(90 days)
Single-use, bipolar forceps are intended for bipolar coagulation to remove tissue and control bleeding by use of high frequency electrical current.
The bipolar forceps must be operated with the following parameters:
-Frequency range between 300 kHz-1,000 kHZ;
-Maximum generator operating voltage 600Vp.
HG Innovations Ltd.'s Electrical Surqical Instruments encompass a wide variety of instruments that are widely used in the medical industry. Electrosurgical forceps and electrodes have been used in surgery for many years. The single-use, bipolar forceps (various lengths and designs), with preattached cables are designed to grasp, manipulate and coagulate soft tissues and are intended for use by a physician familiar with electrosurgery in bipolar coagulation for general open surgery where coagulation of soft tissue is needed. The blood vessel or tissue is grasped between the forceps tines, each of which acts as an electrode, and current passes to desiccate and coagulate the tissue. Bipolar forceps are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Bipolar forceps must only be used with bipolar coagulation current.
This FDA 510(k) summary provides information for a Single Use Bipolar Forceps (K230432).
Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:
Important Note: This document is a 510(k) Summary for a medical device (bipolar forceps), not a diagnostic AI software. Therefore, many of the typical AI/ML study components like multi-reader multi-case (MRMC) studies, expert ground truth adjudication for complex interpretations, and training set details are not applicable here. The "acceptance criteria" discussed are largely related to engineering performance and biological safety, not diagnostic accuracy.
1. Table of Acceptance Criteria and Reported Device Performance:
| Criteria/Test | Acceptance Criteria (Implied/Defined) | Reported Device Performance/Result |
|---|---|---|
| Biocompatibility (ISO 10993-1) | ||
| Cytotoxicity (ISO 10993-5) | Non-Cytotoxic | Non-Cytotoxic (Same as predicate) |
| Irritation (ISO 10993-23) | Non-Irritating | Non-Irritating (Same as predicate) |
| Sensitization (ISO 10993-10) | Non-Sensitizing | Non-Sensitizing (Same as predicate) |
| Pyrogenicity (USP151) |
§ 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.