Intended use: The monopolar electrosurgical pencil with electrode is used to deliver high frequency current to target tissue for cutting and coagulation.

Indication for use: The device is to be used in combination with a standard electrosurgical generator to cut and coagulate soft tissue by means of high frequency electrical current during an electrosurgical procedure.

Device Description

Disposable electrosurgical pencil uses high density and high frequency current on local tissue thermal effect, the tissue or tissue components vaporization or burst, the medical operation so as to achieve the cutting and coagulation. Therefore, it may not only replace surgical knife for a variety of surgical procedures, and obviously reduce the bleeding or no bleeding. This can significantly reduce the labor intensity of the medical staff, and also shorten the operation time, and is good for patient to recover after surgery.

Disposable electrosurgical pencil is the applied parts of high frequency electrosurgical equipment/generator, when the high-frequency generator outputs a certain waveform of highfrequency current, which passes through the electrosurgical electrode and applies to the tissue of patient for cutting or coagulation, then the residual current returns back to the high-frequency generator through a neutral electrode.

AI/ML Overview

The provided document is a 510(k) Summary for a Disposable electrosurgical pencil. It describes the device, its intended use, and a comparison to a predicate device, along with performance data to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study conducted, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria for each performance test with corresponding values. Instead, it states compliance with various standards. The "performance data" section describes the types of tests conducted and concludes that the device performed acceptably by meeting the requirements of recognized standards and guidance.

Here's a summary of the performance testing details:

Acceptance Criteria Category/Standard	Reported Device Performance
Biocompatibility	Cytotoxicity: Compliant
(Per ISO 10993-1, -5, -10, -11)	Intracutaneous Reactivity: Compliant
	Skin Sensitization: Compliant
	Acute Systemic Toxicity: Compliant
	Pyrogen: Compliant
Electrical Safety	Complies with IEC 60601-1:2005 + A1:2012 + A2:2020
(Per IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2)	Complies with IEC 60601-2-2:2017
	Electromagnetic Compatibility (EMC): Complies with IEC 60601-1-2:2014 + A1:2020
Functional Performance (Thermal tissue effects: cutting and coagulation)	A study was performed to compare the penetrating thermal tissue effects. Conforms to FDA's Guidance for Electrosurgical Devices for General Surgery.
Sterilization (EO sterile shelf-life 3 years)	Validation performed according to ISO 11135:2014.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for performance testing (Thermal Tissue Effects): The document states "Tissues of porcine kidney and porcine muscle were used for thermal effect testing." The specific number of samples (e.g., how many porcine kidneys or muscle pieces) is not provided.
Data Provenance: Not explicitly stated. Given that Shenzhen Mecun Medical Supply Co., Ltd. is based in China, it's highly probable the testing was conducted there, but this is not confirmed in the document. The study is presented as performance testing for the subject device to demonstrate substantial equivalence, which implies it's prospective data for this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not Applicable. The described study focuses on the physical performance of the electrosurgical pencil (e.g., thermal effects on tissue). It is a non-clinical performance study rather than a study involving human interpretation of data where "ground truth" would be established by experts (e.g., radiologists interpreting images). The "ground truth" here is the observable physical effect of the device on tissue under controlled conditions, measured instrumentally or visually by qualified personnel involved in the testing, but not explicitly as a panel of "experts" for ground truth establishment in the traditional sense of medical image analysis or diagnostic studies.

4. Adjudication Method for the Test Set

Not Applicable. As explained above, this is a non-clinical performance study. Adjudication methods like 2+1 or 3+1 are used in clinical studies or studies involving human readers/interpreters to resolve discrepancies in diagnoses or assessments, which is not applicable here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document describes non-clinical performance testing of the device itself, not a study evaluating human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not Applicable. The device is a physical electrosurgical pencil, not a software algorithm or an AI system. Therefore, the concept of "standalone (algorithm only)" is not relevant.

