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The Vector " Thi PTA Balloon Dilatation Catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, popliteal, and renal arteries and for the treatment of obstructive lesions of native or synthetic arterio-venous dialysis fistulae.

The Vector Catheter is not indicated for use in the coronary arteries or for placement of or post dilatation of stents

The Vector" PTA Catheter is a high pressure, non-compliant balloon catheter with a radiopaque coating on the balloon. The radio-opaque coating on the working length of the balloon minimizes or eliminates the need for using contrast solution to inflate the balloon. The radioopaque coating delineates the working length of the balloon and provides continuous fluoroscopic visibility during balloon placement. Saline may be used to inflate the balloon without affecting visualization. Contrast mixture may be used at the discretion of the physician.

The Vector4™ PTA Balloon Dilatation Catheter is a coaxial dual lumen over-the-wire balloon dilatation catheter. The central lumen accommodates guide wires up to 0.035 inches in diameter while the outer lumen is the inflation lumen for the balloon. The catheter includes an atraumatic tip to ease advancement of the catheter to and through the stenosis. The distal tip is visible under fluoroscopy.

The balloon is a high pressure composite balloon with a radiopaque coating on the working length to help visualize placement within the lesion during both placement and inflation without the use of contrast. The balloon's rated burst pressure is 30 atm.

The catheter is supplied sterile and non-pyrogenic. Different balloon sizes (5 mm to 10 mm) and catheter lengths (50 to 135 cm) are available. The proximal end of the catheter contains a hub with two female luer locks.

The device is compatible with 6-7F introducers. The introducer compatibility for each device size is listed on the device label itself. The materials used in the construction are biocompatible and latex free.

Here's a breakdown of the acceptance criteria and the study information for the Vector™ PTA Balloon Dilatation Catheter, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details

• Sample size used for the test set and the data provenance:

  • The document describes "preclinical testing" of the device. It doesn't specify a numerical sample size for the test set or the provenance of any data (e.g., country of origin). The testing seems to be laboratory-based rather than involving patient data. This is a common approach for 510(k) submissions where a device is demonstrated to be substantially equivalent to an existing predicate device based on its technical characteristics and performance, rather than clinical outcomes. The studies mentioned are focused on the device's physical and mechanical properties.

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

  • Not applicable. The ground truth for this type of device performance testing is based on engineering specifications and validated test methods, not expert consensus on clinical data.

• Adjudication method for the test set:

  • Not applicable. As the testing is against engineering specifications, there wouldn't be an adjudication method in the context of clinical interpretation.

• 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 device is a medical catheter, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is irrelevant.

• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

  • Not applicable. This is a physical medical device, not an algorithm.

• The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

  • The ground truth used for determining device performance was based on pre-defined physical and performance specifications for PTA catheters, industry standards (e.g., ISO 10993-1 for biocompatibility), and manufacturing requirements. For comparative aspects like radiopacity and particulates, the predicate device served as a benchmark for "similarity."

• The sample size for the training set:

  • Not applicable. This device is not an AI/ML model that requires a training set.

• How the ground truth for the training set was established:

  • Not applicable. As above, no training set is relevant for this device.

Summary of Study Approach:

The study described is a series of non-clinical, laboratory-based engineering and performance tests designed to demonstrate that the Vector™ PTA Balloon Dilatation Catheter meets its product specifications and industry standards. The submission relies heavily on direct comparative testing with a legally marketed predicate device (Bard Conquest PTA catheter) to establish substantial equivalence. Key areas of comparison include materials, construction, intended use, and critical performance characteristics like fluoroscopic visualization and mechanical integrity. The focus is on ensuring the new device performs equivalently or acceptably when compared to a device already deemed safe and effective.

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