The Electrosurgical Pencil with coated and non-coated electrode is the monopolar active device which consists of a conductive electrode tip, an insulated shaft and a conductive post. The electrosurgical pencil consists of a plastic handle, electrical cable and a plug. The switching modes are for "CUT" and "COAG" function. A socket in front of the pencil casing is used to allow the insertion of an electrode. The electrode consists of a conductive electrode tip, an insulated shaft and a conductive post. The electrode tip may be blade, ball and needle. The electrode tip is either coated or non-coated. The diameter of the conductive post is 2,36mm. The pencil with electrode is to be connected to a general high frequency electrosurgical generator by means of the electrical cable and is used in conjunction with a patient grounding pad during an electrosurgical procedure. The switching method of electrosuraical pencil may be push button, rocker switch or foot switch, cable length of the electrosurgical pencil will be around 3m to 5m with 3-pins plug or 1-pin plug, the lengths of the blade, needle and ball electrode may be around 69mm to152mm, with coated or non-coated.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the "Single Use Electrosurgical pencil with non-coated and non-stick electrode (Non-sterile and sterile)", based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly lay out acceptance criteria in a quantitative table format with corresponding reported performance for each criterion. Instead, it states that the device's performance "proved that the subject device and the predicate device are equivalent in the performance" through specific tests. The criteria are indirectly inferred from the performance tests conducted and the standards met.

Therefore, I will interpret the acceptance criteria as meeting the standards and demonstrating equivalence to the predicate device in the specified performance areas.

Acceptance Criteria (Inferred from tests)	Reported Device Performance
Device Sterility (Validation and Verification)	Complies with ISO 11135:2014 for EO sterilization.
Packaging (Validation and Verification)	Packaging integrity tested and found satisfactory.
Performance in Cut Mode (Thermal effects and thermal zone size on porcine tissue: kidney, liver, muscle)	Bench testing on subject and predicate devices using porcine tissue showed that the evaluation of thermal effects on tissues and measurement of thermal zone sizes proved that the subject device and the predicate device are equivalent in performance for Cut mode, in accordance with the "Premarket Notification (510(k) Submissions for Electrosurgical Devices for General Surgery Guidance for Industry and Food and Drug Administration Staff, Document issued on August 15, 2016".
Performance in Coagulation Mode (Thermal effects and thermal zone size on porcine tissue: kidney, liver, muscle)	Bench testing on subject and predicate devices using porcine tissue showed that the evaluation of thermal effects on tissues and measurement of thermal zone sizes proved that the subject device and the predicate device are equivalent in performance for Coagulation mode, in accordance with the "Premarket Notification (510(k) Submissions for Electrosurgical Devices for General Surgery Guidance for Industry and Food and Drug Administration Staff, Document issued on August 15, 2016".
Electrical Safety	Complies with: - IEC60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) (General requirements for basic safety and essential performance) - IEC60601-2-2: 2009 (Fifth Ed) (Particular requirements for basic safety and essential performance of high frequency surgical equipment and accessories) - IEC60601-1-2:2014 (Electromagnetic Disturbances - Requirements and Tests)
Biocompatibility	Complies with ISO10993 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process).
Shelf Life (3 years)	Accelerated aging tests were completed and support the proposed 3-year shelf life.

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

Sample Size: The document does not specify a numerical sample size for the "porcine tissue: kidney, liver, muscle" used in the performance testing. It only mentions that testing was performed on these tissue types. It also doesn't specify the number of devices tested for sterility, packaging, electrical safety, or biocompatibility, beyond implying multiple units to validate processes and claims.
Data Provenance: The data is retrospective, as the tests were conducted to demonstrate equivalence for a 510(k) premarket notification. The country of origin of the data is not specified, but the applicant is based in Hong Kong, China. The testing itself doesn't inherently imply a specific country for data collection beyond the manufacturing location.

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

This information is not provided in the document. The performance testing involved bench testing on porcine tissue and comparison to a predicate device, as well as compliance with international standards. This type of testing typically relies on predefined test methods and measurements rather than expert consensus on a "ground truth" in the way it might for a diagnostic AI device.

4. Adjudication Method for the Test Set:

This information is not provided as it's not applicable to the type of bench testing and standards compliance reported for this electrosurgical pencil. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, often for diagnostic devices.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic performance with human readers, which is not the function of an electrosurgical pencil.

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

This question is not applicable to an electrosurgical pencil. This device is a physical tool used by a human surgeon; it does not involve any algorithms or AI component that would function in a standalone capacity.

7. The Type of Ground Truth Used:

For the performance tests on porcine tissue, the "ground truth" was established by direct measurement and observation of thermal effects and thermal zone sizes on the tissue, deemed equivalent to the predicate device. For other aspects, the "ground truth" was compliance with established international standards (e.g., ISO for sterilization and biocompatibility, IEC for electrical safety), which define acceptable performance parameters.

