Monopolar Cord

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 19, 2019 New Deantronics Taiwan Ltd % Mr. Craig J. Coombs President Coombs Medical Device Consulting, Inc 1100 Pacific Marina, Suite 806 Alameda. California 94501 Re: K193004 Trade/Device Name: Monopolar Cord Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: October 24, 2019 Received: October 28, 2019 Dear Mr. Craig 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 and Part 809): medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or post marketing 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 medical devices and radiation-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) K193004 Device Name Monopolar Cord #### Indications for Use (Describe) A Monopolar Cord is intended to be used with a compatible electrosurgical generator and an RF electrode to cut tissue and control bleeding by use of high-frequency electrical current. 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. 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Device Information: | Category | Comments | |------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sponsor: | New Deantronics Taiwan Ltd.<br>12F., No.51, Sec. 4, Chong Yang Rd.,<br>Tu Cheng District,<br>New Taipei City 23675, 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>Monopolar Cord | | Device Classification Number: | 21 CFR 878.4400 | | Device Classification &<br>Product Code: | Class 2,<br>GEI | | Device Proprietary Name: | Monopolar Cord | ### Predicate Device Information: | Predicate Device: | New Deantronics Foot Control Pencil | |----------------------------------------------------|-------------------------------------------------------------------------------------| | Predicate Device Manufacturer: | New Deantronics Taiwan Ltd. | | Predicate Device Common Name: | Electrosurgical accessory | | Predicate Device Premarket Notification # | K982749 | | Predicate Device Classification: | 21 CFR 878.4400<br>Electrosurgical, Cutting & Coagulation<br>Device and Accessories | | Predicate Device Classification &<br>Product Code: | Class 2,<br>GEI | ## B. Date Summary Prepared 13 December 2019 ## C. Description of Device The Monopolar Cord, sold as sterile packaged, and ready for use devices, is intended to be used with compatible accessories to cut tissue and control bleeding by use of high-frequency electrical current. {4}------------------------------------------------ Image /page/4/Picture/1 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 modern. The Monopolar Cord is compatible with the monopolar instruments with shrouded 2.5 mm female electrical connections, electrosurgical generator, and patient return electrode. During the operation, the sterile cord should connect to the sterile accessory, and then generator connector end is inserted into the adapter and generator which it receives the high frequency current and delivers the current onto a target tissue for cutting and coagulation in a procedure. These devices can be used in hospitals and are used by trained professionally only. ## D. Indications for Use A Monopolar Cord is intended to be used with a compatible electrosurgical generator and an RF electrode to cut tissue and control bleeding by use of high-frequency electrical current. ## E. Comparison to Predicate Device As described below, the application Monopolar Cord is substantially equivalent in intended use, technology, design and physician use to the predicate New Deantronics Foot Control Pencil (K982749). | Feature | Application Device:<br>Monopolar Cord<br>(K193004) | Predicate Device:<br>New Deantronics Foot Control<br>Pencil (K982749) | Pertinence of Feature<br>to Consideration of<br>Substantial<br>Equivalence. | |-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for<br>Use | A Monopolar Cord is intended<br>to be used with a compatible<br>electrosurgical generator and an<br>RF electrode to cut tissue and<br>control bleeding by use of high-<br>frequency electrical current. | Electrosurgical accessory. A<br>foot activated electrosurgical<br>pencil is intended to remove<br>tissue and control bleeding by<br>use of high-frequency electrical<br>current. | The Indications for Use<br>of the application and<br>predicate devices are<br>the same; both devices<br>are for use in standard<br>cutting or coagulation.