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. Oneator adjustable alarms and parameters are accessible via the system menus.

AI/ML Overview

The provided text is a 510(k) Summary for the Levitronix CentriMag Primary Console. This document focuses on demonstrating substantial equivalence to a predicate device for regulatory approval, rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics typically associated with AI/software-as-a-medical-device (SaMD) clearances.

Therefore, much of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, training set details) cannot be found in the provided text because the device is a hardware medical device (a cardiopulmonary bypass pump console), not an AI/SaMD product.

However, I can extract the relevant information from the document regarding its "performance data" in the context of a hardware device submission.

Here's a breakdown based on the provided text, indicating what is present and what is absent:

1. A table of acceptance criteria and the reported device performance

The document does not provide a formal table of acceptance criteria and reported device performance in the manner typically seen for SaMD or diagnostic devices (e.g., sensitivity, specificity, AUC). Instead, it makes a general statement about performance testing against established specifications.

Acceptance Criteria (Implied): "Levitronix performance specifications established for the device" (Section H). These are not detailed in the summary.
Reported Device Performance: "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." (Section H). No specific quantitative performance metrics are provided in this summary document. The comparison confirms functional equivalency rather than specific diagnostic accuracy metrics.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size: Not specified. Performance testing in this context typically refers to engineering bench testing and verification/validation activities of a hardware system, not a clinical test set with patient data.
Data Provenance: Not applicable, as this refers to hardware performance testing, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. This device is a hardware pump console, and its "performance" would be assessed against engineering specifications and predicate device behavior, not by expert interpretation of clinical data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. This is not a clinical study involving human readers or interpretation.

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

No. This is a hardware device; no MRMC study involving human readers and AI assistance was conducted or is relevant for this type of device.

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

Not applicable. This is a hardware device, not an algorithm. Its "standalone" performance would refer to its operational characteristics without external human intervention, which would be part of standard engineering testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Ground Truth: For a hardware device like this, the "ground truth" would be established engineering specifications, design requirements, and the known performance/characteristics of the predicate device. It is not clinical "ground truth" like pathology or expert consensus.

8. The sample size for the training set

Not applicable. This is a hardware device, not a machine learning model.

9. How the ground truth for the training set was established

Not applicable. This is a hardware device, not a machine learning model.

Summary of the Study that Proves the Device Meets Acceptance Criteria (based on the provided text):

The document states under "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."

This indicates that:

Study Type: This was a performance testing and comparison study (likely involving bench testing, verification, and validation activities common for hardware medical devices).
Objective: To demonstrate that the new CentriMag Primary Console performs according to its internal Levitronix performance specifications and is functionally equivalent to the predicate device (Levitronix CentriMag Console, K020271).
Key Finding: The submission implies that these tests confirmed the device meets its specifications and is substantially equivalent, raising "no new safety or effectiveness issues" (Section G).

However, specific details of these tests (e.g., number of test cycles, specific parameters measured, quantitative results, pass/fail criteria) are not included in this 510(k) summary document. These details would typically be found in the full 510(k) submission attachments, but not in the publicly available summary.

Summary

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K053630

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.

Application Information: A.

Date Prepared:	December 27, 2005
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
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.

B.

C. Predicate Device:

Levitronix CentriMag Console (K020271)

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Device Description D.

ய் Intended Use

F. Technological Characteristics

The CentriMag Primary Console has Levitronix 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 features as the predicate device, and has functional characteristics whigh 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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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 6 2006

Levitronix LLC. c/o Mr. Farzad Parsale V.P., RA/QA 45 First Avenue Waltham, MA 02451

Re: K053630

CentriMag® Primary Console (with v200 Application Software onboard) Regulation Number: 21 CFR 870.4380 Regulation Name: Cardiopulmonary Bypass Pump Speed Control Regulatory Class: Class II (Two) Product Code: DWA Dated: December 27, 2005 Received: January 4, 2006

Dear Mr. Parsale:

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 Parsale

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 (240) 276-0120. 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 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/industry/support/index.html.

Sincerely yours,

Duna R. Lochner

JA 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): __ K 6 5 3 ( 3 6

Device Name: CentriMag® Primary Console (with v2.00 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)

Duana R. Vochner

(Division Sign-Off) Division of Cardiovascular Devices

510(K) Number_K653630

Page 1 of 1

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).