Search Results

The VivaTip™ Microwave Ablation Probe is intended for coagulation of soft tissue. Not for use in cardiac procedures.

The VivaTip Microwave Ablation Probe is a needle-like device that is inserted into soft tissue and coagulates a volume of tissue surrounding the active area of the probe. The probe is to be used with the VivaWave™ microwave power generator. Accessories to assist in cooling the shaft of the probe and to hold multiple probes together for simultaneous ablation are included.

This premarket notification (510(k)) does not contain the requested information about acceptance criteria and a study proving the device meets those criteria. The provided text is a 510(k) summary and the FDA's response letter, which primarily focuses on establishing substantial equivalence to predicate devices rather than providing detailed performance study results against specific acceptance criteria.

Here's what can be inferred and what is explicitly missing from the provided text:

Inferences from the provided text:

• Device Type: Microwave Ablation Probe. The purpose is for coagulation of soft tissue.
• Regulatory Pathway: 510(k), which implies that the device is being compared to substantially equivalent predicate devices rather than proving safety and effectiveness de novo through extensive clinical trials.
• Substantial Equivalence: The FDA determined the device to be substantially equivalent to the predicate devices (VivaWave™ Microwave Ablation System K011676 and Tri-Loop™ Microwave Ablation Probe K032047) based on "indications for use, basic overall function, methods of manufacturing, and materials used." This suggests that the performance characteristics (e.g., coagulation size, temperature profile) are considered similar enough to the predicates that a new detailed study proving specific acceptance criteria might not have been a primary requirement for this 510(k) clearance.

Missing Information (and why it's missing from this type of document):

The provided text is a 510(k) summary, which is a high-level overview. Detailed performance studies and acceptance criteria are typically found in the full 510(k) submission, which is not publicly available in its entirety. The summary focuses on establishing equivalence rather than detailing internal validation studies.

Therefore, I cannot provide the requested table or detailed study information based solely on the provided text. To answer your questions, I would need access to the full 510(k) submission document, particularly the sections related to performance testing and validation.

Ask a specific question about this device