(65 days)
These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours or less.
The DLP® Silicone Single Stage Venous Cannula with Inflatable Cuff is used during cardiopulmonary bypass surgical procedures for collecting and directing blood from the right side of the heart via the superior and inferior vena cava into the bypass circuit. These cannulae are comprised of a wire-wound, kink-resistant silicone cannula body with a nominal tip outer diameter of 37Fr and an overall length of 15 inches. The DLP® Silicone Single Stage Venous Cannula with Inflatable Cuff model features a manually inflatable silicone inflatable cuff near the distal tip of the device which, once inflated, assists in maintaining the position of the device throughout the cardiopulmonary bypass procedure.
This 510(k) summary (K120987) describes a medical device, the DLP® Silicone Single Stage Venous Cannula with Inflatable Cuff, but does not contain information about acceptance criteria or a study proving the device meets said criteria.
The submission focuses entirely on demonstrating substantial equivalence to a predicate device (K854487), rather than providing performance data against specific acceptance criteria. This is a common characteristic of 510(k) submissions where the device is not significantly different from an already legally marketed device.
Therefore, I cannot provide the requested information from the provided text. The document explicitly states:
- "Medtronic has demonstrated that the modifications to the DLP® Silicone Single Stage Venous Cannula with Inflatable Cuff described in this submission result in a substantially equivalent device because the fundamental scientific technology, the intended use, operating principle and design features are unchanged since the predicate device. Any noted differences do not raise new issues of safety and effectiveness."
This indicates that the argument for clearance is based on similarity to an existing device, not on new performance studies with acceptance criteria.
To answer your request, here's what's missing:
- A table of acceptance criteria and the reported device performance: This information is not present.
- Sample sized used for the test set and the data provenance: No test set or data provenance is mentioned as a performance study wasn't conducted or reported in this submission for the modified device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no performance study described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an AI algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable, as there's no algorithm or AI involved.
- 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).