(90 days)
The CAPIOX® SX25 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 CAPIOX SX25 Hardshell Reservoir (detachable) is used to store blood during extracorporeal circulation from both the venous line and the cardiotomy line. The reservoir contains filters to remove particulate matter and defoamers to facilitate air bubble removal.
CAPIOX® SX25 Hollow Fiber Oxygenator contains an integrated heat exchanger and a detachable Hardshell Reservoir. This design permits an integrated system for ease of use as well as independent use of the oxyegnator and of the Hardshell reservoir to accommodate a variety of circuit configurations.
The SX25 oxygenator is a membrane oxygenator consisting of microporous hollow fibers with an integrated heat exchanger, consisting of stainless steel tubes.
The detachable Hardshell reservoir has a rotatable connection with the oxygenator which permits optimum positioning for connections in the circuit. The venous blood inlet port is also rotatable to permit minimizing tubing lengths which could result in lower circuit priming volumes.
The Hardshell reservoir contains a defoamer and a screen filter in the venous blood inlet section. The total capacity of the reservoir is 4,000 mL.
The cardiotomy section of the hardshell reservoir contains a defoamer and a cardiotomy filter to facilitate gas bubble removal and the removal of particulates/emboli from suctioned blood entering the reservoir.
A detachable sampling system is positioned at the top of the hardshell reservoir which contains 3 three-way stopcocks. These stopcocks can be used for sampling. The sampling system contains a one-way valve permitting withdrawal of liquid samples but prohibiting entry of air into the blood exiting the oxygenator.
Here's a breakdown of the acceptance criteria and study information for the CAPIOX® SX25 Hollow Fiber Oxygenator, based on the provided text:
Acceptance Criteria and Reported Device Performance
The submission demonstrates substantial equivalence primarily through comparison to the predicate device, the CAPIOX SX18. The acceptance criteria are largely implied by demonstrating that the SX25 meets or exceeds the performance of the SX18 for critical functions, or that differences do not raise new safety or effectiveness concerns.
| Acceptance Criteria Category | Specific Criteria (from SX18) / Performance Target | Reported Device Performance (SX25) |
|---|---|---|
| Intended Use | Same as SX18 | Same |
| Design and Materials | Same as SX18 (basic design & materials) | Same, but larger membrane surface area |
| Technology/Principles of Operation | Same as SX18 | Same |
| Gas Transfer | Equivalent or better than SX18 | Expected increase (due to larger surface area) |
| Effect on Blood Components | Substantially equivalent to SX18 | Substantially equivalent |
| Pressure Drop | Equivalent or better than SX18 (lower is better) | Expected decrease (due to larger surface area) |
| Priming Volume | Within clinically acceptable range | Slightly higher than SX18 (340 mL vs 270 mL), considered acceptable |
| Membrane Surface Area | Provides adequate gas exchange for clinical use | 2.5 m² (vs 1.8 m² for SX18) |
| Maximum Blood Flow Rate | 7 LPM (venous), 5 LPM (cardiotomy) | Same |
| Heat Exchanger Performance | Same as SX18 (K922799 reference) | Same |
| Hardshell Reservoir Performance | Same as SX18 (K922799 reference) | Same |
| Sterilization | SAL of 10⁻⁶ | Validated to provide SAL of 10⁻⁶ |
| Ethylene Oxide Residuals | Not exceed max residue limits (21 CFR Part 821) | Will not exceed limits |
| Manufacturing Control | 100% performance and leak testing | Includes 100% performance and leak testing |
| Blood Contacting Materials | Acceptable per FDA General Program Memorandum #G95-1 (ISO-10993) | Acceptable |
Study Information
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Sample size used for the test set and the data provenance:
- The document does not specify explicit sample sizes for the performance tests (Gas Transfer, Effect on Blood Components, Pressure Drop). It states "Comparison of the SX25 and SX18 performance was conducted."
- Data Provenance: Not specified, but likely laboratory testing conducted by the manufacturer, Terumo Medical Corporation. There is no indication of retrospective or prospective clinical data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This submission is a premarket notification (510(k)) primarily focused on bench testing and substantial equivalence to a predicate device. There is no mention of human-expert-established ground truth in the context of clinical observations or interpretations, which is typical for device performance assessments like gas transfer or blood compatibility. The "ground truth" here is the performance of the predicate device (SX18) as established in its own clearance, and the known physiological principles of oxygenation.
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Adjudication method for the test set:
- Not applicable as this is bench testing comparing objective performance parameters, not subjective expert assessment of medical images or conditions.
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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. This is not an AI/software device. It's a medical device for cardiopulmonary bypass.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable as this is not an AI/software device. The performance data presented are "standalone" in the sense that they are intrinsic device performance metrics (gas transfer, pressure drop, effect on blood components) determined through laboratory testing.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance characteristics (gas transfer, pressure drop, effect on blood components) is established by validated laboratory testing methods and engineering principles. The performance of the predicate device (SX18) serves as the primary reference point. For sterilization and materials, the ground truth is adherence to established regulatory standards (SAL, EO residuals, ISO-10993).
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The sample size for the training set:
- Not applicable. This is not a machine learning/AI device, so there is no concept of a "training set."
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How the ground truth for the training set was established:
- Not applicable for the same reason as above.
§ 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.”