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The VivaWave™ Microwave Ablation System is intended for coagulation of soft tissue. The Coaxial Introducer is intended to aid insertion of the microwave energy applicator component of the system. The system is not intended for use in cardiac procedures.

The VivaWave™ Microwave Ablation System consists of a microwave power generator and a disposable probe that is the microwave energy applicator. The disposable probe is inserted into soft tissue to coagulate a volume of tissue surrounding the active area of the probe. The Coaxial Introducer may be used to aid insertion of the microwave energy applicator.

The provided text describes a 510(k) submission for a medical device called the "Coaxial Introducer," which is part of the VivaWave™ Microwave Ablation System. This submission is for market clearance through substantial equivalence to predicate devices, not for proving a new device's performance against specific acceptance criteria through a clinical study.

Therefore, the document does not contain any information about:

1. Acceptance criteria and reported device performance: This type of information is typically found in design validation or clinical study reports, which are not part of this 510(k) summary. The summary focuses on showing equivalence to existing devices.
2. Sample size used for the test set and data provenance: No test sets or clinical studies are mentioned.
3. Number of experts and their qualifications for ground truth: Not applicable here as no ground truth establishment is described.
4. Adjudication method for the test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned. The focus is on the device itself, not on human reader performance with or without AI.
6. Standalone (algorithm only) performance: Not applicable, as this is a physical medical device, not an AI algorithm.
7. Type of ground truth used: No ground truth is established or discussed.
8. Sample size for the training set: Not applicable, as no training set for an algorithm is discussed.
9. How the ground truth for the training set was established: Not applicable.

Summary of available information related to equivalence:

The 510(k) summary states that the Coaxial Introducer, as an accessory to the VivaWave™ Microwave Ablation System, is substantially equivalent to predicate devices. The basis for this claim is:

• Indications for use: "The VivaWave™ Microwave Ablation System is intended for coagulation of soft tissue. The Coaxial Introducer is intended to aid insertion of the microwave energy applicator component of the system. The system is not intended for use in cardiac procedures." This is similar to the predicate device K011676.
• Basic overall function: The Coaxial Introducer aids in the insertion of the microwave energy applicator.
• Methods of manufacturing: Implied to be similar to existing devices.
• Materials used: "All patient contact materials used in the manufacture of the Coaxial Introducer are suitable for this use and have been used in numerous previously cleared products."

In conclusion, this 510(k) submission seeks market clearance based on substantial equivalence, not on the demonstration of specific acceptance criteria met through a performance study.

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