(56 days)
The Renuvion®/J-Plasma® Precise Handpiece is intended to be used with compatible electrosurgical generators for the delivery of helium plasma for cutting, coagulation and ablation of soft tissue during open and laparoscopic surgical procedures.
The Renuvion®/J-Plasma® Precise Handpiece is compatible with the Electrosurgical Generators BVX-200H and BVX-200P manufactured by Apyx Medical.
The Renuvion®/J-Plasma® Precise Handpiece is a sterile, single use electrosurgical accessory intended to be used in conjunction with compatible electrosurgical generators for the delivery of helium gas plasma for cutting, coagulating, and ablating soft tissue. The compatible Generators operate at an adjustable power of up to 40W (expressed as 0-100% where 100% is 40W) and provide an adjustable helium gas flow of 1-5 LPM. The Renuvion/J-Plasma Precise Handpiece is available with a retractable cutting tip blade for excising tissue. The blade tip serves as an electrode to generate helium plasma.
The blade can be extended in 2mm increments from 0 to 10mm from the distal tip of the shaft via a ratcheted slider and retracted via a release latch. The device is activated via pressing the purple activation trigger. The handpiece is to be used with compatible electrosurgical generators, BVX-200H or BVX-200P, manufactured by Apyx Medical.
The Renuvion®/J-Plasma® Precise Handpiece is available in a 33 cm length for use in laparoscopic or open surgical procedures. The 33 cm is a standard length for laparoscopic instruments and are compatible with standard 5 mm trocars.
The provided document is a 510(k) Premarket Notification from Apyx Medical Corporation for their Renuvion®/J-Plasma® Precise Handpiece (Model # BVX-330 BPS). This submission describes a modification of an already cleared device and aims to demonstrate substantial equivalence to previously marketed predicate devices. Therefore, the "acceptance criteria" and "device performance" described are focused on proving this equivalence through various tests rather than establishing initial clinical efficacy with novel endpoints.
Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria / Test Objective | Reported Device Performance (Result) |
|---|---|
| Mechanical Performance & Functionality: Verify Mechanical functionality of the Renuvion®/J-Plasma® Precise Handpiece. | Mechanical functionality requirements met. |
| Tissue Effect (Plasma Activation): Verify that the tissue effects are similar between the subject device and the Primary Predicate device (K183610 & K151325). | Tissue effects are equivalent between the subject device and Primary Predicate device. |
| Tissue Effect (Monopolar Coagulation): Verify that the tissue effects are similar between the subject device and the Reference device (K183610 & K170188). | Tissue effects are equivalent between the subject device and Reference device. |
| Electrical Safety: Compliance with IEC 60601-1 and IEC 60601-2-2 standards. | Determined to be in conformance with these standards. |
| Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2 standard. | Determined to be in conformance with this standard. |
| Biocompatibility: Evaluation in accordance with FDA guidance "Use of International Standard ISO 10993-1" for cytotoxicity, sensitization, irritation, systemic toxicity, hemolysis, and material mediated pyrogen/pyrogenicity. | Biocompatibility has been established per ISO 10993 guidelines for the device's classification (external communicating device with indirect blood path contact |
§ 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.