(122 days)
The CentriMag™ Pre-connected Pack is indicated for use with the CentriMag™ Acute Circulatory Support System to provide physiologic gas exchange of the blood and to pump a patient's blood through an extracorporeal circuit for periods lasting less than six (6) hours for the purpose of providing either:
(i) Full or partial cardiopulmonary bypass during open surgical procedures on the heart or great vessels; or
(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory necessary for open surgical procedures on the aorta or vena cava.
CentriMag Pre-connected Pack is to be used with the CentriMag™ Acute Circulatory Support System components (console, motor, flow probe and monitor) to provide extracorporeal circulation for full or partial cardiopulmonary bypass support for less than 6 hours. The CentriMag™ Pre-connected Pack contains sterile disposable components: a blood pump, oxygenator, and priming bag pre-connected by tubing. The pack also includes disposable accessories commonly used in the setup of pump and oxygenator connections to the cardiopulmonary bypass extracorporeal circuit.
Several types of performance testing were conducted to demonstrate the substantial equivalence of the CentriMag Pre-connected Pack. Unfortunately, the provided document does not contain all the information requested. Here's a breakdown of what information is available and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Gas Exchange (oxygen and carbon dioxide transfer) | Not specified in the document | Not specified in the document |
| Blood Pathway Pressure Drop | Not specified in the document | Not specified in the document |
| In vitro Hemolysis | Not specified in the document | Not specified in the document |
| Blood, Gas, and Water Pathway Integrity | Not specified in the document | Not specified in the document |
| Heat Exchange Efficiency and Water Pathway Pressure Drop | Not specified in the document | Not specified in the document |
| Usable Life (Reliability) | Not specified in the document | Not specified in the document |
| Functionality and Integrity of Accessories | Not specified in the document | Not specified in the document |
| Shelf Life Testing | Not specified in the document | Not specified in the document |
| Validation of EtO Sterilization | Not specified in the document | Not specified in the document |
| Packaging Testing | Not specified in the document | Not specified in the document |
| Biocompatibility (Genotoxicity, Hemocompatibility, Cytotoxicity, Implantation, Sensitization, Irritation, Systemic Toxicity, Particulate Matter, Volatile Organic Compounds) | Meets requirements for external communicating medical device with limited (≤ 24 hour) circulating blood contact per ISO 10993-1. | Results meet the requirements for external communicating medical device with limited (≤ 24 hour) circulating blood contact. (Specific performance details not provided) |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for any of the performance tests. It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective nature of the data). All tests appear to be laboratory-based performance tests, not clinical studies involving patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the tests described are performance tests of a medical device's physical and functional characteristics, not studies that require expert interpretation of patient data to establish ground truth.
4. Adjudication method for the test set
This information is not applicable for the same reason as point 3.
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
An MRMC study was not conducted. This document describes the performance testing of a physical medical device (CentriMag Pre-connected Pack), not an AI-assisted diagnostic or interpretative system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable as an algorithm or AI system is not the subject of this 510(k) submission.
7. The type of ground truth used
For the performance tests, the "ground truth" would be the established engineering and medical standards for device performance, as referenced by the "Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions Final Guidance for Industry and FDA Staff" and ISO 10993-1 for biocompatibility. The tests aim to demonstrate that the device meets these pre-defined physical, chemical, and biological requirements.
8. The sample size for the training set
This information is not applicable as this is not an AI or machine learning device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as this is not an AI or machine learning device that requires a training set.
Summary of the Study:
The studies conducted for the CentriMag Pre-connected Pack were a series of performance tests in accordance with FDA guidance and international standards for cardiopulmonary bypass oxygenators and biocompatibility. These tests aimed to demonstrate the device's integrity, durability, and functionality, as well as its biological safety. The document explicitly states that "No animal studies or clinical studies are required." The performance testing and comparative testing with reference devices (Rotaflow Centrifugal Pump, Quadrox-iD Adult Oxygenator, HLM Tubing Set, CentriMag Acute Circulatory Support System, Eurosets PMP Sterile Oxygenator) were used to demonstrate substantial equivalence to the predicate device, the OXY-1 System (K200109). The conclusion is that the CentriMag Pre-connected Pack is substantially equivalent as the technological characteristics and performance testing do not raise different questions of safety and effectiveness compared to the predicate 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.”