(447 days)
Bio-Medicus Life Support catheters are peripheral-access catheters used to perfuse vessels or organs in conjunction with extracorporeal cardiopulmonary bypass (CPB) procedures. The catheter introducer is intended to facilitate proper insertion and placement of the appropriately-sized catheter within the vessel. Catheter models with tip lengths of 18 cm (7.09 in), 50 cm (19.7 in), or 55 cm (21.7 in) and without additional side holes may be used as either drainage or reinfusion catheters. This product is intended for use in adult and pediatric patients for up to 6 hours.
The Bio-Medicus Life Support catheter is a single-lumen catheter used to drain or reinfuse blood. These devices are sterile, nonpyrogenic, disposable, and intended for single use only. Do not store the product above 25°C (77°F).
This document is a 510(k) summary for the Bio-Medicus Life Support Catheter and Introducer. It is a premarket notification for a medical device seeking clearance from the U.S. FDA, not a study report that details acceptance criteria and device performance in the way a clinical trial or a deep learning algorithm validation would.
Therefore, the requested information elements related to AI models, ground truth establishment, expert adjudication, sample sizes for training/test sets, MRMC studies, or standalone algorithm performance are not applicable (N/A) to this device or document. This document pertains to a physical medical device (catheter and introducer) and its pre-clinical testing, not an AI/ML algorithm.
However, I can extract the information that is available about the "device performance" in the context of this 510(k) submission, interpreted as the pre-clinical bench and in-vivo animal testing conducted.
1. Table of Acceptance Criteria and the Reported Device Performance:
The document summarises that "Pre-clinical bench testing was used to verify the performance characteristics of this device. In vivo animal testing was also completed to establish substantial equivalence with the predicate device." It also lists the types of performance tests conducted.
However, the document does not provide specific acceptance criteria values or detailed quantitative results for each test. It only states that the data is "sufficient to demonstrate that the Medtronic Bio-Medicus Life Support Catheter and Introducer is substantially equivalent to the legally marketed predicate devices."
| Test Category | Acceptance Criteria (Not explicitly stated in detail) | Reported Device Performance (Summary) |
|---|---|---|
| Catheter testing | To demonstrate performance and safety profile | Data considered sufficient for substantial equivalence |
| Catheter and Introducer Testing | To demonstrate performance and safety profile | Data considered sufficient for substantial equivalence |
| Introducer Testing | To demonstrate performance and safety profile | Data considered sufficient for substantial equivalence |
| Blood trauma testing | To ensure minimal blood damage during use | Data considered sufficient for substantial equivalence |
| Packaging Testing | To ensure sterility and product integrity | Data considered sufficient for substantial equivalence |
| Sterilization Testing | To confirm effective sterilization | Data considered sufficient for substantial equivalence |
| Catheter and Introducer Life Testing | To confirm durability and functional life | Data considered sufficient for substantial equivalence |
| Biocompatibility Testing | To ensure material compatibility with biological systems | Data considered sufficient for substantial equivalence |
| Pressure Drop Testing | To evaluate flow characteristics through the device | Data considered sufficient for substantial equivalence |
| In-vivo animal testing | To establish substantial equivalence with predicates | Demonstrated substantial equivalence with predicate devices |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not specified in this summary. The tests listed are "pre-clinical bench testing" and "in vivo animal testing," which implies physical testing samples rather than human clinical data sets. The exact number of catheters/introducers tested or animals used is not detailed.
- Data Provenance: Not specified in this summary. These are pre-clinical tests, so "country of origin of data" is not typically a relevant factor like it would be for a clinical trial with human subjects. The tests would have been conducted in a lab environment.
- Retrospective or Prospective: These would be considered prospective tests, as they are specifically conducted to evaluate the performance of the new device for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- N/A. This information is not relevant for a physical device's pre-clinical performance testing. There is no "ground truth" to be established by human experts in the context of catheter performance testing, such as flow rates, tensile strength, or blood trauma. These are typically measured by laboratory equipment and standardised protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Not applicable for pre-clinical bench or animal testing of a physical medical device. Adjudication methods are typically used in clinical trials or for subjective assessments by human readers/experts, which is not the case here.
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:
- N/A. This is a clearance for a physical medical device (catheter and introducer), not an AI/ML diagnostic or assistive tool. Therefore, no MRMC study, human readers, or AI assistance is involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. Not applicable for a physical medical device. This is relevant for AI/ML algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- N/A. For pre-clinical bench testing, the "ground truth" would be objective measurements obtained through calibrated equipment and validated test methods (e.g., specific flow rates under defined pressures, measured tensile strength, observed material characteristics under stress, analysis of blood components for trauma). For animal testing, it would involve direct physiological measurements or observation of biological responses, with controls. It's not "ground truth" in the sense of expert diagnosis or pathology.
8. The sample size for the training set:
- N/A. There is no "training set" in the context of a physical medical device. This term applies to machine learning algorithms.
9. How the ground truth for the training set was established:
- N/A. As there is no training set for a physical device, this question is not applicable.
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).