Trigger Switch and Cord

{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 acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the agency's name written out in a smaller font next to it. March 31, 2020 New Deantronics Taiwan, Ltd. % Mr. Craig Coombs President Coombs Medical Device Consulting, Inc 1100 Pacific Marina, Suite 806 Alameda, California 94501 Re: K200455 Trade/Device Name: Trigger Switch and Cord Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: February 21, 2020 Received: February 25, 2020 Dear Mr. Coombs: 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 Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K200455 Device Name Trigger Switch and Cord #### Indications for Use (Describe) The Trigger Switch and Cord are accessories that are intended for use in monopolar laparoscopic and thoracoscopic electrosurgical procedures where handswitching of laparoscopic instruments is desired. Type of Use (Select one or both, as applicable) | <div> <span> <span style="font-size:16px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | |--------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </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}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for New Deantronics. The word "NEW" is in blue, and next to it is a blue circle with a red dot in the center. The word "DEANTRONICS" is in blue and is to the right of the circle. # Section 5: 510(k) Summary # A. Device Information: | Category | Comments | |------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sponsor: | New Deantronics Taiwan Ltd.<br>12F., No.51, Sec. 4, Zhongyang Rd.,<br>TuCheng District<br>New Taipei City 236, Taiwan R.O.C.<br>Tel: (886) 2-2268-1726<br>Fax: (886) 2-2268-3800<br>Sponsor Contact: Ms. Jane Liu, President<br>Email: jane@newdean.com.tw | | Correspondent Contact<br>Information: | Mr. Craig Coombs<br>President<br>Coombs Medical Device Consulting<br>1100 Pacific Marina, Suite 806<br>Alameda, CA 94501<br>Tel: 510-995-8499<br>Email: CraigJCoombs@gmail.com | | Device Common Name: | Electrosurgical accessory<br>Trigger Switch and Cord | | Device Classification Number: | 21 CFR 878.4400 | | Device Classification &<br>Product Code: | Class 2,<br>GEI | | Device Proprietary Name: | Trigger Switch and Cord | # Predicate Device Information: | Predicate Device: | Trigger Switch and Cord | |----------------------------------------------------|----------------------------------------| | Predicate Device Manufacturer: | Valleylab, Inc. | | Predicate Device Common Name: | Electrosurgical accessory | | Predicate Device Premarket Notification # | K970140 | | Predicate Device Classification: | 21 CFR 878.4400 | | | Electrosurgical, Cutting & Coagulation | | | Device and Accessories | | Predicate Device Classification &<br>Product Code: | Class 2,<br>GEI | ## B. Date Summary Prepared 20 March 2020 {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for New Deantronics. The logo features the word "NEW" stacked on top of a stylized letter "O" with a red dot in the center. To the right of the "O" is the word "DEANTRONICS" in a bold, sans-serif font. The logo is primarily blue in color. ## C. Description of Device The Trigger Switch and Cord are an electrical connecting cord assembly, intended to provide an electrical path between an RF electrosurgery generator and an RF surgical electrode. The insulated wire of the Cord is 10ft long. The Cord is intended to be plugged into an in-line Trigger Switch which is attached to the RF electrode handle with an adhesive backing. The Trigger Switch allows hand switching of the electrical current through the Cord during surgery. These devices can be used in hospitals and are used by trained professionals only. The Trigger Switch and Cord are compatible with the monopolar instruments with a shrouded 4mm male electrical connector and with an electrosurgical generator. Typically, these application devices are used in place of foot switches in the flow of electrosurgical current to the target site. These devices are sold as sterile, single-use devices. #### D. Indications for Use The Trigger Switch and Cord are accessories that are intended for use in monopolar laparoscopic and thoracoscopic electrosurgical