Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencil

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. November 30, 2020 Modern Medical Equipment Manufacturing, Ltd. Jerry Cheung Assistant Regulatory Manager Flat A, 11/F., Mai Wah Ind. Bldg., 1-7 Wah Sing Street Kwai Chung N.T. Hong Kong, China Re: K200372 Trade/Device Name: Sterile and Non-sterile Single Use Smoke Evacuation Fingerswitch, Nosecone and Smoke Evacuation System with 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: January 10, 2020 Received: February 14, 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) K2000372 #### Device Name Sterile and Non-sterile Single Use Smoke Evacuation Fingerswitch, Nosecone and Smoke Evacuation System with Electrosurgical Pencil #### Indications for Use (Describe) The device is used to conduct electrosurgical current from an electrosurgical generator to target tissue in electrosurgical procedures for monopolar cutting and coagulation, with the additional function of evacuation to facilitate the removal of surgical smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. Type of Use (Select one or both, as applicable) | <span style="font-family: sans-serif;"> <span style="text-decoration: overline;"></span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <span style="font-family: sans-serif;"> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | #### 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<br>Name: | Modern Medical Equipment Manufacturing Limited | |------------------------------|------------------------------------------------------------------------------------------------------------------------------------------| | Address: | Modern Medical Equipment Mfg., Ltd.<br>Flat A, 11/F., Mai Wah Ind. Bldg.,<br>1-7 Wah Sing Street,<br>Kwai Chung, N.T., Hong Kong, China. | | Telephone: | (852) 2420 9068 | | Fax: | (852) 2481 1234 | | Contact person: | Mr. Jerry Cheung | | Date of preparation: | 26 Nov, 2020 | | 2. Device<br>Name of Device: | Sterile and Non-sterile Single Use Smoke Evacuation<br>Fingerswitch, Nosecone and Smoke Evacuation<br>System with Electrosurgical Pencil | | Trade or proprietary name: | Sterile and Non-sterile Single Use Smoke Evacuation<br>Fingerswitch, Nosecone and Smoke Evacuation<br>System with Electrosurgical Pencil | | Common or usual name: | Sterile and Non-sterile Single Use Smoke<br>Evacuation Pencil | | Classification name: | Electrosurgical Cutting & Coagulation<br>Device & Accessories | | Classification Panel: | General & Plastic Surgery | | Product Code: | GEI | | Class: | II | #### 3. Predicate device MEDTEK PLUMEPEN Integrated Smoke Evacuation Pencil with 510(k) number K103375. ## 4. Device description There are two main series of smoke evacuation pencil. - (1) Smoke Evacuation Fingerswitch (PS947) {4}------------------------------------------------ The device includes the active handle which connects with the active electrode. The diameter of the mating part is 2.36mm+/-0.02mm. The buttons on the active handle control cutting and coagulation, the yellow side activates the cutting function and the blue side activates the coagulation function. The active handle's end is connected to an insulation cord with an active connector. The EVA tubing at the rear of the active handle then leads to a filter and pump system that facilitates the removal of harmful "surgical smoke" from the site of operation. The device is compatible with the socket of generator accommodating the standard 3-pin active connector, the output voltage setting of generator not larger 4.5kVp, compatible cable connection of grounding pad to the generator and all smoke evacuators with an ID22mm EVA tubing connector. In addition to these familiar features and functions, the switching controls are mounted onto an active handle that moves freely up and down the shaft of the device when the device is in vertical position (or moves freely forward and backward when the device is in horizontal position), when the switching control moves freely on the shaft, distance between the front end of the handle and the controls is reduced or increased that works like extending and retracting the suction tip on general smoke evacuation, allowing the surgeon a greater degree of control and removing the need for additional