<br>The application device<br>does not include an<br>attached electrode, so<br>the specific action of<br>the electrode is<br>omitted. | | Product Code | GEI | GEI | Identical | | Technology | | | | | Mechanism of<br>Standard<br>Electrosurgery | The Monopolar Cord is<br>designed to connect a<br>electrosurgical generator with<br>an RF electrode. When<br>electrosurgery is activated by<br>foot pedal, the electrosurgical<br>energy will be delivery from<br>electrosurgical generator<br>through the Cord and to the<br>electrode, to cut or coagulate in<br>surgical procedures | The Foot Control Pencil is<br>designed to connect with<br>electrosurgical generator. When<br>electrosurgery is activated by<br>foot pedal, the electrosurgical<br>energy will be delivery from<br>electrosurgical generator<br>through the cord and to the<br>electrode, to cut or coagulate in<br>surgical procedures | Identical as far as the<br>connecting cord<br>portion is concerned | | 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 | | Feature | Application Device:<br>Monopolar Cord<br>(K193004) | Predicate Device:<br>New Deantronics Foot Control<br>Pencil (K982749) | Pertinence of Feature<br>to Consideration of<br>Substantial<br>Equivalence. | | Required<br>Adapter | New Deantronics AG001<br>adapter or Covidien E0502<br>Series or E0017 adapter. | New Deantronics AG001<br>adapter or Covidien E0502<br>Series or E0017 adapter. | Identical | | Design -Mechanism | | | | | Control Type | Foot Control | Foot Control | Identical | | Activation<br>Mechanism | Foot Switch | Foot Switch | Identical | | Cable Set Length | 10 ft | 10 ft | Identical | | | ESU: banana lead with adapter | ESU: banana lead with adapter | Identical | | Connection<br>Interface | Active Electrode: None.<br>Designed to connect with<br>monopolar instruments with<br>shrouded 2.5 mm female<br>electrical connections. | Active Electrode: Standard<br>Blade | The application device<br>is a subset of the<br>predicate device. | | Design- Electrical Feature | | | | | Electrical Safety | Withstand 3.3kVp for <b>High</b><br><b>Frequency</b> breakdown<br>Withstand 3.3kVp AC at <b>Main</b><br><b>Frequency (60Hz)</b> breakdown | Withstand 3.3kVp for <b>High</b><br><b>Frequency</b> breakdown<br>Withstand 3.3kVp AC at <b>Main</b><br><b>Frequency (60Hz)</b> breakdown | Identical | | Design- Material | | | | | Handle | N/A | ABS | Different | | | Insulation: PE | Insulation: PE | | | Cable | Colorant: Blue, PMS300 | Colorant: Blue, PMS300 | Identical | | | Wire: Copper | Wire: Copper | | | Generator<br>Connector (pin<br>tip) | ESU: Brass | ESU: Brass | Identical | | Active Electrode<br>Connector | LDPE / Nickel plated brass | N/A | Different | | Other Attributes | | | | | Single Use or<br>Reusable | Single use | Single use | Identical | | Sterilization | Gamma (VDmax25) | Gamma (VDmax25) | Identical | | Performance/<br>Electrical Safety<br>Testing in | IEC 60601-1: 2005 +<br>AM1:2012<br>IEC 60601-1-2: 2014 | 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 word "NEW" is in blue, and next to it is a blue circle with a red dot in the middle. The word "DEANTRONICS" is in blue and is to the right 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 a blue outlined font. To the right of the word "NEW" is a blue circle with a red dot in the center. To the right of the circle is the word "DEANTRONICS" in a bold blue font. ### F. Summary of Supporting Data A summary of the bench testing and electrical safety testing is presented on the next page. Electrical safety testing and bench testing has demonstrated that the performance of the Monopolar Cord meets the requirements of its pre-defined acceptance criteria and intended uses. The results of the non-clinical testing demonstrate that the Monopolar 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 Method of Scope (major Verification: Specification Name or Pass / Item component or Standard (list), Comments Description or Test Purpose Fail? system) Testing Method or Audit Provide graphical display of the This submission is not A ESU --output waveform an ESU. This submission is an Active Accessory and Connector pull Pass has demonstrated the force risks associated with mechanical failure and short circuit is 0.26kg Dynamic Pass Perform mechanical testing of minimized by Strain Relief electrosurgical instruments to mechanical testing Active Component / B minimize the risks associated before and after transit. Accessorv with mechanical failure and The mechanical testing 10 Pound Static short circuit includes anchorage test Pass Strain Relief and connector pull force. Also, this submission covers the devices intended to be Anchorage Test Pass single used rather than