(302 days)
The Affinity™ Blood Pump System is intended to be used in an extracorporeal perfusion circuit to pump blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.
The AVECOR Cardiovascular Affinity Pump System consists of the Model 2000 Affinity Pump Console, Affinity Pump Rotor, Affinity Pump Holder, Affinity Pump Chamber, 5/8" Connecting Tube and an AVECOR venous reservoir with 5/8" outlet. The AVECOR Affinity Blood Pump Console and components' shall conform with all the applicable requirements of IEC 601, UL 544 and will display the European Community CE marking. The Affinity Pump Console, Model 2000 provides a system for controlling a variable speed pump motor and additional systems for monitoring flow rate, pump speed (RPM), pressure, timed events and battery status. The AVECOR Affinity Pump has been designed to operate on the principles of a peristaltic pump for extracorporeal use. The pump consists of a polyurethane chamber incorporating polycarbonate inlet and outlet connectors, which fills passively due to the filling pressure exhibited by the fluid height in a reservoir. The peristaltic action of the rollers against the filled pump chamber results in forward flow. Flow rate is affected by the combination of reservoir volume, RPM's of the pump rotor and the total circuit resistance.
This document describes the premarket notification (510(k)) for the AVECOR Affinity Blood Pump System, establishing its substantial equivalence to the Stockert Instrumente (Sorin) Pump System.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criterion for the Affinity Blood Pump System was substantial equivalence in performance to the Stockert Instrumente (Sorin) Pump System. This was assessed across various aspects, particularly focusing on blood trauma.
| Acceptance Criteria (Implicit: Substantial Equivalence to Predicate Device) | Reported Device Performance (Affinity Blood Pump System) |
|---|---|
| In Vitro Operating Characteristics | Found substantially equivalent through testing (specific results not detailed in this summary, but referenced in Section III of the full application). |
| In Vitro Cellular Damage | Found substantially equivalent through testing (specific results not detailed in this summary, but referenced in Section III of the full application). |
| Material Biocompatibility | Found substantially equivalent through testing (specific results not detailed in this summary, but referenced in Section IV of the full application). |
| Sterility | Found substantially equivalent through testing (specific results not detailed in this summary, but referenced in Section V of the full application). |
| Pyrogenicity | Found substantially equivalent through testing (specific results not detailed in this summary, but referenced in Section V of the full application). |
| Sterilant Residuals | Found substantially equivalent through testing (specific results not detailed in this summary, but referenced in Section V of the full application). |
| Software Validation & Verification | Found substantially equivalent through testing (specific results not detailed in this summary, but referenced in Appendix E of the full application). |
| Blood Trauma (Hemolysis, Platelet and White Cell Response) | "Blood trauma testing shows that in all aspects evaluated (hemolysis, platelet and white cell response) the Affinity Blood Pump System and the Stockert Instrumente (Sorin) Pump System are equivalent." |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the sample sizes for the various tests (In Vitro Operating Characteristics, In Vitro Cellular Damage, etc.) used to establish equivalence. It refers to these details being in other sections/appendices of the 510(k) application.
The data provenance is retrospective, as the tests were conducted by AVECOR to compare their new device against an existing, already marketed predicate device. The country of origin of the data is implicitly the USA, as AVECOR Cardiovascular Inc. is based in Minnesota, and the application is to the US FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information is not applicable in this context. The "ground truth" for a medical device's performance in a 510(k) submission for substantial equivalence is typically established by comparing its performance to a predicate device, as opposed to expert consensus on clinical outcomes or diagnoses. The "truth" is whether the new device performs acceptably and similarly to the predicate. The FDA acts as the ultimate arbiter by reviewing the provided data.
4. Adjudication Method for the Test Set
This type of information is not applicable. Adjudication methods (like 2+1, 3+1) are common in clinical trials involving expert interpretation of medical images or diagnoses. In this 510(k) submission, the "adjudication" is essentially the review process by the FDA based on the technical and performance data submitted by AVECOR, comparing it against the predicate 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, an MRMC comparative effectiveness study was not done. This device is a blood pump system, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to a mechanical blood pump system. The device itself operates, and its performance is measured directly, not as an algorithm's output for human interpretation.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this substantial equivalence determination is the established performance characteristics of the predicate device (Stockert Instrumente (Sorin) Pump System). The new device's performance (e.g., blood trauma, operating characteristics) was tested and compared against the known performance of the predicate. This is a direct comparative performance evaluation against an already approved device.
8. The Sample Size for the Training Set
This information is not applicable. This is not a machine learning or AI-based device that would require training data. The "training" for such a mechanical device involves engineering design, material selection, and iterative physical testing and refinement, not data-driven model training.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reasons as #8.
§ 870.4220 Cardiopulmonary bypass heart-lung machine console.
(a)
Identification. A cardiopulmonary bypass heart-lung machine console is a device that consists of a control panel and the electrical power and control circuitry for a heart-lung machine. The console is designed to interface with the basic units used in a gas exchange system, including the pumps, oxygenator, and heat exchanger.(b)
Classification. Class II (performance standards).