The HIMEX Centriflow System is indicated for use in the maintenance of vital circulatory support as an extracorporeal circuit that is intended for use in cardiopulmonary bypass procedures less than six hours in duration.

Device Description

The HIMEX Centriflow ™ is a speed controlled motor device for operating a Nikkiso HMS-12 (FDA 510(k) # K920077) disposable centrifugal pump head. The motor turns a driver magnet at a speed that is set by the device operator. The Driver Magnet magnetically couples to a magnet inside the Nikkiso HMS-12 disposable pump module. Rotation of the Driver Magnet thereby causes the impeller inside the Nikkiso HMS-12 to turn. The device also provides monitoring of motor speed, fluid flow, temperature and pressure through the use of numeric displays, graphical displays, audible alarms and visible alarms.

The HIMEX Centriflow™ is a modular device consisting of a console and a Remote Driver Module. A dual microprocessor configuration is used to control and monitor the speed of a brushless DC motor. The primary microprocessor, located in the console, generates the primary motor control signal, monitors system sensors, generates front display outputs, and provides alarm functions. The secondary microprocessor. located in the Remote Driver Module with the motor, generates the backup motor control signal, tracks motor usage, and displays motor speed. In the event of an error in the primary microprocessor control signal the secondary microprocessor will take control of the motor and lockout the primary microprocessor. Manual override is also provided to allow the operator to take direct control by overriding both microprocessors.

An array of hall sensors in the motor are used to determine motor speed. An ultrasonic flow meter is provided to monitor the pump output. A strain gauge air pressure transducer is provided to monitor outlet pressure. A connection is provided to accommodate a temperature probe to monitor temperature. The primary microprocessor acquires the sensor data for use in generating operator displays and alarms. Self illuminating numeric readouts are used to display monitored data. A liquid crystal graphics screen is used to display system options, menus. Operator setable alarms and parameters are accessible via the system menus. Two accessory digital timers are also provided.

AI/ML Overview

Here's an analysis of the HIMEX Centriflow™ device's acceptance criteria and study, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a non-inferiority study rather than a study with specific, pre-defined quantitative acceptance criteria for the HIMEX Centriflow™'s performance directly. The acceptance criterion was that the HIMEX Centriflow™ had equivalent performance to the predicate Nikkiso NK Pump.

Acceptance Criteria Category	Specific Acceptance Criterion	Reported Device Performance
Comparative Performance	Equivalent to Nikkiso NK Pump	"Analysis of the raw data provided evidence that the HIMEX device was of equivalent performance to the Nikkiso device."
Accuracy	Equivalent to Nikkiso NK Pump	"Analysis of the raw data provided evidence that the HIMEX device was of equivalent performance to the Nikkiso device."
Hemolysis	Equivalent to Nikkiso NK Pump	"Analysis of the raw data provided evidence that the HIMEX device was of equivalent performance to the Nikkiso device."
Safety and Effectiveness	Safe, effective, and performs as well as the predicate device (Nikkiso NK Pump)	"Testing performed on the HIMEX Centriflow™ device indicates that it is safe, effective, and performs as well as the predicate device, when used in accordance with the instructions for use."

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

Sample Size for Test Set: Not explicitly stated. The document mentions "a series of tests" but does not quantify the number of tests performed or the amount of "calf blood" used.
Data Provenance: The non-clinical testing was performed at the Baylor College of Medicine Department of Surgery. The data is prospective as it involved directly conducting tests comparing the new device against the predicate.

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

Not applicable. The study was a non-clinical, benchtop-style comparison of device performance parameters (flow, accuracy, hemolysis) rather than a diagnostic device relying on expert interpretation of results. The "ground truth" was established by direct measurement of physical parameters.

4. Adjudication Method for the Test Set

Not applicable. No human adjudication for ground truth was involved as this was a non-clinical performance comparison.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This was not an MRMC study. It was a non-clinical performance study comparing two mechanical devices. Therefore, there's no effect size of human readers improving with AI vs. without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in a sense. The non-clinical tests evaluated the standalone performance characteristics of the HIMEX Centriflow™ by directly comparing its output (e.g., flow, accuracy, hemolysis markers) against the predicate device under controlled conditions. There is no "algorithm" in the diagnostic sense, but the device's operational performance was assessed independently.

7. The Type of Ground Truth Used

The "ground truth" was established by direct measurement of physical parameters (e.g., flow rates, temperature, pressure, and hemolysis markers) during the non-clinical tests. This is akin to a reference measurement rather than an expert consensus or pathology diagnosis.

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical blood pump, not an AI or machine learning algorithm requiring a training set.

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

Not applicable, as there was no training set for an AI/ML algorithm.

Summary

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K972740

18 510(K) SUMMARY OR STATEMENT

SUBMITTER:

International Medical Products Corporation 4503 Moorland Avenue Minneapolis, Minnesota 55424

Jeffery R. Shideman, Ph.D. Contact: President

DATE PREPARED: 20 May 1997

HIMEX Centriflow TM PROPRIETARY NAME:

CLASSIFICATION NAME: Extracorporeal Centrifugal Blood Pump

Device Description:

Predicate Devices: Nikkiso NK Pump - K920077

Intended Use:

The HIMEX Centriflow™ Console and Remote Drive Module, when used with a Nikkiso HMS-12 disposable pump module, is a centrifugal blood pump that is intended for use in cardiopulmonary bypass procedures less than 6 hours in duration.

Technological Characteristics:

000632

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Summary Of Non-Clinical Tests:

Non-Clinical testing was performed at the Baylor College of Medicine Department of Surgery. The objective of these tests were to verify that the HIMEX Centriflow™ had equivalent performance to the predicate Nikkiso NK Pump (510(k)# K920077). Both the Nikkiso NK and HIMEX Centriflow™ were subjected to a series of tests consisting of comparative performance, accuracy, and hemolysis studies using calf blood. Analysis of the raw data provided evidence that the HIMEX device was of equivalent performance to the Nikkiso device.

Clinical Test Results:

Clinical testing was not performed. Clinical test data from the Nikkiso device is applicable to the HIMEX device since the HIMEX device drives the same disposable pump head as the Nikkiso device.

Conclusion:

Testing performed on the HIMEX Centriflow™ device indicates that it is safe, effective, and performs as well as the predicate device, when used in accordance with the instructions for use.

000633

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.

Rockville MD 20857

6 1998 FEB

Mr. Greg Georges President HIMEX Production Corporation 1709 Dryden Road, Suite 1508 Houston, TX 77030

K972740 Re: HIMEX Centriflow™ Centrifugal Perfusion Pump III (three) Requlatory Class: Product Code: 74 KFM November 14, 1997 Dated: November 17, 1997 Received:

Dear Mr. Georges:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such Existing major regulations affecting your device additional controls. can be found in the Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21-GFR-Part 020)-and-that;-through periodic QS-----------------------------------------------------inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{3}------------------------------------------------

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Thomas J. Allelahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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From:	Michelle Maulsby To: Thinh Nguyen
	870.4360 - KFM III - Non Roller Type CPB Blood Pump
Date:	2/5/88 Time 1:51:58 PM
Page	Page 2 of 2
510(k) Number (if known):	K972740
Page	of

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number	K972740
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Prescription Use (Per 21 CFR 801.109)	X	OR	Over-The-Counter Use
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(Optional Format 1-2 96)

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.