(41 days)
The Edwards Peripheral Dilatation Catheter is intended to:
- dilate stenoses in 10 14mm peripheral arteries, .
- treat obstructive lesions of native or synthetic A-V fistulae and/or .
- expand endoluminal stent graft elements in the aorta and iliac arteries .
The Edwards Peripheral Dilatation 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 end of the catheter and provides the mechanism for dilating the vessel. The shaft of the delivery system is coaxial over the entire length of the catheter. The inner lumen of the coaxial catheter is designed to accommodate a maximum guidewire diameter of 0.035 inches. The outer lumen of the coaxial catheter is used for inflation and deflation of the balloon. The proximal end of the catheter contains a luer adapter with two ports; one port is used for accessing the guidewire lumen while the second port facilitates inflation and deflation of the balloon. The delivery catheter is offered in an 80 cm length. The Edwards Peripheral Dilatation Catheter products are supplied sterile and are "single-use only" devices.
The provided text describes the Edwards Peripheral Dilatation Catheter and its 510(k) submission, focusing on establishing substantial equivalence to predicate devices rather than a standalone study with specific acceptance criteria and detailed performance metrics. As a result, many of the requested details are not present in the document.
Here's an analysis of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Bench Testing Parameters: | |
| Balloon burst strength | Performed in a manner substantially equivalent to predicate devices. |
| Balloon compliance | Performed in a manner substantially equivalent to predicate devices. |
| Balloon inflation | Performed in a manner substantially equivalent to predicate devices. |
| Balloon fatigue | Performed in a manner substantially equivalent to predicate devices. |
| Tensile strength on applicable joints of the delivery system | Performed in a manner substantially equivalent to predicate devices. |
| Overall Performance: | |
| Substantial equivalence to predicate devices (Cordis MAXI LD Esophageal Dilator (K023907), Guidant AGILTRAC™ 035 Peripheral Dilatation Catheter (K023320)) in: | Claimed due to similar intended use, design, materials, performance, safety, effectiveness, and labeling. |
| - Intended Use | Assessed for similarity. |
| - Design | Assessed for similarity. |
| - Materials | Assessed for similarity. |
| - Performance properties | Assessed for similarity. |
| - Biocompatibility | Assessed for similarity. |
| - Packaging | Assessed for similarity. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document mentions "bench testing," which implies laboratory tests, but no specific number of units tested is provided for any of the performance parameters.
- Data Provenance: The studies were internal bench testing conducted by Edwards Lifesciences. The country of origin is not explicitly stated for the testing, but Edwards Lifesciences LLC is located in Irvine, CA, USA. The data is retrospective in the sense that it was generated for the 510(k) submission, but it's not clinical patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This information is for clinical studies where expert review is crucial for ground truth. The provided document only describes bench testing comparing the device to predicates, not a clinical trial requiring human expert assessments for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. As above, this pertains to clinical studies often involving human interpretation of data (e.g., imaging). The tests described are bench tests of physical performance.
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 type of study is relevant for AI/radiological interpretation devices. The Edwards Peripheral Dilatation Catheter is a physical medical device (catheter), not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. Again, this refers to AI algorithms. The device is a physical catheter.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Bench Testing Standards/Specifications: The "ground truth" for the bench tests would be the established engineering specifications for what constitutes acceptable performance (e.g., minimum burst pressure, maximum fatigue cycles, tensile strength limits) and consistency with the performance of the predicate devices. These standards are derived from industry norms and regulatory requirements for such devices.
8. The sample size for the training set:
- Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The design, materials, and manufacturing processes would be developed based on engineering principles and knowledge of the predicate devices.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set mentioned.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).