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510(k) Data Aggregation
(54 days)
The Affinity Fusion oxygenator with integrated arterial filter and Balance biosurface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration.
The Affinity Fusion oxygenator with integrated arterial filter and Balance biosurface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to 6 hours during CPB surgery.
The Affinity Fusion cardiotomy/venous reservoir with Balance biosurface is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to 6 hours in duration. The CVR is also intended for use during vacuum assisted venous drainage (VAVD) procedures.
The Affinity Fusion cardiotomy/venous reservoir with Balance biosurface is also intended for use after open heart surgery to collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement.
Affinity Fusion Oxygenators contain both an integrated arterial filter and integrated heat exchanger. These are microporous, hollow-fiber, gas-exchange devices available with Balance Biosurface or Cortiva BioActive Surface bonded to the blood contacting surfaces.
The Integrated Arterial Filter with Balance Biosurface or Cortiva BioActive Surface is designed to filter from the circuit microemboli larger than the specified micron size from the circuit for periods up to six hours during cardiopulmonary bypass surgery.
Additionally, some models are packaged with an Affinity Fusion Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface which is designed to be an integral part of a cardiopulmonary bypass circuit for use during cardiac surgery. The Affinity Fusion CVR is designed to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to six (6) hours in duration. Additionally, the Affinity Fusion CVR may be used during vacuum assisted venous drainage (VAVD) procedures and collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement during open heart surgery.
Affinity Fusion Oxygenators are designed to be an integral part of the cardiopulmonary heart bypass circuit for use during cardiac surgery. Blood that comes from the patient is delivered through a pump to the oxygenator and other auxiliary devices, and back to the patient.
The oxygenator can be connected to a heater/cooler device, recirculation circuit, cardioplegia circuit, and the main blood path. These connections are made with tubing connected to barbed or luer ports. The oxygenator is under constant fluid pressure. There is pressure exerted on the blood-side of the device from the blood pump and patient, the water-side of the device due to the flow of the heater-cooler for water, and the gas-side of the device due to the flow of gases through the device. The three compartments (blood-side, water-side and gas-side) must not leak into one another for the oxygenator to function properly.
The water-side of the oxygenator is connected to a heater/cooler device to enable temperature control of the blood. To prevent microbial growth within the heater/cooler, some manufacturers specify the addition of disinfectants to the heater/cooler water. During operation, the water path of the polyethylene terephthalate (PET) heat exchanger is exposed to these disinfectants.
The purpose of this 510(k) Notification is to notify the FDA of a change to allow for the use of hydrogen peroxide (330 ppm) in the water path of the oxygenator. There are no actual changes to the oxygenators.
This document is a 510(k) premarket notification for Medtronic's Affinity Fusion Oxygenators, specifically seeking to allow the use of hydrogen peroxide (330 ppm) in the water path of the oxygenator. The submission focuses on demonstrating that this change does not affect the substantial equivalence of the device to its predicates. Therefore, the information provided primarily addresses the impact of hydrogen peroxide exposure rather than the general performance characteristics of the oxygenator itself.
Here's an analysis of the provided information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance data in the typical sense of a clinical or analytical study for device efficacy. Instead, it describes specific tests performed to ensure the device's compatibility with the proposed disinfectant.
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Heat Exchanger Product Material Compatibility with Hydrogen Peroxide: The heat exchanger materials must remain compatible with hydrogen peroxide (330 ppm) without degradation or adverse effects. | Testing was conducted to verify that the chemical disinfectant has no adverse effects on the oxygenator water path. |
| Structural Integrity (pressure integrity, burst and port break tests): The device must maintain its structural integrity after exposure to hydrogen peroxide. | Structural Integrity Testing (pressure integrity, burst and port break tests) was performed. The conclusion states that the oxygenators remain substantially equivalent, implying these tests were passed. |
| Toxicological Risk Assessment for Hydrogen Peroxide: There should be no toxicological risk associated with the use of hydrogen peroxide at the specified concentration. | A Toxicological Risk Assessment for Hydrogen Peroxide was performed. The conclusion states that the oxygenators remain substantially equivalent, implying no unacceptable toxicological risk. |
| Heat Exchanger Permeability Testing: The heat exchanger should maintain its permeability characteristics after exposure to hydrogen peroxide, ensuring no leakage between compartments. | Heat Exchanger Permeability Testing was performed. The conclusion states that the oxygenators remain substantially equivalent, implying that permeability characteristics were maintained. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for the "test set" for each of the compatibility and integrity tests. It generally refers to "testing and analysis was performed." There is no mention of data provenance in terms of country of origin or if it's retrospective/prospective since these are laboratory/engineering tests, not clinical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to the type of testing described. The "ground truth" here is defined by engineering specifications and standards for material compatibility, structural integrity, and toxicology, not by expert consensus on clinical data.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical or image-based studies where expert consensus is needed. The described tests are based on objective physical and chemical measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. This type of study is relevant for evaluating diagnostic or therapeutic efficacy, typically involving human interpretation of data (e.g., medical images) with and without AI assistance. The current submission is for an oxygenator and its compatibility with a disinfectant.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No standalone algorithm performance study was mentioned. This is not relevant for the type of device and change being described.
7. Type of Ground Truth Used
The "ground truth" for the tests performed (material compatibility, structural integrity, permeability, toxicological assessment) would be based on:
- Engineering specifications and material properties.
- Established toxicological thresholds and risk assessment methodologies.
- Physical measurements and performance standards for medical devices.
8. Sample Size for the Training Set
This information is not applicable. The device is a physical product (oxygenator), not an AI algorithm that requires a training set. The tests performed are to confirm the physical and chemical properties of the device after a specific change in intended use.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for this device.
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