Search Results

The Capiox FX05 device is intended to be used during open heart surgical procedures to transfer oxygen and remove carbon dioxide from blood and to control the blood temperature during cardiopulmonary bypass for periods up to 6 hours. The Capiox FX05 is a Neonate/Infant oxygenator intended for use in procedures up to a maximum flow of 1.5 L/min. The patient weight and BSA should be considered upon use.

The FX05 Hardshell Reservoir is also intended for use in vacuum assisted venous drainage procedures.

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 Capiox FX05 device is a modification of the Capiox RX05 device that has an arterial filter integrated into the design. The design of the oxygenator device is such that it utilizes an integrated oxygenator/heat exchanger module that provides for gas transfer (blood oxygenation and carbon dioxide removal) and for blood temperature control. The RX Oxygenator/Arterial Filter device also utilizes a hardshell reservoir that is used to collect and store blood during a cardiopulmonary bypass procedure. The arterial filter contained within the oxygenator module is comprised of 32 micron PET (polyethylene terephalate) mesh material that is wrapped around the outer circumference of the oxygenator fiber bundle.

The provided document describes the Capiox® FX05 Hollow Fiber Oxygenator and Arterial Filter, a medical device intended for use during open heart surgical procedures. The submission is a 510(k) premarket notification, which means it aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than establishing completely new safety and effectiveness. As such, the "study" described is a series of in-vitro performance evaluations comparing the new device to its predicates.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with specific numerical targets. Instead, it states that the device "exhibited performance that is deemed to be substantially equivalent to the performance of the predicate devices." This substantial equivalence is based on a series of in-vitro tests where the new device's performance was compared to the established performance of the predicate devices. The implicit acceptance criterion is that the new device's performance on these tests is comparable to or better than the predicate devices, and that any differences do not raise new issues of safety or effectiveness.

2. Sample size used for the test set and the data provenance

The document explicitly states: "Clinical studies involving patients are not necessary to demonstrate substantial equivalence of the subject device to the predicate devices. Substantial equivalence is demonstrated with the following in-vitro performance evaluations."

• Sample Size for Test Set: Not specified. The document repeatedly refers to "in-vitro performance evaluations" and "testing" without providing numerical sample sizes for each test (e.g., how many units were tested for pressure drop, or how many blood samples were used for hemolysis).
• Data Provenance: In-vitro laboratory testing (likely conducted by Terumo Corporation or its designated testing facilities). The country of origin for the manufacturing and submission is Japan/USA, but the specific location of the in-vitro testing is not detailed. The data is prospective in the sense that these tests were conducted specifically for this submission to demonstrate equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable to this type of submission. The "ground truth" for mechanical and performance characteristics of medical devices is typically established through adherence to recognized international standards and scientifically validated test methods, rather than expert consensus on a test set. The predicate devices themselves represent the "ground truth" for comparison in a 510(k) process, as they are already legally marketed and presumed safe and effective.

4. Adjudication method for the test set

Not applicable. Device performance against technical specifications and predicate device performance is typically determined through direct measurement and comparison, not adjudication by human experts in the context of this 510(k) submission.

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

Not applicable. This device is a physical medical device (an oxygenator and filter), not an AI-powered diagnostic or decision support system. Therefore, MRMC studies and AI-assisted human reader performance are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical device, not an algorithm.

7. The type of ground truth used

For the in-vitro performance evaluations, the "ground truth" is established by:

• Predicate Device Performance: The primary "ground truth" for comparison is the documented and accepted performance characteristics of the predicate devices (Terumo's Capiox® RX05 Oxygenator/Reservoir K022115 and Terumo's Capiox® AF02X Arterial Filter K011804). The new device must perform comparably to these established devices.
• Accepted Industry Standards: Implied adherence to relevant industry standards for medical device testing (e.g., for blood compatibility, mechanical integrity, gas exchange efficiency).
• Biocompatibility Standards: Biocompatibility evaluation was done according to ISO 10993 guidelines, implying this standard serves as the ground truth for safety in this aspect.

8. The sample size for the training set

Not applicable. As this is a physical medical device and not an AI/ML algorithm, there is no "training set."

9. How the ground truth for the training set was established

Not applicable. Since there is no training set, there is no ground truth for it.

Ask a specific question about this device