Who is the manufacturer of Argon Handset?

New Deantronics Taiwan , Ltd. filed the 510(k) submission for Argon Handset (K191064).

What is the FDA product code for Argon Handset?

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 Argon Handset?

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

Who can help prepare an FDA 510(k) submission like Argon Handset?

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.

Argon Handset

K191064 · New Deantronics Taiwan , Ltd. · GEI · Jun 12, 2019 · General, Plastic Surgery

Device Facts

Record ID	K191064
Device Name	Argon Handset
Applicant	New Deantronics Taiwan , Ltd.
Product Code	GEI · General, Plastic Surgery
Decision Date	Jun 12, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Argon Handset is an electrosurgical accessory intended to be used in open or laparoscopic and thoracoscopic surgical procedures (general, neurosurgical, gynecologic) where monopolar standard or argon-enhanced electrosurgery is desired. The electrosurgical energy is controlled by the electrosurgical generator during cutting and coagulation and the argon gas flow is controlled by the argon gas delivery system, via the Argon Handset, during argon-shrouded cutting and argon-enhanced coagulation. When the Argon Handset is activated in the argon-enhanced mode, argon gas plasma is created between the electrode and target tissue.

Device Story

Argon Handset is a single-use, sterile electrosurgical accessory; connects to electrosurgical generator, argon gas delivery system, and patient return electrode. Used in open, laparoscopic, and thoracoscopic procedures by trained professionals in hospitals. Device delivers radiofrequency (RF) electrical current and argon gas to target tissue. In standard mode, functions as a monopolar electrosurgical pencil. In argon-enhanced mode, argon gas plasma is created between electrode and tissue for coagulation. In argon-shrouded mode, argon gas clears smoke from surgical field during RF cutting. Handset features rocker switch for energy activation and slide switch for gas control. Blade electrode is replaceable. Output allows surgeon to perform cutting and coagulation; argon-enhanced mode provides improved coagulation and smoke management. Benefits include precise tissue effect and improved visualization via smoke clearance.

Clinical Evidence

No clinical data. Substantial equivalence established through bench testing, including performance verification (electrode slide, activation force, continuity), gas delivery integrity (filter test, impact/back pressures), HF breakdown testing, thermal effects on tissue, electrical safety, EMC, shelf-life (2-year accelerated aging), and biocompatibility testing.

Technological Characteristics

Monopolar electrosurgical accessory; RF energy source. Materials: Stainless Steel SUS 304 (electrode), Aluminum Ceramic (nozzle), HDPE (guide), PC (switches), HIPS (body), PVC/PE+EVA (cables). Dimensions: ~17.5mm electrode length, 10ft cable. Connectivity: Banana lead (ESU), gas filter (gas delivery), 3-pin connector (signal). Sterilization: Gamma. Standards: IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2, ISO 10993-1.

Indications for Use

Indicated for open, laparoscopic, and thoracoscopic surgical procedures (general, neurosurgical, gynecologic) requiring monopolar standard or argon-enhanced electrosurgery.

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

Valleylab Force Argon II Argon Enhanced Electrosurgical System (K964636)

Related Devices

K962690 — E2590 - B, ARGON ACCESSORY WITH BLADE ELECTRODE AND E2590 - N, ARGON ACCESSORY WITH NEEDLE ELECTRODE · Valleylab, Inc. · Nov 4, 1996
K183126 — Electrosurgical accessory · New Deantronics Taiwan , Ltd. · May 8, 2019
K062082 — CONMED ABC DISSECTING BLADE ELECTRODE, MODEL 139330; BLUNT NEEDLE ELECTRODE, MODEL 139331 · Conmed Corporation · Jan 25, 2007
K200253 — Megadyne Telescoping Smoke Evacuation Pencil - 10ft tubing, Megadyne Telescoping Smoke Evacuation Pencil - 15ft tubing, Megadyne Telescoping Smoke Evacuation Soft Tissue Dissector, Megadyne Telescoping Soft Tissue Dissector · Ethicon Endo-Surgery · May 27, 2020
K072559 — SUCTION COAGULATOR · Megadyne Medical Products, Inc. · Oct 5, 2007

