(35 days)
The Affinity Fusion Cardiotomy/Venous Reservoir with Baiance Biosurface is intended to be used in an extractivered perfusion circuit to collect venous and canioned blood during routine cardiopulmonary procedures up to 6 hours in duntion. 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 head surgery to collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement.
The Affinity Fusion® Cardiotomy/Venous Reservoir (CVR) 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 inside of the jar is coated with Balance Biosurface to reduce platelet activation and preserve platelet function.
This product is single-use, nontoxic, nonpyrogenic, supplied STERILE in individual packaging. The Affinity Fusion Cardiotomy/Venous Reservoir is sterilized by ethylene oxide.
Here's a breakdown of the acceptance criteria and study information for the Affinity Fusion® Cardiotomy/Venous Reservoir with Balance® Biosurface, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Acceptance Criteria (Implied by "Pass" result) | Reported Device Performance |
|---|---|---|
| Blood Damage Testing | Meet specified thresholds for blood damage | Pass |
| Defoaming | Effectively remove foam | Pass |
| Filtration Efficiency | Meet specified filtration standards | Pass |
| Cardiotomy Gaseous Microemboli | Remain below critical levels of microemboli | Pass |
| Dynamic Holdup | Maintain holdup within acceptable limits | Pass |
| Prime Breakthrough | Prevent prime breakthrough | Pass |
| Static Holdup | Maintain static holdup within acceptable limits | Pass |
| Volume Marking Accuracy | Accurate volume markings | Pass |
| Reservoir Capacity | Meet specified capacity | Pass |
| Particulate Count | Remain below specified particulate levels | Pass |
| Cytotoxicity | Non-cytotoxic | Pass |
| Hemocompatibility | Hemocompatible | Pass |
Explanation of Acceptance Criteria:
The document states that the device demonstrated "substantially equivalent" performance to the predicate device and that all tests "Passed." While the specific numerical acceptance criteria values are not explicitly detailed in this summary, the implication of the "Pass" result is that the device met pre-defined, acceptable thresholds for each performance metric, consistent with the predicate device and relevant special controls guidance.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each individual test. It states that "The following verification and validation testing has demonstrated that substantially equivalent to the predicate device."
- Data Provenance: The studies were conducted by Medtronic, Inc. as part of a 510(k) submission. The data is retrospective in the sense that it's being submitted for regulatory approval, but the studies themselves would have been prospective tests undertaken by the manufacturer during product development and validation. No country of origin for data collection is specified, but the applicant is Medtronic, Inc., a US-based company, and the submission is to the FDA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable and not provided. The device is a medical device (cardiotomy/venous reservoir), not an AI/software device that requires expert-established ground truth for its performance metrics (like diagnostic accuracy). The tests conducted are engineering and biocompatibility evaluations.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of data where consensus among experts is needed to establish ground truth for algorithm comparison. The studies for this device are laboratory/benchtop performance and biocompatibility tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This device is a physical medical device, and its performance is evaluated through engineering and biocompatibility tests, not human interpretation tasks.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This information is not applicable and not provided. This device is a physical product (a reservoir), not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply.
7. The Type of Ground Truth Used
The "ground truth" for the tests performed is based on:
- Pre-defined performance specifications and industry standards: For tests like
Blood Damage Testing,Defoaming,Filtration Efficiency,Gaseous Microemboli,Dynamic Holdup,Prime Breakthrough,Static Holdup,Volume Marking Accuracy,Reservoir Capacity, andParticulate Count. These would be established through engineering requirements, regulatory guidance (Special Controls Guidance Document), and comparison to the predicate device. - Biocompatibility standards: For
CytotoxicityandHemocompatibility, the ground truth is established by the criteria defined in ISO 10993-1.
8. The Sample Size for the Training Set
This information is not applicable and not provided. This device is a physical medical product, not a machine learning model. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided for the same reason as point 8.
§ 870.4400 Cardiopulmonary bypass blood reservoir.
(a)
Identification. A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.(b)
Classification. Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.