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510(k) Data Aggregation
(25 days)
EDWARDS PERIPHERAL DILATION CATHETER
The Edwards Peripheral Dilation Catheter is intended to:
- dilate stenoses in peripheral arteries, .
- treat obstructive lesions of native or synthetic A-V fistulae and/or .
- re-expand endoluminal stent graft elements in the aorta and iliac arteries
The Edwards Peripheral Dilation Catheter is an over-the-wire catheter with a flexible distal portion for maneuvering through regions of the peripheral vasculature. A balloon is mounted on the distal for mather and provides the mechanism for dilating the vessel. Two (2) lumens extended end of the cather and prohless the The first lumen is designed to accommodate a maximum this only of 0.035 inches. The second lumen is used for inflation and deflation of the galloon. The proximal end of the catheter contains a luer adapter with two ports; one port is used bulloon. The guidewire lumen while the second port facilitates inflation and deflation of the beloon. A strain relief between the proximal shaft and the luer adapter provides rigidity and transition between the two parts. The delivery catheter is offered in both 80cm and 120cm working lengths.
The Edwards Peripheral Dilation Catheter's performance data is primarily based on bench testing, designed to demonstrate substantial equivalence to predicate devices, rather than a clinical study establishing specific acceptance criteria for a new clinical outcome.
Here's an analysis based on the provided text, addressing your questions:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance | Study Type |
|---|---|---|
| Dimensional Requirements | Performed in a manner substantially equivalent to predicate devices. | Bench Testing |
| Balloon Minimum Burst Strength | Performed in a manner substantially equivalent to predicate devices. | Bench Testing |
| Balloon Compliance | Performed in a manner substantially equivalent to predicate devices. | Bench Testing |
| Balloon Inflation/Deflation | Performed in a manner substantially equivalent to predicate devices. | Bench Testing |
| Balloon Fatigue | Performed in a manner substantially equivalent to predicate devices. | Bench Testing |
| Tensile Strength | Performed in a manner substantially equivalent to predicate devices. | Bench Testing |
| Biocompatibility | Identical or substantially equivalent to predicate devices. | Comparison to predicate (likely based on material testing, not specific new study) |
| Method of Sterilization | Identical or substantially equivalent to predicate devices. | Comparison to predicate |
| Packaging | Identical or substantially equivalent to predicate devices. | Comparison to predicate |
2. Sample size used for the test set and the data provenance
Not applicable. The study was bench testing of the device itself, not a test set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for bench testing is typically based on engineering specifications and direct measurement, not expert consensus on clinical data.
4. Adjudication method for the test set
Not applicable. This device underwent bench testing, not a clinical study requiring adjudication of expert opinions on medical images or patient outcomes.
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 not an AI/imaging device and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (catheter), not an algorithm.
7. The type of ground truth used
The ground truth for the bench testing was based on engineering specifications and direct measurements of the device against predefined performance parameters (e.g., burst pressure, compliance, tensile strength). The performance was then compared to that of legally marketed predicate devices to establish substantial equivalence.
8. The sample size for the training set
Not applicable. This is a medical device, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a medical device, not an AI algorithm that requires ground truth for a training set.
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