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510(k) Data Aggregation
(29 days)
Affinity Fusion Oxygenator System
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 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 six hours during cardiopulmonary bypass 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.
The Affinity Fusion oxygenator with integrated arterial filter and Cortiva bioactive surface 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 Cortiva bioactive surface 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 Oxygenator is intended to be used in an extracorporeal perfusion blood circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration. The Affinity Fusion Oxygenator contains both an integrated arterial filter and integrated heat exchanger. The Affinity Fusion Oxygenator is a microporous, hollow-fiber, gas-exchange devices available with Cortiva BioActive Surface or Balance Biosurface bonded to the blood contacting surface of the integrated arterial filter 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. Some models of the Affinity Fusion Oxygenator 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.
The provided text is a 510(k) Summary for the Medtronic Affinity Fusion Oxygenator System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance data for a novel device. Therefore, much of the requested information about a specific study proving the device meets acceptance criteria is not explicitly provided in this type of regulatory submission.
However, I can extract the relevant information that is available and clarify what is not present.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a table format for performance metrics relevant to an "AI system" or "medical device performance" in the general sense, as typically sought in such a request. Instead, it refers to "predetermined requirements" and "improved bond performance" for specific components.
The "performance" referred to in this document primarily relates to the device meeting its intended function as an oxygenator and arterial filter during cardiopulmonary bypass. The summary states that "Operation and performance qualification... were completed" and that "the manufacturing process consistently produces product that meets predetermined requirements."
| Aspect of Performance/Criteria | Reported Device Performance / Evaluation Outcome |
|---|---|
| Overall Performance | - "No newly emerging hazards or risks were identified." - "Modifications... result in a substantially equivalent device because the fundamental scientific principle, operating principle, design features and intended use are unchanged from the predicate device." |
| Manufacturing Process | "Consistently produces product that meets predetermined requirements under challenge and normal operating conditions." |
| Pressure Integrity | Evaluated as part of OQ/PQ. (Specific criteria/results not detailed) |
| Burst (Strength) | Evaluated as part of OQ/PQ. (Specific criteria/results not detailed) |
| Torque (TMA bond) | "Improved bond performance relative to the current material." |
| Insertion Depth (TMA) | Evaluated as part of OQ/PQ. (Specific criteria/results not detailed) |
| Biocompatibility | New material is "biocompatible per the ISO 10993 standard and does not require new biocompatibility testing." |
| TMA Seal (non-patient contacting) | "Verified through the part specifications, along with random sampling and statistical modeling." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of an AI/algorithm evaluation. For the physical device modifications, it mentions "random sampling and statistical modeling" for the TMA seal, but no specific sample sizes or data provenance (country, retrospective/prospective) are provided for these manufacturing/design evaluations.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable to the provided document. The submission pertains to modifications of a physical medical device (oxygenator) and its manufacturing process, not to an AI/algorithm that requires expert-established ground truth from a dataset.
4. Adjudication Method
This information is not applicable to the provided document, as it does not describe an AI/algorithm evaluation requiring adjudication of ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable to the provided document. The submission is for a physical medical device and does not involve AI assistance to human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable to the provided document. The submission is for a physical medical device and does not involve an AI algorithm.
7. Type of Ground Truth Used
This information is not applicable in the context of an AI/algorithm. For the physical device, the "ground truth" or verification is based on engineering specifications, performance testing (pressure integrity, burst, torque, insertion depth), and biocompatibility standards (ISO 10993).
8. Sample Size for the Training Set
This information is not applicable to the provided document, as it does not describe an AI/algorithm that would require a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable to the provided document, as it does not describe an AI/algorithm.
Summary of what the document does provide:
The document describes a 510(k) premarket notification for the Affinity Fusion Oxygenator System, which involves modifications to a legally marketed predicate device (K203111). The core of the submission is to demonstrate substantial equivalence to this predicate device.
The study presented is not a classic "clinical trial" or "AI validation study" but rather a series of engineering and qualification tests to ensure that the modifications (specifically, changes to the Temperature Monitoring Adapter (TMA) insert component material and insertion depth, and different bioactive surfaces) do not alter the fundamental performance, safety, or efficacy of the device.
Key points from the document regarding "proof" and "acceptance":
- Proof of Meeting Acceptance Criteria: The proof is based on "Operation and performance qualification (OQ/PQ)" and "Design Characterization" activities. These activities evaluate various physical properties and manufacturing consistency.
- Acceptance Criteria (Implied): The implied acceptance criteria are that the modified device's performance (e.g., pressure integrity, burst, torque, insertion depth, biocompatibility) meets internal predetermined requirements and does not introduce new hazards compared to the predicate device. For example, the TMA bond evaluation "indicated improved bond performance relative to the current material," suggesting a performance target was met or exceeded. Biocompatibility was accepted based on the new material already being used in another cleared device and conforming to ISO 10993.
- Study Design: The study is a non-clinical engineering and bench testing evaluation rather than a clinical trial or AI performance study. It's focused on validating the impact of specific component changes.
- Conclusion: The manufacturer concluded, and the FDA agreed by clearing the device, that these modifications maintain substantial equivalence to the predicate device, meaning it is as safe and effective as a device already on the market.
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(336 days)
Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System
The Affinity Fusion oxygenator with integrated arterial filter and Cortiva bioactive surface 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 Cortiva bioactive surface 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.
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 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 six hours during cardiopulmonary bypass 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.
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 Hollow Fiber Oxygenator with Balance Biosurface are indicated for use for neonate, infant, and small pediatric patients undergoing cardiopulmonary bypass 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 cardiopulmonary bypass 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 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 cardiopulmonary bypass 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 Fusion Oxygenator is intended to be used in an extracorporeal perfusion blood circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration. The Affinity Fusion Oxygenator contains both an integrated arterial filter and integrated heat exchanger. The Affinity Fusion Oxygenator is a microporous, hollow-fiber, gas-exchange devices available with Cortiva BioActive Surface or Balance Biosurface bonded to the blood contacting surface of the device. The integrated arterial filter 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. Some models of the Affinity Fusion Oxygenator 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.
The Affinity Pixie Oxygenator is intended to be used in an extracorporeal perfusion blood 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 Pixie hollow fiber oxygenator is a single-use, microporous, hollow-fiber, gas exchange device with plasma-resistant fiber and integrated heat exchanger. The primary blood-contacting surfaces of the oxygenator are coated with either Balance Biosurface or Cortiva BioActive Surface. Some models are packaged with an Affinity Pixie Cardiotomy/Venous Reservoir (CVR) which are designed to be an integral part of a cardiopulmonary bypass circuit for use during cardiac surgery. The Pixie CVR associated with the Balance or Cortiva coated Oxygenators are also Balance or Cortiva coated respectively. The Affinity Pixie CVR is 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. All are provided sterile, nonpyrogenic, and for single use.
I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML device. The document is a 510(k) premarket notification for a medical device (cardiopulmonary bypass oxygenators) and focuses on the device description, indications for use, and comparison to predicate devices, primarily regarding a material modification. It discusses the device's function (oxygenation, CO2 removal, temperature control, filtering emboli, blood collection) but does not include any performance metrics for AI or ML algorithms, sample sizes for test sets, expert ground truth adjudication, or comparative effectiveness studies involving AI. Therefore, I cannot generate the requested information based on the given input.
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