(30 days)
The Hollow Fiber Membrane Oxygenator Quadrox Safeline is intended for use in an extracorporeal perfusion circuit to oxygenate blood and remove carbon dioxide and to temper blood during short duration cardiopulmonary bypass procedures lasting 6 hours or less.
The Jostra Hollow Fiber Oxyqenator Quadrox Safeline HMO 2030 is identical to the Jostra Hollow Fiber Oxygenator Safeline Quadrox HMO 1030 in design, intended use, method of operation, components, packaging, and fundamental scientific technology. The primary difference between the two devices is that the Jostra Hollow Fiber Oxygenator Quadrox Safeline HMO 2030 contains a heat exchanger fiber made of polyurethane (instead of polyethylene) which reduces the risk of electrostatic discharge for the patient significantly.
1. A table of acceptance criteria and the reported device performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Material Composition | Change in the heat exchanger fiber material from polyethylene to polyurethane. | The Jostra Hollow Fiber Oxygenator Quadrox Safeline HMO 2030 contains a heat exchanger fiber made of polyurethane. |
| Risk Reduction | The new material (polyurethane) should significantly reduce the risk of electrostatic discharge for the patient. | The change in heat exchanger fiber material to polyurethane "reduces the risk of electrostatic discharge for the patient significantly." |
| Functional Equivalence | The device should be identical to the predicate device (Jostra Hollow Fiber Oxygenator Safeline Quadrox HMO 1030) in design, intended use, method of operation, components, packaging, and fundamental scientific technology, with the exception of the heat exchanger fiber material. | The Jostra Hollow Fiber Oxyqenator Quadrox Safeline HMO 2030 is identical to the predicate device in design, intended use, method of operation, components, packaging, and fundamental scientific technology. |
| In-vitro Performance | In-vitro tests should demonstrate substantial equivalence to the predicate device. | In-vitro tests were performed to demonstrate substantial equivalence to the predicate device (K992559). |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size used for the test set beyond mentioning "In-vitro tests were performed." The data provenance is also not specified; however, given that the manufacturer is based in Germany (Jostra AG, Hirrlingen, Germany) and the submission is to the US FDA, it can be inferred that the testing would have been conducted by the manufacturer, likely in Germany, to meet international standards for device evaluation. The data is retrospective in the sense that it's based on tests conducted on the modified device to compare against an existing predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This submission concerns a device modification, focusing on material change and functional equivalence demonstrated through in-vitro tests, not diagnostic performance requiring expert interpretation of results. No expert adjudication of "ground truth" as typically understood in AI/imaging studies is relevant here.
4. Adjudication method for the test set
Not applicable. As this is not a study involving human interpretation of data for diagnostic purposes, no adjudication method was used.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No. This is not an MRMC comparative effectiveness study. This submission is for a modification to a medical device (oxygenator) and relies on in-vitro testing to show substantial equivalence to a predicate device, not on human reader performance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in a way. The "performance" of the device is evaluated in a standalone manner through in-vitro tests without human intervention in the device's operation or data interpretation during the test, beyond setting up the experiment and analyzing the results. The focus is on the device's physical and functional characteristics.
7. The type of ground truth used
The "ground truth" in this context is the predicate device's established performance and safety profile (Jostra Hollow Fiber Oxygenator Safeline Quadrox HMO 1030, K992559). The new device's performance is compared against the known and accepted performance of this predicate through physical and functional equivalence demonstrated by in-vitro testing. It's about demonstrating that the modified device performs effectively identically to the previously approved one, despite a material change.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning study, so there is no concept of a "training set" for an algorithm.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth establishment for it.
§ 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.”