(122 days)
The Apyx Plasma/RF Handpiece is intended to be used with compatible electrosurgical generators for the delivery of radiofrequency energy and/or helium plasma for cutting, coagulation of soft tissue during open surgical procedures. The Apyx Plasma/RF Handpiece is compatible with the Electrosurgical Generators, BVX-200H and BVX-200P, owned by Apyx Medical.
The Apyx Plasma/RF Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of 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. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation.
The Apyx Plasma/RF 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 text describes the performance data for the Apyx Plasma/RF Handpiece (K191542) to demonstrate its substantial equivalence to predicate devices, focusing on non-clinical testing.
Here's the breakdown of the acceptance criteria and the studies that prove the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
This section synthesizes the various tests and their outcomes as presented in the document.
| Test Category | Acceptance Criteria/Objective | Reported Device Performance/Result |
|---|---|---|
| Bench Testing | ||
| Mechanical Verification & Functionality | Verify mechanical functionality of the Apyx Plasma/RF Handpiece. | Mechanical functionality requirements met. |
| Energy & Power Output | Verify via calorimetric testing that the tissue effects are equivalent between the subject device (Apyx Plasma/RF Handpiece), primary predicate device (Renuvion/J-Plasma® Precise Open Handpiece - K183610 & K170188), and predicate device (Renuvion/J-Plasma® Precise Handpiece - K183610 & K151325). Aim to show all deliver the same amount of energy to tissue at equivalent generator settings. | There are no significant differences in energy and power outputs between the subject device, Primary Predicate devices owned by Apyx Medical; all 3 devices will deliver the same amount of energy to tissue at equivalent generator settings. |
| Electrical Safety & EMC | ||
| Standards Compliance | Complies with ANSI/AAMI/IEC 60601-1:2015/(R)2012 and A1:2012, AAMI/ANSI/IEC 60601-2-2:2017 for safety, and AAMI/ANSI/IEC 60601-1-2:2014 (4th Edition) for EMC. | The Apyx Plasma/RF System was determined to be in conformance with these standards. |
| Biocompatibility Testing | ||
| ISO 10993 Compliance | Evaluation in accordance with FDA Guidance "Use of International Standard ISO 10993-1" and AAMI/ANSI/ISO 10993-1:2009/(R2013). Focus on cytotoxicity, sensitization, systemic toxicity, irritation, hemolysis, and material-mediated pyrogen/pyrogenicity for an external communicating device with an indirect blood path contact for |
§ 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.