(89 days)
The CAPIOX® E Hollow Fiber Oxygenator is 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 the blood or perfusion fluid flowing through the device. The reservoir is used to store blood and the defoamer facilitates air removal. The device is intended for use during extracorporeal circulation for up to 6 hours.
CAPIOX® E Hollow Fiber Oxygenator contains an integrated heat exchanger. The CAPIOX E oxygenator is a membrane oxygenator consisting of microporous polypropylene hollow fibers. Blood flows external to the hollow fibers while gases flow inside the fibers. The heat exchanger consists of stainless steel pipes with blood flowing outside the pipes and water flowing inside the pipes. A thermistor probe is located near the blood ports of the oxygenator which can be connected to accessory temperature monitoring equipment if desired. The device also contains an arterial reservoir with a defoamer which facilitates removal of air.
Here's a breakdown of the acceptance criteria and study information for the CAPIOX® E Hollow Fiber Oxygenator based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document establishes substantial equivalence by comparing the CAPIOX® E (the new device) to the CAPIOX® SX18 (the predicate device). The "acceptance criteria" are implicitly the specifications and performance characteristics of the predicate device, which the new device must meet or be sufficiently similar to, without raising new issues of safety or effectiveness.
| Specifications / Performance Metric | Acceptance Criteria (CAPIOX® SX18) | Reported Device Performance (CAPIOX® E) |
|---|---|---|
| Intended Use (Oxygenator) | Used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of patients during open heart surgery for up to 6 hours | Used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of patients during open heart surgery for up to 6 hours |
| Membrane technology | Hollow Fiber | Hollow Fiber |
| Membrane material | Polypropylene | Polypropylene |
| Blood flow relative to fiber | Outside | Outside |
| Effective surface area of oxygenator | 1.8 m2 | 3.0 m2 |
| Heat exchanger | Integrated | Integrated |
| Heat Exch. Material | Stainless steel tubes | Stainless steel tubes |
| Heat Exch. Max. water Pressure | 42 PSI | 42 PSI |
| Blood Flow relative to Heat Exchanger Pipes | Inside | Outside |
| Blood Flow Path | Reservoir-> Pump-> HE -> Oxygenator-> Patient | HE-> Oxygenator-> Reservoir-> Pump -> Patient |
| Blood Flow Rate (Oxygenator) | 0.5-7 LPM | 0.5-6.5 LPM |
| Static Priming Volume (Oxygenator and heat exchanger) | 270 mL (oxygenator and heat exchanger) | 800 mL (with 300 mL of priming solution in arterial reservoir) |
| Hardshell Reservoir | Detachable | Integrated |
| Maximum Gas Flow | 20 LPM | 20 LPM |
| Blood Port | Blood Inlet port: 3/8", Blood Outlet port: 3/8" | Blood Inlet/Outlet port: 1/2" |
| Female Luer Port | 1 port (air purge port) | (Not specified for oxygenator, but 2 to inside filter for reservoir) |
| Gas Port | Gas inlet and outlet ports: 1/4" | Gas inlet and outlet ports: 1/4" |
| Water Port | Water inlet and outlet ports: 1/2" (Hansen quick connect fittings) | Water inlet and outlet ports: 1/2" (Hansen quick connect fittings) |
| Cardiotomy Port | --- | 3/8" |
| Intended Use (Reservoir) | To temporarily store blood, facilitate filtration of particulates and air removal from venous return and suctioned blood during cardiopulmonary bypass for up to 6 hours | To temporarily store blood, facilitate air removal from venous return during cardiopulmonary bypass for up to 6 hours |
| Venous blood inlet (Reservoir) | 1/2" rotatable | --- |
| Suction (Reservoir) | 1/4" X 6 | --- |
| Blood Outlet (Reservoir) | 3/8" | 3/8" |
| Vertical port to filter (Reservoir) | 3/8" | --- |
| Quick prime & vent port (Reservoir) | 1/4" | 1/4" |
| Female Luer (Reservoir) | 4 to inside filter, 1 to outside filter, 2 on venous blood inlet | 2 to inside filter |
| Auxiliary (Reservoir) | 3/8" | --- |
| Maximum Reservoir Volume | 4,000 mL | 3,500 mL |
| Minimum Reservoir Volume | 200 mL | 300 mL |
| Maximum blood flow rate (Reservoir) | Cardiotomy inlet: 5 LPM, Venous flow: 7 LPM, Combined: 7 LPM | 6.5 LPM |
| Antifoam component | Polyurethane foam defoamer | Polyurethane foam defoamer |
| Thermistor probe | Luer thermistor on venous blood inlet | Luer thermistor on venous blood inlet and arterial blood outlet |
| Overall Performance | Adequate gas exchange for clinical use (implicit via predicate) | "The test results indicated the CAPIOX E performs in a substantially equivalent manner to the CAPIOX SX18." and "both provide adequate gas exchange for clinical use." |
2. Sample size used for the test set and the data provenance:
- The document states "Comparison of the CAPIOX E oxygenator with integrated heat exchanger and the CAPIOX SX18 oxygenator with integrated heat exchanger performance was conducted." However, it does not specify the sample size for this performance testing.
- Data provenance is not explicitly mentioned. The testing appears to be internal device performance testing, rather than human clinical trial data from a specific country or in a retrospective/prospective manner. It is laboratory or bench testing data.
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 to this type of device submission. The "ground truth" for oxygenator performance is established by direct measurement of physical and chemical parameters (e.g., gas exchange rates, pressure drops, heat exchange efficiency) in a laboratory setting, not by expert consensus or interpretation of images/data by human experts.
4. Adjudication method for the test set:
- Not applicable. As the "ground truth" is derived from direct measurements, there's no need for human adjudication of results.
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. This type of study is relevant for AI-powered diagnostic/interpretive devices where human performance is being evaluated. This submission is for a physical medical device (an oxygenator) and does not involve AI or human "readers."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device does not have an "algorithm only" component. It is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance evaluation of the CAPIOX E, as inferred from the context of oxygenator testing, is based on direct physical and chemical measurements obtained under controlled laboratory conditions, simulating physiological parameters. These measurements likely included parameters such as oxygen transfer rate, carbon dioxide removal rate, pressure drop, blood flow rates, heat exchange efficiency, and priming volume.
8. The sample size for the training set:
- Not applicable. This submission is for a physical medical device and does not involve machine learning algorithms that require a "training set."
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set for an algorithm, this question is irrelevant.
§ 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.”