(133 days)
The Pioneer Laboratories Elec-Trocar is intended to be used in general surgical procedures to place a wound drain for evacuation of serosanguineous fluid, blood, pus, or other bodily fluids.
The device is used in general surgical procedures to place a wound drain by electrocautery action for extraction of serosanguineous fluid, blood, pus, or other bodily fluids.
The Pioneer Laboratories Elec-Trocar is a wound drain placement device. It cuts with radio frequency energy supplied by an electrosurgical generator to create a tunnel from the inside cavity of the wound through the skin. The Elec-Trocar is composed of an insulated wire, a drain tube surrounding the wire, and an exposed cutting tip, which is connected to the wire and positioned at the distal end of the tube. The proximal end of the wire connects to a conventional electrosurgical generator with an adapter. The electrosurgical current is activated with the generator's footswitch controls.
The cutting tip is positioned inside the wound area, and the Elec-Trocar is activated electrically via the footswitch. The cutting tip is advanced through the tissue, toward and through the skin. After the entire hand grip is positioned outside the skin, the wire is detached from the generator and the hand grip is cut off. The insulated wire is then pulled from the drain tube retrograde through the wound, leaving the drain tube in the tissue tunnel.
The provided text is a 510(k) summary for the Pioneer Elec-Trocar Device, seeking substantial equivalence to predicate devices. It describes the device's function, intended use, and technological characteristics. However, it does not contain any information regarding acceptance criteria, study design, reported device performance, sample sizes, ground truth establishment, or expert involvement for a study proving the device meets acceptance criteria.
The document is a regulatory submission for premarket notification (510(k)) to the FDA, which focuses on demonstrating substantial equivalence to already legally marketed devices, rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics.
Therefore, I cannot fulfill your request for the specific details of a study and its results because this information is not present in the provided text.
§ 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.