(13 days)
The Capiox FX Hollow Fiber Oxygenator and Arterial Filter is intended to be used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during cardiopulmonary bypass surgery.
The integrated arterial filter is intended to filtrate 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 3-liter and 4-liter reservoirs may be used for Vacuum Assisted Drainage procedures and Post Operative Chest Drainage Procedures.
The Capiox FX15 is for use with patients when the required blood flow rate will not exceed 5.0 L/min. when used with a 4 Liter Reservoir; and when the required blood flow rate will not exceed 4.0 L/min. when used with a 3 Liter Reservoir.
The Capiox FX25 is for use with patients when the required blood flow rate will not exceed 7.0 L/min.
The Capiox FX Oxygenator/Reservoir/Arterial Filter assemblies can be used in procedures lasting up to 6 hours.
The modified Capiox® FX15 and FX25 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 modified Capiox® FX15 and FX25 device has an integrated heat exchanger that is comprised of stainless steel encased in a polycarbonate housing. The stainless steel acts as a heat transfer material that permits heat that is generated from a temperature controlled external water bath to transverse across the walls of the stainless steel to effect the necessary temperature change upon circulating blood.
With respect to the filtration of arterial blood, the modified Capiox® FX15 and FX25 Oxygenator/Reservoir relies upon mechanical entrapment of particulates and emboli within the filter mesh as a means to remove those particulates from the blood.
The subject of this Special 510(k) is a modification being made to the detachable Hardshell Reservoir. The design of the Hardshell Reservoir component remains identical to the design of the original reservoir that was cleared by FDA with K071494 -- except that a positive pressure relief valve will be included on the lid of the reservoir.
The materials that are used in the construction of the Capiox® FX15 and FX25 Oxygenator/Reservoir, but are not limited to, nylon, polycarbonate, stainless steel, polyvinyl chloride, polyurethane, polyester, polypropylene, polyethylene terephthalate, polyethylene and X-Coating™. The positive pressure relief valve that is included with the modified reservoir is constructed of polycarbonate and nylon.
The provided text describes a 510(k) summary for modifications to the Capiox® FX15 and FX25 Oxygenator/Reservoir. This document is a regulatory submission for medical devices, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed scientific study with specific acceptance criteria, experimental results, and statistical analyses typically found in research papers.
Therefore, many of the requested elements (like sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and detailed ground truth data for training sets) are not applicable or extractable from this type of regulatory document.
Here's an attempt to answer the questions based only on the provided text, indicating where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes "Performance Evaluations" as a demonstration of "substantial equivalence" to the predicate device, implying that the modified device should perform comparably to the original. Explicit numerical acceptance criteria are not detailed, but the evaluations are qualitative in nature to confirm the safety and effectiveness of the modification (the pressure relief valve).
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Pressure Relief Valve-to-Reservoir Interface Testing | The modification ensures the relief valve functions correctly at its interface with the reservoir. |
| Relief Valve performance following application of vacuum to the reservoir | The relief valve performs as intended when vacuum is applied to the reservoir. |
| Assessment of reservoir pressure during simulated bypass procedure at flow rates of 1, 2, 3, 4 and 5 liters per minute | The relief valve effectively manages reservoir pressure during simulated bypass procedures at various flow rates (1-5 L/min), preventing excessive pressure accumulation. |
| Sterilization Assessment | Sterilization conditions have been validated to provide a Sterility Assurance Level (SAL) of 10^-6. Ethylene oxide residues will not exceed maximum residue limits. Biocompatibility studies conducted per ISO 10993 found blood-contacting materials to be biocompatible. |
| Drop Testing | Not explicitly detailed, but implied to show the device maintains integrity after drops. |
| Vibration Testing | Not explicitly detailed, but implied to show the device maintains integrity after vibration. |
| Overall Performance Equivalence | The modified Capiox® FX15 and FX25 device exhibits equivalent performance to the unmodified predicate device, with "no changes made to the finished device that would alter the performance of the device" beyond the addition of the relief valve. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size (Test Set): Not specified. The performance evaluations are described as "in-vitro," implying laboratory testing, but the number of units tested is not provided.
- Data Provenance: The studies are described as "in-vitro performance evaluations," which are laboratory tests. The manufacturer is Terumo Corporation (Ashitaka Factory) in Fujinomiya City, Shizuoka Pref., Japan, suggesting the testing likely occurred in-house or by a contracted lab in Japan. The nature of the tests (e.g., pressure, sterilization) would be considered prospective for the specific purpose of this submission.
- Retrospective or Prospective: Prospective, as these evaluations were conducted to support the 510(k) submission for the device modification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Number of Experts: Not applicable. These were in-vitro engineering and performance tests, not clinical studies requiring expert interpretation of patient data to establish "ground truth."
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable. This refers to consensus methods for expert interpretation of data, which is not relevant for in-vitro engineering tests.
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:
- MRMC Study: No, an MRMC study was not done. This device is an oxygenator/reservoir, not an AI-powered diagnostic tool, so such a study would not be relevant.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Performance: Not applicable. This device is not an algorithm or AI system; it's a medical hardware device. The performance evaluations assess the device's physical and functional properties, which is its "standalone" performance in a laboratory setting.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: For the in-vitro performance evaluations, the "ground truth" would be established engineering specifications, validated test methods, and industry standards for medical device performance (e.g., pressure measurements, sterility levels, biocompatibility standards).
8. The sample size for the training set:
- Sample Size (Training Set): Not applicable. This is not an AI/machine learning device that requires a training set. The device's design and materials are based on established engineering principles and prior validated devices.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of device. The "ground truth" for the device's design and manufacturing is based on established medical device standards and the performance of its 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.”