(54 days)
The CAPIOX® Flexible Venous is intended for use as a blood collection and storage device during cardiopulmonary bypass procedures. The device is intended for use in conjunction with blood-gas oxygenators in the extra-corporeal circuit.
The device may be used in procedures lasting up to 6 hours in duration.
The design of the CAPIOX® Flexible Venous Reservoir is one of a soft-shell casing that serves as a blood containment system within the bypass circuit.
The device is designed such that it contains a forked blood inlet port (Y-Connector) that will allow the entry of cardiotomy and venous blood. On the opposing side of the bag along its base edge - is a blood outlet port, which allows for the blood's exit from the bag.
The top edge of the bag is characterized by a dual three-way stopcock assembly that is intended to facilitate the purging of air that could be contained within the stored blood. Additionally, the stopcock assembly may be used for the administration of drugs and/or necessary solutions used in bypass procedures.
A mesh filter is sealed to the inside of the bag, and is intended to facilitate the destruction of air bolus' that may be contained within the patient's blood.
The generic materials used in the CAPIOX® Flexible Venous Reservoir are polyvinyl chloride, polycarbonate, polyethylene, polyester, stainless steel, ABS, cyclohexanone and Terumo's X-CoatingTM polymer solution.
Here's a breakdown of the acceptance criteria and study information for the CAPIOX® Flexible Venous Reservoir, based on the provided 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly define "acceptance criteria" with specific numerical thresholds as one might expect in a typical performance study. Instead, the performance evaluations were conducted to demonstrate substantial equivalence to the predicate device. Therefore, the "acceptance criteria" are implied to be "performance comparable to the predicate device."
| Performance Evaluation Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Effects Upon Cellular Blood Components | Comparable to predicate device. | Studies conducted to demonstrate equivalence. |
| Pressure Drop | Comparable to predicate device. | Studies conducted to demonstrate equivalence. |
| Air Handling Capability | Comparable to predicate device. | Studies conducted to demonstrate equivalence. |
| Prime Volume Evaluation | Comparable to predicate device. | Studies conducted to demonstrate equivalence. |
| Connector Pull Strength Evaluation | Comparable to predicate device. | Studies conducted to demonstrate equivalence. |
| Mechanical Integrity | Comparable to predicate device. | Studies conducted to demonstrate equivalence. |
| Leaching/Extraction (of X-Coating) | Acceptable levels, demonstrating safety. | Studies conducted to demonstrate safety. |
| Biocompatibility | Satisfy all biocompatibility test specifications (ISO 10993). | Found to satisfy all biocompatibility test specifications. |
| Platelet Adhesion | Acceptable, demonstrating safety and effectiveness. | Studies conducted to demonstrate safety and effectiveness. |
| Sterilization Assurance Level (SAL) | 10⁻⁶ | Validated in accordance with applicable guidelines. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (e.g., number of devices, number of blood samples, number of tests) used for each of the performance evaluations. It generally states "exhaustive in-vitro studies."
The data provenance is in-vitro studies. The country of origin of the data is not explicitly stated. Given that Terumo Cardiovascular Systems is the submitter and their address is in Elkton, MD, USA, it's highly probable the studies were conducted in the USA or by a Terumo affiliate. The studies are prospective in the sense that they were designed and conducted specifically to evaluate the CAPIOX® device against the predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The "ground truth" for this medical device submission is based on engineering and biological performance metrics (e.g., pressure measurements, blood cell counts, physical strength tests, biocompatibility assays), not on expert clinical interpretation of data like images or patient outcomes.
4. Adjudication Method for the Test Set
This is not applicable as the evaluations are objective performance tests rather than subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices that involve human interpretation of medical images or data. The CAPIOX® Flexible Venous Reservoir is a therapeutic/support device used in cardiopulmonary bypass, and its evaluation focuses on its physical and biological performance characteristics, not on human reader performance.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable in the context of the CAPIOX® Flexible Venous Reservoir. This device does not involve an algorithm or AI. All performance evaluations can be considered "standalone" in that they assess the device's inherent characteristics and performance without human intervention during operation, but this is not analogous to "algorithm only" studies in AI.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluations consists of objective, measurable physical and biological parameters established through standardized testing methods, in comparison to the performance of a legally marketed predicate device. This includes:
- Measurement of cellular blood component integrity.
- Quantification of pressure drop.
- Assessment of air handling capacity.
- Measurement of priming volume.
- Measurement of connector pull strength.
- Evaluation of mechanical integrity.
- Results from validated leaching/extraction and biocompatibility studies (e.g., ISO 10993 standards).
- Assessment of platelet adhesion.
8. The Sample Size for the Training Set
This is not applicable. The CAPIOX® Flexible Venous Reservoir is a physical medical device, not a machine learning model. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for this device.
§ 870.4400 Cardiopulmonary bypass blood reservoir.
(a)
Identification. A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.(b)
Classification. Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.