(28 days)
The APEX HP M 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 HP M Adult Hollow Fiber Membrane Oxygenator is a cardiopulmonary bypass blood oxygenator with an integral heat exchanger.
This document is a 510(k) summary for the APEX HP M Adult Hollow Fiber Membrane Oxygenator. It describes the device, its intended use, and the testing performed to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the provided information, focusing on acceptance criteria and supporting studies, while noting the limitations of what can be extracted directly from this specific document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list "acceptance criteria" for performance metrics in a quantitative manner (e.g., minimum oxygen transfer rate, maximum pressure drop). Instead, it states that the device is "identical in design, materials, operating principles and control mechanisms" to a predicate device (APEX HP M Ph.I.S.I.O. Adult Hollow Fiber Membrane Oxygenator), with the primary change being the lack of a coating material.
Therefore, the implicit acceptance criteria are that the APEX HP M performs substantially equivalently to the predicate device in all relevant functional parameters.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence in operating principles and control mechanisms to predicate device. | "The Apex HP M Adult Hollow Fiber Membrane Oxygenator is identical in design, materials, operating principles and control mechanisms to the Apex HP M Ph.I.S.I.O. Adult Hollow Fiber Membrane Oxygenator, unmodified device." |
| Functional parameters are equivalent to predicate device. | "The functional parameters exhibited by APEX HP M Ph.I.S.I.O. apply also to APEX HP M as no technical modifications were introduced into the device." |
| Biocompatibility according to intended use. | "Biocompatibility studies demonstrate that the device is biocompatible according to its intended use." (Cross-references data for predicate device #K014080 due to no new materials except coating removal). |
| Sterility and nonpyrogenicity. | "Additional testing has also demonstrated the effectiveness of production techniques to assure that APEX HP M is sterile and nonpyrogenic." |
| Package integrity. | Cross-references packaging data for unmodified device (#K083021) as packaging is unchanged. |
| Compliance with ISO 10993-1:1997 for biocompatibility. | "Applicable tests were carried out in accordance with the requirements of ISO 10993-1:1997 and the FDA May 1, 1995 Memorandum on the use of the ISO 10993 standard for biocompatibility testing of raw materials." |
| Met established specifications for all non-clinical tests (sterility, pyrogenicity, EO residuals, package integrity). | "The results of testing met established specifications." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size for any test sets.
The data provenance is not explicitly stated as country of origin, nor is it categorized as retrospective or prospective. However, based on the context of a 510(k) summary for a medical device, the "tests were performed on devices accelerated aged to an equivalent of three years real time aging," implying a laboratory-based, prospective testing scenario for the physical and biological characteristics of the device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable and therefore not provided in the document. This is a medical device (oxygenator) 510(k), not an AI/software device that requires expert-established ground truth for diagnostic or interpretative performance. The "ground truth" for this device relates to its physical performance, material safety, and sterility, which are evaluated through standardized laboratory tests and regulatory compliance.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or clinical endpoints that require consensus among experts, which is not the nature of the testing described for this device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable and therefore not provided. An MRMC study is relevant for evaluating the impact of an AI system on human reader performance, typically in diagnostic imaging. This document describes a physical medical device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable and therefore not provided. This device is an oxygenator, not a software algorithm. Its performance is inherent to its physical design and materials, not a standalone algorithm.
7. Type of Ground Truth Used
For this medical device, the "ground truth" for product safety and effectiveness is established through:
- Laboratory test results against established specifications: For functional parameters, sterility, pyrogenicity, EO residuals, and package integrity.
- Compliance with international standards: Specifically, ISO 10993-1:1997 for biocompatibility.
- Demonstrated substantial equivalence: To a predicate device that has already established safety and effectiveness.
8. Sample Size for the Training Set
This information is not applicable and therefore not provided. The development of this physical medical device does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and therefore not provided. As noted above, there is no "training set" for this type of 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.”