accessories to extend the length of the device when working in cavities and other areas with restrictive access. Furthermore, the electrode can be exchanged with 63.5mm, 69mm and 120mm long electrodes in diameter 2.36±0.2mm with corresponding nosecone for further extending the length of suction tip for smoke evacuation. ## (2) Smoke evacuation system with electrosurgical pencil (CE809) The device includes electrosurgical pencil with electrode and smoke evacuation handle connected with EVA tubing with ID22mm tubing connector. Electrosurgical pencil (PD646 or PD631) with 69mm long electrodes in diameter 2.36±0.2mm, can be put into the handle that functions as smoke evacuation pencil. The device is compatible with the socket of generator accommodating the standard 3-pin active connector, the output voltage setting of generator not larger 5kVp, compatible cable connection of grounding pad to the generator and all smoke evacuators with an ID22mm EVA tubing connector. The products, PS947 and CE809 do not have technology difference. ## 5. Indication for use The device is used to conduct electrosurgical current from an electrosurgical generator to target tissue in electrosurgical procedures for monopolar cutting and coagulation, with the additional function of evacuation to facilitate the removal of surgical smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. {5}------------------------------------------------ ## 6. Technological characteristics Single Use Smoke Evacuation Fingerswitch and Smoke Evacuation System with Electrosurgical Pencil integrates two technologies of electrosurgery and smoke evacuation. These two 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 devices and the predicate device. | Compared<br>Items | Proposed Device | Proposed Device | Predicate Device<br>(K103375) | Comments on<br>difference | |------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended use | Single Use Smoke<br>Evacuation<br>Fingerswitch<br>(PS947)<br>The device is<br>intended to be used<br>as the active<br>monopolar electrode<br>in an electrosurgery<br>generator system for<br>cutting and<br>coagulation, with the<br>additional function to<br>facilitate the removal<br>of surgical smoke<br>generated by<br>electrosurgery when<br>used in conjunction<br>with an effective<br>smoke evacuation<br>system | Single Use Smoke<br>evacuation system<br>with electrosurgical<br>pencil (CE809)<br>The device is<br>intended to be used<br>as the active<br>monopolar electrode<br>in an electrosurgery<br>generator system for<br>cutting and<br>coagulation, with the<br>additional function to<br>facilitate the removal<br>of surgical smoke<br>generated by<br>electrosurgery when<br>used in conjunction<br>with an effective<br>smoke evacuation<br>system | MEDTEK<br>PLUMEPEN<br>Integrated Smoke<br>Evacuation Pencil<br>The PLUMEPEN is<br>designed for general<br>electrosurgical<br>applications,<br>including cutting and<br>coagulation, and for<br>removing smoke<br>generated by<br>electrosurgery when<br>used in conjunction<br>with an effective<br>smoke evacuation<br>system. The pencil<br>enables the operator<br>to remotely conduct<br>an electrosurgical<br>current from the<br>output connector of<br>an electrosurgical<br>unit to the operative<br>site for the desired<br>surgical effect. | Same | | | | | | | | Indication for<br>use | The device is used<br>to conduct<br>electrosurgical<br>current from an<br>electrosurgical<br>generator to target<br>tissue in<br>electrosurgical<br>procedures for<br>monopolar cutting<br>and coagulation,<br>with the additional<br>function of<br>evacuation to<br>facilitate the removal<br>of surgical smoke<br>generated by<br>electrosurgery when<br>used in conjunction<br>with an effective<br>smoke evacuation<br>system. | The device is used<br>to conduct<br>electrosurgical<br>current from an<br>electrosurgical<br>generator to target<br>tissue in<br>electrosurgical<br>procedures for<br>monopolar cutting<br>and coagulation,<br>with the additional<br>function of<br>evacuation to<br>facilitate the removal<br>of surgical smoke<br>generated by<br>electrosurgery when<br>used in conjunction<br>with an effective<br>smoke evacuation<br>system. | To remove smoke<br>plume form the<br>surgical site and<br>remotely conduct an<br>electrosurgical<br>current