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The PTA Balloon Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including illac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The PTA Balloon Catheters (PVQ) is a sterile, single use, non-pyrogenic balloon catheter for peripheral indication. The device features an ultra-low profile, semi-compliant balloon combined with a low-profile tip.

The PTA Balloon Catheters (PVQ) has a coaxial shaft design. The outer lumen is used for inflation of the balloon, and the wire lumen permits the use of 0.014 in (0.36 mm), 0.018 in (0.46mm), guidewires to facilitate advancement of the catheter to and through the stenosis to be dilated. The PTA Balloon Catheters (PVQ) features a dual lumen shaft that provides rapid inflation/deflation times for the catheters compatible with 0.035 in (0.89mm) guidewires. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. The catheter includes a tapered tip to facilitate advancement of the catheter. The working lengths of the balloon catheter range between 10 mm and 280 mm. and are selected based on patient requirements for PTA. The radiopaque marker(s) (see RMD in Figure 1) are placed beneath the "usable balloon length" of the balloon and are visible when used in conjunction with fluoroscopy and aid in the placement of the balloon. The effective length could increase by 1 cm in a fully hydrated state.

Each balloon inflates to the stated diameter and length at a specific pressure. The maximum rated burst pressure is different for each size. It is important that the balloon not be inflated beyond the rated burst pressure.

The proximal portion of the catheter includes one female luer-lock port connected to the inflation lumen, and one female luer-lock port for the guidewire lumen. The devices can be supplied with and without hydrophilic coating. The hydrophilic coating when applied is applied proximally to the balloon for a length of 20 mm and 40 mm.

Each PTA Balloon Catheters (PVQ) is packaged as follows:

• . The balloon is protected within a protective tube with an inner lumen protective stainless-steel wire.
• The entire catheter is provided in a Polyethylene or Poly propylene Protectivetubing ● spiral dispenser.
• The protected catheter is placed in a Tyvec pouch, which is sealed to form the sterile ● barrier.
• Then the pouch is placed into an outer box. .

The PTA Balloon Catheters (PVQ) is used with commercially available sheath introducers, guide catheter and guidewires. These are not included with the PTA Balloon Catheter (PVQ).

The provided text is a 510(k) summary for the QualiMed USA PTA Balloon Catheter (PVQ). It describes the device, its intended use, and the testing performed to demonstrate substantial equivalence to predicate devices. However, this document does not describe the acceptance criteria or a study proving the device meets said criteria in the format requested for AI/ML devices.

The document outlines performance testing for a medical device (a balloon catheter), which involves established engineering and biocompatibility tests to ensure the catheter's physical characteristics, safety, and functionality. These tests are not AI/ML-related performance studies.

Therefore, I cannot extract the requested AI/ML specific information from this document. The concepts of "test set," "training set," "ground truth," "experts," "adjudication," and "MRMC studies with AI assistance" are not applicable to the type of device and testing described in this 510(k) summary.

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