(199 days)
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.
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.
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.
§ 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.