(149 days)
These devices are to be used by a trained physician only. Cannulate vessels, perfuse vessels or organs, and/or connect with accessory extracorporeal equipment. The cannula introducer is intended to facilitate proper insertion and placement of the appropriately sized cannula within the vessel for cardiopulmonary bypass. These products are intended for use up to 6 hours.
The pediatric venous cannulae consist of a polyurethane wirewound body with a multi-port distal tip. All pediatric venous cannulae come with a non-vented 1/4-in connector. The one-piece nonphthalate PVC blunt and guidewire style introducers and included with these cannulae have an elongated taper for dilation over a longer distance.
The pediatric arterial cannulae consist of a polyurethane wirewound body and distal tip. All of the pediatric arterial cannulae come with a non-vented 1/4-in connector. The one-piece nonphthalate PVC blunt and guidewire introducers included with these cannulae have an elongated taper for dilation over a longer distance.
Sterile, nonpyrogenic disposable, single use only
This document describes the FDA's 510(k) clearance for the Medtronic Bio-Medicus Pediatric Cannulae and Introducers. It focuses on the device's substantial equivalence to previously marketed predicate devices rather than a detailed study proving performance against defined acceptance criteria in the context of an AI/algorithm-based device. Therefore, a direct response to your detailed questions on AI study specifics (like sample size for test sets, expert ground truth, MRMC studies, etc.) cannot be fully provided from this document.
However, I can extract the information related to the device's acceptance criteria and the studies performed to demonstrate its performance where available in this regulatory document.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria for each test. Instead, it states that "Performance and biological tests confirm that the Medtronic Bio-Medicus Pediatric Arterial and Venous Cannulae product met pre-determined acceptance criteria." It also notes that the proposed device "performed as well or better than the legally marketed devices."
| Test Performed | Reported Device Performance |
|---|---|
| Blood Trauma Testing | Passed (met pre-determined acceptance criteria) |
| Sterilization Testing | Passed (met pre-determined acceptance criteria) |
| Packaging Testing | Passed (met pre-determined acceptance criteria) |
| Pressure Drop Testing | Passed (met pre-determined acceptance criteria) |
| Cannula Shelf Life Testing | Passed (met pre-determined acceptance criteria) |
| Cannula and Introducer Performance Testing | Passed (met pre-determined acceptance criteria) |
| Cannula Testing | Passed (met pre-determined acceptance criteria) |
| Introducer Testing | Passed (met pre-determined acceptance criteria) |
| Securement Clip Testing | Passed (met pre-determined acceptance criteria) |
| Biocompatibility Testing | Passed (met pre-determined acceptance criteria and ISO 10993-1 standards) |
| Substantially equivalent to predicate device |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide details on the specific sample sizes for each test set or the provenance of the data. It mentions "Pre-clinical bench testing" and "Animal testing."
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)
This information is not applicable and not provided in this document, as it pertains to a physical medical device clearance, not an AI/algorithm-based diagnostic device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided in this document.
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
This information is not applicable and not provided in this document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided in this document.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For physical device testing, "ground truth" equates to established engineering and biological standards and expected performance parameters. The document states "Pre-clinical bench testing was used to verify the performance characteristics of this device. Animal testing was also completed to establish substantial equivalence with the predicate devices." Biocompatibility testing followed ISO 10993-1.
8. The sample size for the training set
This information is not applicable as it is not an AI/algorithm-based device.
9. How the ground truth for the training set was established
This information is not applicable as it is not an AI/algorithm-based device.
§ 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).