NON-STERILE HOLSTER, STERILE HOLSTER MODEL ESH1-NS, ESH1, ES PENCIL W/ HOLSTER, ES SMOKE & FLUID PENCIL W/ HOLSTER MODEL

• K Number: K981614
• Device Name: NON-STERILE HOLSTER, STERILE HOLSTER MODEL ESH1-NS, ESH1, ES PENCIL W/ HOLSTER, ES SMOKE & FLUID PENCIL W/ HOLSTER MODEL
• Manufacturer: AARON MEDICAL INDUSTRIES
• Date Cleared: 1998-07-17 ( 72 days)
• Product Code: GEI
• Regulation Number: 878.4400
• Type: Traditional
• Panel: General & Plastic Surgery
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The Aaron Electrosurgical Pencil Holster is supplied sterile, and is designed to hold an electrosurgical pencil in the operating room when not in use.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA to Aaron Medical Industries regarding their Electrosurgical Pencil Holster. This document is related to device clearance rather than the performance study of a device. Therefore, it does not contain the detailed information necessary to answer most of the questions about acceptance criteria and a study proving device performance as it pertains to AI/algorithm-based medical devices.

Specifically, this document does not contain:

• A table of acceptance criteria and reported device performance.
• Information on sample sizes, data provenance, or ground truth establishment for a performance study.
• Details about expert involvement, adjudication methods, or MRMC comparative effectiveness studies.
• Information about standalone algorithm performance or training set details.

The letter explicitly states that the device is "substantially equivalent" to predicate devices, which is the basis for its clearance. This process typically relies on demonstrating that the new device has the same intended use and technological characteristics as a legally marketed predicate device, or if there are differences, that those differences do not raise new questions of safety and effectiveness. It does not typically involve a de novo clinical performance study with specific acceptance criteria as you would find for a novel diagnostic or AI-driven device.

The "Indications For Use" provided are simply a description of how the device is intended to be used: "The Aaron Electrosurgical Pencil Holster is supplied sterile, and is designed to hold an electrosurgical pencil in the operating room when not in use." This is not an acceptance criterion related to diagnostic or evaluative performance.

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.