(79 days)
Not Found
No
The summary describes a standard electrosurgical pencil and does not mention any AI or ML capabilities. The performance studies focus on biocompatibility, electrical safety, sterilization, aging, and packaging, which are typical for this type of device.
Yes
The device is described as being used to "remove tissue and control bleeding by use of high frequency electrical current" and further explains its functions as "incise, desiccate, or coagulate," which are all therapeutic actions.
No
The device is used to remove tissue and control bleeding using high-frequency electrical current, which are therapeutic functions, not diagnostic.
No
The device is a physical, hand-held electrosurgical pencil that delivers electrical current for surgical procedures. It is described as a "hand-held device" with "switches built into it" and "plugs into the electrosurgical generator." This clearly indicates a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "remove tissue and control bleeding by use of high frequency electrical current" during surgical procedures. This is a therapeutic and surgical function performed directly on the patient's body.
- Device Description: The description clearly states it's a "hand-held device operated by the surgeon or other trained professional" that "delivers the current to the patient." This is a surgical tool used in vivo.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. This device does not interact with such specimens.
The device is an electrosurgical pencil, which is a surgical instrument used for cutting and coagulation during surgery.
N/A
Intended Use / Indications for Use
The DeRoyal® Electrosurgical Pencil is intended to be used to remove tissue and control bleeding by use of high frequency electrical current. The pencil can be used during electrosurgical procedures for both cutting and coagulation.
Product codes
GEI
Device Description
Electrosurgery can be used to accomplish any one of three functions in the surgical environment: incise, desiccate, or coagulate.
The "pencil" is the portion of the system that delivers the current to the patient. It is a hand-held device operated by the surgeon or other trained professional. It has switches built into it for hand switching capability.
This is a single use, disposable device. It plugs into the electrosurgical generator via an industry standard three-prong offset plug.
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
surgeon or other trained professional
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
| Test Performed | Conclusion |
|---|---|
| Biocompatibility | Cytotoxicity, Irritation, Sensitization, System Toxicity, and Haemocompatibility tests were performed and passed according to ISO 10993-1. |
| Electrical | IEC 60601-2-2:2009 testing was performed and passed when used with over-molded electrodes only. |
| Sterilization | EO sterilization validation was performed and passed according to ISO 11135:2007. The SAL of the sterilized pencil reached 106. |
| Aging | Aging studies performed according to ASTM F 1980-02. The shelf life was determined to be 3 years. |
| Package Seal Integrity | Package seal integrity tests were performed and passed according to ISO 11607-1:2006, ASTM F 1929-98, and EN868-5:1999. |
Key Metrics
Not Found
Predicate Device(s)
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
K132199
510(k) Summary of Safety and Effectiveness
Date prepared:
510(k) Owner:
510(k) Contact:
August 8, 2013
Courtney Rinehart
DeRoyal Industries, Inc. 200 DeBusk Lane Powell, TN 37849 Owner/Operator #1044833
Regulatory Affairs Specialist
OCT 0.3 2013
865-362-2122 crinehart@deroyal.com Zhejiang Jinhua Huatong Medical Appliance Co., Ltd. Manufacturer: No 23, Meixi Street, Sumeng Cun, Sumeng Xiang, Wucheng Area, 321051, Jinhua City, Zhejiang Province, China Owner/Operator #10044444 Registration number pending FDA processing DeRoyal® Electrosurgical Pencil Trade Name: Electrosurgical Pencil Common Name: Classification: Electrosurgical cutting and coagulation device and accessories 21 CFR 878.4400, Class II Device Product Code: GEI- Electrosurgical, Cutting & Coagulation & Accessories Substantial Equivalency: DeRoyal Industries Inc. Electrocautery Pencil- K940909
Indications for Use:
The DeRoval Electrosuraical Pencil is intended to be used to remove tissue and control bleeding by use of high frequency electrical current. The pencil can be used during electrosurgical procedures for both cutting and coagulation.
Device Description:
Electrosurgery can be used to accomplish any one of three functions in the surgical environment: incise, desiccate, or coagulate.
The "pencil" is the portion of the system that delivers the current to the patient. It is a hand-held device operated by the surgeon or other trained professional. It has switches built into it for hand switching capability.
This is a single use, disposable device. It plugs into the electrosurgical generator via an industry standard three-prong offset plug.
Summary of Technological Characteristics:
| Feature | Predicate: K940909 | This submission: DeRoyal Electrosurgical Pencil |
|---|---|---|
| Button Style | Two buttons for hand switching control | Same as predicate |
| Rocker Style | One rocking button for hand switching control | Same as predicate |
1
Basis for Substantial Equivalence:
. . .
:
.
In order to demonstrate substantial equivalence, DeRoyal evaluated the indications for use, materials, and product specifications. Testing has been successfully completed and documented to demonstrate that the proposed device is substantially equivalent to the DeRoyal Electrocautery Pencil.
| Test Performed | Conclusion |
|---|---|
| Biocompatibility | Cytotoxicity, Irritation, Sensitization, System Toxicity, and |
| Haemocompatibility tests were performed and passed according to ISO | |
| 10993-1. | |
| Electrical | IEC 60601-2-2:2009 testing was performed and passed when used with |
| over-molded electrodes only. | |
| Sterilization | EO sterilization validation was performed and passed according to ISO |
| 11135:2007. The SAL of the sterilized pencil reached 106. | |
| Aging | Aging studies performed according to ASTM F 1980-02. The shelf life was |
| determined to be 3 years. | |
| Package Seal Integrity | Package seal integrity tests were performed and passed according to ISO |
| 11607-1:2006, ASTM F 1929-98, and EN868-5:1999. |
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the department's name written around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms. The image is in black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 3, 2013
DeRoyal Industries, Incorporated Ms. Courtney Rinehart Regulatory Affairs Specialist 200 DeBusk Lanc Powell, Tennessee 37849
Re: K132199
Trade/Device Name: DeRoyal" Electrosurgical Pencil Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: August 9. 2013 Received: August 12: 2013
Dear Ms. Rinchart:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803): good manufacturing practice requirements as set
3
Page 2 - Ms. Courtney Rinehart
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Form
K132199 510(k) Number (if known):
Device Name: DeRoyal® Electrosurgical Pencil
INDICATIONS FOR USE
The DeRoyal® Electrosurgical Pencil is intended to be used to remove tissue and control bleeding by use of high frequency electrical current. The pencil can be used during electrosurgical procedures for both cutting and coagulation.
Prescription Use X (Per 21 CFR 801 Subpart D) . OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Long H. Chen -A
Digitally signed by Long H. Chen -A DN callS, os-U.S. Government.
outsHS, our FDA, overPeople, cnct.ong HL Chen -A
0.9.2342.19200300.100.1.1=1 30036905 Date: 2013. 10.03 06:53:15 -04'00'
For MXM
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K132199
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