8. The Sample Size for the Training Set:

This question is not applicable. The device is an electrosurgical pencil, not an AI/ML-based device that requires a training set.

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

This question is not applicable as there is no training set for this device.

Summary

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June 16, 2020

Modern Medical Equipment Manufacturing, LTD. Jerry Cheung Assistant Regulatory Manager Flat A, 11/F., Mai Wah Ind. Bldg., 1-7 Kwai Chung, N.T., Hong Kong, China

Re: K192542

Trade/Device Name: Single Use Electrosurgical pencil with non-coated and non-stick electrode (Nonsterile and sterile)

Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: September 10, 2019 Received: May 11, 2020

Dear Jerry Cheung:

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. 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 located 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.

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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) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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.

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K192542

Device Name

Single Use Electrosurgical pencil with non-coated and non-stick electrode (Non-sterile and sterile)

Indications for Use (Describe)

The devices are used 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)
Production Use (Part 21 CFR 301 Subpart D) Own-Time Support Use (21 CFR 301 Subpart C)	Production Use (Part 21 CFR 301 Subpart D)	Own-Time Support Use (21 CFR 301 Subpart C)
Production Use (Part 21 CFR 301 Subpart D)	Own-Time Support Use (21 CFR 301 Subpart C)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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1. 510(k) OwnerName:	Modern Medical Equipment Manufacturing Limited
Address:	Modern Medical Equipment Mfg., Ltd.Flat A, 11/F., Mai Wah Ind. Bldg.,1-7 Wah Sing Street,Kwai Chung, N.T., Hong Kong, China.
Telephone:	(852) 2420 9068
Fax:	(852) 2481 1234
Contact person:	Mr. Jerry Cheung
Date of preparation:	30 July, 2019
2. DeviceName of Device:	Single Use Electrosurgical pencil with non-coated andnon-stick electrode (Non-sterile and sterile)
Trade or proprietary name:	Single Use Electrosurgical pencil with non-coated andnon-stick electrode;
Common or usual name:	Single Use Electrosurgical pencil with electrode
Classification name:	Electrosurgical, Cutting & Coagulation & Accessories
Classification Panel:	General & Plastic Surgery
Regulation number:	21 CFR 878.4400
Product Code:	GEI
Class:	II

3. Predicate and Reference devices

Predicate Device: Megadyne Pencil with 510(k) number K965054. Reference Device: Megadyne E-Z Clean electrosurgical electrode with 510(k) number K081791

4. Device description

The Electrosurgical Pencil with coated and non-coated electrode is the monopolar active device which consists of a conductive electrode tip, an insulated shaft and a conductive post.

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The electrosurgical pencil consists of a plastic handle, electrical cable and a plug. The switching modes are for "CUT" and "COAG" function. A socket in front of the pencil casing is used to allow the insertion of an electrode.

The electrode consists of a conductive electrode tip, an insulated shaft and a conductive post. The electrode tip may be blade, ball and needle. The electrode tip is either coated or non-coated. The diameter of the conductive post is 2,36mm. The pencil with electrode is to be connected to a general high frequency electrosurgical generator by means of the electrical cable and is used in conjunction with a patient grounding pad during an electrosurgical procedure.

The switching method of electrosuraical pencil may be push button, rocker switch or foot switch, cable length of the electrosurgical pencil will be around 3m to 5m with 3-pins plug or 1-pin plug, the lengths of the blade, needle and ball electrode may be around 69mm to152mm, with coated or non-coated.

5. Indication for use

The devices are used to cut and coagulate soft tissue by means of high frequency electrical current during an electrosurgical procedure.

6 Technological characteristics

The proposed devices have substantially equivalent construction and performance as the predicate devices.

7. Substantial Equivalence

The technological characteristics and performance testing of the subject and predicate devices are substantially equivalent. The following table shows the comparisons in more detail information among the subject device and the predicate devices.

