(551 days)
The POTENZA is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
The POTENZA is an RF (radiofrequency), software-controlled electrosurgical device used for electrocoagulation of soft tissue and hemostasis. The POTENZA generates radiofrequency (RF) energy by means of high RF at 1MHz or 2MHz. The RF energy is delivered through the skin into the target tissue via a handpiece equipped with an electrode tip. As the RF energy passes through the tissue, it generates an electrothermal reaction which is capable of coagulating the tissue. The POTENZA has two operating modes: monopolar mode and bipolar mode. The NEW POTENZA consists of the following components: Electrosurgical Unit - Main body, handpieces (Predicate Device have Motor, AC handpieces), electrode tips for the handpiece – Add three non-invasive tips connect to S handpiece, Neutral electrode pad and neutral electrode pad cable, cleared under K201685, Handpiece stand, Foot switch, Power cord.
This 510(k) summary describes a device (POTENZA) that is substantially equivalent to a previously cleared predicate device. The key changes are the addition of a new S handpiece and three new non-invasive electrode tips. The provided text primarily focuses on demonstrating the safety and effectiveness of these additions through non-clinical testing rather than complex AI performance studies. As such, many of the requested points regarding AI acceptance criteria, MRMC studies, and large-scale data sets are not directly applicable or available in this specific document.
However, based on the provided text, we can describe the acceptance criteria and study that proves the device meets them as they relate to the changes in the device.
1. Table of Acceptance Criteria and Reported Device Performance
For the specific changes (new S handpiece and non-invasive tips), the acceptance criteria are generally focused on safety and functionality demonstrating equivalence to the predicate device.
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from text) | Reported Device Performance (as stated or inferred) |
|---|---|---|
| Biocompatibility | All four newly added electrode tips must pass biocompatibility tests (Cytotoxicity, Sensitization, Skin Irritation) as per ISO 10993 standards for devices with limited skin 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.