(102 days)
Renuvion® APR Handpiece is intended for the delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures.
The Renuvion® APR Handpiece is indicated for use in subcutaneous dermatological and aesthetic procedures to improve the appearance of lax (loose) skin in the neck and submental region.
The Renuvion® APR Handpiece is intended to be used with compatible electrosurgical generators owned by Apyx Medical (specifically BVX-200H, BVX-200P, APYX-200H, APYX-200P, APYX-RS3, and APYX-JS3).
The Renuvion® APR Handpiece is a sterile, single-use electrosurgical (monopolar) device intended to be used in conjunction with compatible electrosurgical generators. 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. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas passes over the energized electrode, a helium plasma is generated for soft tissue cutting, coaqulation or ablation.
The Renuvion® APR Handpiece has a non-extendable electrode to generate helium plasma. The handpiece is available in two different lengths: 15cm and 27cm. The 15cm length is available in a single port (APYX-15-SP) as well as a twin port configuration (APYX-15-TP). The 27cm length is only available with a twin port configuration (APYX-27-TP).
The provided document describes the K220970 Premarket Notification for the Renuvion APR Handpiece. The focus of this submission is not on a new device but on an expanded indication for use for an existing, previously cleared device (Renuvion APR Handpiece, cleared under K191542). Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are specifically related to proving the safety and effectiveness of the device for this new indication, rather than the core functionality of the electrosurgical device itself, as no modifications were made to the hardware.
Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are effectively the primary and safety endpoints defined for the clinical study.
| Acceptance Criterion (Endpoint) | Reported Device Performance |
|---|---|
| Primary Effectiveness Endpoint: Improvement in the appearance of lax tissue in the neck and submental region at 180-days as determined by 2 out of 3 blinded Independent Photographic Reviewers. | 82.5% (52/63 subjects demonstrated improvement, with a 97.5% one-sided lower CL=70.9%, p |
§ 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.