(23 days)
The Stöckert Pediatric Aortic Cannulae are designed to be used as perfusion cannulae to return arterial blood from the extracorporeal circuit to the patient during cardiopulmonary bypass up to six hours or less.
The Stöckert Pediatric Aortic Cannulae, A272-15 through A272-35 are sterile, non-pyrogenic devices, for single use only, and are not to be resterilized by the user. The devices are wire reinforced aortic cannulae with a curved distal tip.
The cannulae are comprised of two components, the cannula tube and the curved tip. Encapsulated within the cannula outer wall is a helically wound stainless steel wire which allows the cannula tube to resist kinking. The devices range in diameter from 4.5 to 10.5 Fr and have an overall length of 22 cm.
This document is a 510(k) pre-market notification for a medical device, specifically Stöckert Pediatric Aortic Cannulae. It is not a study describing the acceptance criteria or performance of an AI/ML powered device.
Therefore, most of the requested information regarding AI/ML device performance and study design cannot be extracted from this document. This document pertains to traditional medical device approval based on substantial equivalence to a predicate device.
However, I can extract the following relevant information:
1. A table of acceptance criteria and the reported device performance
Since this is a submission for a traditional medical device (cannulae) and not an AI/ML powered device, there are no "acceptance criteria" in the sense of performance metrics like accuracy, sensitivity, or specificity commonly associated with AI/ML. Instead, the document focuses on demonstrating substantial equivalence to a predicate device through:
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| Same intended use | "The Stöckert Pediatric Aortic Cannulae are designed to be used as perfusion cannulae to return arterial blood from the extracorporeal circuit to the patient during cardiopulmonary bypass up to six hours or less." This matches the implied intended use of the Jostra Arterial Perfusion Cannulae (predicate). |
| Overall design features (flexible tapered aortic cannula with a distal tip including suture ring, and without an attached connector) | "The devices share the same intended use and overall design features (flexible tapered aortic cannula with a distal tip including suture ring, and without an attached connector)." |
| In-vitro performance | "In-vitro performance...tests demonstrate substantial equivalence of the Stöckert Pediatric Aortic Cannulae to the Research Medical Inc. Pediatric Aortic Cannula." Specific metrics are not provided in this summary. |
| Biocompatibility | "Biocompatibility tests demonstrate substantial equivalence of the Stöckert Pediatric Aortic Cannulae to the Research Medical Inc. Pediatric Aortic Cannula." Specific test results are not provided in this summary. |
| Sterility, non-pyrogenic, single-use | "The Stöckert Pediatric Aortic Cannulae...are sterile, non-pyrogenic devices, for single use only, and are not to be resterilized by the user." This is a characteristic of the device itself and likely aligns with the predicate. |
| Materials (e.g., wire reinforcement) | "Encapsulated within the cannula outer wall is a helically wound stainless steel wire which allows the cannula tube to resist kinking." While not explicitly stated as an "acceptance criterion" from the predicate, it's a design feature described. |
| Dimensions (diameter range, overall length) | "The devices range in diameter from 4.5 to 10.5 Fr and have an overall length of 22 cm." These characteristics would be compared to the predicate device to establish equivalence. |
The study that proves the device meets the acceptance criteria:
The "study" in this context is a comparison to a predicate device using in-vitro performance and biocompatibility tests.
- Predicate Device: Jostra Arterial Perfusion Cannulae (mentioned in the first section) and Research Medical Inc. Pediatric Aortic Cannula (mentioned in the "STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON"). It seems two different predicate devices are referenced for different aspects of the comparison.
The following information cannot be provided as it is not relevant to this type of medical device submission for a cannulae:
- Sample sized used for the test set and the data provenance (Not applicable for a physical device where "test set" implies algorithmic evaluation)
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (Not applicable)
- Adjudication method (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, as this is not an AI/ML device)
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done (Not applicable)
- The type of ground truth used (expert consensus, pathology, outcomes data, etc) (Not applicable)
- The sample size for the training set (Not applicable, as there is no "training set" for a physical device)
- How the ground truth for the training set was established (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).