(54 days)
The Affinity Pixie hollow fiber oxygenator with Balance biosurface is indicated for use for neonate, infant, and small pediatric patients undergoing cardiopulmonary bypass (CPB) procedures requiring a blood flow rate up to 2.0 L/min.
The Affinity Pixie hollow fiber oxygenator 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 CPB procedures up to 6 hours in duration.
The Affinity Pixie hollow fiber oxygenator and cardiotomy/venous reservoir with Balance biosurface are indicated for use for neonate, infant, and small pediatric patients undergoing cardiopulmonary bypass (CPB) procedures requiring a blood flow rate up to 2.0 L/min.
The Affinity Pixie hollow fiber oxygenator 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 CPB procedures up to 6 hours in duration.
The Affinity Pixie cardiotomy/ venous reservoir 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 Pixie hollow fiber oxygenator with Cortiva bioactive surface are indicated for use for neonate, infant, and small pediatric patients undergoing cardiopulmonary bypass (CPB) procedures requiring a blood flow rate up to 2.0 L/min.
The Affinity Pixie hollow fiber oxygenator 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 CPB procedures up to 6 hours in duration.
The Affinity Pixie hollow fiber oxygenator and cardiotomy/venous reservoir with Cortiva bioactive surface are indicated for use for neonate, infant, and small pediatric patients undergoing cardiopulmonary bypass (CPB) procedures requiring a blood flow rate up to 2.0 L/min.
The Affinity Pixie hollow fiber oxygenator 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 CPB procedures up to 6 hours in duration.
The Affinity Pixie cardiotomy/ venous reservoir 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 Pixie Oxygenators are microporous, hollow-fiber, gas-exchange devices available with Cortiva BioActive Surface or Balance Biosurface bonded blood contacting surface. The oxygenator is used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool and warm the blood during routine cardiopulmonary bypass procedures up to six (6) hours in duration. The oxygenator has a low prime volume which is appropriate for use in neonate, infant and small pediatric patients.
The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Cortiva BioActive Surface or Balance Biosurface is a single use device designed to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to six (6) hours in duration. Additionally, the Affinity Pixie 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. The CVR allows a lower operating volume which is appropriate for use in neonate, infant and small pediatric patients.
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.
The provided FDA 510(k) summary (K172984) is for Medtronic's Affinity Pixie Oxygenator devices and addresses a specific modification related to the use of hydrogen peroxide in the water path, rather than a clinical study evaluating the primary performance of the oxygenator itself or an AI-based device. Therefore, much of the requested information regarding acceptance criteria and performance as it relates to AI or human interpretation is not applicable here.
However, based on the document, I can extract information related to the device modification study:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria for "device performance" in terms of clinical outcomes or diagnostic accuracy. Instead, the study focuses on the material compatibility and structural integrity of the existing oxygenator when exposed to hydrogen peroxide. The "reported device performance" is that the device meets the requirements for continued function and safety under the new condition.
| Acceptance Criteria Category | Reported Device Performance (for the modified use) |
|---|---|
| Material Compatibility | Device materials (specifically the heat exchanger) demonstrated compatibility with hydrogen peroxide (330 ppm) without adverse effects. |
| Structural Integrity (Pressure) | The device maintained pressure integrity, burst strength, and port break strength after exposure to hydrogen peroxide. (Implied to meet pre-defined thresholds) |
| Toxicological Risk | Assessment concluded no toxicological risk associated with hydrogen peroxide exposure. (Implied to be below acceptable safety limits) |
| Heat Exchanger Permeability | Maintained required permeability characteristics after hydrogen peroxide exposure. (Implied to be within functional specifications) |
| Premarket Special Controls | Most special controls were deemed not applicable for this change, and applicable ones were addressed (e.g., material compatibility, structural integrity). |
| Substantial Equivalence | Demonstrated substantial equivalence to predicate devices under the new condition, confirming no change in intended use, operating principle, or fundamental characteristics. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the exact sample sizes (e.g., number of devices tested) for the material compatibility, structural integrity, toxicological risk assessment, or permeability testing. It refers to these as "testing and analysis performed." The provenance of the data is implied to be from Medtronic's own testing as part of their 510(k) submission (manufacturer-generated data), and it would be prospective in the sense that the tests were conducted specifically to evaluate this proposed change. There is no information regarding country of origin for the data within this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable. The study is a bench and laboratory-based engineering and materials assessment, not an AI or clinical study requiring expert ground truth for interpretation of diagnostic images or clinical outcomes. The "ground truth" here is the physical and chemical properties of the materials and device performance under specified test conditions, measured by instruments and analyzed by engineers and toxicologists.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable, as it's a bench testing study, not a clinical or AI performance study involving human interpretation or adjudication.
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
This is not applicable. The device is a cardiopulmonary bypass oxygenator, not a diagnostic AI system requiring MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is not an algorithm or AI device. The study described is bench testing of a medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the tests conducted:
- Material Compatibility, Structural Integrity, Heat Exchanger Permeability: The "ground truth" is established by direct physical and chemical measurements using standardized testing methods and engineering principles. For example, burst pressure is a direct measurement, and material degradation is assessed through chemical analysis or visual inspection.
- Toxicological Risk Assessment: The "ground truth" is established through scientific literature, established toxicology principles, and potential migration studies to determine patient exposure and compare it against toxicological thresholds.
8. The sample size for the training set
This is not applicable. The device is a physical medical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for this type of device.
§ 870.4350 Cardiopulmonary bypass oxygenator.
(a)
Identification. A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.”