(89 days)
The Affinity Fusion Oxygenator with Integrated Arterial Filter and 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.
The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda BioActive Surface 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 Oxygenator with Integrated Arterial Filter and Carmeda BioActive Surface is a single-use, microporous, hollow-fiber, gas-exchange device with plasma-resistant fiber and integrated heat exchanger and arterial filter. The oxygenator is bonded on its primary blood contacting surfaces with a non-leaching biocompatible surface to reduce platelet activation and adhesion and preserve platelet function. The device is single-use, nontoxic, nonpyrogenic, supplied STERILE in individual packaging. The device is sterilized by ethylene oxide.
Here's an analysis of the provided information regarding the acceptance criteria and supporting studies for the Affinity Fusion Oxygenator.
The document indicates that the device is a Class II medical device, and its approval is based on substantial equivalence to a predicate device (Affinity NT Hollow Fiber Oxygenator with Plasma Resistant Fiber with Carmeda BioActive Surface Model CB511, K000430). The assessment does not involve AI or algorithms, as it is a physical medical device. Therefore, many of the typical questions for AI/ML device descriptions regarding training sets, validation sets, expert adjudication, and MRMC studies are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally established by the referenced standards and guidance documents. The document states that the device "passed each test mentioned in the table below." Specific numerical acceptance values are not provided within this summary, but the tests themselves represent the criteria.
| Test Title | Test Classification | Reported Device Performance |
|---|---|---|
| Oxygen and Carbon Dioxide Transfer | Functional/Performance | Passed |
| Time Dependent Performance Changes | Functional/Performance | Passed |
| Heat Exchanger Performance | Functional/Performance | Passed |
| High Flow Blood Trauma | Functional/Performance | Passed |
| Min Flow Blood Trauma | Functional/Performance | Passed |
| Plasma Breakthrough | Functional/Performance | Passed |
| Time to Prime | Functional/Performance | Passed |
| Gross Air Handling | Functional/Performance | Passed |
| Filtration Efficiency | Functional/Performance | Passed |
| Cap Pulls | Physical/Mechanical | Passed |
| Integrity | Physical/Mechanical | Passed |
| Blood Volumes | Physical/Mechanical | Passed |
| Port Break and Tube Pull | Physical/Mechanical | Passed |
| Luer port design - sampling port | Physical/Mechanical | Passed |
| Luer port design - air purge line | Physical/Mechanical | Passed |
| Carmeda Coverage/Leaching | Functional/Performance | Passed |
| Carmeda Bioactivity | Functional/Performance | Passed |
| Particulate Shedding | Functional/Performance | Passed |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable as the device is a physical medical device, not an AI/ML-based diagnostic or prognostic tool. The "test set" would refer to the physical units of the oxygenator that underwent in vitro testing. The document does not specify the number of units tested.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This is not applicable for a physical medical device. "Ground truth" in this context refers to established performance benchmarks for oxygenators, as outlined in the cited guidance documents and ISO standards. These standards are developed by consensus among experts in the field, but individual experts are not "establishing ground truth" for each test.
4. Adjudication Method for the Test Set
This is not applicable for a physical medical device. The evaluation is based on objective measurements against pre-defined performance specifications derived from standards and guidance documents.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not applicable to a physical medical device like an oxygenator.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical medical device and does not involve an algorithm. The performance evaluation is inherently "standalone" in the sense that the device's functional integrity and performance are tested in vitro.
7. The Type of Ground Truth Used
For this physical medical device, the "ground truth" for performance is established by:
- Standards: ISO 7199 "Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)" and ISO 15675 "Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters."
- FDA Guidance Documents: "Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions" and "Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions."
These documents define the performance parameters and acceptable ranges for such devices.
8. The Sample Size for the Training Set
This is not applicable as the device is a physical medical device, not an AI/ML system requiring a training set.
9. How the Ground Truth for the Training Set was Established
This is not applicable as the device is a physical medical 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.”