(161 days)
The DeRoyal Cautery Pencil is indicated for use whenever an electrosurgical procedure requires the removal of tissue or the control of bleeding by either cutting or coagulation.
The DeRoyal Industries, Inc. Electrosurgical Cautery Pencil functions in the same manner as predicate devices in that it is intended to be used in electrosurgical procedures to remove tissue and control bleeding. The device can be used for both cutting and coagulating. Device Design/Materials Used/Physical Properties: The DeRoyal Industries, Inc. Electrosurgical Cautery Pencil is made of materials commonly used for their purpose. The concept of use is intended to remove tissue and control bleeding by use of high frequency electrical current.
This document describes a 510(k) summary for the DeRoyal Industries, Inc. Electrosurgical Cautery Pencil, which appears to be a traditional medical device and not an AI/ML-driven device.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment, which are typically relevant for AI/ML device evaluations, are not applicable to this submission.
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (DeBusk Technology Corporation) based on design, materials, intended use, and technological characteristics. The "predicate or legally marketed devices" section and the "technological comparison with predicate or legally marketed device(s)" table confirm this approach.
In summary, as this is a traditional electrosurgical cautery pencil and not an AI/ML device, the specific types of acceptance criteria and performance study details asked for in the prompt (e.g., related to accuracy, sensitivity, specificity, expert consensus, training sets, etc.) are not present in the provided text and are not typically required for this class of device submission.
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DEROY AL INDUSTRIES, INC. ELECTROSURGICAL CAUTERY PENCIL
K 961647
510(k) Summary
OCT - 8 1996 SUMMARY OF THE SAFETY AND EFFECTIVENESS INFORMATION UPON WHICH AN EQUIVALENCE DETERMINATION COULD BE BASED
SUBMITTER INFORMATION
ﻨﻬﺎ
| NAME: | DeRoyal Industries, Inc. | TELEPHONE: | (423) 938-7828 |
|---|---|---|---|
| ADDRESS: | 200 DeBusk Lane | CONTACT: | Debra F. Manning |
| Powell, TN 37849 | DATE OF PREPARATION: | April 22, 1996 |
DEVICE NAMES DeRoyal Industries, Inc. Electrosurgical Cautery Pencil NAME: COMMON/USUAL NAME: Cautery Pencil CLASSIFICATION NAME (if known): Electrosurgical Cutting & Coagulation Device and Accessories (79 GEI)
PREDICATE OR LEGALLY MARKETED DEVICES
DeBusk Technology Corporation
DEVICE DESCRIPTION
The DeRoyal Industries, Inc. Electrosurgical Cautery Pencil functions in the same manner as predicate devices in that it is intended to be used in electrosurgical procedures to remove tissue and control bleeding. The device can be used for both cutting and coagulating. Device Design/Materials Used/Physical Properties: The DeRoyal Industries, Inc. Electrosurgical Cautery Pencil is made of materials commonly used for their purpose. The concept of use is intended to remove tissue and control bleeding by use of high frequency electrical current.
DEVICE INTENDED USE
The DeRoyal Cautery Pencil is indicated for use whenever an electrosurgical procedure requires the removal of tissue or the control of bleeding by either cutting or coagulation.
TECHNOLOGICAL COMPARISON WITH PREDICATE OR LEGALLY MARKETED DEVICE(S)
| Characteristic | DeRoyal Device | DeBusk Technology Device | Rationale |
|---|---|---|---|
| Length of Pencil Body | 6.0" | 6.0" | |
| Length of Cable | 10'0" | 10'0" | |
| Material of Outer Cable Insulation | PVC | PVC | |
| Method of Manufacturing of Tip | Stamped and formed fromsheet of stainless steel | Stamped and formed from sheetof stainless steel | |
| Tip Coating | Titanium Nitride | None | Provides a non-toxic, anti-stick, lubricated surface. |
§ 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.