7. The Type of Ground Truth Used

For the performance testing on thermal tissue effects, the "ground truth" would be the physical and observable effects (cutting and coagulation characteristics, extent of thermal damage) on the porcine tissue, measured or observed directly during the test. This is an experimental observation under controlled conditions, not expert consensus, pathology, or outcomes data in the typical sense for a diagnostic device.

8. The Sample Size for the Training Set

Not Applicable. This device is not an AI/ML algorithm or a software device requiring a training set. The performance testing involves direct physical testing of the electrosurgical pencil.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As mentioned above, there is no training set for this type of device.

Summary

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October 11, 2023

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized representation of a human figure, while the FDA name on the right is written in blue and consists of the words "FDA U.S. FOOD & DRUG ADMINISTRATION".

Shenzhen Mecun Medical Supply Co., Ltd. Mr. Bo Zheng General Manager 2nd Level, 2nd Building, Fuqiang S&T Park 6 Ailian Industrial Park,Zhugushi,Wulian Community, Longgang District Shenzhen, Guangdong 518000 China

Re: K232460

Trade/Device Name: Disposable 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 15, 2023 Received: August 15, 2023

Dear Mr. Zheng:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Colin K. Chen -S

for

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices

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OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K232460

Device Name Disposable electrosurgical pencil

Indications for Use (Describe)

The device is to be used in combination with a standard electrosurgical generator to cut and coagulate soft tissue by means of high frequency electrical current during an electrosurgical procedure.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

(K232460)

This summary of 510(K) safety and effectiveness information is submitted as required by requirements of SMDA and 21 CFR §807.92.

1. Submitter

Submitter's Name	Shenzhen Mecun Medical Supply Co., Ltd.
Address	2nd Level, 2nd Building, Fuqiang S&T Park, 6 AilianIndustrial Park, Zhugushi, Wulian Community, LonggangStreet, Longgang District, Shenzhen City, China
Telephone	+86-755-86062204
Fax number	+86-755-86062204
First Contact person	Name: Mr. Zheng BoTitle: General managerE-mail: manager@mecun.com
Second contact person	Name: Mr. James CaiTitle: Regulatory managerE-mail: james@szcsqy.com
Data preparation	October 09, 2023

2. Device Information

Type of 510(k) submission:	Traditional
Trade Name:	Disposable electrosurgical pencil
Classification name:	Electrosurgical cutting and coagulation device and accessories
Classification:	II
Review Panel:	General & Plastic Surgery
Product Code:	GEI
Regulation Number:	878.4400

3. Predicate Device Information

Trade Name	Single use electrosurgical pencil with electrode
510(k) Number	K213786
Classification name	Electrosurgical cutting and coagulation device andaccessories
Classification:	II
Review Panel:	General & Plastic Surgery
Product code	GEI

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Regulation No. 878.4400

4. Device Descriptions

5. Intended Use/Indications for Use

Intended use: The monopolar electrosurgical pencil with electrode is used to deliver high frequency current to target tissue for cutting and coagulation.

6. Comparisons of technological characteristics with the predicate device

The subject device and the predicate device are similar in intended use, compositions, functions, scientific technology, sterilization and method of operation, the following table provides a comparison summary:

