(343 days)
The CAPIOX Cardioplegia is cardiopulmonary bypass heat exchanger consisting of a heat exchange system used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device for periods up to 6 hours.
CAPIOX® Cardioplegia consists of heat exchanger pipes, filter screen, casing, ports, screw ring, O-ring and potting material. A thermistor probe is located on the blood outlet port which can be connected to temperature monitoring equipment. The water ports can be connected to 1/2" inner diameter water tube or coupler (e.g. Hansen-quick connect). This device provides high heat exchanger performance and air trapping function. Blood (or perfusion fluid) flows through the heat exchanger pipes and water flows outside the pipes. Blood (or perfusion fluid) flow is counter-current to the water flow.
The provided text describes a medical device, the CAPIOX® Cardioplegia, and its substantial equivalence to predicate devices, but does not contain information about a study proving the device meets acceptance criteria in the way typically required for AI/software-based medical devices. The document is a 510(k) submission for a hardware medical device (a heat exchanger) and focuses on comparing its specifications and performance to legally marketed predicate devices to demonstrate substantial equivalence, rather than establishing acceptance criteria and proving performance through a clinical or technical study against those criteria for a novel AI algorithm.
Therefore, many of the requested sections (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance, training set details) are not applicable to this type of device submission.
However, I can extract information related to "acceptance criteria" through the lens of device specifications and performance comparison, which served as the basis for its substantial equivalence determination.
Acceptance Criteria and Device Performance (Interpreted from Substantial Equivalence Information)
For this device, "acceptance criteria" are implicitly defined by the specifications and performance of the predicate devices (Sorin BCD Vanguard and Sarns Conducer). The CAPIOX® Cardioplegia is considered acceptable if its performance and specifications are found to be substantially equivalent and do not raise new safety or effectiveness concerns compared to these predicates.
Table 1: Key Specifications and Performance (CAPIOX® Cardioplegia vs. Predicate Devices)
| Characteristic | Acceptance Criterion (Predicate Range/Value) | Reported CAPIOX® Cardioplegia Performance |
|---|---|---|
| Intended Use | Used to cool or warm oxygenated blood, cardioplegic solution, or their mixture (Both Predicates) | Used to cool or warm oxygenated blood, cardioplegic solution, or their mixture |
| Priming volume (mL) | 15 - 335 (Sarns: 15, Sorin: 335) | $52 \pm 5$ |
| Maximum blood flow rate (mL/min) | 500 (Sorin Adult: 500) | 500 |
| Maximum operating pressure (mmHg) | 500 (Sorin: 500, Sarns: 600) | 500 |
| Filter material | Polyester (Sorin) | Polyester |
| Filter area (cm²) | 3.81 (Sorin) | $9.8 \pm 1.0$ |
| Pore size (um) | 105 (Sorin) | $96 \pm 10$ |
| Heat Exchanger Type | Pleated plate (Sorin), Bellows (Sarns) | Straight pipe |
| Heat Exchanger Material | Epoxy-coated Stainless steel (Sorin) | Stainless steel (SUS-304, 304L, 316, 316L) |
| Surface area (cm²) | 500 (Sorin) | $640 \pm 60$ |
| Blood inlet port | 1/4 inch (Both Predicates) | 1/4 inch |
| Blood outlet port | 3/16 inch (Sorin), 1/4 inch (Sarns) | 3/16 inch |
| Heat exchanger performance factor | Tbo-Tbi / Twi-Tbi (General formula applies to all) | Compared against Sorin BCD Vanguard |
| Water compartment pressure drop | Compared against Sarns Conducer | Compared against Sarns Conducer |
Conclusion of Study/Comparison: "In summary, some differences in performance were observed between the CAPIOX Cardioplegia and the Sorin BCD Vanguard, however, these differences are not clinically significant nor do they raise new issues of safety or effectiveness."
Information Not Applicable/Available for this Device Submission:
- Sample size used for the test set and the data provenance: Not applicable. This is a hardware medical device submission focused on substantial equivalence to predicate devices, not an AI/software device undergoing performance testing on a discrete test set with patient data. Performance was likely evaluated through bench testing and engineering comparisons rather than clinical trials with patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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: Not applicable. This is a hardware device, not an AI/software diagnostic or assistive tool for human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: For this device, the "ground truth" for comparison effectively relied on the established performance and safety profiles of the legally marketed predicate devices. Performance tests (e.g., heat exchange efficiency, pressure drop) were conducted against physical measurements and engineering specifications, not expert-derived labels on clinical data.
- The sample size for the training set: Not applicable. There is no AI/machine learning component to this device that would require a training set.
- How the ground truth for the training set was established: Not applicable.
§ 870.4240 Cardiopulmonary bypass heat exchanger.
(a)
Identification. A cardiopulmonary bypass heat exchanger is a device, consisting of a heat exchange system used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device.(b)
Classification. Class II (performance standards).