New Deantronics E Green™ Electrosurgical Monopolar Pencils

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure, with three profiles overlapping to create a sense of depth and connection. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular pattern around the figure. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 29, 2017 New Deantronics Taiwan, Ltd % Mr. Lewis Ward Consultant L.W. Ward and Associates Incorporated 4655 Kirkwood Court Boulder, Colorado 80301 Re: K170161 Trade/Device Name: New Deantronics E Green™ Electrosurgical Monopolar Pencils Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: March 16, 2017 Received: March 22, 2017 Dear Mr. Ward: 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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, Jennifer R. Stevenson -S For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) K170161 Device Name New Deantronics E Green™ Electrosurgical Monopolar Pencils Indications for Use (Describe) The New Deantronics E Green™ Electrosurgical Monopolar Pencils are intended to remove tissue and control bleeding by use of high-frequency electrical current. | 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. | | | 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.* | | of this information collection, including suggestions for reducing this burden, to: | The burden time for this collection of information is estimated to average 79 hours per response, including the<br>time to review instructions, search existing data sources, gather and maintain the data needed and complete<br>and review the collection of information. Send comments regarding this burden estimate or any other aspect | | Food and Druq Administration<br>Office of Chief Information Officer<br>PRAStaff(@fda.hhs.gov | Department of Health and Human Services<br>Paperwork Reduction Act (PRA) Staff | | | | "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 ### Submitter: New Deantronics Taiwan Ltd. 12F., No.51, Sec. 4, Chong Yang Rd., Tu Cheng Dist, New Taipei City 23675, Taiwan R.O.C. (886) 2-2268-1726 Phone 大瓏企業股份有限公司 New Deantronics Taiwan, Ltd. 新北市土城區中央路4段51號12樓 12F., No.51, Sec. 4, Chong Yang Rd., Tu Cheng Dist., New Taipei City 23675, Taiwan R.O.C. Tel: 886 2 2268-1726 Fax: 886 2 2268-3800 ### US I. II. (886) 2-2268-3800 Fax ### Contact Person: Lewis Ward L.W. Ward and Associates, Inc. 4655 Kirkwood Court Boulder, CO 80301 USA 303-530-3279 lwward@qwest.net Date Prepared: Jan. 11, 2017 Trade Name: New Deantronics E Green™ Electrosurgical Monopolar Pencil Common Name: Electrosurgical accessory, Electrosurgical Monopolar Pencil Classification: 21 CFR 878.4400, electrosurgical cutting and coagulation device and III. accessories. Class 2, General and Plastic Surgery Panel 79 IV. Product Code: GEI ### V. Indications for Use: The New Deantronics E Green™ Electrosurgical Monopolar Pencils are intended to remove tissue and control bleeding by use of high-frequency electrical current. ### VI. Predicate Device 510(k) 982744. New Deantronics Disposable Hand Switching Pencil, Push Button, 2 Piece With and Without Holster. Device Description and Technological Characteristics VII. The E Green™ Reusable Monopolar Cord is an electrosurgical accessory used with E Green™ Disposable Electrosurgical Pencil. Electrosurgical Pencils are intended to remove tissue and control bleeding by use of high-frequency electrical current. {4}------------------------------------------------ Image /page/4/Picture/2 description: The image shows the logo for New Deantronics Group. The logo features a blue letter 'D' with a red circle inside, followed by the text 'DEANTRONICS' in blue, bold letters. Below the main logo, the words 'New Deantronics Group' are written in a smaller, less bold font. This product is a monopolar, electrosurgical pencil which is used for most open surgeries. The pencil can be divided in two parts, one is a gamma sterilized disposable electrosurgical pencil and another is a reusable cord which needs to be autoclaved by the user before use in a standard operating room environment. The E Green™ Reusable Monopolar Cord is used ONLY in combination with E Green™ Disposable Electrosurgical Pencil. The number of uses of the Reusable Monopolar Cord following steam sterilization is 100 times. This device and the predicate devices have the similar technological characteristics, operating principles and performance characteristics. The proposed device is equivalent to the identified 大瓏企業股份有限公司 New Deantronics Taiwan, Ltd. 新北市土城區中央路4段51號12樓 12F., No.51, Sec. 4, Chong Yang Rd., Tu Cheng Dist., New Taipei City 23675, Taiwan R.O.C. Tel: 886 2 2268-1726 Table 1: New Deantronics E Green™ Reusable Monopolar Cord | Item | Catalog No. | ND P/N | Description | |------|-------------|----------|----------------------------------------| | 1 | GMC01 | P0001NE1 | E Green™ Reusable Monopolar Cord, 10ft | | 2 | GMC015 | P0001NE2 | E Green™ Reusable Monopolar Cord, 15ft | Table 2: New Deantronics E Green™ Disposable Electrosurgical Pencil predicate device with respect to technological characteristics and function. | Item | Catalog No. | ND P/N | Description | |------|-------------|----------|--------------------------------------------| | 1 | GPEN01 | P0101SE1 | E Green™ Disposable Electrosurgical Pencil | ### VIII. Non-Clinical Testing IEC 60601-1: 2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012: 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 Disturbances - Requirements And Tests. IEC 60601-2-2: 2009 + C1:2014, Medical electrical equipment = Part 2-2: Particular requirements for the safety of high frequency surgical equipment. ISO 14971:2007, Medical Device- Application of Risk Management to Medical Devices ISO 10993-1: 2009. Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process. ISO 10993-5: 2009, Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity. ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization ISO 10993-12: 2012, Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials. ISO 11137-2:2013, Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose. U.S. {5}------------------------------------------------ Image /page/5/Picture/2 description: The image contains the logo for New Deantronics. The logo features the word "NEW" in a light gray outlined font, followed by a blue circle with a red dot in the center. To the right of the circle is the word "DEANTRONICS" in a bold, dark blue font. Below the logo is the text "New Deantronics Group" in a smaller, dark blue font. ISO 11607:2006, Packaging for terminally sterilized medical devices -Part 1: Requirements for materials, sterile barrier systems and packaging systems [Including: Amendment 1 (2014)]; Part 2: Validation requirements for forming, sealing and assembly processes [Including: Amendment 1 (2014)]. ISTA 2A Packaged-Products 150 lb (68 kg) or Less U.S 大瓏企業股份有限公司 New Deantronics Taiwan, Ltd. 新北市土城區中央路4段51號12樓 12F., No.51, Sec. 4, Chong Yang Rd., Tu Cheng Dist., New Taipei City 23675, Taiwan R.O.C. Tel: 886 2 2268-1726 Fax: 886 2 2268-3800 criteria for cleaning reusable medical devices. ISO 17665-1:2006/(R) 2013, Sterilization Of Health Care Products -- Moist Heat -- Part 1: AAMI TIR30:2011, A compendium of processes, materials, test methods, and acceptance Requirements For The Development, Validation, And Routine Control Of A Sterilization Process For Medical Devices. ANSVAAMI ST81:2004/(R) 2010, Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices. IEC 62366-1:2015, Medical devices -- Part 1: Application of usability engineering to medical devices ASTM F1980-07:2011, Standard guide for accelerated aging of sterile barrier systems for medical devices. (Sterility) ### Non-clinical testing conclusion: All the test results demonstrate the performance of New Deantronics E Green™ Electrosurgical Monopolar Pencil meet the requirements of its pre-defined acceptance criteria and intended uses. The results confirm that the New Deantronics E Green™ Electrosurgical Monopolar Pencil is as safe and effective as the predicate devices. ## IX. Substantial Equivalence The New Deantronics E Green™ Electrosurgical Monopolar Pencil is substantially equivalent to the New Deantronics Disposable Hand Switching Pencil, Push Button, 2 Piece With and Without Holster (K982744) based on intended use, technology, materials, and performance. The claim of substantial equivalence is supported by information the information provided in this submission. | X. Key Features Comparison | | | |----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------| | FEATURE | New Deantronics E Green™<br>Electrosurgical Monopolar Pencil | New Deantronics Disposable Hand<br>Switching Pencil, Push Button<br>(K982744) | | Intended Use | E Green™ Electrosurgical Monopolar<br>Pencils are intended to remove tissue and<br>control bleeding by use of high-frequency<br>electrical current. | Electrosurgical Pencils are intended to<br>remove tissue and control bleeding by use of<br>high-frequency electrical current. | | Use | E Green™ Disposable Electrosurgical<br>Pencil is single use.<br>E Green™ Reusable Monopolar Cord is<br>reusable. | Single Use | ### X. Kev Features Comparison {6}------------------------------------------------ | FEATURE | New Deantronics E Green™<br>Electrosurgical Monopolar Pencil | New Deantronics Disposable Hand<br>Switching Pencil, Push Button<br>(K982744) | |---------------------------|--------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------| | Use Environment | Hospital, clinic | Hospital clinic | | Dimensions | Pen body length : 12.3 cm<br>Cord length : 10 ft and 15 ft | Pen body length : 16.2 cm<br>Cord length : 10 ft and 15 ft | | Rated Voltage | 4600 V | 4600 V | | Material | Electrode: stainless steel, HDPE overmold<br>Pen body: ABS, Nylon<br>Cord: Silicone, TPV, PPSU | Electrode: stainless steel, HDPE overmold<br>Pen body: ABS, Nylon<br>Cord: PVC | | Specification | Button switch Two piece body | Button switch Two piece body | | Energy Source<br>Type | RF Energy | RF Energy | | Sterile method<br>and SAL | E Green™ Disposable Electrosurgical<br>Pencil: Gamma irradiation, SAL 10-6.<br>E Green™ Reusable Monopolar Cord:<br>Steam, SAL 10-6. | Gamma irradiation, SAL 10-6. | # Taiwan 大瑞企業股份有限公司 New Deantronics Taiwan, Ltd. 新北市土城區中央路 4段 51 號 12 樓 12F., No.51, Sec. 4, Chong Yang Rd., Tu Cheng Dist., New Taipei City 23675, Taiwan R.O.C. Tel: 886 2 2268-1726 Fax: 886 2 2268-3800 ------------------------- ### U.S. New Deantronics Ltd. 1990 North California Blvd. Suite 1040 Walnut Creek, CA. 94596 Tel: (925) 280 8388 Fax: (925) 280 1788 4