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. June 12, 2019 New Deantronics Taiwan Ltd % Craig Coombs President Coombs Medical Device Consulting, Inc 1193 Sherman St Alameda, California 94501 Re: K191064 Trade/Device Name: Argon Handset 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, 2019 Received: April 22, 2019 Dear 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. 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 {1}------------------------------------------------ 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 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, 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) K191064 Device Name Argon Handset #### Indications for Use (Describe) The Argon Handset is an electrosurgical accessory intended to be used in open or laparoscopic and thoracoscopic surgical procedures (general, neurosurgical, gynecologic) where monopolar standard or argon-enhanced electrosurgery is desired. The electrosurgical energy is controlled by the electrosurgical generator during and coagulation and the argon gas flow is controlled by the argon gas delivery system, via the Argon Handset, during argon-shrouded cutting and argonenhanced coagulation. When the Argon Handset is activated in the argon-enhanced mode, argon gas plasma is created between the electrode and target tissue. | 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.* 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 "DEANTRONICS". The logo consists of the word "NEW" in blue, followed by a blue circle with a red dot in the center. To the right of the circle is the word "DEANTRONICS" in blue. The logo is simple and professional, and it is likely used to represent a company or organization. # 510(k) Summary #### A. Device Information: | Category | Comments | |------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sponsor: | New Deantronics Taiwan Ltd. 12F., No.51, Sec. 4, Chong Yang Rd., Tu Cheng District, New Taipei City 23675, Taiwan R.O.C. Tel: (886) 2-2268-1726 Fax: (886) 2-2268-3800 | | Correspondent Contact Information: | Craig Coombs Coombs Medical Device Consulting 1193 Sherman Street Alameda, CA 94501 Tel: 510-337-0140 | | Device Common Name: | Electrosurgical accessory | | Device Classification Number: | 21 CFR 878.4400 | | Device Classification & Product Code: | Class 2, GEI | | Device Proprietary Name: | Argon Handset | #### Predicate Device Information: | Predicate Device: | Valleylab Force Argon II Argon Enhanced Electrosurgical System | |-------------------------------------------|-------------------------------------------------------------------------------------| | Predicate Device Manufacturer: | Valleylab, Inc. | | Predicate Device Common Name: | Electrosurgical accessory | | Predicate Device Premarket Notification # | K964636 | | Predicate Device Classification: | 21 CFR 878.4400 Electrosurgical, Cutting & Coagulation Device and Accessories | | Predicate Device Class & Product Code: | Class 2, GEI | # B. Date Summary Prepared 11 June 2019 # C. Description of Device The Argon Handset is intended to be used in electrosurgical procedures where monopolar standard or argon enhanced electrosurgery is desired. The pre-installed blade electrode is used in open surgery, while the longer argon electrodes can replace the blade electrode to be used in minimally invasive procedure. The Argon Handset has to be in conjunction with an electrosurgical generator, argon gas delivery system and patient return electrode. During the operation, the argon handset performs like a standard electrosurgical pencil, while it receives {4}------------------------------------------------ Image /page/4/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. both the argon gas and high frequency current, and delivers the electrosurgical energy onto a target tissue for either a standard or argon-enhanced procedure. The Argon Handset is sold in sterile packaging and is a single use device. These devices can be used in hospitals and are used by trained professionals only. The Argon Handset is designed for fitting into the Covidien Argon Gas Delivery Unit II or Force™ GSU Argon Gas Delivery Systems, and Covidien Force EZ™ or Force FX™ series electrosurgical generators. The blade electrode of the Argon Handset is replaceable by the New Deantronics Argon Electrode Series or Covidien E35XX series Argon Electrodes depending on the surgical procedures