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510(k) Data Aggregation
(72 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 utilizes porous fiber technology to facilitate the transfer of gases between a blood-phase environment and a gas-phase environment for the intent of satisfying the gas exchange needs of a patient during cardiopulmonary bypass surgery. A fiber bundle offers the porous membrane surface to sufficiently permit the movement of gases through the walls of the hollow fibers via diffusion.
The Capiox® NX19 Oxygenator device has an integrated heat exchanger that is comprised of Polyethylene Terephthalate tubes arranged in a cylindrical shape. The circulating blood contacts the exterior surface of these tubes. Temperature-controlled water distributed from an external water bath fills the interior of the tubes. The heat exchanger material permits heat transfer to occur across the walls of the heat exchanger tubes to achieve the necessary temperature of the circulating blood.
The Capiox® NX19 Oxygenator device can be operated at flow rates up to 8 liters per minute (1/min) and at a minimum flow rate of 2.0 liters per minute (1/min) or 0.5 liters per minute (1/min) for up to 2 hours.
The integrated arterial filter of the Capiox® NX19 Oxygenator device relies upon mechanical entrapment of particulates and emboli within the filter mesh as a means to remove those particulates from the blood.
The Capiox® NX19 Oxygenator device also includes a 4-liter hardshell reservoir used to store blood during extra-corporeal circulation from the venous line and the cardiotomy line. The reservoir contains a venous section with a filter and defoamer and a cardiotomy section with a filter and defoamer.
This document describes the premarket notification (510(k)) for the Terumo Capiox NX19 Oxygenator with Integrated Arterial Filter and other components, seeking to demonstrate its substantial equivalence to a predicate device. This is NOT a study proving the device meets acceptance criteria in the context of an AI/ML medical device, but rather an FDA submission for a traditional medical device (oxygenator) based on non-clinical performance testing and comparison to a predicate device.
Therefore, I cannot fulfill the request to provide information regarding acceptance criteria and a study proving device performance as if it were an AI/ML medical device submission, as the provided text pertains to a traditional medical device submission. The concepts of "test set," "ground truth," "expert adjudication," "MRMC studies," "human readers improve with AI," and "standalone algorithm performance" are not applicable here.
However, I can extract the acceptance criteria and performance data for the physical medical device based on the provided text, reinterpreting "acceptance criteria" as the performance benchmarks established by comparison to predicate/reference devices.
Re-interpretation of Acceptance Criteria and Performance for the Terumo Capiox NX19 Oxygenator:
The document states that Terumo conducted in-vitro performance evaluations to demonstrate substantial equivalence to the predicate Capiox FX25 Advance Oxygenator. The acceptance criteria essentially infer that the performance of the NX19 must be "substantially equivalent" to or better than the predicate and reference devices for various functional parameters.
Here's a breakdown of what can be inferred, framed as closely as possible to the requested structure, though with caveats for the fundamental difference in device type:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Inferred from Predicate/Reference) | Reported Device Performance (NX19) |
|---|---|---|
| Gas Transfer and Pressure Drop | Substantially equivalent to predicate Capiox FX25 Advance Oxygenator and reference devices (Sorin Inspire 8F, Terumo Capiox NX19 K172071). | "Similar gas exchange performance can be achieved with a lower blood volume." "The Capiox® NX19 Oxygenator device can be operated at flow rates up to 8 liters per minute (l/min) and at a minimum flow rate of 2.0 liters per minute (l/min) or 0.5 liters per minute (l/min) for up to 2 hours." (Specific quantitative values are not provided in this summary, but the claim is for substantial equivalence). |
| Heat Exchanger Performance | Substantially equivalent to predicate Capiox FX25 Advance Oxygenator and reference devices. | "This increased surface area [of 0.43m² in NX19 vs 0.2m² in FX25] ensures that adequate (equivalent) heat exchange is achieved." (Claim of equivalence despite material/surface area difference). |
| Hemolysis Performance | Substantially equivalent to predicate Capiox FX25 Advance Oxygenator and reference devices. | Testing conducted. (Specific quantitative results not provided in this summary, but general statement of performance: "The Terumo Cardiovascular Systems Corporation Capiox® NX19 Oxygenator exhibits performance features that are deemed "substantially equivalent" to the predicate Capiox® FX25 Advance Oxygenator - K151791.") |
| Air Removal Performance | Substantially equivalent to predicate Capiox FX25 Advance Oxygenator and reference devices. | NX19 utilizes pre-HE microporous fiber, oxygenator microporous fiber, and a purge port; predicate relies on oxygenator microporous fiber and purge port. (Implied improved or equivalent performance). |
| Capnography Assessment | Substantially equivalent to predicate Capiox FX25 Advance Oxygenator and reference devices. | Testing conducted. (Specific quantitative results not provided). |
