(384 days)
The VivaWave™ Microwave System is intended for coagulation of soft tissue
The VivaWave™ Microwave System consists of an external microwave generator and probe. The generator is manually set at the desired power levels by the operator. Procedure time is also preset by the operator. The generator is connected to the probe through a connector.
The external generator unit measures approximately ( 13"H x 17"W x 3.5"D) The exterior housing is formed of aluminum coated with plastic.
The unit contains electric circuits, circuit boards, and integrated control panel. The major components of the generator are cooling fans, power supply, microwave module and the front panel/control board assembly.
The probe is a specifically designed antenna coated with Teflon (PTFE). The probe is permanently attached to a cable that carries the energy from the generator to the tip of the probe. The proximal end of the cable has a connector that fits into the generator and allows the energy to be delivered to the probe.
I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets those criteria. The provided document is a 510(k) premarket notification letter from the FDA, a summary of the device, its intended use, and a comparison to predicate devices for substantial equivalence.
It outlines:
- The device name: VivaWave™ Microwave System
- Its intended use: Coagulation of soft tissue.
- That it consists of an external microwave generator and a probe.
- Electrical safety, electromagnetic compatibility, and biocompatibility testing were performed to comply with standards (EN60601-1, EN60601-1-2, ISO 10993).
However, it does not include:
- A table of acceptance criteria and reported device performance.
- Details on sample size, data provenance, or expert involvement in any studies.
- Information on adjudication methods.
- Data from multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Specifics on ground truth establishment or training set details.
The document primarily focuses on establishing substantial equivalence to previously marketed devices based on indications for use, basic function, manufacturing methods, and materials, rather than presenting detailed performance study results against specific acceptance criteria.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.