(199 days)
Not Found
No
The device description details a speed-controlled motor with microprocessors for control and monitoring of basic physiological parameters (speed, flow, temperature, pressure). There is no mention of AI or ML algorithms being used for data analysis, decision-making, or control beyond basic feedback loops and error handling. The performance studies focus on equivalence to a predicate device based on standard performance metrics, not AI/ML performance.
Yes
The device is described as an extracorporeal circuit used in cardiopulmonary bypass procedures, which are therapeutic interventions. Its function in maintaining vital circulatory support during these procedures directly contributes to a patient's treatment and recovery.
No
The device is described as providing "vital circulatory support as an extracorporeal circuit" and performing functions like "monitoring of motor speed, fluid flow, temperature and pressure." Its purpose is to operate a pump for cardiopulmonary bypass procedures, not to diagnose a condition.
No
The device description clearly outlines hardware components such as a motor, driver magnet, microprocessors, sensors (hall sensors, ultrasonic flow meter, strain gauge air pressure transducer), displays, and alarms. It is a physical device with integrated software for control and monitoring.
Based on the provided information, the HIMEX Centriflow System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is "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." This describes a device used directly on a patient to support their circulation during surgery.
- Device Description: The description details a system that controls a pump head to move blood through an extracorporeal circuit. It monitors parameters like flow, temperature, and pressure within this circuit.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening. The HIMEX Centriflow System does not perform any such analysis of specimens.
The device is clearly intended for direct patient support during a medical procedure, which falls under the category of a therapeutic or life support device, not an IVD.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
74 KFM
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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:
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.
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:
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.
000632
1
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.
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
2
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
4
| 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:
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.
(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 |
|---|---|
| --------------- | --------- |
| Prescription Use (Per 21 CFR 801.109) | X | OR | Over-The-Counter Use |
|---|---|---|---|
| --------------------------------------- | --- | ---- | ---------------------- |
(Optional Format 1-2 96)
.