procedures where handswitching of laparoscopic and thoracoscopic instruments is desired. #### E. Comparison to Predicate Device As described below, the application New Deantronics Trigger Switch and Cord is substantially equivalent in intended use, technology, design and physician use to the predicate Valleylab, Inc. Trigger Switch and Cord (K970140). | Feature | Application Device:<br>New Deantronics Trigger Switch<br>and Cord (Catalog No. LC002) | Predicate Device:<br>Valleylab, Inc. Trigger Switch<br>and Cord (K970140) | Pertinence of Feature<br>to Consideration of<br>Substantial<br>Equivalence. | |---------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------| | Indications for<br>Use | The Trigger Switch and Cord are<br>accessories that are intended<br>for<br>in<br>monopolar<br>use<br>laparoscopic and thoracoscopic<br>electrosurgical<br>procedures<br>handswitching<br>of<br>where<br>laparoscopic and thoracoscopic<br>instruments is desired. | The Trigger Switch and Cord<br>accessories are intended for use<br>in monopolar laparoscopic and<br>thoracoscopic electrosurgical<br>procedures where<br>handswitching of laparoscopic<br>and thoracoscopic instruments,<br>such as scissors and graspers, is<br>desired. | Identical, except for<br>grammatical changes,<br>and specific examples<br>of instruments were<br>dropped as<br>unnecessary. | | Product Code | GEI | GEI | Identical | | Feature | Application Device:<br>New Deantronics Trigger Switch<br>and Cord (Catalog No. LC002) | Predicate Device:<br>Valleylab, Inc. Trigger Switch<br>and Cord (K970140) | Pertinence of Feature<br>to Consideration of<br>Substantial<br>Equivalence. | | Technology | | | | | Mechanism of<br>Standard<br>Electrosurgery | The Trigger Switch and Cord is<br>designed to connect an<br>electrosurgical generator with a<br>monopolar instrument. When<br>electrosurgery is activated by<br>Trigger Switch, the<br>electrosurgical energy will be<br>delivery from electrosurgical<br>generator through the Cord and<br>to the electrode, to coagulate in<br>surgical procedures. | The Trigger Switch and Cord is<br>designed to connect an<br>electrosurgical generator with a<br>monopolar instrument. When<br>electrosurgery is activated by<br>Trigger Switch, the<br>electrosurgical energy will be<br>delivery from electrosurgical<br>generator through the Cord and<br>to the electrode, to coagulate in<br>surgical procedures. | Identical | | Energy Used | Radiofrequency Electrical<br>Current | Radiofrequency Electrical<br>Current | Identical | | Operation<br>Principle | Monopolar Electrosurgery | Monopolar Electrosurgery | Identical | | Equipment<br>Mated | Electrosurgical Generator:<br>Force FX or Force Triad | Electrosurgical Generator:<br>Force FX or Force Triad | Identical | | Design -Mechanism | | | | | Control Type | Hand Control | Hand Control | Identical | | Cord Set<br>Length | Trigger Cord: 10 ft<br>Trigger Switch: 0.5 ft. | Trigger Cord: 10 ft<br>Trigger Switch: 0.5 ft. | Identical | | Design- Material | | | | | Cable | Insulation: PVC | Insulation: PVC | Identical | | | Wire: Copper (24 AWG) | Wire: Copper (24 AWG) | | | Generator<br>connector | Brass, nickel-plated female<br>contact terminal with PVC<br>overmold. | Identical | Identical | | Monopolar<br>instrument<br>connector | Brass, nickel-plated female<br>contact terminal with PVC<br>overmold. 4mm female<br>connector | Identical | Identical | | Other Attributes | | | | | Single Use or<br>Reusable | Single use | Single use | Identical | | Sterilized | Yes | Yes | Identical | | Performance/<br>Safety Testing<br>in accordance<br>with | IEC 60601-1:2005+A1:2012<br>IEC 60601-1-2:2014<br>IEC 60601-2-2:2017<br>Premarket Notification (510(k))<br>Submissions for Electrosurgical<br>Devices for General Surgery:<br>Guidance for Industry and Food<br>and Drug Administration Staff | IEC 601-1:1988<br>IEC 601-2-2:1991<br>AAMI HF-18:1993 | Application device in<br>conformance with<br>latest version of the<br>listed Standards | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for New Deantronics. The logo has the word "NEW" in a smaller font on the left side of a blue circle with a red dot in the center. The word "DEANTRONICS" is in a larger blue font on the right side of the circle. New Deantronics concludes that the devices are substantially equivalent. