(149 days)
The Affinity NT Hollow Fiber Oxygenator with Plasma Resistant Fiber 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.
Model CB511:
The Affinity NT Hollow Fiber Oxygenator with Plasma Resistant Fiber with Carmeda 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 procedures up to 6 hours in duration.
Model 511T:
The Affinity NT Hollow Fiber Oxygenator with Plasma Resistant Fiber with Trillium Biosurface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.
The Medtronic Affinity NT Hollow Fiber Oxygenator is a single use gas exchange device with plasma resistant fiber. It is designed to have the blood flow outside the fiber and includes an integral heat exchanger. The oxygenator is available uncoated or bonded on its blood contacting surfaces with either Carmeda BioActive Surface or Trillium Biosurface. The device is single-use, nontoxic, nonpyrogenic, and supplied sterile for clinical use.
Here's an analysis of the acceptance criteria and study information for the Affinity NT Oxygenator based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Biocompatible according to ISO 10993-1, externally communicating, circulating blood contact, limited duration | Pass |
| Positive Pressure Integrity Testing | Maintains appropriate seal on the device, no leaks | Pass |
| Gas Transfer (Oxygen and Carbon Dioxide) | Transfers gas to specification | Pass |
| Pressure Drop (Blood and Gas) | Meets pressure drop requirements | Pass |
| Plasma Breakthrough | Meets Plasma Breakthrough requirements | Pass |
| Blood Trauma (Hemolysis, Platelets, WBC) | Meets Blood Trauma requirements | Pass |
| Pressure Integrity | Meets Pressure Integrity requirements | Pass |
| Heat Exchanger Performance | Meets heat exchanger efficiency requirements | Pass |
| Coating Testing | Meets coating requirements | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for each specific bench test performed. It refers to "bench testing" and "real-time aging testing" but does not quantify the number of devices or data points used for these tests.
- Data Provenance: The studies were conducted internally by Medtronic ("Bench testing was used to verify the performance characteristics of this device. In addition, real-time aging testing for devices incorporating the previously implemented changes was completed..."). The country of origin is not specified, but the submitter (Medtronic) is based in Minneapolis, Minnesota, USA. The testing is retrospective in the sense that it's performed on manufactured devices to demonstrate compliance, not prospective clinical trials.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not applicable as the document describes bench testing of a medical device (an oxygenator) rather than a diagnostic AI algorithm that requires expert-established ground truth from medical images or patient data. The "ground truth" for these tests would be the established engineering specifications and performance standards for oxygenators.
4. Adjudication Method for the Test Set
This information is not applicable for the same reason as point 3. Bench testing results are typically objectively measured against predefined specifications, not subject to human adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
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. The Affinity NT Oxygenator is a physical medical device, not an AI software.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone performance evaluation of an algorithm was not done. This device is not an AI algorithm. The performance evaluation presented is for the physical device itself.
7. The Type of Ground Truth Used
The ground truth used for these performance tests is engineering specifications and established performance requirements for cardiopulmonary bypass oxygenators. For example, "Demonstrates the devices transfer gas to specification" implies a predefined target range or minimum for gas transfer efficiency. Similarly, "Demonstrates the devices meet Plasma Breakthrough requirements" refers to conforming to a pre-established threshold for plasma leakage.
8. The Sample Size for the Training Set
This information 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 information is not applicable for the same reason as point 8.
§ 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.”