(53 days)
This cannula is intended for short term use (six hours or less) in conjunction with cardiopulmonary bypass surgery for delivering cardioplegia solutions. The cannula may also be used to aspirate air from the aorta at the conclusion of the bypass procedure.
The Pediatric Aortic Root Cannula (18 Gauge) is a device with a flange and two side holes. The tip is attached to a flexible tapered tube that terminates in a female luer fitting. A stainless steel 18 gauge introducer with needle tip and locking male luer fitting is supplied inside the cannula.
This document describes the premarket notification for a Pediatric Aortic Root Cannula (18 Gauge). The submission aims to demonstrate substantial equivalence to predicate devices, not primarily to prove specific acceptance criteria through a clinical study or AI performance. Therefore, many of the requested elements for an AI/clinical study are not directly applicable or available in this type of regulatory submission.
However, I can extract the information relevant to the device's performance assessment as presented in the 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Dimensional properties | Meet design specifications | All testing passed. |
| Functional properties | Operate as intended | All testing passed. |
| Biocompatibility | Meet established standards | Evaluated. |
| Sterilization | Effective sterilization | Evaluated. |
| Packaging integrity | Maintain sterility and protection | Evaluated. |
| Accelerated Aging (Dimensional) | Maintain dimensions after aging | All testing passed. |
| Accelerated Aging (Functional) | Maintain function after aging | All testing passed. |
Note: The document doesn't explicitly list numerical acceptance criteria. The statement "All testing passed" implies that the device met internal, established criteria for successful performance in each category, which are typically defined by the manufacturer based on regulatory standards and predicate device performance.
2. Sample Size Used for the Test Set and Data Provenance
The document states "In vitro dimensional and functional testing was used" and "Accelerated aged dimensional and functional testing was also performed."
- Sample Size: Not specified. The document does not provide the number of devices or units tested for the in vitro or accelerated aging tests.
- Data Provenance: Not specified, but implied to be from internal lab testing conducted by Medtronic Perfusion Systems (manufacturer). It is retrospective in the sense that the testing was completed before the 510(k) submission. No country of origin for the data is mentioned, but the manufacturer is based in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable. This type of 510(k) submission for a physical medical device (cannula) does not involve establishing ground truth by human experts in the manner of an AI or diagnostic imaging study. Performance is assessed through direct physical and functional testing against engineering specifications and industry standards.
4. Adjudication Method for the Test Set
- Not Applicable. As per point 3, there's no "ground truth" adjudicated by experts in this context. Testing results ("All testing passed") are likely determined by comparing measurements and observations against pre-defined engineering tolerances and performance requirements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- Not Applicable. This is a physical medical device, not an AI or diagnostic imaging device that involves human readers interpreting results.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- Engineering Specifications and Standardized Test Methods: The "ground truth" for this device's performance is based on its ability to meet predefined dimensional tolerances, material properties, functional requirements (e.g., flow rates, leak resistance, introducer needle functionality), biocompatibility standards (e.g., ISO 10993), sterilization efficacy, and packaging integrity. These are established through internal design specifications and compliance with relevant industry and regulatory standards.
8. The Sample Size for the Training Set
- Not Applicable. This is a physical medical device. There is no "training set" in the context of machine learning or AI. Design and manufacturing are based on established engineering principles and prior device experience, not algorithmic training.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. There is no "training set" or "ground truth" in the AI sense for this device. The design and validation are based on engineering specifications and empirical testing.
§ 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).