Who is the manufacturer of ShinEvac Smoke Evacuation Pencil?

Shining World Health Care Co., Ltd. filed the 510(k) submission for ShinEvac Smoke Evacuation Pencil (K213317).

What is the FDA product code for ShinEvac Smoke Evacuation Pencil?

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

What is the regulatory pathway for ShinEvac Smoke Evacuation Pencil?

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

What are the predicate devices for ShinEvac Smoke Evacuation Pencil?

PLUMEPEN® Integrated Smoke Evacuation Pencil (K103375).

Who can help prepare an FDA 510(k) submission like ShinEvac Smoke Evacuation Pencil?

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.

ShinEvac Smoke Evacuation Pencil

K213317 · Shining World Health Care Co., Ltd. · GEI · Jan 28, 2022 · General, Plastic Surgery

Device Facts

Record ID	K213317
Device Name	ShinEvac Smoke Evacuation Pencil
Applicant	Shining World Health Care Co., Ltd.
Product Code	GEI · General, Plastic Surgery
Decision Date	Jan 28, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The ShinEvac® Smoke Evacuation Pencil is designed for general electrosurgical applications, including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct and electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect.

Device Story

The ShinEvac Smoke Evacuation Pencil is a sterile, single-use electrosurgical accessory; it connects to an electrosurgical unit (ESU) and an external smoke evacuation system. The device features a pencil body with a detachable tip electrode and an integrated evacuation tube. During surgery, the operator uses the pencil to conduct high-frequency electrical current (300-600 kHz, up to 120W) from the ESU to the operative site for cutting or coagulation. Simultaneously, the integrated tube removes surgical smoke generated at the site. The device is operated by a surgeon or clinician in a surgical setting. By providing both electrosurgical functionality and smoke removal, the device assists in maintaining a clear operative field and reducing exposure to surgical smoke, potentially benefiting both the patient and the surgical team.

Clinical Evidence

No clinical data. Evidence consists of bench testing and an animal study. The animal study evaluated cutting performance and thermal damage (tissue temperature, cooling time) in liver, kidney, and muscle tissues under various power settings. Safety testing included IEC 60601-1 (general safety), IEC 60601-1-2 (EMC), and IEC 60601-2-2 (high-frequency surgical equipment). Biocompatibility was verified per ISO 10993 standards (cytotoxicity, irritation, sensitization, systemic toxicity) and USP pyrogen testing. Sterilization was validated per ISO 11135.

Technological Characteristics

Disposable electrosurgical pencil; stainless/non-stick tip electrode (2.38mm); 3M/5M cable; integrated smoke evacuation tube. Energy source: external electrosurgical generator (300-600 kHz, max 4.5 kV peak). Sterilization: Ethylene Oxide (EO). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, ISO 10993, ISO 11135.

Indications for Use

Indicated for general electrosurgical applications, including cutting and coagulation, and smoke removal in the general patient population. Prescription use only.

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

PLUMEPEN® Integrated Smoke Evacuation Pencil (K103375)

Related Devices

K202962 — Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D1, Smoke Evacuation Button Switch Pencil, Non-Ext., 15ft, D1, Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D2, Smoke Evacuation Button Switch Pencil, Non-Ext., 15ft, D2, Telescopic Smoke Evacuation Button Switch Pencil, 10ft, Telescopic Smoke Evacuation Button Switch Pencil, 15ft, Telescopic Smoke Evacuation Button Switch Pencil, 15ft, Telescopic Smoke Evacuation Button Switch Pencil, Lock, 15ft · New Deantronics Taiwan , Ltd. · Nov 20, 2020
K081634 — CONMED GOLDVAC INTEGRATED SMOKE EVACUATION PENCIL · Conmed Corporation · Jun 25, 2008
K201129 — Medline Smoke Evacuation Pencil · Medline Industires, Inc. · Oct 16, 2020
K141587 — E-Z CLEAR SMOKE EVACUATION ELECTROSURGICAL PENCIL;CLEAR NOZZLE EXTENTION, ULPA FILTER, CHARCOAL FILTER, ADAPTER · Megadyne Medical Products, Inc. · Feb 18, 2015
K120454 — SAFEAIR SMOKE PENCIL, · Lna Medical Aps · Dec 7, 2012

