Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch Electrosurgical Pencil, Holster, Electorde

Q: Who is the manufacturer of Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch Electrosurgical Pencil, Holster, Electorde?

Modern Medical Equipment Manufacturing, Ltd. filed the 510(k) submission for Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch Electrosurgical Pencil, Holster, Electorde (K192542).

Q: What is the FDA product code for Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch Electrosurgical Pencil, Holster, Electorde?

GEI. It is classified under 21 CFR 878.4400 as a Class 2 device in the General, Plastic Surgery panel.

Q: What is the regulatory pathway for Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch Electrosurgical Pencil, Holster, Electorde?

510(k) clearance (submission type: Traditional).

Q: Who can help prepare an FDA 510(k) submission like Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch Electrosurgical Pencil, Holster, Electorde?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K192542 · Modern Medical Equipment Manufacturing, Ltd. · GEI · Jun 16, 2020 · General, Plastic Surgery

Device Facts

Record ID	K192542
Device Name	Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch Electrosurgical Pencil, Holster, Electorde
Applicant	Modern Medical Equipment Manufacturing, Ltd.
Product Code	GEI · General, Plastic Surgery
Decision Date	Jun 16, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

The monopolar electrosurgical pencil with electrode is used to deliver high frequency current to target issue for cutting and coagulation

Device Story

Monopolar electrosurgical pencil; consists of plastic handle, electrical cable, plug, and interchangeable electrode tip (blade, ball, or needle). Device connects to high-frequency electrosurgical generator; used with patient grounding pad. Operator (physician) uses push-button, rocker switch, or foot switch to select 'CUT' or 'COAG' modes. High-frequency electrical current travels through conductive post and electrode tip to target tissue. Used in clinical settings for soft tissue management. Benefits include precise tissue cutting and coagulation during surgery.

Clinical Evidence

Bench testing only. Performance evaluated using porcine tissue (kidney, liver, muscle) in both Cut and Coagulation modes per FDA guidance. Thermal effects and thermal zone sizes compared to predicate, showing equivalent performance. Safety testing included dielectric strength, electromagnetic compatibility, and biocompatibility per international standards (IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2, ISO 10993). Packaging integrity and accelerated aging tests validated 3-year shelf life.

Technological Characteristics

Monopolar electrosurgical pencil; ABS plastic housing, PVC cable. Electrode: stainless steel, 2.36mm diameter, insulated with polyolefin/PTFE shrink wrap or ABS/HIPS overmold. Tip configurations: blade, needle, ball (coated/non-coated). Energy: high-frequency electrical current (4kVp/5kVp). Sterilization: EO (ISO 11135). Connectivity: wired to electrosurgical generator. Standards: IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2, ISO 10993.

Indications for Use

Indicated for cutting and coagulating soft tissue using high frequency electrical current during electrosurgical procedures.

Regulatory Classification

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.

Predicate Devices

Megadyne Pencil (K965054)

