CiRX Single use electrosurgical pencil with non-coated and coated electrode

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue box. To the right of the blue box is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Ningbo Shun Ye Medical Company, Ltd. Mr. Frank Yu Official Correspondent No.5 Industry Road, Zhangqi Industry Zone, Cixi Ningbo City , Zhejiang 315313 China June 27, 2022 Re: K213786 Trade/Device Name: Single use electrosurgical pencil with electrode Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: April 19, 2022 Received: April 28, 2022 Dear Mr. Yu: 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. 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 {1}------------------------------------------------ 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/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, for 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 Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K213786 Device Name single use electrosurgical pencil with electrode Indications for Use (Describe) The device is to be used in combination with a standard electrosurgical generator to cut and coagniate soft tissus by means of high frequency electrical current during an electrosurgical procedure. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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A circled "R" trademark symbol is located in the upper right corner of the logo. ## SECTION 5 # 510(K) SUMMARY Page 1 of 10 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for CiR, with the letters "CiR" in a stylized font. The letters are in a light blue color. Below the letters, there are two Chinese characters in a darker color. The background is white. ### 510(k) SUMMARY #### (Submitted As Required per 21 CFR 807.92) ## I. GENERAL INFORMATION | Submitter Name: | Ningbo Shun Ye Medical Company, Ltd. | | |---------------------------------------|--------------------------------------------------------------------|--| | Establishment Registration<br>Number: | 3007593903 | | | Submitter Address: | No. 5 Industry Road, | | | | Zhangqi Industry Zone, Cixi, Ningbo City<br>315313 Zhejiang, China | | | Submitter Telephone Number: | 011 - 86 - 574 - 6377 - 8018 | | | Submitter FAX Number: | 011 - 86 - 574 - 6377 - 8028 | | | Contact Person: | Frank Yu<br>General Manager | | | Date Prepared: | October 2021 | | ## II.DEVICE IDENTIFICATION | Proprietary Name: | Single use electrosurgical pencil with non-coated and non-stick<br>electrode; | |----------------------|-------------------------------------------------------------------------------| | Common Name: | Single use electrosurgical pencil with electrode | | Classification Name: | Electrosurgical Cutting and Coagulation Device and Accessories | | Classification: | 21CFR 878.4400; Class II; Product Code GEI | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows a logo with the letters "CiR" in a light blue color. Below the letters, there are two Chinese characters in a similar light blue hue. A circled "R" trademark symbol is positioned in the upper right corner of the logo, slightly above and to the right of the "R" in "CiR". ### III.PREDICATE DEVICE #### Table 1: Predicate device information | Predicate device | 510k number | 510k holder | Clearance date | |------------------------------------------------------------------------------------|-------------|------------------------------------------------------|----------------| | Single Use<br>Electrosurgical pencil<br>with non-coated and<br>non-stick electrode | K192542 | Modern Medical<br>Equipment<br>Manufacturing Limited | 16-Jun-20 | ### IV.DEVICE DESCRIPTION The Single use electrosurgical pencil with electrode is a monopolar active device which consists of a conductive electrode tip, an insulated shaft and a conductive post. It directs high frequency alternating current to heat target tissue thereby bringing about cutting and coagulation during surgical procedures. The electrosurgical pencil handpiece 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 electrosurgical pencil handpiece is available in 3 models, differing only in their button configuration: Push Button Electrosurgical Pencil (Model #: GDSA), Electrosurgical Rocker Pencil (Model #: GDSB), and Electrosurgical Foot Control (Model #: GDJA). The electrode consists of a conductive electrode tip, an insulated shaft and a conductive post. The electrode tip may be blade, ball, needle and dermal tip. The electrode tip is either coated or noncoated. There may or may not be a heat shrink attached. There are 47 different types of electrodes. The model number of each subjective device "Single use electrosurgical pencil with electrode" consists of two parts: the first four letters representing model number of the pencil, and the second part representing model number of the electrode. For example, model number: GDSA-DA-C66 is for Push Button Electrosurgical Pencil with Standard Blade 2.6". There are 141 different combinations of pencil and electrode. The diameter of the conductive post is 2.36mm. The pencil with electrode attached 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 this electrosurgical pencil may be push button, rocker switch or foot switch. The cable length of the electrosurgical pencil will be around 3m to 5m with 3-pins plug or 1-pin plug. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows a logo with the text "CiR" in a light blue color. Below the text "CiR" are two Chinese characters in a darker color. A circled "R" symbol is located in the upper right corner of the logo. The single use electrosurgical pencil with electrode has the same intended use and energy type as the predicate device. There are no technological differences, no changes to the principle of operation or the method of application. ## V.INTENDED USE/INDICATIONS The monopolar electrosurgical pencil with electrode is used to deliver high frequency current to target tissue for cutting and coagulation. This is identical to the intended use/indications of the predicate device. | Compared items | Proposed device<br>(K213786)<br>Single use electrosurgical pencil<br>and non-coated and non-stick<br>electrode | Predicate device<br>(K192542)<br>Single use electrosurgical pencil<br>and non-coated and non-stick<br>electrode | Comments | |------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended use | The monopolar<br>electrosurgical pencil with<br>electrode is used to deliver<br>high frequency current to<br>target tissue for cutting and<br>coagulation | The monopolar<br>electrosurgical pencil with<br>electrode is used to deliver<br>high frequency current to<br>target tissue for cutting and<br>coagulation | same | | Indication for use | To cut and coagulate soft<br>tissue by means of high<br>frequency electrical current<br>during an electrosurgical<br>procedure. | To cut and coagulate soft<br>tissue by means of high<br>frequency electrical current<br>during an electrosurgical<br>procedure. | same | | Regulation<br>number | 21 CFR<br>878.4400 | 21 CFR 878.4400 | same | | Product code | GEI | GEI | same | | OTC or<br>prescription | For prescription<br>use | For prescription use | same | | | | | | | Energy delivery | High frequency electrical<br>current/energy | High frequency electrical<br>current/energy | same | | Monopolar or<br>bipolar | Monopolar | Monopolar | same | | Generator<br>Compatibility | To be used with a standard<br>electrosurgical generator<br>with footswitch control and a<br>standardreturn electrode<br>connection | To be used with a standard<br>electrosurgical generator<br>withfootswitch control and a<br>standard return electrode<br>connection | same | | Design | Monopolar electrosurgical<br>pencil for cutting and<br>coagulation and with different<br>electrode tips as blade,<br>needle, and ball | Monopolar electrosurgical<br>pencil for cutting and<br>coagulation and with<br>different electrode tips as<br>blade, needle, and ball | same target<br>purpose | | User Interface | Footswitch/Hand | Footswitch/Hand | same | | Structure<br>Pencil<br>- Housing<br>- Cable<br>- Switching | ABS<br>PVC<br>Push button, rocker switch &<br>footcontrol | ABS<br>PVC<br>Push button, rocker switch<br>&foot control | The material used<br>and structure among<br>the proposed and<br>predicate devices are<br>very similar and do<br>not raise safety and<br>effectiveness issues<br>because those were<br>tested according to<br>IEC test and<br>biocompatibility<br>requirements | | Electrode<br>- Material | Stainless steel | Stainless steel | Same | | - Length | 66mm, 70mm, 101mm,152mm<br>(blade)<br>65mm (angled blade) | 69 mm, 102mm, 152mm (blade<br>& needle) | Similar, length of<br>electrode does not<br>raise any safety and<br>performance issues | | | 72mm, 101mm, 152mm (needle)<br>60mm, 66mm (angled needle)<br>60mm (dermal tip)<br>49mm, 50mm, 51mm,<br>132mm,133mm,134mm(ball) | 69-71mm, 105-107mm,135-<br>137mm (ball) | | | Diameter | ~2.36mm | ~2.36mm | Same | | Insulation<br>material | Kynar Shrink Wrap and/or<br>ABS/HIPS overmold | Polyolefin Shrink Wrap<br>and/or PTFE Shrink Wrap,<br>Or ABS/HIPS overmold | Similar. The proposed<br>electrode passes the<br>required tests according<br>to IEC60601-1 and<br>IEC60601-2-2 so there<br>are not any issues for<br>safety. | | Electrode Tip<br>Configuration | Blade, Needle, Ball | Blade, Needle, Ball | Same | | Electrode<br>coating | Teflon coat | Teflon coat | Same | | Rated<br>accessory<br>voltage | 4kVp | 4kVp, 5kVp | Similar. The proposed<br>electrode passes the<br>required tests according<br>to IEC60601-1 and<br>IEC60601-2-2 so there<br>are not any issues for<br>safety and performance. | | Sterilization | EO sterile | EO sterile | Same. EO sterilization<br>is validated according<br>to ISO 11135. | | Shelf life | 3 years | 3 years | Same | | Electrical safety | Comply with dielectric strength in<br>accordance with IEC60601-1,<br>IEC60601-1-2 & IEC60601-2-2 | Comply with dielectric strength<br>in accordance with