| Connection Strength of Ports | Substantially equivalent to predicate Capiox FX25 Advance Oxygenator and reference devices. Also, reservoir testing from K151791. | Testing conducted. (Specific quantitative results not provided). |
| Filtration Efficiency | Substantially equivalent to predicate Capiox FX25 Advance Oxygenator and reference devices. | The integrated arterial filter relies on "mechanical entrapment of particulates and emboli within the filter mesh." Testing conducted. (Specific quantitative results not provided). |
| Mechanical Integrity | Substantially equivalent to predicate Capiox FX25 Advance Oxygenator and reference devices. | Testing conducted. (Specific quantitative results not provided). |
| Luer Port Assessment | Substantially equivalent to predicate Capiox FX25 Advance Oxygenator and reference devices. | Testing conducted. (Specific quantitative results not provided). |
| NX Blood Compatibility | Biocompatible, per ISO 10993 (External Communicating Devices, Circulating Blood, Limited Exposure ≤ 24 hours). | Blood contacting materials found to be biocompatible. |
| Sterility | Sterility Assurance Level (SAL) of 10⁻⁶. | Sterilization conditions validated to provide SAL of 10⁻⁶. Ethylene oxide residues will not exceed maximum limits. |
| Reservoir Testing (Air Handling) | Supported by testing from predicate K151791, as it's the exact same reservoir. | Testing presented in K151791 and Appendix D. |
| Reservoir Testing (Hemolysis) | Supported by testing from predicate K151791, as it's the exact same reservoir. | Testing presented in K151791 and Appendix D. |
| Reservoir Testing (Venous Defoaming) | Supported by testing from predicate K151791, as it's the exact same reservoir. | Testing presented in K151791 and Appendix D. "The reservoir contains a venous section that is comprised of a filter and defoamer to facilitate air bubble removal." |
| Reservoir Testing (Pressure Drop) | Supported by testing from predicate K151791, as it's the exact same reservoir. | Testing presented in K151791 and Appendix D. |
| Reservoir Testing (Clotting) | Supported by testing from predicate K151791, as it's the exact same reservoir. | Testing presented in K151791 and Appendix D. |
| Reservoir Testing (Connection Strength) | Supported by testing from predicate K151791, as it's the exact same reservoir. | Testing presented in K151791 and Appendix D. |
| Priming Volume | Lower than predicate (260mL for FX25). | 185mL, which is lower than predicate FX25 (260mL). Reduces amount of blood removed and hemodilution. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as "sample size" in the context of an AI test set. The document refers to "in-vitro performance evaluations" and "verification testing." The number of units tested for each in-vitro evaluation (e.g., how many oxygenators were subjected to gas transfer tests, hemolysis, etc.) is not detailed in this summary.
- Data Provenance: The studies were in-vitro performance evaluations conducted by Terumo Cardiovascular Systems. They are not clinical studies involving patients. The provenance is internal company testing to demonstrate substantial equivalence to legally marketed predicate devices. It is a prospective set of tests designed for this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This is not applicable to this type of traditional medical device submission. Ground truth, in the AI/ML sense, is not established by human experts reviewing data for the device's performance. The "ground truth" for these physical tests is typically the measured physical performance against engineering specifications or established performance of the predicate device.
4. Adjudication Method for the Test Set
- Not applicable. There is no "adjudication" in the sense of reconciling expert opinions for test set ground truth as would be found in an AI/ML study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. This type of study is relevant for AI/ML diagnostic devices where human readers (clinicians) interact with the AI. This is a physical oxygenator. The document explicitly states: "Clinical studies involving patients are not necessary to demonstrate substantial equivalence of the subject device to the predicate device."
6. If a Standalone (i.e. Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. This concept pertains directly to AI/ML algorithms, not a physical medical device like an oxygenator. The "standalone performance" is the device's measured in-vitro performance.
7. The Type of Ground Truth Used
- The "ground truth" for the performance comparison is the established performance characteristics of the legally marketed predicate device (Capiox FX25 Advance Oxygenator - K151791) and other reference devices (Sorin Inspire 8F Oxygenator - K121536, and Terumo Capiox NX19 - K172071).
- These are based on previously accepted engineering and performance specifications and in-vitro testing results for those devices.
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI/ML algorithm that is "trained" on data. It is a manufactured physical product.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. There is no "training set" or "ground truth" establishment in the context of machine learning for this device. The design and materials are based on engineering principles and knowledge of the predicate device.
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