(262 days)
The Capiox® NX19 Oxygenator with Integrated Arterial Filter and UltraPrime™ Technology is intended to be used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of adult and small adult patients during cardiopulmonary bypass surgery.
The integrated arterial filter is intended to filter non-biologic particles and emboli and to facilitate air bubble removal from the blood flowing through the cardiopulmonary bypass circuit. The integrated heat exchanger is used to warm or cool blood and/or perfusion fluid as it flows through the device.
The hardshell reservoir is used to store blood during extra-corporeal circulation from the venous line and the cardiotomy line. The reservoir contains a venous section that is comprised of a filter and defoamer to facilitate air bubble removal. The cardiotomy section of the reservoir contains a filter to remove particulate matter and a defoamer to facilitate air bubble removal. The 4-liter reservoir may be used for Vacuum Assisted Drainage procedures and Post-Operative Chest Drainage Procedures.
The Capiox® NX19 Oxygenator with Integrated Arterial Filter and UltraPrime™ Technology is for use with patients when the required blood flow rate will not exceed 8.0 L/min.
The Capiox® NX19 Oxygenator with Integrated Arterial Filter and UltraPrime™ Technology can be used in procedures lasting up to 6 hours.
The Capiox® NX19 Oxygenator with Integrated Arterial Filter and UltraPrime™ Technology is a device used during cardiopulmonary bypass surgery. It includes an oxygenator that utilizes porous fiber technology for gas exchange, an integrated heat exchanger made of Polyethylene Terephthalate tubes for warming or cooling blood, an integrated arterial filter for removing particles and emboli, and a hardshell reservoir for storing blood. The reservoir has sections for venous and cardiotomy blood, each with filters and defoamers. The device is designed for blood flow rates up to 8.0 L/min and procedures lasting up to 6 hours.
The provided text describes the Terumo Capiox NX19 Oxygenator with Integrated Arterial Filter and the study performed to demonstrate its substantial equivalence to a predicate device (Capiox FX25 Advance Oxygenator) and a reference device (Sorin Inspire 8F Oxygenator).
Here's an analysis of the acceptance criteria and study details based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly present a direct side-by-side table of acceptance criteria and reported device performance values. Instead, it describes various performance evaluations conducted and states that the NX19's performance features are "deemed substantially equivalent" to the predicate and reference devices. The text indicates that the acceptance criteria for performance testing for the NX19 were set using the Sorin Inspire 8F as a reference device. It implies that the NX19 met these criteria to be considered substantially equivalent.
However, based on the text, we can infer the categories of performance for which criteria exist and that the device met these criteria:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Gas Transfer and Pressure Drop1 | Deemed "substantially equivalent" to predicate and reference devices. |
| Heat Exchanger Performance1 | Deemed "substantially equivalent" to predicate and reference devices. |
| Hemolysis Performance1 | Deemed "substantially equivalent" to predicate and reference devices. |
| Air Removal Performance1 | Deemed "substantially equivalent" to predicate and reference devices. |
| Capnography Assessment1 | Deemed "substantially equivalent" to predicate and reference devices. |
| Connection Strength of Ports1 | Deemed "substantially equivalent" to predicate and reference devices. |
| Filtration Efficiency1 | Deemed "substantially equivalent" to predicate and reference devices. |
| Mechanical Integrity1 | Deemed "substantially equivalent" to predicate and reference devices. |
| Luer Port Assessment1 | Deemed "substantially equivalent" to predicate and reference devices. |
| NX Blood Compatibility1 | Deemed "substantially equivalent" to predicate and reference devices. |
| For Reservoir (cleared in K151791) | |
| Air Handling2 | Supported by prior K151791 clearance; deemed "substantially equivalent." |
| Hemolysis2 | Supported by prior K151791 clearance; deemed "substantially equivalent." |
| Venous Defoaming2 | Supported by prior K151791 clearance; deemed "substantially equivalent." |
| Pressure Drop2 | Supported by prior K151791 clearance; deemed "substantially equivalent." |
| Clotting2 | Supported by prior K151791 clearance; deemed "substantially equivalent." |
| Connection Strength2 | Supported by prior K151791 clearance; deemed "substantially equivalent." |
Note 1: These tests were conducted on the NX19 Oxygenator.
Note 2: These tests were conducted on the reservoir and cleared with the predicate FX25 in K151791. The NX19 uses the exact same reservoir.
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the numerical sample sizes for each in-vitro performance test. It refers to these as "in-vitro performance evaluations." The data provenance is in-vitro testing conducted by Terumo Cardiovascular Systems Corporation. There is no mention of country of origin of the data for these specific tests, but the company is based in the US (Elkton, Maryland). The nature of "in-vitro" implies a controlled laboratory environment rather than retrospective or prospective patient data for these performance evaluations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The performance evaluations are in-vitro physical and functional tests, likely assessed against pre-defined engineering and performance specifications derived from the predicate and reference devices, rather than expert review of clinical data.
4. Adjudication method for the test set:
This information is not applicable/provided. For in-vitro performance tests, adjudication methods like 2+1 or 3+1 (typically used for clinical image review or diagnostic assessments) are not relevant. The assessment would involve comparing quantitative measurements against established criteria.
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:
This information is not applicable/provided. The device is an oxygenator and integrated components for cardiopulmonary bypass surgery, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study or evaluation of AI assistance for human readers is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable/provided. The device is a physical medical device (oxygenator, filter, heat exchanger, reservoir) and does not involve an algorithm or AI. The performance studies are for the device's physical functions.
7. The type of ground truth used:
The ground truth for the performance evaluations is based on established engineering and performance specifications derived from the legally marketed predicate device (Capiox FX25 Advance Oxygenator) and further informed by the reference device (Sorin Inspire 8F Oxygenator). The goal was to demonstrate "substantial equivalence" to these devices, meaning the NX19's performance met comparable levels.
8. The sample size for the training set:
This information is not applicable/provided. As a physical medical device, there is no "training set" in the context of machine learning or AI models. The device's design and manufacturing are based on engineering principles and material science.
9. How the ground truth for the training set was established:
This information is not applicable/provided for the same reason as point 8.
§ 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.”