(21 days)
The AngioSculpt PTA Scoring Balloon Catheter is intended for dilatation of lesions in the iliac, femoral, ilio-femoral, popliteal, and infra popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.
The AngioSculpt catheter is a standard two-lumen catheter with a scoring balloon near the distal tip. The distal end of the catheter has a conventional nylon-blend balloon with a nitinol scoring element that wraps around the balloon. The scoring element creates focal concentrations of dilating force which minimizes balloon. slippage and assists with luminal expansion of stenotic arteries. The balloon has radiopaque markers to aid in positioning the balloon in the stennsis, and is designed to provide an expandable segment of known diameter and length at a specific pressure.
Unfortunately, the provided document K082059 is a 510(k) premarket notification correcting a previous letter for the AngioSculpt® PTA Scoring Balloon Catheter. This type of document, particularly for a device that is substantially equivalent to a predicate, typically focuses on demonstrating equivalence rather than detailing a specific clinical study with acceptance criteria and a comprehensive study report as you've requested.
Therefore, the document does not contain the following information:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
- If a standalone performance (algorithm only) study was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc).
- The sample size for the training set.
- How the ground truth for the training set was established.
The document states that "Design verification and validation testing demonstrated adequate device performance and confirmed that no new questions of safety or effectiveness for peripheral balloon angioplasty devices were raised." However, it does not provide the specifics of these tests, including the acceptance criteria or detailed results in a format that would allow me to populate the requested table or answer the specific questions about study design and ground truth.
In summary, this document is a regulatory approval letter based on substantial equivalence to existing devices, not a detailed clinical study report.
§ 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).