(7 days)
The Apex Ph.I.S.I.O Adult Hollow Fiber Membrane Oxygenator is intended to be used in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours.
The Apex Ph.I.S.I.O Adult Hollow Fiber Membrane Oxygenator is a cardiopulmonary bypass blood oxygenator with an integral heat exchanger.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Apex Ph.I.S.I.O. Adult Hollow Fiber Membrane Oxygenator, formatted to address your specific questions.
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It does not contain a typical detailed clinical study report or a "device performance" section as one might find in a peer-reviewed publication or a PMA submission. Therefore, some of your requested information (e.g., specific performance metrics with numerical values, sample sizes for test/training sets, expert qualifications, and detailed ground truth establishment for AI/diagnostic devices) is not present in this type of regulatory document concerning a mechanical, non-AI device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (from predicate device standards) | Reported Device Performance (as demonstrated by predicate) |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1:1997 and FDA May 1, 1995 Memorandum for biocompatibility testing of raw materials. (Studies performed on devices aged to 2 years real-time equivalent.) | "The results of testing met established specifications." (Implied: The device is biocompatible according to its intended use, based on the D 903 Avant 2 Ph.I.S.I.O predicate device's performance, as the modification (coating) does not affect performance). |
| Sterility | Established specifications for sterility. | "Sterility... testing were also conducted. The results of testing met established specifications." "Additional testing has also demonstrated the effectiveness of production techniques to assure that Apex Ph.I.S.I.O. is sterile..." |
| Pyrogenicity | Established specifications for pyrogenicity. | "Pyrogenicity... testing were also conducted. The results of testing met established specifications." "...Additional testing has also demonstrated the effectiveness of production techniques to assure that Apex Ph.I.S.I.O. is... non-pyrogenic." |
| Ethylene Oxide (EO) Residuals | Established specifications for EO residuals. | "EO residuals... testing were also conducted. The results of testing met established specifications." |
| Package Integrity | Established specifications for package integrity. | "Package integrity testing were also conducted. The results of testing met established specifications." |
| In Vitro Performance | Compliance with ISO 7199 and the Guidance for Cardiopulmonary Bypass Oxygenators 510(k) submissions - Final Guidance for Industry and FDA Staff November 13, 2000. This includes: |
- Gas transfer characteristics
- Pressure drop
- Plasma leakage data
- Operating blood volume
- Heat exchanger performance evaluation
- Hemolysis/cell depletion
- Mechanical integrity
- Leaking/flaking test | "The D 903 Avant 2 Ph.I.S.I.O. Oxygenator was aged to 2 years and tested for gas transfer characteristics, pressure drop, plasma leakage data, operating blood volume, heat exchanger performance evaluation, hemolysis/cell depletion, mechanical integrity and leaking/flaking test. The results of these tests met established specifications. The modifications made to the Apex Ph.I.S.I.O. Oxygenator do not affect the performance of the device; therefore, the functional and biocompatibility parameters exhibited by D 903 Avant 2 Ph.I.S.I.O. apply to Apex Ph.I.S.I.O." (Performance for the predicate device, which is considered equivalent to the new device). |
Information Not Applicable to this Document Type / Not Provided:
The provided document is a 510(k) summary for a mechanical medical device (oxygenator), not an AI/diagnostic software. Therefore, the following AI-specific questions are not relevant and the information is not present:
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
- Adjudication method for the test set.
- If a multi-reader, multi-case (MRMC) comparative effectiveness study was done.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- The sample size for the training set.
- How the ground truth for the training set was established.
Study Design of the Device for Substantial Equivalence:
The core of the "study" for this 510(k) submission is to demonstrate substantial equivalence to an existing legally marketed device (predicate device).
The approach taken is:
- Identify Changes: The new device (Apex Ph.I.S.I.O. Adult Hollow Fiber Membrane Oxygenator) is "identical in design, operating principles and control mechanisms" to the predicate device (Apex Adult Hollow Fiber Membrane Oxygenator), with the only modification being the addition of a phosphorylcholine coating to all blood contact surfaces.
- Leverage Predicate Data: The phosphorylcholine coating itself is identical to one used on another predicate device (D 903 Avant 2 Ph.I.S.I.O. Adult Hollow Fiber Oxygenator).
- Prove Non-Inferiority/Equivalence of Coating: The claim is that "The modifications made to the Apex Ph.I.S.I.O. Oxygenator do not affect the performance of the device."
- Testing Strategy:
- Biocompatibility: Tests were carried out on the new device (accelerated aged to 2 years) to ensure the integrated system with the new coating met ISO 10993-1:1997 standards.
- Sterility, Pyrogenicity, EO Residuals, Package Integrity: These were conducted on the new device to ensure manufacturing processes were adequate.
- In Vitro Performance (Functional Testing): Instead of re-testing all functional parameters on the new Apex Ph.I.S.I.O. device, the document states that the D 903 Avant 2 Ph.I.S.I.O. Oxygenator (the predicate with the same coating) was tested for all key performance metrics (gas transfer, pressure drop, plasma leakage, blood volume, heat exchanger, hemolysis, mechanical integrity, leaking/flaking). The results of these tests on the D 903 Avant 2 Ph.I.S.I.O. were then deemed applicable to the Apex Ph.I.S.I.O. because the modifications in the Apex Ph.I.S.I.O. (the addition of the coating) were judged not to affect these performance parameters.
In essence, the study primarily relies on the existing performance data of two predicate devices and the demonstration that the minor change (the coating) in the new device does not negatively impact its safety and effectiveness, nor introduce new questions of safety or effectiveness.
§ 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.”