(88 days)
The CAPIOX® RX05 Hollow Fiber Oxygenator with/without hardshell reservoir 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 integral heat exchanger is used to warm or cool blood and/or perfusion fluid as it flows through the device.
The (detachable) hardshell reservoir is used to store blood during extracorporeal circulation from both venous line and the cardiotomy line (via gravity or vacuum assisted venous drainage procedures). 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 CAPIOX® RX05 Oxygenator with/without hardshell reservoir can be used in procedures lasting up to 6 hours.
The CAPIOX® RX05 is for use with neonatal and infant patients when the required blood flow rate will not exceed 1.5 L/min.
The design of the CAPIOX® RX05 Hollow Fiber Oxygenator with/without Hardshell Reservoir provides a semi-integral device whereby the oxygenator and heat exchanger are joined together, while the hardshell reservoir can be detached from the device assembly.
The provided text describes a 510(k) submission for the CAPIOX® RX05 Hollow Fiber Oxygenator with/without Hardshell Reservoir. The document primarily focuses on establishing substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a study.
Therefore, the information requested in categories 1-9 is largely not present in the provided text, as it pertains to clinical performance and a type of study that was explicitly stated as "not necessary."
Here's a breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document states: "Clinical studies 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:"
| Acceptance Criteria (Inferred from Performance Evaluations) | Reported Device Performance |
|---|---|
| Gas Transfer | "no clinically significant performance differences between the devices" (compared to predicate) |
| Effects on Blood Components (Hemolysis) | "no clinically significant performance differences between the devices" (compared to predicate) |
| Pressure Drop | "no clinically significant performance differences between the devices" (compared to predicate) |
| Mechanical Integrity | "no clinically significant performance differences between the devices" (compared to predicate) |
| Static Priming Volume | "no clinically significant performance differences between the devices" (compared to predicate) |
| Heat Exchanger Performance | "no clinically significant performance differences between the devices" (compared to predicate) |
| Defoaming | "no clinically significant performance differences between the devices" (compared to predicate) |
| Filtration Efficiency | "no clinically significant performance differences between the devices" (compared to predicate) |
| Flow Rate | "no clinically significant performance differences between the devices" (compared to predicate) |
| Biocompatibility (ISO 10993) | "The blood contacting materials were found to be biocompatible." |
| Sterility Assurance Level (SAL) of 10-6 | "Sterilization conditions have been validated in accordance with AAMI guidelines to provide a Sterility Assurance Level (SAL) of 10-6." |
| Ethylene Oxide residues not exceeding limits | "Ethylene Oxide residues will not exceed the maximum residue limits proposed..." |
| Polymer coating material safety (in-vivo animal study) | "No adverse conditions were noted." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for the in-vitro performance evaluations.
- Data Provenance: The studies were in-vitro performance evaluations, with one "in-vivo animal study" for the polymer coating. The country of origin of the data is not explicitly stated for individual studies, but the submitter is Terumo Corporation (Ashitaka Factory, Fujinomiya City, Shizuoka Pref. Japan). The studies are retrospective as they summarize performed 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 applicable and not provided. The evaluations were in-vitro and comparisons to predicate devices, not requiring expert ground truth in the way described for AI/diagnostic devices.
4. Adjudication method for the test set:
Not applicable and not provided.
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:
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical studies are not necessary to demonstrate substantial equivalence of the subject device to the predicate devices."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
No, this device is not an algorithm, and the concept of "standalone performance" in this context (an oxygenator) is not directly applicable as it would be for an AI algorithm. Its performance is evaluated through its physical and biological interactions.
7. The type of ground truth used:
For the in-vitro performance evaluations, the "ground truth" would be established by the validated testing methodologies and standards for each performance characteristic (e.g., measuring gas transfer rates, hemolysis levels, pressure drops, etc.) and comparison to the predicate devices' known performance. For biocompatibility, it's adherence to ISO 10993. For sterilization, it's AAMI guidelines.
8. The sample size for the training set:
Not applicable and not provided. This device is not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established:
Not applicable and not provided.
§ 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.”