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510(k) Data Aggregation
(188 days)
A-MED SYSTEMS, INC.
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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(25 days)
A-MED SYSTEMS, INC.
The A-Med Heparin Coated Miniature Centrifugal Blood Pump System is indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring artificial oxygenation (e.g., valvuloplasty, circulatory support during surgery of the vena cava or aorta, liver transplants, etc). The A-Med Heparin Coated Miniature Centrifugal Blood Pump is indicated for use only with the A-Med Blood Pump Controller.
The A-Med Heparin Coated Miniature 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. The coating which A-Med propose to add to the pump will be a photoactivated hydrogel surface modification. The process uses light activated chemistry to coat the device. A motor ultrasonic flow sensor and a microcomputer-based control console are available separately.
The provided text is a 510(k) summary for a medical device called the "A-Med Heparin Coated Miniature Centrifugal Pump System." It describes the device, its intended use, and its similarities to a predicate device. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving the device meets those criteria.
Here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
This information is not present in the provided text. The submission focuses on demonstrating substantial equivalence to a predicate device, primarily due to the addition of a heparin coating. It does not include specific performance metrics, acceptance criteria, or their corresponding test results for the heparin-coated device.
2. Sample size used for the test set and the data provenance
This information is not present in the provided text. No specific test sets or study data are detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not present in the provided text. Since no specific test set or study is described, there's no mention of experts establishing ground truth.
4. Adjudication method for the test set
This information is not present in the provided text.
5. 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
A MRMC study is not applicable to this device. This device is a centrifugal blood pump, not an AI-powered diagnostic or interpretive tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable to this device. This is a medical device (centrifugal pump), not an algorithm.
7. The type of ground truth used
This information is not present in the provided text.
8. The sample size for the training set
This information is not present in the provided text.
9. How the ground truth for the training set was established
This information is not present in the provided text.
Summary of available information from the document:
- Device: A-Med Heparin Coated Miniature Centrifugal Pump System
- Predicate Device: A-Med Miniature Centrifugal Blood Pump System (K992592)
- Key Change: Addition of a photoactivated hydrogel surface modification (heparin coating).
- Basis for Equivalence: Similarities to the predicate device in intended use, material, design, performance, and physical characteristics. The heparin coating is the only change and is stated not to impact the currently cleared indication.
- Intended Use: Extracorporeal circulatory support systems (up to six hours) not requiring artificial oxygenation (e.g., valvuloplasty, circulatory support during surgery of the vena cava or aorta, liver transplants, etc.). For use only with the A-Med Blood Pump Controller.
Conclusion:
The provided 510(k) summary focuses on demonstrating substantial equivalence through a comparison of the modified device (with heparin coating) to an existing predicate device. It explicitly states that the modification (heparin coating) is the only change to the existing device and that it does not impact the currently cleared indication. This type of submission typically relies on showing that the new modification does not negatively alter the fundamental safety and effectiveness demonstrated by the predicate device, often without presenting new, extensive clinical or performance studies with detailed acceptance criteria in the summary itself. The detailed performance data, acceptance criteria, and specific study results that would typically answer your questions are not included in this high-level regulatory summary.
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(276 days)
A-MED SYSTEMS, INC.
The A-Med Miniature Centrifugal Blood Pump System is indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring artificial oxygenation (e.g., valvuloplasty, circulatory support during surgery of the vena cava or aorta, liver transplants, etc.). The A-Med Miniature Centrifugal Blood Pump is indicated for use only with the A-Med Blood Pump Controller.
The A-MED Miniature Centrifugal Pump is a sterile, disposable, non-roller pump which utilizes a rotor to impart energy to the blood through centrifugal forces. The flow of the miniature pump is "demand responsive" by automatically responding to the resistance against which it is pumping and to the amount of fluid returned to the miniature pump with the appropriate changes in flow and pressure. A drive cable and magnetic coupling are hermetically sealed components of the miniature pump.
The A-MED Miniature Centrifugal Pump System includes a motor, ultrasonic flow sensor and a microcomputer-based control console which are available separately. The Miniature pump consists of inner and outer housings containing a rotor which imparts energy to the pumping fluid through centrifugal forces. The inlet to the pump runs concentric with the axis of the rotor. The outlet of the pump is perpendicular to the inlet and tangent to the outer diameter. The shaft of the rotor is constrained by two sets of bearings that allow it to rotate freely. A lip seal is used just behind the rotor to seal fluid from entering into the bearing area.
A sheath cable assembly connects the pump to the drive motor. The pump end of the cable has a square drive shaft that is bonded and crimped to the cable. This drive shaft fits into a square opening in the end of the rotor. The other end of the cable is connected to a magnet rotor housed in a plastic shell. This end is assembled onto the motor-stator for operation. By assembling the magnet rotor into the end of the cable-sheath assembly, hermitic sealing of the pumping chamber is obtained.
