(161 days)
Not Found
Not Found
No
The summary describes a standard electrosurgical cautery pencil and makes no mention of AI or ML capabilities.
Yes
The device is used to remove tissue and control bleeding, which are therapeutic actions performed on a patient.
No
Explanation: The device is described as an electrosurgical cautery pencil used for removing tissue and controlling bleeding, which are therapeutic rather than diagnostic functions. It does not mention any ability to identify or characterize medical conditions.
No
The device description clearly states it is an "Electrosurgical Cautery Pencil" and describes its physical properties and function using high-frequency electrical current, indicating it is a hardware device.
Based on the provided information, the DeRoyal Cautery Pencil is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "electrosurgical procedures [requiring] the removal of tissue or the control of bleeding by either cutting or coagulation." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The description reinforces its use in "electrosurgical procedures to remove tissue and control bleeding."
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. The DeRoyal Cautery Pencil does not perform this function.
Therefore, the DeRoyal Cautery Pencil is an electrosurgical device used for surgical procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
79 GEI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
DeBusk Technology Corporation
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 from | ||
| sheet of stainless steel | Stamped and formed from sheet | ||
| of stainless steel | |||
| Tip Coating | Titanium Nitride | None | Provides a non-toxic, anti-stick, lubricated surface. |