(167 days)
This product is intended for use with cardiopulmonary bypass as an arterial return cannula.
These Medtronic DLP Arterial Cannulae feature a thin-wall cannula body with a beveled tip which is fabricated from either polyurethane or wire-reinforced polyvinyl chloride. The proximal end of the cannula terminates in a barbed 3/8" connector. A plastic, blunt tip introducer with a porous plug is provided to aid in insertion of the cannula and prevent excessive blood loss during priming. The introducer includes a port which enables insertion along a 0.038" guidewire.
The provided text describes a 510(k) premarket notification for the Medtronic DLP Arterial Cannula Family and its modifications. Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The submission describes a single non-clinical performance test related to an introducer tip modification. The acceptance criteria aren't explicitly stated as numerical thresholds for "performance," but rather the outcome of the test supported the assertion of safety and effectiveness.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| The modified introducer tip should not decrease the force required for penetration, thus ensuring safety (e.g., preventing easier puncture of tissue). | Increasing the radius of the introducer tip significantly increased the amount of force required to penetrate the test material. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The description mentions "A laboratory assessment," but doesn't specify the number of cannulae or tests performed.
- Data Provenance: Laboratory assessment, implying a controlled lab environment. No information about country of origin, or if it was retrospective or prospective is provided beyond "laboratory assessment."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for this non-clinical test was based on physical measurements of force using a semi-solid matrix, not expert-based assessment.
4. Adjudication Method for the Test Set
Not applicable. The test involved physical measurement, not subjective expert judgment requiring adjudication.
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
Not applicable. This is a medical device (cannula) and not an AI/imaging diagnostic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this test was the measured force required for penetration of a standardized aqueous, semi-solid matrix. This is a form of physical and material properties testing.
8. The Sample Size for the Training Set
Not applicable. This is a medical device and not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There was no training set for this 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).