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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. January 28, 2021 Shining World Health Care Co., Ltd. Mrs. Anita Chen Regulatory Advisor No.22, Ln. 116, Wugong 2nd Rd., Wugu Dist New Taipei City, Taiwan 248 Taiwan (R.O.C) Re: K213317 Trade/Device Name: ShinEvac Smoke Evacuation Pencil Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: September 16, 2021 Received: October 4, 2021 Dear Mrs. Chen: 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 a ware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/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 (OS) 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/cdrl-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) K213317 Device Name ShinEvac® Smoke Evacuation Pencil #### Indications for Use (Describe) The ShinEvac® Smoke Evacuation Pencil is designed for general electrosurgical applications, including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct and electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect. Type of Use (Select one or both, as applicable) | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | |----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------| |----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------| #### 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}------------------------------------------------ # Section 5 510(k) Summary #### 510(k) Summary of Safety and Effectiveness This 510(k) summary of safety and effectiveness information is submitted as part of the Premarket Notification in compliance with requirements of CFR Part 807, Subpart E and Section 807.92 | 1. | Manufacturer | Shining World Health Care Co., Ltd. | |----|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------| | | Address | No.22, Ln. 116, Wugong 2nd Rd., Wugu Dist., New Taipei City 248, Taiwan (R.O.C.). TEL: +886-2-22900966 FAX: +886-2-22903966 | | | Establishment Registration No.: | 1000448660 | | | Contact Person | Mrs. Anita Chen/ Regulatory Advisor of Shining World Health Care Co., Ltd. | | | Cell Phone: | +886-939-855-759 | | | Phone: | +886-2-22900966 | | | E-mail: | Anita9104303@gmail.com | | | Date Prepared | January 21, 2022 | | The assigned 510(k) Number: | K213317 | |-----------------------------|---------| |-----------------------------|---------| | 2 | Device Name | | |---|--------------------|----------------------------------------------------| | | Proprietary Name: | ShinEvac® Smoke Evacuation Pencil | | | Model Name | Classic, AIO | | | Model No. | SW12200-APBCSE36 | | | | SW12200-APBCSE36G | | | | SW12200-APBCSE56 | | | | SW12200-APBCSE56G | | | | SW12200-APBCSB36 | | | | SW12200-APBCSB56 | | | Regulation Number: | 21 CFR 878.4400 | | | Regulation Name: | Electrosurgical cutting and coagulation device and | Section 5. 510(k) Summary {4}------------------------------------------------ | | accessories | |-------------------|-------------| | Regulatory Class: | Class II | | Product Code: | GEI | | 3 | Predicate Device Name | PLUMEPEN® Integrated Smoke Evacuation Pencil | |---|-----------------------|----------------------------------------------------| | | 510(k) number | K103375 | | | Trade/Device Name: | PLUMEPEN | | | Regulation Number: | 21 CFR 878.4400 | | | Regulation Name: | Electrosurgical cutting and coagulation device and | | | | accessories | | | Regulatory Class: | Class II | | | Product Code: | GEI | | 4 | Device Description | The ShinEvac® Smoke Evacuation Pencil, model: | |---|--------------------|--------------------------------------------------------| | | | SW12200-APBCSE36, SW12200-APBCSE36G, | | | | SW12200-APBCSE56, SW12200-APBCSE56G, | | | | SW12200-APBCSB36 and SW12200-APBCSB56 is | | | | designed for general electrosurgical applications, | | | | including cutting and coagulation, and for removing | | | | smoke generated by electrosurgery when used in | | | | conjunction with an effective smoke evacuation | | | | system. The pencil enables the operator to remotely | | | | conduct an electrosurgical current from the output | | | | connector of an electrosurgical unit to the operative | | | | site for the desired surgical effect. | | | | Electro surgical Pencil is one of accessories of HF | | | | Electro Surgical Unit generates frequency from | | | | 300~600KHz for coagulation and cutting function, | | | | power up to 80W and 120W respectively. It is | | | | connected with cable conducting electro energy from | | | | unit and is holding a detachable tip electrode for the | {5}------------------------------------------------ | | | electrosurgery. This device is compatible with the Ø 2.38mm tip electrode and the maximum voltage is 4.5 KV peak. Th is device can remove surgical smoke when connected to a smoke evacuator. | |----|--------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 5. | Intended Use: | The ShinEvac® Smoke Evacuation Pencil is