A priming port (valve) is provided on the housing to clear the pump of air before starting circulation. The port is designed to open when a syringe is inserted and seals when the syringe is removed.
The pump is designed to be placed in the sterile field and operated from the A-Med remote motor and microcomputer based blood pump controller, located outside the sterile field. The A-Med Centrifugal Pump System also includes an ultrasonic flow meter, manufactured by Transonics, Inc.
This document is a 510(k) summary for the A-Med Miniature Centrifugal Pump System. It provides information about the device's substantial equivalence to predicate devices, but it does not contain acceptance criteria or a study proving the device meets acceptance criteria.
Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting specific performance metrics and associated studies.
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(239 days)
A-MED SYSTEMS, INC.
The A-Med Vascular Cannula is intended for use in accessing the circulatory system during extracorporeal circulation.
The A-Med Vascular Cannula is intended for intraoperative access to the arterial (i.e., aorta, femoral artery or pulmonary artery) or venous system. (i.e., femoral vein, right atrium) during procedures requiring arterial or venous access for short term extracorporeal support (less than six hours). Arterial or venous access is left to the discretion of the physician.
The A-Med Vascular Cannula is a cannula comprised of a flexible tip, radiopaque stripes, wire reinforced tubing, non-reinforced proximal clamp zone, and a proximal connector. Configurations are available with the following options:
- . Outer diameter: 24 French
- . Effective length: 10, 21 inch
- Number of holes in tip: 8, 16, 32, 44 (dependant on length) ●
- Proximal connector: barb, barb with side luer lock, quick connect ●
The provided 510(k) premarket submission for the A-Med Systems, Inc. Vascular Cannula (K991541) does not contain acceptance criteria or study details in the requested format for AI/software-as-a-medical-device (SaMD) products.
This submission is for a physical medical device (a vascular cannula) and follows the regulatory pathway for such devices, primarily relying on non-clinical performance testing and substantial equivalence to a predicate device.
Therefore, many of the requested fields are not applicable to this submission. I will address the applicable parts based on the provided text, and explicitly state when a requested piece of information is not available or not relevant to this type of device submission.
Acceptance Criteria and Study to Prove Device Meets Criteria
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (Baxter/RMI FEM FLEX II Cannula K891576, K974259) | Achieved; "The performance of this device is substantially equivalent to the predicate device and performs as intended." |
| Compliance with A-Med Systems, Inc. performance specifications | Achieved; "performance characteristics of this device were tested and compared with A-Med Systems, Inc. performance specifications." |
| No clinical testing required for intended use | Not applicable; "Clinical testing was not performed on this device." |
2. Sample size used for the test set and the data provenance
- Not Applicable in the context of SaMD. For this physical device, the "test set" refers to the specific cannulas and materials used in the non-clinical performance tests (e.g., mechanical strength, flow rates, material compatibility). The document does not specify the number of units tested.
- Data Provenance: The tests were conducted internally by A-Med Systems, Inc. (implied by "A-Med Systems, Inc. performance specifications"). The country of origin for the data is not explicitly stated but is presumed to be the United States, given the submitter's address. The data is "prospective" in the sense that the tests were performed specifically for this submission, not a retrospective analysis of existing data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. For a physical device like a vascular cannula, "ground truth" in the SaMD sense (e.g., expert consensus on image interpretation) is not established. Performance is measured directly (e.g., flow rates, material properties, mechanical integrity) against specifications validated by engineering and regulatory standards. The expertise involved would be in engineering, material science, and quality assurance, rather than clinical interpretation.
4. Adjudication method for the test set
- Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations, typically in studies involving subjective assessments (e.g., radiology reads). This is not relevant for the non-clinical performance testing of a physical device.
5. 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. This is a physical medical device, not an AI/software device designed to assist human readers. Therefore, an MRMC study is not relevant or applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a physical medical device, not an algorithm. Therefore, "standalone performance" in the SaMD context is not applicable.
7. The type of ground truth used
- Engineering Specifications and Predicate Device Performance: The "ground truth" for this device's performance is established by:
- Comparison to the performance characteristics of the legally marketed predicate device (Baxter/RMI FEM FLEX II Cannula).
- Adherence to internal A-Med Systems, Inc. performance specifications, which would be derived from engineering requirements, material standards, and clinical needs for such a device.
- This is not "expert consensus," "pathology," or "outcomes data" in the typical SaMD sense.
8. The sample size for the training set
- Not Applicable. This is a physical device, not a machine learning algorithm. There is no concept of a "training set" for manufacturing and testing a vascular cannula for regulatory submission in this context.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, this question is not relevant.
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