Comparisonitem	Subject Device (K232460)	Predicate Device (K213786)	Remark
Manufacturer	Shenzhen Mecun MedicalSupply Co., Ltd.	Ningbo Shun Ye MedicalCompany, Ltd.	Remark
Product name	Disposable electrosurgicalpencil	Single use electrosurgicalpencil with electrode
Product Code	GEI	GEI	Same
RegulationNumber	878.4400	878.4400	Same
Classification	II	II	Same
Intendeduse	The monopolar electrosurgicalpencil with electrode is used todeliver high frequency currentto target tissue for cutting andcoagulation.	The monopolar electrosurgicalpencil with electrode is used todeliver high frequency currentto target tissue for cutting andcoagulation.	Same
Indications forUse	The device is to be used incombination with a standardelectrosurgical generator to cutand coagulate soft tissue bymeans of high frequencyelectrical current during anelectrosurgical procedure.	The device is to be used incombination with a standardelectrosurgical generator to cutand coagulate soft tissue bymeans of high frequencyelectrical current during anelectrosurgical procedure.	Same
Prescription or	Prescription	Prescription	Same
OTC
Energy delivery	High frequency electricalcurrent/energy	High frequency electricalcurrent/energy	Same
User interface	Hand	Footswitch/Hand	Same
Structure	Electrode (with a cap),insulating sleeve, plastichandle, manual controlledbuttons, cables and plug	Pencil handpiece: a plastichandle, electrical cable and aplug;Electrode: a conductiveelectrode tip, an insulated shaftand a conductive post	Same
Material	Pencil:-Housing: ABS;-Cable: PVC-Switching: ABS-Cap: PVCElectrode:- Stainless steel:- Coating: Teflon coat;	Pencil:-Housing: ABS;-Cable: PVC-Switching: ABSElectrode:- Stainless steel;- Coating: Teflon coat;	Same
Switching type	Push button	Push button, rocker switch &foot control;	Same(included)
Shape ofelectrode tip	Blade	Blade, Needle, Ball	Same(included)
Diameter ofelectrode tip	2.36 mm	2.36 mm	Same
Length ofelectrode tip	Blade: 69mm, 100mm, 150mm	Blade: 66mm, 70mm, 101mm,152mm;Angled blade: 65mm;Needle: 72mm, 101mm,152mm;Angled needle: 60mm, 66mm;Dermal tip: 60mm;Ball: 49mm, 50mm, 51mm,132mm, 133mm, 134mm;	Similar(Note 1)
Ratedaccessoryvoltage	4kVp	4kVp	Same
Sterilization	EO sterile	EO sterile	Same
Shelf-life	3 years	3 years	Same
Biocompatibility	Comply with ISO10993-5,ISO10993-10 & 10993-11	Comply with ISO10993	Same
ElectricalPerformanceand Safety	Comply with IEC60601-1,IEC60601-1-2,ISO60601-2-2	Comply with IEC60601-1,IEC60601-1-2,ISO60601-2-2	Same

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Note 1:

The length of the electrode tip is different, the subject device has been tested the safety test, EMC test, and thermal effect test, the difference will not affect the safety and effectiveness of the subject device.

7. Performance data

The subject device conforms to the following standards and guidance:

7.1 Biocompatibility testing

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The biocompatibility evaluation for Neutral electrode was conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process," as recognized by FDA. The subject device is contacted with patient's breached or compromised surface during the electrosurgery operation for duration of less than 24 hours. The biocompatibility testing includes the following:

. Cytotoxicity
. Intracutaneous Reactivity
Skin Sensitization ●
. Acute systemic toxicity
. Pyrogen

7.2 Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted, and the results show that the subject device complies with the following standards:

. IEC 60601-1: 2005 + A1:2012 + A2:2020 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2: 2014 + A1:2020 Medical electrical equipment Part 1-2: General . requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances – Requirements and tests standard for EMC
IEC 60601-2-2:2017 Medical electrical equipment Part 2-2: Particular requirements for . the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

7.3 Performance testing

Performance testing was conducted for the proposed device in accordance with requirements of FDA's Guidance: Guidance for Industry and FDA Staff: Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery (issued on March 9, 2020).

A study was performed to compare the penetrating thermal tissue effects of the Mecun disposable electrosurgical pencil. Tissues of porcine kidney and porcine muscle were used for thermal effect testing.

7.4 EO sterilization

The proposed device is also provided for sterilization validation is performed as the standard of ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices.

8. Conclusions

Based on device comparison information and performance data, the subject device is as safety and effectiveness as predicate device, and the differences do not raise any new issue of safety and effectiveness. Therefore, the subject device is substantially equivalent to the predicate device.

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.