(81 days)
The bubble trap is intended for use in an extracorporeal circulation system during a cardiopulmonary bypass within the framework of surgical intervention. Within the specified flow rate limits, the bubble trap separates macroscopic air bubbles from the venous line, eliminating them through the deaeration line and out of the extracorporeal circulation, and by doing so supports the perfusionist's obligation to exercise due caution. The product must not be used for more than 6 hours at a time. The physician in charge of treatment must make all decisions concerning use of the venous bubble trap.
The Venous Bubble Trap is a sterile and non-pyrogenic device, for single use only and is not to be re-sterilized by the user. The device is sterilized with Ethylene Oxide. The bubble trap is intended for use in an extracorporeal circulation system during a cardiopulmonary bypass within the framework of surgical intervention. Within the specified flow rate limits, the bubble trap separates macroscopic air bubbles from the venous line, eliminating them through the deaeration line and out of the extracorporeal circulation. The device is to be used for up to 6 hours.
The provided text describes a 510(k) submission for the "Venous Bubble Trap with and without Bioline Coating." The study described is a non-clinical study focused on demonstrating substantial equivalence to predicate devices, rather than a clinical trial with specific performance metrics against an acceptance criterion in the way modern AI/ML device studies are conducted.
Here's a breakdown based on the provided information, noting where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from device-specific performance tests) | Reported Device Performance |
|---|---|
| Integrity | Tested, deemed substantially equivalent |
| Performance | Tested, deemed substantially equivalent (separates macroscopic air bubbles from venous line within specified flow rates) |
| Stability of the Coating | Tested, deemed substantially equivalent (same as cleared Quadrox D Diffusion Membrane Oxygenator with Bioline Coating) |
| Biocompatibility | Tested, deemed substantially equivalent |
| Sterility | Tested, deemed substantially equivalent |
Note: The document states that "Testing and evaluation on safety and effectiveness was executed to demonstrate that the Venous Bubble Trap with and without Bioline Coating described in this submission is substantially equivalent to the Capiox Bubble Trap from Terumo Medical Corp. as a bubble trap as well as with the Quadrox D Diffusion Membrane Oxygenator with Bioline Coating with regards to the coating." This indicates that the acceptance criterion was substantial equivalence to the predicate devices across these tested areas. Specific quantitative acceptance values (e.g., "bubble removal efficiency > X%") are not provided in this summary but would have been part of the underlying test protocols that supported the substantial equivalence claim. The reported performance is that it met these criteria, thus supporting the substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided summary.
- Data Provenance: Not specified. This was a non-clinical (bench) testing, so there is no patient data provenance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not applicable and not provided for this type of non-clinical device testing. Ground truth for device performance features like integrity, performance (bubble separation), stability of coating, biocompatibility, and sterility would be established through established scientific and engineering test methods and standards, not through expert consensus in the way a diagnostic AI would use medical expert labels.
4. Adjudication Method for the Test Set
- Not applicable for this type of non-clinical device testing. Adjudication is typically relevant for studies involving human interpretation or clinical endpoints.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a mechanical bubble trap, not an AI or imaging device that would typically involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. The device is a physical bubble trap, not an algorithm. The "performance" assessment would have been a standalone test of the physical device's ability to remove bubbles.
7. The Type of Ground Truth Used
- For "Integrity," "Performance," "Stability of the Coating," "Biocompatibility," and "Sterility," the ground truth would have been established through validated laboratory testing methods and engineering specifications. For example, "Performance" (bubble removal) would be measured against a defined standard for air volume or bubble size removed, which would serve as the ground truth. "Biocompatibility" would be assessed according to ISO standards, with the "ground truth" being compliance with those standards.
8. The Sample Size for the Training Set
- Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for a physical device.
§ 870.4230 Cardiopulmonary bypass defoamer.
(a)
Identification. A cardiopulmonary bypass defoamer is a device used in conjunction with an oxygenator during cardiopulmonary bypass surgery to remove gas bubbles from the blood.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Extracorporeal Blood Circuit Defoamer 510(k) Submissions.”