(149 days)
Trapper Exchange Device is indicated to facilitate interventional device exchange while maintaining wire position in patients undergoing PCI procedures. Trapper Exchange Device is not intended for use outside of the guide catheter.
Boston Scientific Trapper" Exchange Device is an accessory device used to facilitate interventional device exchange while maintaining wire position in patients undergoing Percutaneous Coronary Intervention (PCI) procedures. Trapper" Exchange Device is a fixed wire catheter that has a balloon near the distal tip. The 10mm balloon is designed to secure a 0.014inch wire within a 6F to 8F guide catheter when inflated to 12atm. There is a 1mm radiopaque marker band in the tip and a 2mm marker band at the proximal edge of the balloon to facilitate its placement and identification during catheter exchanges. Trapper" Exchange Device has a single lumen luer hub for inflation and deflation of the balloon. The proximal shaft has markings with an adjustable stop for 90cm and 100cm guide catheter lengths to facilitate balloon placement. The proximal stop is pre-set for a 90cm guide.
Trapper" Exchange Device is designed for use with guide catheters having internal lumen diameters in the range of 6F (0.070inch or 1.7mm) to 8F (0.091inch or 2.3mm) and lengths ≥ 90cm. In 6F guide catheters the PCI catheter to be exchanged must have a shaft OD (Outer Diameter) ≤ 3.2F (0.043inch or 1.1mm).
The set is supplied as a single use sterile device.
I am sorry, but the provided text does not contain the specific information required to answer your request about acceptance criteria and the study proving the device meets them. The document is a 510(k) premarket notification summary for the Trapper™ Exchange Device, which states that clinical studies were not deemed necessary.
Therefore, I cannot provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for the test set and data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
- Information on a standalone algorithm performance study.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical engineering tests and a literature review, rather than presenting results from a study against specific acceptance criteria for performance metrics.
§ 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).