IEC60601-1,<br>IEC60601-1-2 & IEC60601-2-2 | Same | | Biocompatibility | Comply with ISO10993 | Comply with ISO10993 | Same | ### VI. PROPOSED/PREDICATE DEVICE COMPARISON {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows a logo with the letters "CiR" in a stylized font, with the "R" slightly smaller and raised, accompanied by the Chinese characters "弈业" below. The letters and characters are in a light blue color. A registered trademark symbol (®) is positioned to the upper right of the "R". {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for CiR, with the letters "CiR" in a light blue color. Below the letters, there are two Chinese characters in a darker color. The "R" in "CiR" has a circled "R" symbol next to it, indicating that it is a registered trademark. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for CiR, which is a company or organization. The logo consists of the letters "CiR" in a light blue color, with the "R" having a curved extension. Below the letters, there are two Chinese characters in a similar light blue color. To the right of the "R", there is a circled "R" symbol, indicating that the logo is a registered trademark. {10}------------------------------------------------ Image /page/10/Picture/1 description: The image shows a logo with the text "CiRx" in a stylized font, with the "R" having a registered trademark symbol next to it. Below the text "CiRx" are two Chinese characters stacked vertically. The logo has a light blue color scheme. ### VII. SAFETY/PERFORMANCE TESTING The following performance data are provided in support of substantial equivalence determination. #### 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 Shun Ye Medical Electrosurgical Pencil to MMEO Electrosurgical Pencil. Test specimens used are listed as follows: - Porcine Liver ● - Porcine Kidney - Porcine Muscle tissues #### Biocompatibility testing The biocompatibility evaluation for the single use electrosurgical pencil with electrode was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and 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 battery of testing included the following tests: - Cytotoxicity - Skin sensitization - Intracutaneous reactivity test - Acute systemic toxicity - Pyrogen Testing {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows a logo with the text "CiR" in a light blue color, with the "R" having a small check mark-like symbol in the lower right corner. Above the "R" is a small circled "R" symbol, indicating a registered trademark. Below the "CiR" text are two Chinese characters in a darker color, possibly representing the company's name or a related term. #### Electrical safety and electromagnetic compatibility (EMC) Electrical safety and EMC testing were conducted on the single use electrosurgical pencil with electrode. The product complies with the IEC 60601-1 and IEC60601-2-2 standards for safety, IEC 60601-1-2 standard for EMC. The single use electrosurgical pencil with electrode was designed in accordance with the following standards: | International Standard | Description | |-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | IEC 60601-1, Edition 3.1 | Medical Electrical Equipment - Part 1: General Requirements for Safety | | IEC 60601-1-2 Edition 4.0 2014-02 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests | | IEC 60601-2-2 Edition 6.0 2017-03 | Particular requirements for the safety of high frequency surgical equipment | | ISO 11135-1: 2007 | Sterilization of Healthcare Products – Ethylene Oxide – Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices. | | ISO 10993-7:2008 | Biological Evaluation of Medical Devices – Part 7: Ethylene Oxide Residuals | | ISO 10993-12: 2012 | Biological evaluation of medical devices – Part12: Sample preparation and reference materials | | ISO 10993-2:2006 | Biological evaluation of medical devices Part 2: Animal welfare requirements | | ISO 10993-11: 2017 | Biological evaluation of medical devices Part 11: Tests for systemic toxicity | | ISO 10993-5:2009 | Biological Evaluation of Medical Devices – Part 5: Tests for in vitro cytotoxicity | | ISO 10993-1:2018 | Biological Evaluation of Medical Devices Part 1: Evaluation and Testing with a Risk Management Process | {12}------------------------------------------------ Image /page/12/Picture/1 description: The image shows a logo with the text "CiRx" in a stylized font, with the "Ci" in a lighter blue color and the "Rx" in a darker blue. Above the "Rx" is a circled "R" symbol, indicating a registered trademark. Below the "CiRx" text is the Chinese characters "舜业". #### CONCLUSION VIII. There is no difference between the Single use electrosurgical pencil with electrode and the predicate device in terms of intended use, principle of operation, and the technology used for device performance. There is no new technology and no difference that would raise new or different questions of safety or efficacy. Therefore, we conclude that the devices are substantially equivalent.