(13 days)
The VasoView® 6 Harvesting Cannula is intended for cutting and coagulation of tissue and providing access in minimally invasive vessel harvesting procedures for patients undergoing coronary artery bypass grafting.
The VasoView® 6 Harvesting Cannula has applications in minimally invasive surgery and is primarily indicated for patients undergoing endoscopic surgery for vessel harvesting. It is indicated for cutting tissue and controlling bleeding through coagulation in general and cardiothoracic surgery including minimally invasive direct coronary artery bypass (MIDCAB), lower extremity and thoracoscopic procedures. Lower extremity procedures include tissue dissection/vessel harvesting along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass. Thoracoscopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall.
The VasoView 6 Harvesting Cannula is a disposable device designed to perform endoscopic cutting and coagulation, including vessel isolation and division of vessel branches. The device has a tubular cannula for introduction of instrumentation into the surgical site with a proximal handle to hold and control the device during procedures. A lumen of the cannula allows insertion of an endoscope for illumination and visualization of the procedure. Extension, retraction and actuation of the transector cutting and coagulation tool is achieved with controls located on the handle.
The provided text describes a 510(k) premarket notification for the VasoView®6 Harvesting Cannula. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
The document primarily focuses on establishing substantial equivalence to a predicate device (VasoView 5 Harvesting Cannula) based on:
- Intended Use: Identical.
- Technological Characteristics: Similar, with minor modifications (blades, electrode configuration, bipolar tool rotation, insufflation capability).
- Materials, Manufacturing Processes, and Components: Identical.
Therefore, I cannot fulfill your request for the tables and study details as they are not present in the provided text. The submission is a regulatory filing, not a clinical study report.
§ 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.