(33 days)
The CAPIOX® RX25 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 extra-corporcal circulation from both venous line and the cardiotomy line (via gravity or vacuum assisted venous drainage nom over vollows internairs a venous section that is comprised of a filter and defoamer to procedured). The 1000 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® RX25 Oxygenator with/without Hardshell Reservoir can be used in proccdures lasting up to 6 hours.
The CAPIOX® RX25 is for use with patients when the required blood flow rate will not exceed 7.0 I /min.
The design of the CAPIOX® RX25 Hollow Fiber Oxygenator with/without Hardshell Reservoir is such that blood is collected into the reservoir via gravity or external vacuum. Blood may enter is such that brood is confect and/or the cardiotomy inlet port. The reservoir contains filtering devices to remove particulate matter and air. Blood is then pumped from the reservoir into the devices to remove partisance by blood temperature is controlled. After the blood exits the heat exchanger, it enters the oxygenator device whereby gas transfer (introduction of oxygen and removal of carbon dioxide) occurs. After gas transfer has occurred, the blood exits the device and is pumped towards the patient.
The provided text describes the Terumo CAPIOX® RX25 Hollow Fiber Oxygenator with/without Hardshell Reservoir, a medical device used during cardiopulmonary bypass surgery. It details the device's intended use, principles of operation, design, materials, and performance evaluations to demonstrate substantial equivalence to predicate devices.
Here's an analysis of the acceptance criteria and study aspects based on the given information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list acceptance criteria values. Instead, it states that performance evaluations were conducted and "no noted, product-related, clinically significant performance differences between the devices" were found when compared to predicate devices. This implies that the acceptance criteria were met by demonstrating similar performance to the already cleared predicate devices.
| Performance Evaluation Category | Reported Device Performance |
|---|---|
| Gas Transfer | No clinically significant differences compared to predicate devices. |
| Effects on Blood Components (Hemolysis) | No clinically significant differences compared to predicate devices. |
| Pressure Drop | No clinically significant differences compared to predicate devices. |
| Mechanical Integrity | No clinically significant differences compared to predicate devices. |
| Static Priming Volume | No clinically significant differences compared to predicate devices. |
| Heat Exchanger Performance | No clinically significant differences compared to predicate devices. |
| Defoaming | No clinically significant differences compared to predicate devices. |
| Filtration Efficiency | No clinically significant differences compared to predicate devices. |
| Flow Rate | No clinically significant differences compared to predicate devices. |
| Tubing Connection Strength | No clinically significant differences compared to predicate devices. |
| Biocompatibility | Blood contacting materials found to be biocompatible, consistent with ISO 10993. |
| Sterilization | Validated in accordance with AAMI guidelines to achieve a Sterility Assurance Level (SAL) of 10⁻⁶. Ethylene oxide residue limits met. |
| Polymer Coating (X-Coating) | Evaluated in an in-vivo animal study; no adverse conditions noted. |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "Clinical studies are not necessary to demonstrate substantial equivalence of the subject device to the predicate devices." Therefore, there is no specific test set sample size or data provenance (country of origin, retrospective/prospective) for clinical data provided. The evaluations were in-vitro performance evaluations, material characterizations, and a limited in-vivo animal study for the coating.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since no clinical studies were performed for the test set, there is no mention of experts establishing ground truth. The evaluations were primarily laboratory-based and compared to established performance of predicate devices.
4. Adjudication Method for the Test Set
As there was no clinical test set requiring human interpretation, no adjudication method is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The submission explicitly states that clinical studies were not necessary as substantial equivalence was demonstrated through in-vitro performance evaluations and comparison to predicate devices. Therefore, there is no effect size related to human reader improvement with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a mechanical oxygenator, not an AI-driven algorithm. The performance studies evaluated the physical and functional aspects of the device itself.
7. Type of Ground Truth Used
The "ground truth" for the device's performance was established through:
- In-vitro performance evaluations: Measurements of physical parameters (gas transfer, pressure drop, flow rate, etc.) under controlled laboratory conditions.
- Biocompatibility testing: Adherence to established standards (ISO 10993).
- Sterilization validation: Adherence to AAMI guidelines.
- Comparison to predicate device performance: The performance of the new device was deemed substantially equivalent if it did not show "clinically significant performance differences" from the established performance of the predicate devices.
- In-vivo animal study for coating: Directly observed outcomes in an animal model.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth established for it.
§ 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.”