K973011

Predicate Device - Blood Pump Speed Controller
Device Name	Manufacturer	510(k) No.
Bio-Console, Model 550	Medtronic	K941921

D. Device Description

System - The Levitronix CentriMag® Extracorporeal Blood Pumping System is a fault-tolerant system comprised of four (4) main assemblies which are available separately:

트 Blood Pump
트 Remote Motor Drive Unit
트 Control Console
l Ultrasonic Flow Sensor

The pump operates from the Levitronix Remote Motor Drive Unit and microprocessor-based console, located outside the sterile field.

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Ultrasonic Flow Sensor - The Levitronix CentriMag® Extracorporeal Blood Pumping System includes an ultrasonic flow meter.

E. Intended Use

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® Extracorporeal Blood Pumping System has technological characteristics similar to the predicate devices.

Blood Pump - The Levitronix CentriMag® Extracorporeal Blood Pump consists of iniection-molded polycarbonate inner and outer housings containing an injection-molded polycarbonate rotor, which imparts energy to the pumping fluid through centrifyaal forces. The ioints are bonded with an ultraviolet light cured adhesive. The inlet port (3/8") is located at the top center of the pump and the fluid inflow runs concentric with the axis of the rotor. The outlet port (3/8") of the pump is perpendicular to the inlet and tangent to the outer diameter. The rotor contains a magnet that is hermetically sealed. The Levitronix CentriMag® Extracorporeal Blood Pump is designed to be used only with Levitronix CentriMag® Console.

An ultrasonic flow meter is provided to monitor the pump output. Optional pressure transducers are available to monitor inlet/outlet pressures.

Remote Motor Drive Unit - The Motor Drive Unit turns a magnet that is hermetically sealed in the pump's rotor at a speed that is set by the console operator. Three bayonet sockets are provided on the top of the Motor allowing coupling and mounting of the disposable blood pump in three angular directions (90 degrees apart) of the pump outlet. An array of hall sensors in the motor is used to determine motor speed.

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Control Console - The Levitronix CentriMag Console is a microprocessorbased 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 settable alarms and parameters are accessible via the system menus.

The CentriMag® console operates off of single phase AC power and is capable of flow rate of up to 9.99 LPM against a maximum pressure head of 600 mmHq. In addition each contains an internal battery that is capable of running the pump for a minimum of 60 minutes when fully charged at maximum speed of 5,500 and under nominal load in the event of a loss of AC Power.

Ultrasonic Flow Sensor - The Flow Sensor is a reusable, non-patient contacting ultrasonic flow sensor which can detect flows from 0-9.99 LPM and can detect retrograde flow of >40 cc/min. This sensor is compatible with 3/8" ID by 3/32" wall tubing.

Comparison to Predicate Devices G.

The Levitronix CentriMag® Extracorporeal Blood Pumping System has indications for use which are substantially equivalent to those of predicate devices, is composed of the same or equivalent materials as the commercially marketed devices, has equivalent design features as the predicate devices, and has 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 device raises no new safety or effectiveness issues.

H. Summary of Performance Data

The performance characteristics of the Levitronix CentriMag® Extracorporeal Blood Pumping System were tested and compared with Levitronix performance specifications established for the system and with commercially available predicate devices.

1) Iv-vivo Animal Studies

In-vivo testing was not performed on this system.

2) In-vitro Bench Testing:

In-Vitro bench testing demonstrates that when compared to the predicate devices (BPX-80 Bio-Pump), the Levitronix CentriMag® Extracorporeal Blood Pump does not significantly affect safety and effectiveness and is substantially equivalent to other commercially distributed centrifugal blood pumps.

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3) Software

Software on-board the CentriMag® Console was validated and verified in accordance with the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

4) Biocompatibility:

Biocompatibility testing of Levitronix CentriMag® Extracorporeal Blood Pump was performed in accordance with the FDA Blue Book Memorandum - #395-1 and Biological Evaluation of Medical Devices Guidance - International Standard ISO 10993-1, and in accordance with United States Pharmacopoeia - XXIII.

Based on the results of the biocompatibility testing performed, the Levitronix CentriMag® Extracorporeal Blood Pump was determined to be biocompatible and non-toxic and, therefore, safe for its intended use.

