(28 days)
The 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).
The CentriMag™ Circulatory Support System, hereafter referred to as the CentriMag System, was designed to provide temporary mechanical circulatory support. To date, the CentriMag system in the United States (US) is indicated as a component of an extracorporeal bypass circulatory support circuit for use during cardiopulmonary bypass (CPB) surgery (up to 6 hours). The CentriMag System provides circulatory assistance for patients in acute hemodynamic compromise, a population whose treatment options are limited.
The CentriMag System is composed of:
- CentriMag Primary Console
- CentriMag Motor
- CentriMag Blood Pump
- CentriMag Flow Probe
- Mag Monitor (optional, not shown)
The CentriMag Motor is a reusable, non-sterile component of the CentriMag Acute Circulatory Support System. The CentriMag Motor holds the blood pump and drives the impeller inside the blood pump. The motor turns the magnet (and impeller) within the blood pump (Full MagLev™ technology) at a speed that is set on the console by the user. When the impeller is rotated, a pressure gradient develops between the center and outside edge of the pump, causing blood to flow from the inflow to the outflow port of the pump. The amount of flow through the pump depends on the speed of the impeller, and the difference between the inlet and outlet pressures.
The provided text describes a 510(k) premarket notification for a design modification to the CentriMag™ Acute Circulatory Support System, specifically a redesigned motor cable with enhanced bend protection. This is a medical device, and the submission focuses on proving the substantial equivalence of the modified device to its predicate, rather than establishing clinical effectiveness for a new-to-market device or an AI algorithm.
Therefore, the typical metrics and study designs used for AI/algorithm performance (e.g., sensitivity, specificity, MRMC studies, expert consensus for ground truth of an AI algorithm) do not apply in this context. The acceptance criteria and "study" are focused on mechanical and electrical performance to ensure the modified cable is at least as safe and effective as the original, and does not introduce new safety concerns.
Here's a breakdown of the requested information based solely on the provided text, recognizing its limited scope for AI-specific metrics:
Acceptance Criteria and Device Performance (for a Medical Device Component Modification)
The acceptance criteria for this device modification are focused on maintaining or improving the mechanical and electrical integrity of the motor cable compared to the predicate device.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance (as stated in the text) |
|---|---|
| Motor Cable Endurance: Durability and functionality under simulated severe handling to meet expected service life. Integrity of outer surface after bending. | Passed: Successfully passed the cable endurance (bend) test protocol. The redesigned robust motor cable with extended bend relief successfully passed (no failures), whereas the original cable design was less robust under high stress. Visual inspection showed the integrity of the outer surface of the motor cable or bend protection in the area of bending. This demonstrates meeting the expected service life under worst-case conditions. |
| Motor Cable Kink Test: Tolerance to excessive kinking/bending with small radius for targeted expected service life. Absence of defects after kinking. | Passed: Successfully passed the kink test protocol. Visual inspection showed no defects on the surface of the motor cable or bend protection in the area of bending. This proves it can tolerate excessive kinking or bending with small radius for the targeted expected service life. |
| Electrical / Safety Compliance: Compliance with relevant electrical safety standards. | Passed: Compliance to IEC 60601-1, Medical electrical equipment, Part 1: General requirements for basic safety and essential performance for the redesigned CentriMag Motor cable and new bend protection assembly has been confirmed, and it is therefore, substantially equivalent. The design modifications enhance cable flexibility and durability, and reduce the impact of rough handling and the occurrence of cable breaks and short circuiting, indicating improved electrical integrity and safety over the predicate. |
| Maintain Substantial Equivalence: No new safety or effectiveness concerns compared to predicate. | Met: "The redesigned CentriMag Motor cable assembly with longer bend protection has indication for use, technological characteristics, and performance an characteristics which are substantially equivalent to the predicate CentriMag Motor cable. Due to this, the redesigned CentriMag Motor cable structure with enhanced bend protection raises no new safety or effectiveness concerns." "The redesigned Motor cable offers enhanced cable flexibility and durability and improved protection from bending and kinking at the bend protection over the current commercial cable design." |
Study Details (Bench Testing for a Device Component Modification):
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Sample sizes used for the test set and data provenance:
- Sample Size: The text states "Comparison bench testing was performed" and refers to "both designs" (redesigned and current/original cable designs). It does not specify the number of individual cables or test repetitions for each test (Endurance and Kink test).
- Data Provenance: The testing was carried out by Thoratec (now part of Abbott) as part of their 510(k) submission, implied to be internal company testing. The country of origin of the data is not explicitly stated beyond the company's US address (Pleasanton, CA). This was not a human clinical study, but rather laboratory bench testing. The term "retrospective or prospective" doesn't directly apply here; it's a controlled bench test evaluating a manufactured component.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable (N/A) / None specified: For these types of mechanical and electrical bench tests, "ground truth" is established by direct measurement and observation of physical parameters, not by expert interpretation in the way it is for diagnostic imaging or clinical outcomes. Engineering specifications and industry standards (like IEC 60601-1) serve as the "truth" against which performance is measured.
- Qualifications of personnel conducting the tests are not provided, but would typically be engineers or technicians trained in relevant mechanical and electrical testing protocols.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable (N/A): Adjudication methods like 2+1 or 3+1 refer to consensus-building among human readers for subjective data interpretation (e.g., reading medical images). This was a series of objective bench tests with pass/fail criteria based on physical performance and visual inspection. Any "adjudication" would be part of standard quality control and engineering verification processes, not a multi-reader review.
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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, Not Applicable (N/A): This was a 510(k) for a physical medical device component (motor cable) and not an AI algorithm. Therefore, an MRMC study comparing human reader performance with or without AI assistance was not conducted, nor would it be relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, Not Applicable (N/A): This is a physical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Engineering Specifications and Industry Standards: The "ground truth" for these tests consisted of predefined pass/fail criteria derived from engineering design specifications and compliance with recognized international standards (e.g., IEC 60601-1). Performance data (e.g., integrity of cable after specified bends, absence of short circuits) formed the direct evidence.
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The sample size for the training set:
- Not Applicable (N/A): This device modification did not involve machine learning or AI, so there was no "training set."
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How the ground truth for the training set was established:
- Not Applicable (N/A): As there was no training set, this question is not applicable.
§ 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).