designed for general electrosurgical applications, including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct and electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect. | | 6. | Technological Characteristics and Substantial Equivalence Comparison with Predicate: | A comparison of the device features, intended use, and other information demonstrates that the ShinEvac® Smoke Evacuation Pencil is substantially equivalent to the predicate device as summarized in Table 1. The differences raise no new question of safety and effectiveness. | {6}------------------------------------------------ ### Table 1 | | | MEDTEK DEVICES, INC., | |------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Shining World Health Care Co., Ltd. | dba Buffalo Filter | | | | Predicate device | | | Subject Device | PLUMEPEN® INTEGRATED SMOKE | | Device name | ShinEvac® Smoke Evacuation Pencil | EVACUATION PENCIL | | 510(k) Number | K213317 | K103375 | | Intended Use | The ShinEvac® Smoke Evacuation Pencil is designed for general electrosurgical applications, including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct and electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect. | The PLUMEPEN is designed for general electrosurgical applications, including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct and electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect. | | Regulation name | Electrosurgical cutting and coagulation device and accessories | Electrosurgical cutting and coagulation device and accessories | | Rag Number | 21 CFR 878.4400 | 21 CFR 878.4400 | | Product Code | GEI | GEI | | Class | II | II | | Energy Source | Electrosurgical Generator | Electrosurgical Generator | | Sterility | Sterile by Ethylene Oxide (EO) | Sterile by Ethylene Oxide (EO) | | Technical Design | Pencil body with removable evacuation tube | Pencil body with removable evacuation tube | {7}------------------------------------------------ | Patient Contact | Invasive tissue contact | Invasive tissue contact | | |---------------------|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------| | Electrode | Stainless/non-stick | Stainless/non-stick | | | Patient Population | General population | General population | | | Prescription or OTC | Prescription | Prescription | | | Single Use | Yes | Yes | | | Model | Classic | AIO | NA | | Design | Pencil body with removable evacuation tube | Extendable suction tube | Pencil body with removable evacuation tube | | Specification | Disposable with 65mm electrode, 3M/5M cable, and holster. Cut and Coagulation button | Disposable with 70mm electrode, 3M/5M cable, and holster. Cut and Coagulation button | Disposable with 70mm electrode, 3M cable, and holster. Cut and Coagulation button | {8}------------------------------------------------ #### 7. Performance and Safety Test - a. Performance Testing - Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery Guidance for Industry and Food and Drug Administration Staff, 2020. - Animal study and clinical investigation । The Animal study was evaluated the safety and performance of the device in three different tissues under worst case scenarios. The outputs of energy were applied with low, moderate, and high watts in liver, kidney and muscle to test of the cutting performance and also evaluated the safety from tissue temperature, tissue cooling time and the extent of tissues' thermal damage. - Clinical investigation isn't required for these devices. - - b. Safety Test: -IEC 60601-1:2005+COPR.1:2006+COPR.2:2007+A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility requirements and tests - 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 Medical electrical equipment -Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability ### c. Biocompatibility testing The biocompatibility evaluation and testing of the ShinEvac® Smoke Evacuation Pencilwas conducted in accordance with the following standards and guidance, as recognized by the FDA: -FDA Guidance - Use of International Standard ISO- 10993, "Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing". -ISO 10993-5, Biological evaluation of medical devices- Part 5: Tests for in vitro {9}------------------------------------------------ #### cytotoxicity -ISO 10993-10, Biological evaluation of medical devices- Part 10: Tests for irritation and skin sensitization -ISO 10993-11, Biological evaluation of medical devices Part 11: Tests for systemic toxicity -USP 42/NF37:2019 <151> Pharmacopeia US : Pyrogen Test ### d. Sterilization Validation - ISO 11135:2014 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices ### 8. Conclusion Based on the intended use and/or indications for use, technological characteristics, performance testing and comparison to the predicate device, the ShinEvac® Smoke Evacuation Pencil is substantially equivalent to the predicate device and raises no new questions of safety or effectiveness.