re-used. This submission does C Neutral Electrodes Perform the following testing not include a Neutral ---Electrode The Monopolar Cord is Miscellaneous an Active Component Meet the design and D Components / ーー instead of performance specifications Accessories Miscellaneous Component {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for New Deantronics. The word "NEW" is in blue, followed by a blue circle with a red dot in the center. The word "DEANTRONICS" is in blue and to the right of the circle. The logo is simple and professional. Monopolar Cord K193004: Traditional Premarket Notification | Item | Scope (major<br>component or<br>system) | Specification Name or<br>Description or Test Purpose | Method of<br>Verification:<br>Standard (list),<br>Testing Method<br>or Audit | Pass /<br>Fail? | Comments | |------|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|-----------------|--------------------------------------------------------------------------------------------------------------------------------------| | E | | | | | | | E.1 | Thermal Effects on<br>Tissue | Active component or electrode<br>should demonstrate the<br>measurement of the size of the<br>thermal damage zone | -- | - | This submission does not<br>include an Active<br>Electrode. This accessory<br>is not intended to create<br>thermal damage by itself. | | E.2 | Temperature<br>Monitoring | The temperature sensing under<br>simulated conditions meets<br>design specification and<br>performance requirements | -- | - | This submission does not<br>intend to include any<br>temperature sensing<br>capability. | | E.3 | CQM and/or<br>Continuity<br>Monitoring | Test to demonstrate the CQM<br>and/or continuity monitoring<br>features work as intended. | -- | - | This is the requirement for<br>ESU and Neutral<br>Electrodes. This submission<br>does not include both of<br>these components. | | E.4 | Capacitive Coupling | For minimally invasive surgery<br>application, test for active<br>coupling resistance between the<br>subject device and a conductive<br>cannula/trocar device under<br>simulated normal use condition. | -- | - | This device is not for<br>minimally invasive surgery<br>application. | The following table summarizes the electrical safety tests performed and test results. Some listed here are repeated from the Guidelines table above. The results demonstrated that the Monopolar Cord is safe for its intended use and supports a finding of substantial equivalence with the predicate device. | Standard Used for<br>Testing Protocol | Specific Clause in<br>Standard used for<br>Testing Protocol | Test Description | Results | |---------------------------------------|-------------------------------------------------------------|---------------------------------------------|---------| | (General Mfr Requirement) | | Visual Inspection | PASS | | (General Mfr Requirement) | | Continuity test | PASS | | IEC 60601-1:2005+<br>AM1:2012 | 15.3.4.1 | Drop Test (preconditioning) | PASS | | IEC 60601-1:2005+<br>AM1:2012 | 8.10.2 | Cable pull force from Terminal Pin | PASS | | | | 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 | | IEC 60601-2-2:2017 | 201.8.8.3.102 | HF Leakage Current Test | PASS | | IEC 60601-2-2:2017 | 201.8.8.3.103 | High Frequency Dielectric Test | PASS | | IEC 60601-2-2:2017 | 201.8.8.3.104 | Hi-Pot Test | PASS | | | | Mains Frequency Dielectric<br>Strength Test | PASS | | IEC 60601-2-2:2017 | 201.15.4.1 | Connector pull force | PASS | | IEC 60601-2-2:2017 | 201.17<br>202 | EMC Test | PASS | # Monopolar Cord Electrical Testing {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for New Deantronics. The word "NEW" is in blue outlined letters. To the right of the word "NEW" is a blue letter "D" with a red circle in the middle. The word "DEANTRONICS" is in blue and to the right of the letter "D". The transit test was to define the product ship testing requirements and package and product performance after ship testing. The Package system performance testing per ASTM D4169 met the acceptance criteria. The results demonstrate that the Monopolar Cord is functional and remains in the sterile barrier after shipping transportation. ## G. Conclusion After comparing the Indications for Use, technology and design of the Monopolar 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 FDArecognized consensus standards for electrical safety, New Deantronics concludes that the Monopolar Cord is substantially equivalent to the predicate New Deantronics Foot Control Pencil (K982749).