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for New Deantronics. The word "NEW" is in black font and is located to the left of a blue circle with a red dot in the center. The word "DEANTRONICS" is in blue font and is located to the right of the circle. The logo is simple and professional. ## F. Summary of Supporting Data Electrical safety testing and bench testing has demonstrated that the performance of New Deantronics Trigger Switch and Cord meet the requirements of its pre-defined acceptance criteria and intended uses. The results of the non-clinical testing demonstrate that the Trigger Switch and Cord is as safe and effective as the predicate device. #### Summary Tables of Supporting Data Performance Data for FDA Guidance for Reviewer of Electrosurgical Device for General Surgery, issued on August 15, 2016 Only Item B, Active Component/Accessory is applicable | ltem | Scope (major<br>component or<br>system) | Specification Name<br>or Description or<br>Test Purpose | Method of<br>Verification: Standard<br>(list), Testing Method<br>or Audit | Pass /<br>Fail? | Comments | |------|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | B | Active<br>Component/<br>Accessory | Perform mechanical<br>testing of<br>electrosurgical<br>instruments to<br>minimize the risks<br>associated with<br>mechanical failure<br>and short circuit | Connector pull force | Pass | This submission is an Active<br>Accessory and has demonstrated<br>the risks associated with<br>mechanical failure and short<br>circuit is minimized by<br>mechanical testing before and<br>after transit. The mechanical<br>testing includes anchorage test<br>and connector pull force. Also,<br>this submission covers the<br>devices intended to be single<br>used rather than re-used. | | | | | 0.26kg Dynamic<br>Strain Relief | Pass | | | | | | 10 Pound Static<br>Strain Relief | Pass | | | | | | Anchorage Test | Pass | | The following table summarizes the tests performed and test results. Some listed here are repeated from the Guidelines table above. The results demonstrated that the Trigger Switch and Cord is safe for its intended use and supports a finding of substantial equivalence with the predicate device. | Standard Used for Testing<br>Protocol | Specific Clause in<br>Standard used for<br>Testing Protocol | Test Item | Results | |---------------------------------------|-------------------------------------------------------------|------------------------------------------|---------| | (General Requirement) | | Visual Inspection | PASS | | | | Continuity test | PASS | | IEC 60601-1:2005+ AM1:2012 | 15.3.4.1 | Drop Test (preconditioning) | PASS | | | 8.10.2 | 0.26kg Dynamic Strain Relief | PASS | | | | 10 Pound Static Strain Relief | PASS | | IEC 60601-2-2:2017 | 201.8.10.4.2 | Anchorage Test | PASS | | | 201.8.8.3.102 | HF Leakage Current Test | PASS | | | 201.8.8.3.103 | High Frequency Dielectric Test | PASS | | | 201.8.8.3.104 | Hi-Pot Test | PASS | | | | Mains Frequency Dielectric Strength Test | PASS | | | 201.11.6.5 | Fluid Ingress Test | PASS | | | 201.17<br>202 | EMC Test | PASS | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for New Deantronics. The word "NEW" is in blue, and the word "DEANTRONICS" is in a darker blue. There is a blue circle with a red dot in the middle between the two words. The logo is simple and easy to read. A transit test validated achievement of the package and product performance criteria after ship testing. The package system performance testing per ASTM D4169 met the acceptance criteria. The results demonstrate that the device and sterile packaging is functional after shipping transportation. ### G. Conclusion After comparing the Indications for Use, technology and design of the Trigger Switch and Cord, along with all electrical safety (including IEC 60601-1: 2005 + AM1:2012; IEC 60601-1-2: 2014; IEC 60601-2-2: 2017) and performance testing, in accordance with the FDA's guidelines and FDA-recognized consensus standards for electrical safety, New Deantronics concludes that the Trigger Switch and Cord are substantially equivalent to the predicate Valleylab, Inc. Trigger Switch and Cord (K970140).