(21 days)
The Viveve 2.0 System is indicated for use in general surgical procedures for electrocoagulation and hemostasis.
The Viveve® 2.0 System consists of four (4) primary components:
- . An RF Generator to provide the heating energy. The Generator incorporates the Cooling Module to supply coolant which provides the cooling energy.
- . A hand piece that couples the cooling and heating energy to the tissue through the treatment tip.
- A footswitch that allows the user to turn the RF Energy on or off.
- . 5cm or 8cm Sterile Disposable Treatment Tips.
Accessories include:
- Coupling Fluid
- Cryogen ●
- Return Cable ●
- Return Pad ●
- . Power Cord
The provided document describes the Viveve 2.0 System, an electrosurgical device that delivers radiofrequency energy. The primary change in this 510(k) submission (K193611) compared to its predicate device (K190422) is the addition of Contact Quality Monitoring (CQM) software and a modified user interface. The study focuses on demonstrating the safety and effectiveness of this added feature.
Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| CQM Contact Resistance Measurement | 0 to 200 Ω with ±10% (100 Ω - 200 Ω range) and ± 10 Ω accuracy ( |
§ 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.