from the<br>output connector of<br>an electrosurgical<br>unit to the target<br>tissue for the<br>desired surgical<br>effect | Same | | Regulation<br>number | 21 CFR 878.4400 | 21 CFR 878.4400 | 21 CFR 878.4400 | Same | | Product code | GEI | GEI | GEI | Same | | OTC or<br>prescription | For prescription use | For prescription use | For prescription use | Same | | Energy<br>delivery | High frequency<br>electrical<br>current/energy | High frequency<br>electrical<br>current/energy | High frequency<br>electrical<br>current/energy | Same | | Technology | Monopolar<br>electrosurgery and<br>use of vacuum<br>source to capture<br>smoke | Monopolar<br>electrosurgery and<br>use of vacuum<br>source to capture<br>smoke | Monopolar<br>electrosurgery and<br>use of vacuum<br>source to capture<br>smoke | Same | | Device mode | Cut and coag. | Cut and coag. | Cut and coag. | Same | | Design | Smoke evacuation | Smoke evacuation | Electrosurgical | Similar<br>construction and<br>provide the same<br>technology to<br>achieve target<br>function.<br>Extending the<br>suction tip and | | | fingerswitch is | system with pencil | pencil is integrated | | | | produced from that | includes pencil is | with smoke | | | | electrosurgical | combined with the | evacuation with | | | | pencil is integrated | specified suction | extendable suction | | | | with smoke | handle that performs | tip A variety of | | | | evacuation with | as those of suction | length of electrode | | | | switching control | evacuation pencil. | be used with | | | | moving on the shaft<br>of device in order to<br>perform as<br>extending or<br>retracting suction<br>tip. Nosecone can<br>be added to further<br>extend the suction<br>tip. | | extendable suction<br>tip. | electrode is only<br>for facilitating<br>operation in<br>deeper surgical<br>site | | Structure of<br>Pencil<br>- Housing<br>- Cable | | | | | | - Housing<br>- Cable | - ABS<br>- PVC | - ABS<br>- PVC | - ABS<br>- PVC | The material<br>used and<br>structure among | | -Nosecone /<br>Suction tip | - K-resin | - K-resin | - K-resin | the purposed<br>and predicate<br>devices are very | | -Suction<br>tubing | - EVA | - EVA | - EVA and PVC | similar and do<br>not raise safety<br>and<br>effectiveness<br>issues because<br>those were<br>tested according<br>to IEC test and<br>biocompatibility<br>requirements | | -Switching | - Push button, rocker | - Push button, rocker | - Push button | Same function | | -Electrode tip<br>style | -Blade | -Blade | -Blade | Same | | -Electrode<br>Material | -Stainless steel | -Stainless steel | - Stainless steel | Same | | - Length | - 50mm, 63.5mm, 69<br>mm, and 120mm. | - 69 mm | -69mm or longer | Similar, longer<br>lengths do not<br>affect cut and<br>coag.<br>performance but<br>only facilitates<br>the electrode tip<br>go to deeper<br>surgical site. | | | | | | | | - Diameter | -2,36 mm | -2,36 mm | ~2.36mm | Same | | - Conductive<br>end | -15.5mm | -15.5mm | -15.5mm | Same | | - Tip width | - 2.3mm | - 2.3mm | - 2.3mm | Same | | - Tip depth | ~0.5mm | ~0.5mm | ~0.5mm | Same | | - Insulation<br>material | - PTFE Shrink Wrap | - HIPS | - HIPS | The proposed<br>electrode passes<br>the required tests<br>according to<br>ISO10993,<br>IEC60601-1 and<br>IEC60601-2-2 so<br>there will not any<br>issue for safety. | | - Electrode<br>coating | -Teflon one coat | -Teflon one coat | - Teflon one coat | Same | | -Rated<br>accessory<br>voltage | - 4.5kVp | - 5kVp | - 5kVp | Similar, does not<br>affect<br>performance | | Max.<br>operation<br>power | -300W | -300W | -300W | Same | | Sterile | EO sterile SAL 10-6 | EO sterile SAL 10-6 | EO sterile SAL 10-6 | Same purpose,<br>EO sterilization is<br>validated<br>according to ISO<br>11135 | | Shelf life | 3 years | 3 years | 3 years | Same | | Electrical<br>safety | Comply with<br>dielectric strength in<br>with accordance<br>ES60601-1,<br>IEC60601-1-2 &<br>IEC60601-2-2 | Comply with<br>dielectric strength in<br>with accordance<br>ES60601-1,<br>IEC60601-1-2 &<br>IEC60601-2-2 | Comply with<br>dielectric strength in<br>with accordance<br>AAMI HF-18 | Same kinds of<br>safety<br>requirements | | Biocompatibil<br>ity | Comply with<br>ISO10993 | Comply with<br>ISO10993 | Comply with<br>ISO10993 | Meet to<br>biocompatibility<br>requirements so<br>it does not raise | | |…