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510(k) Data Aggregation
(188 days)
LARGE CENTRIFUGAL BLOOD PUMP, MODEL CP-2
The A-Med Large Centrifugal Blood Pump is indicated for pumping 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 operations, surgery of the vena cava or aorta, liver transplants, etc). The A-Med Large Centrifugal Blood Pump is indicated for use only with the A-Med Blood Pump Controller.
The A-Med Large Centrifugal Blood Pump is a sterile, disposable, non-pulsatile, non-roller pump that utilizes an impeller to impart energy to the blood through centrifugal forces. The flow of the pump is "demand responsive" by automatically responding to the resistance against which it is pumping and to the amount of fluid returned to the large pump with the appropriate changes in flow and pressure. A drive cable and magnetic coupling are hermetically sealed components of the pump. A motor ultrasonic flow sensor and a microcomputer-based control console are available separately.
Acceptance Criteria and Device Performance Study for A-Med Large Centrifugal Blood Pump
This document outlines the acceptance criteria for the A-Med Large Centrifugal Blood Pump and describes the study that supports its substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary (K020529) does not explicitly list specific acceptance criteria with numerical targets for the A-Med Large Centrifugal Blood Pump. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices based on similarities in intended use, material, design, performance, and physical characteristics.
The core of the "acceptance" in this context is the FDA's determination of substantial equivalence, meaning the device is "as safe and effective as a legally marketed device."
| Acceptance Criteria Category | Description (as inferred from submission) | Reported Device Performance (as described in submission) |
|---|---|---|
| Intended Use | The device must be indicated for pumping blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours), and 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 operations, surgery of the vena cava or aorta, liver transplants, etc.). It must also be indicated for use only with the A-Med Blood Pump Controller. This must be substantially equivalent to the predicate devices. | The A-Med Large Centrifugal Blood Pump's intended use statement precisely matches the acceptance criteria. It is stated to be "identical in design, material, intended use and technological characteristics to the predicate devices" with the only difference being "size and pressure only." This implies that its functional performance for the stated duration is comparable since the intended use is the same. |
| Technological Characteristics | The device must be substantially equivalent in design, material, and technological characteristics to the predicate devices. This implies similar principles of operation (non-pulsatile, non-roller, centrifugal impeller), and blood compatibility. | The device "is identical in design, material, intended use and technological characteristics to the predicate devices. The difference is size and pressure only." This indicates that the fundamental technology and how it interacts with blood are considered equivalent, despite the physical dimension and the resulting capacity to generate more pressure. The mechanism of being "demand responsive" is also noted as a function. |
| Safety and Effectiveness | The device must be demonstrated to be as safe and effective as the predicate devices, despite the larger size and ability to produce more pressure. This would implicitly involve considerations of hemolysis, thrombosis, and adequate flow/pressure delivery for the indicated procedures. | The submission explicitly states that "The line extension A-Med Large Centrifugal Blood Pump is substantially equivalent to the predicates in intended use, material, design, performance and physical characteristics." While no specific test data on hemolysis or pressure/flow curves are provided in this summary, the claim of substantial equivalence, particularly regarding "performance," suggests that any necessary testing to demonstrate comparable safety and effectiveness (e.g., concerning blood damage) for the increased size and pressure capability was conducted and found acceptable. The reliance on literature discussing aspects like pulsatile vs. non-pulsatile perfusion, hemorrhagic complications, and hemolytic characteristics of similar pumps (though not directly on this specific device) further suggests a consideration of these safety aspects. |
| Compatibility | The device must be compatible with the A-Med Blood Pump Controller. | The indications for use explicitly state that the device "is indicated for use only with the A-Med Blood Pump Controller." This directly confirms the compatibility requirement. |
Description of the Study Proving Acceptance Criteria
The provided 510(k) summary for the A-Med Large Centrifugal Blood Pump (K020529) does not describe an explicit, dedicated clinical or performance study to prove the device meets specific acceptance criteria in the manner one might expect for a novel device. Instead, the entire submission is a comparative effectiveness argument based on substantial equivalence to predicate devices.
The study "proving" the device meets the acceptance criteria is effectively the demonstration of substantial equivalence to the A-Med Miniature Centrifugal Blood Pump System (K992592) and the Medtronic Bio-Medicus Centrifugal Blood Pump (K973011).
The rationale for substantial equivalence is based on the following:
- Identical Intended Use: The indications for use are described as being the same as the predicate devices.
- Identical Design, Material, and Technological Characteristics: The device is stated to be "identical in design, material, intended use and technological characteristics to the predicate devices." The only stated difference is "size and pressure only," implying a scaled-up version of an already approved technology.
- Performance: While not detailed with specific metrics, the claim of substantial equivalence in "performance" implies that the larger pump, despite its increased pressure capability, operates within acceptable parameters for its intended use, similar to its smaller counterpart or the Medtronic predicate. This would implicitly cover aspects like blood flow, pressure generation, and potential for blood damage (hemolysis), though specific test data is not provided in this summary.
The literature cited (Driessen et al., Glauber et al., Noon et al., Dantas & Costa, Takami et al.) are general medical literature related to cardiopulmonary bypass, centrifugal pumps, and their physiological effects. These references appear to provide background and context for the technology and its implications rather than being specific performance studies conducted on the A-Med Large Centrifugal Blood Pump itself. For instance, Takami et al. discusses hemolytic characteristics of a different gyro centrifugal pump, suggesting these are relevant considerations for this type of device, but not data generated for this device.
2. Sample Size Used for the Test Set and Data Provenance
Given that this is a substantial equivalence (510(k)) submission relying on comparison to predicate devices and not a de novo clinical trial, there is no "test set" in the traditional sense with a specific sample size of patients or physical devices subjected to a statistical performance study for this specific device.
The "data provenance" would refer to the existing regulatory approvals and performance data for the two predicate devices (A-Med Miniature Centrifugal Blood Pump System (K992592) and Medtronic Bio-Medicus Centrifugal Blood Pump (K973011)), which would have previously undergone their own approval processes. The current submission leverages the safety and effectiveness established by those prior approvals.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Since there was no dedicated "test set" or de novo clinical study described in this summary requiring expert adjudication for ground truth, this information is not applicable. The "ground truth" for the current submission is the established safety and effectiveness of the predicate devices as determined by prior FDA clearances.
4. Adjudication Method for the Test Set
As there was no dedicated "test set" or de novo clinical study, adjudication methods are not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done or is mentioned in the provided 510(k) summary. This type of study is typically associated with AI/imaging devices where human interpretation is a key component, and the impact of AI assistance on human performance needs to be quantified. The A-Med Large Centrifugal Blood Pump is a medical device (a mechanical pump), not an AI-assisted diagnostic tool.
6. Standalone Performance Study (Algorithm Only)
Not applicable. This device is a mechanical blood pump, not an algorithm. Therefore, there is no "standalone (algorithm only)" performance to evaluate. The device inherently involves a human operator (surgeon/perfusionist) during its use, but its core function is mechanical.
7. Type of Ground Truth Used
The "ground truth" for this substantial equivalence determination is the regulatory precedent and established safety and effectiveness of the legally marketed predicate devices. The device's "acceptance" is based on its demonstrated similarity (in function, material, design) to devices already deemed safe and effective by the FDA. This is a common approach for Class II and Class III (pre-amendments, 510k pathway) devices where a new device doesn't raise new questions of safety or effectiveness.
8. Sample Size for the Training Set
Not applicable. As this is a mechanical medical device submission and not a machine learning model, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an algorithm, the concept of establishing ground truth for it does not apply here.
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