Reference Devices

Megadyne E-Z Clean electrosurgical electrode (K081791)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION". 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) | | | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <table style="border: none;"><tr><td><div style="display: flex; align-items: center;"> <div style="margin-right: 5px;"> </div> <div> Production Use (Part 21 CFR 301 Subpart D) </div> </div></td><td><div style="display: flex; align-items: center;"> <div style="margin-right: 5px;"> </div> <div> Own-Time Support Use (21 CFR 301 Subpart C) </div> </div></td></tr></table> | <div style="display: flex; align-items: center;"> <div style="margin-right: 5px;"> </div> <div> Production Use (Part 21 CFR 301 Subpart D) </div> </div> | <div style="display: flex; align-items: center;"> <div style="margin-right: 5px;"> </div> <div> Own-Time Support Use (21 CFR 301 Subpart C) </div> </div> | | <div style="display: flex; align-items: center;"> <div style="margin-right: 5px;"> </div> <div> Production Use (Part 21 CFR 301 Subpart D) </div> </div> | <div style="display: flex; align-items: center;"> <div style="margin-right: 5px;"> </div> <div> Own-Time Support Use (21 CFR 301 Subpart C) </div> </div> | | X Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ | 1. 510(k) Owner Name: | 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. Device Name of Device: | Single Use Electrosurgical pencil with non-coated and non-stick electrode (Non-sterile and sterile) | | Trade or proprietary name: | Single Use Electrosurgical pencil with non-coated and non-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. {4}------------------------------------------------ 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. | Compared Items | Proposed Device | Predicate Device (K965054) | Reference Device (K081791) | Comments on difference | |---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Single use electrosurgical pencil and non-coated and non-stick electrode | Megadyne Pencil | E-Z Clean electrosurgical electrode | | | Intended use | The monopolar electrosurgical pencil with electrode is used to deliver high frequency current to target issue for cutting and coagulation | The monopolar electrosurgical pencil with electrode is used to conduct electrosurgical energy from electrosurgical generator to the target tissue | The monopolar electrosurgical electrode is used with pencil to conduct radio frequency current for cutting and coagulation from the electrosurgical generator to the target tissue | Same | | Indication for use | To cut and coagulate soft tissue by means of high frequency electrical current during an electrosurgical procedure. | To conduct radio frequency current for cutting and coagulation from the electrosurgical generator to the target tissue | To conduct radio frequency current for cutting and coagulation from the electrosurgical generator to the target tissue | Same | | Regulation number | 21 CFR 878.4400 | 21 CFR 878.4400 | 21 CFR 878.4400 | Same | | Product code | GEI | GEI | GEI | Same | | OTC or prescriptio n | For prescription use | For prescription use | For prescription use | Same | | Energy delivery | High frequency electrical current/energy | High frequency electrical current/energy | High frequency electrical current/energy | Same | | Monopolar or bipolar | Monopolar | Monopolar | Monopolar | Same | | Design | Monopolar electrosurgical pencil for cutting and coagulation and with different electrode tips as blade, needle and ball | Monopolar electrosurgical pencil for cutting and coagulation and with different electrode tips as blade, needle and ball | Monopolar electrosurgical electrodes of different electrode tips as blade, needle and ball for cutting and coagulation | Same target purpose | | Structure Pencil - Housing - Cable | ABS PVC | ABS PVC | NA NA | The material used and structure among the purposed and predicate | | -Switching | Push button, rocker switch & footcontrol | Push button, rocker switch | NA | devices are very similar and do not raise safety and effectiveness issues because those were tested according to IEC test and biocompatibility requirements | | 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 - Insulation material | ~2.36mm -Polyolefin Shrink, Wrap and/or PTFE Shrink Wrap Or ABS/HIPS overmold | ~2.36mm -Polyolefin Shrink, Wrap and/or PTFE Shrink Wrap | ~2.36mm -Polyolefin Shrink, Wrap and/or PTFE Shrink Wrap | The proposed electrode passes the required tests according to IEC60601-1 and IEC60601-2-2 so there will not any issue for safety Same | | - Electrode Tip Configurati on | -Blade, Needle, Ball | -Blade, Needle, Ball | -Blade, Needle, Ball | Similar, provide the similar function | | - Electrode coating | -Teflon one coat | Teflon coat | Teflon coat | Similar, does not affect performance | | -Rated accessory voltage | - 4kVp, 5kVp | 5kVp | 5kVp | | | Sterile | EO sterile | Gamma | Gamma | Same purpose, EO sterilization is validated according to ISO 11135 | | Shelf life | 3 years | 3 years | 3 years | Same | | Electrical safety | Comply with dielectric strength in with accordance IEC60601-1, IEC60601-1-2 & IEC60601-2-2 | Comply with dielectric strength in with accordance AAMI HF-18 | Comply with dielectric strength in with accordance AAMI HF-18 and IEC60601-2-2 & | Same kinds of safety requirements | | Biocompati bility | Comply with ISO10993 | Should comply with ISO10993 | Should comply with ISO10993 | Meet to biocompatibility requirements so it does not raise any safety issue for biocomnatibility | {5}------------------------------------------------ {6}------------------------------------------------ ## 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 {7}------------------------------------------------ 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

Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch Electrosurgical Pencil, Holster, Electorde

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Submission Summary (Full Text)

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Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch Electrosurgical Pencil, Holster, Electorde

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Submission Summary (Full Text)

Panel 1

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