(9 days)
The CAPIOX® RX Hollow Fiber Oxygenators with/without Hardshell Reservoir are 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(s) is (are) used to store blood during extra-corporeal 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 reservoir may also be used for Post Operative Chest Drainage Procedures.
The CAPIOX® RX Oxygenators with/without Hardshell Reservoirs can be used in procedures lasting up to 6 hours.
The CAPIOX® RX15 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® RX25 is for use with patients when the required blood flow rate will not exceed 70 L/min.
The design of the Capiox RX Hollow Fiber Oxygenator/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 materials that are used in the construction of the Capiox RX Hollow Fiber Oxygenator/ Reservoir includes, but are not limited to, polycarbonate, stainless steel, polyviny] chloride, polyurethane, polyester, polypropylene, polyethylene and X-Coating™.
Here's a summary of the acceptance criteria and study information for the Capiox RX Hollow Fiber Oxygenator/Reservoir, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The submission states that "The comparisons demonstrated that there are no clinically significant performance differences between the devices" when comparing the new Capiox RX device to predicate devices. While specific numerical acceptance criteria and reported performance metrics are not explicitly detailed in a table format in the provided text, the document indicates performance evaluations were conducted for the following aspects:
| Acceptance Criteria (Evaluated against predicate devices) | Reported Device Performance (Implied) |
|---|---|
| Gas Transfer | No clinically significant performance differences |
| Effects on Blood Components (Hemolysis) | No clinically significant performance differences |
| Pressure Drop | No clinically significant performance differences |
| Mechanical Integrity | No clinically significant performance differences |
| Static Priming Volume | No clinically significant performance differences |
| Heat Exchanger Performance | No clinically significant performance differences |
| Defoaming | No clinically significant performance differences |
| Filtration Efficiency | No clinically significant performance differences |
| Flow Rate | No clinically significant performance differences |
| Tubing Connection Strength | No clinically significant performance differences |
| Biocompatibility (ISO 10993) | Blood contacting materials found to be biocompatible |
| Sterility Assurance Level (SAL) | 10⁻⁶ (validated per AAMI guidelines) |
| Ethylene Oxide Residues | Will not exceed maximum residue limits |
| X-Coating Safety and Effectiveness (In-vivo animal study) | Well documented for being safe and effective; no adverse conditions noted in animal study |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in the provided text for each performance evaluation.
- Data Provenance: The studies were in-vitro performance evaluations. No information is given regarding the country of origin, but as it's a submission to the FDA, it's presumed to be conducted by the manufacturer, Terumo Cardiovascular Systems Corporation. The studies are not described as retrospective or prospective clinical studies, but rather laboratory-based performance tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This information is not applicable to this type of submission. The performance evaluations are in-vitro studies comparing the device to predicate devices, not studies requiring expert interpretation of medical images or data from human subjects for ground truth establishment.
4. Adjudication Method for the Test Set
- This information is not applicable. The performance evaluations are in-vitro studies that do not involve adjudication by experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "Clinical studies involving patients are not necessary to demonstrate substantial equivalence of the subject device to the predicate devices." The evaluations performed were in-vitro.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- This information is not applicable. The device is a medical device (oxygenator/reservoir), not an AI algorithm. The performance evaluations were conducted on the physical device's characteristics and function.
7. Type of Ground Truth Used
- The "ground truth" for the performance evaluations (e.g., Gas Transfer, Hemolysis, Pressure Drop) would likely be established scientific and engineering principles, industry standards, and the validated performance characteristics of the predicate devices. The goal was to demonstrate that the new device performed "without clinically significant differences" compared to these established benchmarks and predicate devices. For biocompatibility, ISO 10993 standards served as the ground truth.
8. Sample Size for the Training Set
- This information is not applicable. There is no mention of a "training set" as this device is a physical medical device, not an AI model requiring machine learning training.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable 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.”