(76 days)
The Renuvion®/J-Plasma® Precise Handpiece is intended to be used with compatible J-Plasma electrosurgical generators for the delivery of helium plasma for cutting, coagulation of soft tissue during open and laparoscopic surgical procedures.
The Renuvion®/J-Plasma® Precise Open Handpiece is intended to be used with compatible J-Plasma electrosurgical generators for the delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures. The Renuvion®/J-Plasma® Precise Open® Handpieces are compatible with electrosurgical Generators BVX-200H, and BVX-200P.
The Renuvion/J-Plasma Handpieces are sterile, single use electrosurgical accessories intended to be used in conjunction with compatible electrosurgical generators for the delivery of helium gas plasma for cutting, coagulating soft tissue. The compatible Generators operate at an adjustable power of up to 40W (expressed as 0-100% is 40W) and provide an adjustable helium gas flow of 1-5 LPM. The Renuvion/J-Plasma Handpieces are available with a retractable cutting blade tip for excising tissue. The blade tip serves as an electrode to generate helium plasma.
The Renuvion/J-Plasma Precise devices are available in 15cm, 27cm and 33cm lengths for use in laparoscopic or open surgical procedures. The 27cm are standard lengths for laparoscopic instruments and are compatible with standard 5mm trocars.
The Renuvion/J-Plasma Precise Open devices are available in 44mm and 150mm for used in open surgical procedures.
This document describes the Renuvion/J-Plasma Precise Handpiece and Renuvion/J-Plasma Precise Open Handpiece, intended for use with compatible electrosurgical generators for soft tissue cutting, coagulation, and ablation during open and laparoscopic surgical procedures.
Here's an analysis of the acceptance criteria and the supporting studies:
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Table of acceptance criteria and the reported device performance:
Test / Acceptance Criteria Reported Device Performance Mechanical & Electrical Verification and Functionality Pneumatic Testing Verified Electrical Continuity Test Verified Cable Flexure / Tension Test Verified Connector Dielectric Strength Test Verified Mold Stress Test Verified Free-fall Drop Test Verified Insertion/Extraction Integrity (Reduced insertion/extraction force to plug/unplug) Verified (The document specifically notes a reduction in insertion/extraction force compared to predicate devices, indicating this was a design change tested and met) Usability Evaluation Protocol executed to verify and validate usability "as it relates to safety." (Satisfactorily conducted) Biocompatibility Testing (for external communicating device with indirect blood path,
§ 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.