(29 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 Return (Arterial) Cannula is indicated for use as an arterial return cannula with an extracorporeal bypass circuit for extracorporeal circulatory support for periods up to six hours.
The CentriMag Drainage (Venous) Cannula is indicated for use with an extracorporeal bypass circuit for extracorporeal circulatory support for periods up to six hours.
The CentriMag™ Circulatory Support System, hereafter referred to as the CentriMag System, was designed to provide temporary mechanical circulatory support. 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)
The Thoratec CentriMag Return (Arterial) Cannula Kit consists of the return (arterial) cannula and several accessories used in the surgical placement procedure. The cannula and all kit accessories are sterile, single-use, disposable devices. The cannula kit is designed for use with the Thoratec CentriMag® Extracorporeal Blood Pumping System.
The Thoratec CentriMag® Drainage (Venous) Cannula Kit consists of the drainage (venous) cannula and several accessories used in the surgical placement procedure. The cannula and all kit its accessories are sterile, single use, disposable devices. The cannula kit is designed for use with the Thoratec CentriMag® Extracorporeal Blood Pumping System.
The provided text is a 510(k) summary for a medical device (CentriMag Acute Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, and CentriMag Drainage (Venous) Cannula Kit).
Based on the content of the document, the device did not undergo a study to prove its performance against acceptance criteria in the typical sense of a new or modified device requiring such evidence. This 510(k) submission is a "Special 510(k)" which implies that the changes being made are minor and do not affect the device's fundamental performance, design, or intended use. Specifically, the document states:
- "The technological characteristics of the CentriMag Acute Circulatory Support System, CentriMag Return (Arterial) Cannula Kit and CentriMag Drainage (Venous) Cannula Kit have not changed from the predicate devices."
- "Components of the CentriMag Acute Circulatory Support System, CentriMag Return (Arterial) Cannula Kit and CentriMag Drainage (Venous) Cannula Kit are not affected by the labeling changes proposed in this Special 510(k) premarket notification. The labeling changes make the contraindications consistent among all labeling, add and/or strengthen warnings and precautions, and generally align and update the content for consistency."
- "The performance characteristics of the CentriMag Acute Circulatory Support System, CentriMag Return (Arterial) Cannula Kit and CentriMag Drainage (Venous) Cannula Kit have not changed. The labeling changes included in this 510(k) are for the Thoratec (now Abbott's) devices (predicates listed above) and do not require performance data to evaluate the change."
- "Clinical testing was not necessary for the labeling changes stated herein since the changes do not impact the design and performance of the devices."
Therefore, I cannot provide a table of acceptance criteria, reported device performance, or details of a study with sample sizes, expert ground truth, adjudication methods, or MRMC studies, as these types of studies were explicitly stated as not necessary for this specific 510(k) submission.
The document argues for substantial equivalence primarily based on the lack of change in technological characteristics and performance from legally marketed predicate devices (K191557, K152161, and K152190).
§ 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).