Search Results

The Triumph™ VTX® Port with LifeValve® Catheter is a totally implantable vascular access system intended for the delivery of medications, intravenous fluids, parenteral nutrition solutions or blood products. The Triumph™ VTX® Port with LifeValve® Catheter is also indicated for the withdrawal of blood samples.

The Triumph™ VTX® Port with LifeValve® Catheter is a device comprised of a vascular access port and a catheter. The Triumph™ VTX® Port is available in a titanium or polysulfone configuration with a self sealing silicone rubber septum designed to maintain integrity after repeated punctures with an anti-coring needle. The LifeValve® Catheter incorporates a bidirectional valve assembly at the distal tip. The catheter is equipped with a pre-threaded stiffening stylet to facilitate passage of the catheter through the introducer. The positioned LifeValve® Catheter is secured to the Triumph™ VTX® Port reservoir with a locking mechanism. The products are packaged in a sterile tray with an introducer kit and components.

The provided text is a 510(k) summary for a medical device (Triumph™ VTX® Port with LifeValve® Catheter) seeking clearance from the FDA. It does not contain information about a study proving the device meets acceptance criteria.

Instead, the document focuses on demonstrating substantial equivalence to previously cleared predicate devices, which is a different regulatory pathway than proving a novel device meets predefined acceptance criteria through performance studies.

Therefore, I cannot provide the requested information, which includes a table of acceptance criteria and reported performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The document explicitly states:

• "No new questions of safety or effectiveness for implantable ports or central venous catheters were raised by the risk analysis or testing of the Triumph™ VTX® Port with LifeValve® Catheter."
• "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices..."

This indicates that the clearance was based on similarity to existing devices, not on direct performance testing against specific acceptance criteria for a novel functionality.

Ask a specific question about this device