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.

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.

AI/ML Overview

The provided text does not contain information about acceptance criteria for device performance or a study proving the device meets performance criteria in the way a diagnostic AI device would. Instead, it details the testing done to demonstrate the substantial equivalence of DeRoyal® Electrosurgical Pencil to a predicate device, focusing on safety, manufacturing, and general device characteristics.

However, I can extract the information related to the tests performed to demonstrate substantial equivalence, which can be thought of as "acceptance criteria" for regulatory approval in this context.

Here's the information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Test Performed)	Reported Device Performance (Conclusion)
Pencil Feature (Technological Characteristics Comparison)
Button Style	Two buttons for hand switching control (Same as predicate: DeRoyal Industries Inc. Electrocautery Pencil- K940909)
Rocker Style	One rocking button for hand switching control (Same as predicate: DeRoyal Industries Inc. Electrocautery Pencil- K940909)
Safety and Manufacturing-Related Tests
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 (Sterility Assurance Level) of the sterilized pencil reached 10⁻⁶.
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.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not specify the sample sizes used for each of the tests (Biocompatibility, Electrical, Sterilization, Aging, Package Seal Integrity).
- The data provenance is not explicitly stated as country of origin, but the manufacturer is Zhejiang Jinhua Huatong Medical Appliance Co., Ltd. in Jinhua City, Zhejiang Province, China, suggesting the testing data may originate from China or be conducted for a Chinese manufacturer seeking US market approval. The studies are technical validation studies rather than clinical studies with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable. The tests performed are technical and regulatory compliance tests (e.g., electrical safety, sterility validation, material biocompatibility) on the device itself, not diagnostic performance evaluations that require expert interpretation of results to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This is not applicable as the tests are objective compliance assessments, not subjective diagnostic interpretations requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is an electrosurgical pencil and not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable. The device is a physical electrosurgical pencil, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the tests performed are established international standards (e.g., ISO 10993-1 for biocompatibility, IEC 60601-2-2 for electrical safety, ISO 11135:2007 for EO sterilization, ASTM F 1980-02 for aging, ISO 11607-1 for package seal integrity). The device "passing" these tests means it meets the objective criteria defined by these standards.
8. The sample size for the training set
- This is not applicable. There is no concept of a "training set" for this type of medical device as it is not an AI/ML algorithm.
9. How the ground truth for the training set was established
- This is not applicable.

Summary

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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

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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, andHaemocompatibility tests were performed and passed according to ISO10993-1.
Electrical	IEC 60601-2-2:2009 testing was performed and passed when used withover-molded electrodes only.
Sterilization	EO sterilization validation was performed and passed according to ISO11135:2007. The SAL of the sterilized pencil reached 106.
Aging	Aging studies performed according to ASTM F 1980-02. The shelf life wasdetermined to be 3 years.
Package Seal Integrity	Package seal integrity tests were performed and passed according to ISO11607-1:2006, 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

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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

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Indications for Use Form

K132199 510(k) Number (if known):

Device Name: DeRoyal® Electrosurgical Pencil

INDICATIONS FOR USE

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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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.