(84 days)
The Stöckert V172-28 Venous Femoral Cannula is intended to cannulate the inferior vena cava and the right atrium via femoral access during cardiopulmonary bypass surgery for periods up to six hours.
The Stöckert V172-28 Venous Femoral Cannula is a sterile, non-pyrogenic device, for single use only, and is not to be resterilized by the user. The device is a polyvinyl chloride (PVC) wire reinforced Cannula with a non-wire reinforced proximal end for connecting the device to a cardiopulmonary bypass circuit. The Stöckert V172-28 Cannula is intended to be used to cannulate the femoral vessels during cardiopulmonary bypass surgery. During use, the cannula is inserted into the vena femoralis and advanced into the right atrium, allowing blood from the systemic circulation to enter the extracorporeal circuit. Insertion of the cannula into the vena femoralis during cardiopulmonary bypass surgery is an alternative method for insertion of a cannula into the superior or inferior vena cava.
The Stöckert V172-28 Cannula is 28 Fr and 90 cm in length, with a flexible proximal end that can accommodate a 1/2" connector. The cannula tube contains two sets of side holes, one set for drainage from the right atrium and one set for drainage from the inferior vena cava and hepatic veins. An obturator is provided with each cannula, which seals the inside of the cannula tube in the areas of the side holes to prevent blood leakage from the cannula during insertion. After insertion, the obturator is removed and discarded by the user.
The provided text describes a 510(k) pre-market notification for a medical device, the Stöckert V172-28 Venous Femoral Cannula. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a de novo study to establish performance from scratch. Therefore, the information typically associated with AI/software device studies (e.g., sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, ground truth types) is not present here.
Instead, the study performed is a series of engineering and biological tests demonstrating that the new device performs as safely and effectively as the predicate device.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states that the Stöckert V172-28 Venous Femoral Cannula is "substantially equivalent to the Medtronic DLP Venous Femoral Cannula." This is the overarching acceptance criterion, meaning the new device must perform comparably to the predicate device in key functional areas. The "reported device performance" is implicitly that the Stöckert V172-28 meets this substantial equivalence through the tests listed.
| Acceptance Criterion (Implicit) | Reported Device Performance (Demonstrated by) |
|---|---|
| Substantial Equivalence to Medtronic DLP Venous Femoral Cannula | - Pressure Drop test results comparable to predicate |
| - Blood Trauma test results comparable to predicate | |
| - Leak test results comparable to predicate | |
| - Kink Resistance test results comparable to predicate |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided. For this type of device (a physical medical cannula), "test set" typically refers to the number of units tested for each characteristic (e.g., how many cannulas were subjected to pressure drop tests). The data provenance refers to whether the tests were conducted internally by the manufacturer or by an independent lab, and this detail is also not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable for this type of device submission. "Ground truth" for a physical device like a cannula is established through objective engineering and biological test results, not expert consensus interpreting data like images.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods are typically used in studies involving subjective interpretation of data (e.g., medical images), which is not the nature of these tests.
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 physical medical device, not an AI or software device. Therefore, no MRMC study or AI assistance is relevant.
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
The ground truth is established through objective quantitative measurements from the specified engineering and biological tests (Pressure Drop, Blood Trauma, Leak, Kink Resistance). The "ground truth" for each test would be the empirically measured outcome of the Stöckert V172-28 device compared against the expected performance or against the performance of the predicate device.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/machine learning model. There is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth to establish for it.
§ 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).