(30 days)
The QuickDraw venous cannula is indicated for use in patients undergoing cardiopulmonary bypass. The QuickDraw venous cannula serves to drain non-oxygenated blood from the venae cavae and/or right atrium during cardiopulmonary bypass.
The Edwards Lifesciences QuickDraw venous cannula kit includes a wirewound cannula, introducer(s), guidewire, connector hub, and percutaneous insertion components. The cannula and introducer(s) have tapered tips to aid in insertion and advancement into the femoral vein. The cannula is marked at 5 cm intervals from the first marker band to indicate the depth of insertion. The soft, clear tubing near the barbed end of the cannula allows visualization of air and blood and provides a non-reinforced clamp site. The cannula connector is a 3/8 in. (9.5 mm) barbed connector. The introducers accept a 0.038 in. (0.97 mm) guidewire for assistance in cannula insertion. The connector hub secures and immobilizes the introducer within the cannula for easier, one-person insertion of the cannula/introducer assembly. For percutaneous insertion, percutaneous insertion components are provided.
The provided text is a 510(k) premarket notification for a medical device called the "QuickDraw Venous Cannula." It states that the subject device is identical to a previously cleared predicate device, with only the addition of a contraindication and a warning to the Instructions for Use.
Because the device itself is identical and the changes are only to the labeling (adding contraindications and warnings), the description explicitly states:
"Functional and safety testing were not applicable for this changed device as the change is only adding a contraindication and warning to the Instructions for Use."
Therefore, there is no performance study described in this document to demonstrate that the device meets acceptance criteria. The 510(k) submission relies on the substantial equivalence to the predicate device, which would have undergone performance testing for its initial clearance.
As such, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria based solely on the provided text, as no such study was conducted or described for this particular 510(k) submission.
To directly answer your prompt based on the provided text, and acknowledging the lack of a performance study for this specific submission:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not applicable for this submission as no new performance testing was conducted. The criteria would have been established and met for the predicate device.
- Reported Device Performance: Not applicable for this submission as no new performance testing was conducted. The performance essentially mirrors that of the identical predicate device.
2. Sample size used for the test set and the data provenance:
- Not applicable; no new test set was used for performance evaluation in this 510(k).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable; no new test set requiring ground truth establishment was used for performance evaluation in this 510(k).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable; no new test set requiring adjudication was used for performance evaluation in this 510(k).
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 (cannula), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable; this is a physical medical device (cannula), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable; no new performance study was conducted requiring ground truth.
8. The sample size for the training set:
- Not applicable; this is a physical medical device (cannula), not an algorithm that requires a training set.
9. 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).