5) Sterilization:

Sterilization of the Levitronix CentriMag® Extracorporeal Blood Pump has been validated to assure a sterility assurance level (SAL) of 10°. Efo sterilized CentriMag® Extracorporeal Blood Pumps are sterilized in accordance with the American National Standards Institute, Inc. (ANSI) standard ANSI/AAMI/ISO 11135-1994 (Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization).

6) Eto Residuals:

EtO dissipation curves are used for routine product release to assure EtO sterilized CentriMag® Extracorporeal Blood Pumps meet the limits for residual concentrations of ethylene oxide (<25ppm), ethylene chlorohydrin (<25ppm), and ethylene glycol (<250ppm) as published in ANSI standard Number ANSI/AAMI/ISO 10993-7 (Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals).

7) Pyrogens:

Routine Pyrogen Testing is performed using the Limulus Amebocyte Lysate (LAL) method. Product testing and release criteria (less than .5 EU/ml) is in accordance to the December 1987 Guideline issued by the Food and Drug Administration, Office of Compliance ("Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices").

l. Clinical Performance

Clinical testing was not performed on this system.

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J. Conclusion & Statement of Equivalence

Through data and information presented, numerous similarities support a determination of substantial equivalence, and subsequently market clearance of the Levitronix CentriMag® Extracorporeal Blood Pumping System through his 510(k) Premarket Submission.

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Image /page/6/Picture/2 description: The image is a black and white logo. The logo features the words "HUMAN SERVICES - USA" in a circular arrangement at the top. Below the text is a stylized graphic of three human profiles facing to the right. The words "DEPARTMENTAL" are arranged vertically along the left side of the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 5 2003

Levitronix, LLC c/o Mr. Farzad Parsaie 85 First Avenue Waltham, MA 02451

Re: K020271

CentriMag® Extracorporeal Blood Pumping System Regulation Number: 21 CFR 870.4360 Regulation Name: Non-roller type CPB Blood Pump Regulatory Class: Class III (three) Product Code: KFM Dated: December 31, 2002 Received: January 6, 2003

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 Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours,

Kellerth
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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III. Indications For Use Statement

Applicant:

Levitronix, LLC
K020271

Device Name:

CentriMag® Extracorporeal Blood Pumping System

Indications for Use:

510(k) Number (if known):

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Keletu

510(k) Number K02071/

Prescription Use
(per 21 CFR 801.109)

Over-the Counter Use

(Optional Format 1-2-96)

CONFIDENTIAL

Regulation Number and Section

§ 870.4360 Nonroller-type blood pump.

(a)
Nonroller-type cardiopulmonary and circulatory bypass blood pump —(1)Identification. A nonroller-type cardiopulmonary and circulatory bypass blood pump is a prescription device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:(i) Full or partial cardiopulmonary bypass (
i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
(2)
Classification —Class II (special controls). The special controls for this device are:(i) Non-clinical performance testing must perform as intended over the intended duration of use and demonstrate the following: Operating parameters, dynamic blood damage, heat generation, air entrapment, mechanical integrity, and durability/reliability;
(ii) The patient-contacting components of the device must be demonstrated to be biocompatible;
(iii) Sterility and shelf life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components; and
(iv) Labeling must include information regarding the duration of use, and a detailed summary of the device- and procedure-related complications pertinent to use of the device.
(b)
Nonroller-type temporary ventricular support blood pump —(1)Identification. A nonroller-type temporary ventricular support blood pump is a prescription device that uses any method resulting in blood propulsion to provide the temporary ventricular assistance required for support of the systemic and/or pulmonary circulations during periods when there is ongoing or anticipated hemodynamic instability due to immediately reversible alterations in ventricular myocardial function resulting from mechanical or physiologic causes. Duration of use would be less than 6 hours.(2)
Classification. Class III (premarket approval).(c)
Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with FDA on or before September 8, 2015, for any nonroller-type temporary ventricular support blood pump that was in commercial distribution before May 28, 1976, or that has, on or before September 8, 2015, been found to be substantially equivalent to any nonroller-type temporary ventricular support blood pump that was in commercial distribution before May 28, 1976. Any other nonroller-type temporary ventricular support blood pump shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.