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The Opta LP PTA balloon catheters is intended to dilate stemoral, ilio-femoral, popliteal infra popliteal and renal arteries, and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The Opta LP PTA Balloon Catheter is intended to dilate stenoses in iliac, femoral, iliofemoral, popliteal, infra popliteal and renal arteries, and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The Cordis Opta LP PTA balloon catheter is a dual lumen design with a distal inflatable balloon. Two radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement.

The working pressure range for the balloon is between the nominal size pressure and the rated burst pressure. All balloons distend to sizes above the nominal size at pressures greater than the nominal pressure.

The balloon inflation lumen is used to inflate and deflate the balloon. The nominal balloon size is printed on the hub.

The guidewire lumen is used to track the catheter over a prepositioned guidewire or to inject contrast medium and/or saline. The maximum injection pressure is 450 psi. The compatible guidewire size, catheter shaft French size and catheter length are printed on the hub. The radiopaque marker bands indicate the stated nominal length of the balloon.

The provided document is a 510(k) submission for the Cordis Opta LP PTA Balloon Catheter. It outlines the intended use, device description, and substantial equivalence to predicate devices, but does not contain information on acceptance criteria or a study proving the device meets said criteria. The document primarily focuses on regulatory approval based on substantial equivalence, rather than performance studies with specific metrics and acceptance criteria. Therefore, most of the requested information cannot be extracted from this document.

However, I can provide the following based on the available text:

1. A table of acceptance criteria and the reported device performance:

• Not available in the document. The document primarily addresses regulatory clearance through substantial equivalence, not detailed performance metrics against acceptance criteria.

2. Sample size used for the test set and the data provenance:

• Not applicable. No specific test set or clinical study data is reported in this 510(k) submission for the device itself. The submission relies on the substantial equivalence to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. No test set requiring expert ground truth is described.

4. Adjudication method for the test set:

• Not applicable. No test set is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This document is for a medical device (balloon catheter), 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 document is for a medical device (balloon catheter), not an algorithm.

7. The type of ground truth used:

• Not applicable. No performance study with ground truth is detailed in this document.

8. The sample size for the training set:

• Not applicable. No training set for an algorithm is discussed.

9. How the ground truth for the training set was established:

• Not applicable. No training set for an algorithm is discussed.

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