ComparedItems	Proposed Device	Predicate Device(K965054)	Reference Device(K081791)	Comments on difference
	Single useelectrosurgicalpencil andnon-coated andnon-stick electrode	Megadyne Pencil	E-Z Cleanelectrosurgicalelectrode
Intendeduse	The monopolarelectrosurgicalpencil withelectrode is used todeliver highfrequency currentto target issue forcutting andcoagulation	The monopolarelectrosurgicalpencil withelectrode is usedto conductelectrosurgicalenergy fromelectrosurgicalgenerator to thetarget tissue	The monopolarelectrosurgicalelectrode is usedwith pencil toconduct radiofrequency currentfor cutting andcoagulation fromthe electrosurgicalgenerator to thetarget tissue	Same
Indicationfor use	To cut andcoagulate softtissue by means ofhigh frequencyelectrical currentduring anelectrosurgicalprocedure.	To conduct radiofrequency currentfor cutting andcoagulation fromthe electrosurgicalgenerator to thetarget tissue	To conduct radiofrequency currentfor cutting andcoagulation fromthe electrosurgicalgenerator to thetarget tissue	Same
Regulationnumber	21 CFR 878.4400	21 CFR 878.4400	21 CFR 878.4400	Same
Productcode	GEI	GEI	GEI	Same
OTC orprescription	For prescriptionuse	For prescriptionuse	For prescriptionuse	Same
Energydelivery	High frequencyelectricalcurrent/energy	High frequencyelectricalcurrent/energy	High frequencyelectricalcurrent/energy	Same
Monopolaror bipolar	Monopolar	Monopolar	Monopolar	Same
Design	Monopolarelectrosurgicalpencil for cuttingand coagulationand with differentelectrode tips asblade, needle andball	Monopolarelectrosurgicalpencil for cuttingand coagulationand with differentelectrode tips asblade, needle andball	Monopolarelectrosurgicalelectrodes ofdifferent electrodetips as blade, needleand ball for cuttingand coagulation	Same target purpose
StructurePencil- Housing- Cable	ABSPVC	ABSPVC	NANA	The material used andstructure among thepurposed and predicate
-Switching	Push button, rockerswitch &footcontrol	Push button, rockerswitch	NA	devices are very similarand do not raise safetyand effectiveness issuesbecause those weretested according to IECtest and biocompatibilityrequirements
Electrode-Material	-Stainless steel	-Stainless steel	-Stainless steel	Similar, those do not raise
- Length	- 69 mm, 102mm,152mm (blade &needle)- 69-71mm,105-107mm,135-137mm (ball)	-2.5", 2.75", 4", 5",6.5"	-2.5", 2.75", 4", 5",6.5"	any safety issue

- Diameter- Insulationmaterial	~2.36mm-Polyolefin Shrink,Wrap and/orPTFE Shrink WrapOrABS/HIPS overmold	~2.36mm-Polyolefin Shrink,Wrap and/orPTFE Shrink Wrap	~2.36mm-Polyolefin Shrink,Wrap and/orPTFE ShrinkWrap	The proposedelectrode passes therequired testsaccording to IEC60601-1and IEC60601-2-2 so therewill not any issue for safetySame
- ElectrodeTipConfiguration	-Blade,Needle, Ball	-Blade,Needle, Ball	-Blade,Needle, Ball	Similar, provide the similarfunction
- Electrodecoating	-Teflon one coat	Teflon coat	Teflon coat	Similar, does not affectperformance
-Ratedaccessoryvoltage	- 4kVp, 5kVp	5kVp	5kVp
Sterile	EO sterile	Gamma	Gamma	Same purpose, EOsterilization is validatedaccording to ISO 11135
Shelf life	3 years	3 years	3 years	Same
Electricalsafety	Comply withdielectric strengthin with accordanceIEC60601-1,IEC60601-1-2 &IEC60601-2-2	Comply withdielectric strengthin with accordanceAAMI HF-18	Comply withdielectric strengthin with accordanceAAMI HF-18 andIEC60601-2-2 &	Same kinds of safetyrequirements
Biocompatibility	Comply withISO10993	Should complywith ISO10993	Should comply withISO10993	Meet to biocompatibilityrequirements so it does notraise any safetyissue forbiocomnatibility

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8. Non-clinical Performance Testing Data

Validation and Verification testing was performed on device sterility in accordance with ISO 11135:2014 and packaging.

Performance Testing included bench testing on the subject device and predicate devices by using porcine tissue: kidney, liver, muscle for both Cut mode and Coagulation mode in accordance with the Premarket Notification (510(k) Submissions for Electrosurgical Devices for General Surgery Guidance for Industry and Food and Drug Administration Staff, Document issued on August 15, 2016, the evaluation of the thermal effects on the tissues and measurement of the thermal zone sizes are proved that the subject device and the predicate device are equivalent in the performance.

The safety performance of the subject device passed all the testing according to

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internal requirements and international standards shown below to support the substantial equivalence of the subject device

IEC60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007), Medica electrical equipment - Part 1: General requirements for basic safety and essential performance
-IEC60601-2-2: 2009 (Fifth Ed), 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.
IEC60601-1-2:2014, Medical Electrical Equipment Part 1-2: General -Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests
-ISO10993, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

Furthermore, the packaging integrity and accelerated aging test were completed on the subject device to support the proposed shelf life.

9. Conclusion

Based on comparing technological characteristic and performance testing data, the subject devices are substantially equivalent to predicate devices

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.