E2590 - B, ARGON ACCESSORY WITH BLADE ELECTRODE AND E2590 - N, ARGON ACCESSORY WITH NEEDLE ELECTRODE

• K Number: K962690
• Device Name: E2590 - B, ARGON ACCESSORY WITH BLADE ELECTRODE AND E2590 - N, ARGON ACCESSORY WITH NEEDLE ELECTRODE
• Manufacturer: VALLEYLAB, INC.
• Date Cleared: 1996-11-04 ( 116 days)
• Product Code: GEI
• Regulation Number: 878.4400
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: N/A

Intended Use

The E2590-B & E2590-N Argon Accessories are intended for use in open surgical procedures where argon-enhanced monopolar electrosurqery is desired.

Device Description

The E2590-B & E2590-N Argon Accessories are sterile, single use, fixed electrode devices which allow for the introduction of argon gas around the electrosurgical electrode of an electrosurgical pencil. The Argon Accessories are designed for use with the following Valleylab Handswitching Pencils: E2515 & E2516, E2525, E2550 & E2555.

AI/ML Overview

This document describes the safety and effectiveness of the E2590-B & E2590-N Argon Accessories. However, it does not contain information about acceptance criteria or a study proving device performance in the way typically associated with AI/ML-driven medical devices.

The provided text focuses on:

• Intended Use: Open surgical procedures requiring argon-enhanced monopolar electrosurgery.
• Device Description: Sterile, single-use, fixed electrode devices introducing argon gas around an electrosurgical electrode, designed for specific Valleylab Handswitching Pencils.
• Biological Safety: Assured through material selection for biocompatibility.
• Conformity to Standards: Compliance with IEC 601-1 (1988), IEC 601-2-2 (1991), and ANSI/AAMI HF18 (1993) for medical electrical equipment and electrosurgical devices.

Therefore, I cannot extract the requested information regarding acceptance criteria and performance studies in the context of AI/ML evaluation from this document. The concepts of "acceptance criteria," "device performance," "sample size," "ground truth," "MRMC studies," "standalone performance," and "training set" as they relate to AI/ML device validation are not present in this regulatory submission for a conventional medical device.

Regulation Number and Section

§ 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.