(154 days)
The ELM Extension PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.
The Creagh Medical ELM Balloon Dilatation Catheter is a coaxial catheter with a semi compliant balloon near the distal tip. It is an Over-the-Wire (OTW) PTA device with shaft lengths of 40cm & 75cm. The ELM PTA Balloon Dilatation Catheter is compatible with a 0.035" guide wire. The balloon has two radiopaque markers at either end of the balloon body that aid in the placement of the balloon within the stenosis. These two radiopaque marker bands indicate the dilating section of the balloon and aid in the balloon placement. The marker bands also indicate the nominal length of the balloon. The catheter tip is designed to ease entry into the peripheral arteries and to facilitate the crossing of tight stenosis. The clearance between the inner and outer catheter shaft acts as the passage for the inflation medium for balloon expansion. The proximal end of the catheter has a bifurcated manifold and strain relief that allows for the use of the 0.035" guidewire and the attachment of a balloon inflation device via a standard luer connector. The inflation device is used to inflate and deflate the balloon with a contrast medium. The ELM PTA Balloon Dilatation Catheter is to be provided sterile (via ethylene oxide) and is intended for single use only. The catheter is designed so that a specific balloon diameter can be reached depending on the Balloon size and defined pressure. A compliance chart is provided on the product label which provides the diameter of balloons at given pressures. Each product is packaged with a balloon protector which is positioned over the balloon for its protection prior to use. A re-wrap tool is also provided on the catheter shaft. The modified ELM 0.035" PTA Balloon Dilatation Catheter, hereafter referred to as ELM Extension, introduces 3 additional product codes with reduced Rated Burst Pressure as detailed below in Table 1.
The provided text describes specific details about a medical device (ELM PTA Balloon Dilatation Catheter) and its substantial equivalence to a predicate device. However, it does not contain information about a study proving the device meets acceptance criteria in the context of an AI/ML algorithm or software device as implicitly requested by the prompt's structure (e.g., "test set," "training set," "ground truth," "MRMC study," "human readers").
The document is a 510(k) submission for a physical medical device, focusing on mechanical and performance testing rather than algorithm performance.
Therefore, I cannot provide answers to the specific points in your request because the provided text describes a traditional medical device (catheter) and its testing for regulatory clearance, not an AI/ML system.
The closest relevant information, regarding "acceptance criteria" and "device performance" would relate to the mechanical tests performed on the physical catheter. However, this is distinct from the type of "acceptance criteria" and "study" an AI/ML device would undergo.
If the prompt were for a physical medical device, I would highlight:
- Acceptance Criteria & Performance: The document states, "The results were shown to meet the specified acceptance criteria and did not raise new questions of safety or effectiveness." It also lists the types of mechanical tests performed, such as "Working Length," "Radiopacity," "Fatigue Testing," "Burst / Compliance Testing," etc. without providing the specific numerical acceptance criteria or reported performance values for these tests.
- Study Type: Design verification and validation testing, mechanical tests.
- No information on sample sizes, ground truth (in the AI/ML sense), experts, or comparative effectiveness studies with human readers is present, as these concepts are not applicable to the type of device and submission described.
§ 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).