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The VivaWave™ Microwave Ablation System is intended for coagulation (ablation) of soft tissue.

The VivaWave™ Microwave Ablation System is not intended for use in cardiac procedures.

Valleylab recommends against the use of microwave ablation in the following situations:

• . Pregnant patients - potential risks to the patient and/or fetus have not been established.
• Patients with implantable pacemakers and other electronic . implants. Implanted electronic devices may be adversely affected by microwave power output.

The VivaWave™ Microwave Ablation System consists of one or two microwave output modules and a pump for circulating cooling fluid, installed in an integrated cart. Each microwave module has three output channels, allowing one, two, or three microwave antennas (a.k.a. probes, applicators, accessories, or instruments) to be used simultaneously. Multiple antennas may be positioned to ablate separate areas, or placed closer together to produce larger single ablations. Each output channel is limited to 65 watts maximum; a microwave module can power all three channels simultaneously at full power if desired. Systems with two microwave modules have six output channels available for simultaneous use.

Microwave module controls provided to the operator include ablation power and ablation time. All output channels that have an antenna connected operate simultaneously. Each channel receives the same power, corresponding to the power setting on the microwave module front panel. Power delivery is initiated by pushing the Ablate button on the microwave module front panel. Power delivery continues until the duration time setting is reached, or until the Ablate button is pushed again.

The VivaWave™ Microwave Ablation System is designed for use with proprietary microwave antennas such as those cleared for Vivant Medical in submissions K011676 and K032702. (Note: Vivant Medical is owned by Valleylab, a Division of Tyco Healthcare Group LP.) The antennas are connected to the VivaWave System with a proprietary connector incorporating an identification device that allows the microwave module to verify that a correct antenna is attached.

Antennas designed for percutaneous use are cooled internally with sterile saline. They are connected to the VivaWave system cooling fluid pump via sterile tubing. The pump has capacity to supply coolant to six antennas simultaneously if desired. The microwave module monitors coolant temperature within each antenna using an internal thermocouple. Delivery of microwave energy is stopped if an unsafe temperature is reached. Coolant is confined within the antenna and tubing, and does not contact the patient. The pump is controlled by an ON/OFF/Speed Control switch located adjacent to the pump.

Each microwave module can also accommodate up to three proprietary auxiliary temperature probes. (Existing device, refer to K031556.) When auxiliary temperature probes are in use, the temperature at the probe tip is displayed on the microwave module front panel. Auxiliary temperature probes are not required for operation of the VivaWave™ system.

Here's an analysis of the provided text regarding the VivaWave™ Microwave Ablation System, structured to address your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific, quantifiable acceptance criteria or report performance metrics in a way that suggests a formal acceptance criteria table. Instead, it describes general performance testing to ensure the device "functions as intended, and meets design specifications." The primary "performance data" presented is that the device was found to be "substantially equivalent" to its predicate device. This substantial equivalence determination inherently suggests that the device performs comparably to the predicate, which is itself a legally marketed device.

Therefore, since explicit criteria and direct performance values are absent, I cannot create such a table from the given information. The "performance" assessment is based on regulatory substantial equivalence rather than a detailed list of engineering or clinical performance metrics.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a sample size for a "test set" in the context of clinical or performance data. The performance data section vaguely states, "Performance testing was performed to ensure that the VivaWave™ Microwave Ablation System functions as intended, and meets design specifications. Sufficient data were obtained to show that the device is substantially equivalent to the predicate device, and meets safety and effectiveness criteria."

There is no mention of data provenance (e.g., country of origin, retrospective or prospective) for any performance data. The focus is on technical equivalence to a predicate device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The submission is a 510(k) for substantial equivalence, which often relies more on engineering and design specifications compared to a predicate device than on extensive clinical trials with expert-adjudicated ground truth.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or described in the provided text. The document focuses on the device's technical specifications and its substantial equivalence to a predicate device, not on assessing human reader performance with or without AI assistance. The VivaWave™ system is an ablation device, not an AI diagnostic tool.

6. Standalone (i.e. algorithm only without human-in-the-loop performance) Study

This concept is not applicable to the VivaWave™ Microwave Ablation System as described. It is a medical device for tissue ablation, not an AI algorithm. Its "performance" would be related to its ability to ablate tissue effectively and safely, as demonstrated through engineering tests and comparison to a predicate, rather than an "algorithm only" performance.

7. Type of Ground Truth Used

The document does not detail specific "ground truth" establishment in a clinical sense. The "ground truth" for this 510(k) submission appears to be regulatory substantial equivalence to the predicate device (Vivant Medical VivaWave™ Microwave System K011676). This implies that if the new device functions similarly and meets the same safety and effectiveness criteria as the predicate, it is considered safe and effective. The "Performance Data" section states, "Sufficient data were obtained to show that the device is substantially equivalent to the predicate device, and meets safety and effectiveness criteria."

8. Sample Size for the Training Set

The document does not mention a "training set" as would be relevant for an AI or machine learning model. The VivaWave™ system is a hardware device with software controls, not a learning algorithm that undergoes traditional "training."

9. How the Ground Truth for the Training Set Was Established

As no "training set" is described for this device, the question of how its ground truth was established is not applicable.

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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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