(50 days)
Model 511:
The Affinity NT 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 (CPB) procedures up to 6 hours in duration.
Model 511T:
The Affinity NT Oxygenator with Trillium 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 (CPB) procedures up to 6 hours in duration.
The device listed in this 510(k) Notification is single use, non-toxic, non-pyrogenic, and is supplied sterile in packaging.
The Medtronic Affinity NT Oxygenator is a single use device designed to oxygenate and remove carbon dioxide from the blood and with the heat exchanger and arterial filter cools or warms the blood during extracorporeal circulation. The oxygenator has either a blood contacting Trillium™ Biosurface or is uncoated.
The Affinity NT 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.
Affinity NT Oxygenator is designed to be an integral part of the cardiopulmonary heart lung bypass circuit for use during cardiac surgery. Blood that comes from the patient is delivered through a blood pump to the oxygenator and other auxiliary devices, and then back to the patient.
The purpose of this 510(k) Notification is to notify the FDA of a labeling change to the disinfectant warning on the Instructions for Use to allow for disinfectant use in the water path of the oxygenator as well as report previous changes for the Affinity NT Oxygenator models included in this submission.
The request concerns a 510(k) submission for the Medtronic Affinity NT Oxygenator (Models 511 and 511T). This document is a regulatory notice granting 'substantial equivalence' and does not describe a study evaluating an AI/ML device or its performance against acceptance criteria in the manner requested (e.g., in terms of clinical performance, ground truth, expert consensus, MRMC studies, etc.).
The device is a cardiopulmonary bypass oxygenator, which is a physical medical device, not an AI/ML product. The performance data provided is related to its mechanical integrity and basic function rather than diagnostic or analytical performance.
Therefore, many of the requested fields are not applicable to this type of device and submission.
Here's the relevant information that can be extracted, and an explanation for why other fields are not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Pressure Integrity | Water path must withstand 45 PSI pressure for 6 hours without leaking | Pass |
| Burst | Water path burst testing should be comparable to that of control devices | Pass |
| Port Break | Water path break force shall be comparable to that of the control device | Pass |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided document for the mechanical tests.
- Data Provenance: Not specified. Testing was conducted internally by Medtronic. It is a pre-market submission, so the data is prospective relative to the submission but does not involve patient data in these physical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The ground truth for these physical tests is based on observable mechanical performance (e.g., does it leak, does it burst at a comparable pressure, does the port break at a comparable force) under controlled laboratory conditions, not expert interpretation of complex data.
4. Adjudication method for the test set:
- Not applicable. Results are objective pass/fail based on predetermined physical thresholds or comparison to a predicate device's physical thresholds.
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:
- Not applicable. This is not an AI/ML device, and no MRMC study was conducted or is relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used:
- The "ground truth" for the performance tests (Pressure Integrity, Burst, Port Break) is based on objective physical measurements and adherence to predefined engineering specifications or comparison to the physical properties of a predicate device.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML 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.”