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Dorado™ PTA Balloon Dilatation Catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the renal, iliac, femoral, popliteal, tibial, peroneal, and subclavian arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for post-dilatation of balloon expandable and self expanding stents in the peripheral vasculature. This catheter is not for use in coronary arteries.

The Dorado™ PTA Balloon Dilatation Catheter is a high-performance balloon catheter consisting of an over the wire catheter with a balloon fixed at the distal tip. The proprietary non-compliant, low-profile balloon is designed to provide consistent balloon diameters and lengths even at high pressures. Two radiopaque markers delineate the working length of the balloon and aid in balloon placement. The catheter includes an atraumatic tip to facilitate advancement of the catheter to and through the stenosis. The novel catheter consists of a distal triple lumen and a proximal coaxial lumen and is designed to optimize the balance between pushabilty and trackability. The over the wire catheter is compatible with 0.035" guidewire and is available in 40, 80, 120, and 135 cm working lengths. The proximal portion of the catheter includes a female luer lock hub connected to the inflation lumen, and a female luer-lock hub connected to the guidewire lumen. Packaged with every product is a profile reducing sheath that is positioned over the balloon for protection before use. A re-wrapping tool is also provided on the catheter shaft. A stylet is placed into the tip of the catheter to aid in rewrap/refolding of the balloon. These products are not made with natural rubber latex.

This 510(k) clearance letter is for a medical device (Dorado™ PTA Balloon Dilatation Catheter), not an AI/Software as a Medical Device (SaMD).

Therefore, the information requested in your prompt (e.g., acceptance criteria for AI algorithm performance, sample sizes for test/training sets, expert adjudication, MRMC studies, ground truth establishment) is not applicable to this document.

The document discusses the performance evaluation of a physical medical device, focusing on in vitro pre-clinical testing to demonstrate substantial equivalence to a predicate device. This includes:

• Performance Data: Trackability, Balloon Burst Strength, Balloon Fatigue, Sheath Compatibility, Dimensional Verification, Simulated Use, etc.
• Biocompatibility Testing: Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Hemocompatibility.

The acceptance criteria for this device would be engineering specifications and safety standards for balloon catheters, not statistical metrics for AI algorithm performance.

In summary, based on the provided document, I cannot answer the questions related to AI/SaMD acceptance criteria and study design. The document describes the clearance of a traditional physical medical device.

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The Dorado™ PTA Balloon Dilatation Catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the renal, iliac, femoral, popliteal, tibial, peroneal, and subclavian arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature. This catheter is not for use in the coronary arteries.

The subject device, the Dorado™ PTA Balloon Dilatation Catheter, is composed of a multi-lumen catheter with 5 or 5.8 French shaft outer diameter, depending on balloon size. A composite balloon is mounted onto the distal tip of the catheter. During use, the balloon position in the vessel is identified by two radiopaque marker bands that indicate the working length of the balloon and aid in placement.

The provided text is a 510(k) summary for a medical device (Dorado™ PTA Balloon Dilatation Catheter), which focuses on demonstrating substantial equivalence to predicate devices, rather than an AI/ML device study. Therefore, much of the requested information regarding AI/ML device performance, such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, and ground truth types, is not applicable or available in this document.

However, I can extract the general acceptance criteria and the conclusion regarding the device's performance based on the provided text.

Acceptance Criteria and Device Performance for Dorado™ PTA Balloon Dilatation Catheter

Study Information (Based on provided text):

• Sample Size for Test Set and Data Provenance: Not applicable. This document describes a device submission based on design verification and validation to demonstrate substantial equivalence to predicate devices, not a clinical study with a test set in the conventional sense of AI/ML performance evaluation.
• Number of Experts and Qualifications for Ground Truth: Not applicable. Ground truth as typically defined for AI/ML models is not relevant here. The evaluation is against engineering specifications, standards, and comparison to legally marketed predicate devices.
• Adjudication Method: Not applicable. No adjudication method in the context of expert review for AI/ML performance is described. The "adjudication" is essentially the FDA's review and determination of substantial equivalence based on the provided data.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No. This is not an AI/ML device, and no MRMC study is mentioned.
• Standalone Performance Study (Algorithm Only): No. This information is not relevant for a traditional medical device like a balloon catheter.
• Type of Ground Truth Used: Not applicable in the context of AI/ML. The "ground truth" for this device's acceptance would be its adherence to established engineering specifications, performance standards, and comparison to the documented performance and design of the predicate devices.
• Sample Size for Training Set: Not applicable. This is not an AI/ML device, so there is no "training set."
• How Ground Truth for Training Set was Established: Not applicable.

Summary of the Device's Evaluation:

The Dorado™ PTA Balloon Dilatation Catheter underwent a design verification and validation process. The conclusion states that the device "met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs." This implies that the device manufacturing, materials, and performance (e.g., balloon inflation/deflation, catheter trackability, radiopacity, etc.) were tested against established specifications and found to be compliant.

The 510(k) submission primarily focuses on demonstrating "substantial equivalence" to existing, legally marketed predicate devices rather than proving novel clinical efficacy or safety through a large-scale clinical trial. The comparison of indications for use, technological characteristics, and fundamental scientific technology to predicate devices formed the basis of this substantial equivalence claim.

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