required. ### D. Indications for Use The Argon Handset is an electrosurgical accessory intended to be used in open or laparoscopic and thoracoscopic surgical procedures (general, neurosurgical, gynecologic) where monopolar standard or argon-enhanced electrosurgery is desired. The electrosurgical energy is controlled by the electrosurgical generator during cutting and coagulation and the argon gas flow is controlled by the argon gas delivery system, via the Argon Handset, during argon-shrouded cutting and argon-enhanced coagulation. When the Argon Handset is activated in the argonenhanced mode, argon gas plasma is created between the electrode and target tissue. {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 center. The word "DEANTRONICS" is in blue and is to the right of the circle. # E. Comparison to Predicate Device As described below, the application Argon Electrodes is substantially equivalent in intended use, technology, design and physician use to the predicate Force Argon II Argon Enhanced Electrosurgical System (K964636). | Feature | Application Device: Argon Handset | Predicate Device: Force Argon II Argon Enhanced Electrosurgical System (K964636) | Pertinence of Feature to Consideration of Substantial Equivalence. | |----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | The Argon Handset is an electrosurgical accessory intended to be used in open or laparoscopic and thoracoscopic surgical procedures (general, neurosurgical, gynecologic) where monopolar standard or argon enhanced electrosurgery is desired. The electrosurgical energy is controlled by the electrosurgical generator during cutting and coagulation and the argon gas flow is controlled by the argon gas delivery system, via the Argon Handset, during argon-shrouded cutting and argon-enhanced coagulation. When the Argon Handset is activated in the argon-enhanced mode, argon gas plasma is created between the electrode and target tissue. | The Force Argon II Enhanced Electrosurgical System is intended for use in both open, laparoscopic and thoracoscopic surgical procedures (general, neurosurgical, gynecologic) where monopolar electrosurgery (cutting and coagulation) is normally used. The Force Argon II Argon Enhanced Electrosurgical System provides a controlled flow of argon to electrosurgical handset during cutting and coagulation. When the handset is activated in the gas enhanced mode, an argon gas plasma is created between the electrode and the tissue. | The Indications for Use of the application and predicate devices are the same, both devices are for standard cutting or coagulation; argon enhanced electrosurgery is also available when the handset is activated in the gas enhanced mode. The Argon shrouded mode was included in the device description of the predicate. It allows the use of argon gas to blow smoke out of the surgical field during RF cutting. | | Product Code | GEI | GEI | Identical | | Technology | | | | | Mechanism of Standard Electrosurgery | The Argon Handset is designed to connect with electrosurgical generator and argon gas delivery system. When standard electrosurgery is activated, the electrosurgical energy will be delivery from electrosurgical generator to the handset electrode, to cut or coagulate in surgical procedures | Same for K964636 | Identical | | Feature | Application Device: Argon Handset | Predicate Device: Force Argon II Argon Enhanced Electrosurgical System (K964636) | Pertinence of Feature to Consideration of Substantial Equivalence. | | Mechanism of Argon- Enhanced or Shrouded Operation | The Argon Handset is designed to connect with electrosurgical generator and argon gas delivery system. The argon gas tube serves a gas path for argon gas to flow through to the surgical field. At the distal end of electrode, the argon gas will turn into plasma state and then emit to the target site when the Argon Gas Delivery System is in the "enhanced" mode or the gas will blow out smoke formed during RF cutting when in "shrouded" mode. | Same for K964636 | Identical | | Energy Used | Radiofrequency Electrical Current | Radiofrequency Electrical Current | Identical | | Operation Principle | Monopolar Electrosurgery | Monopolar Electrosurgery | Identical | | Operation Gas | Argon Gas | Argon Gas | Identical | | Equipment Mated | Electrosurgical Generator: Covidien Force EZTM or Force FXTM series Argon Gas Delivery System: Covidien Argon Gas Delivery Unit II or ForceTM GSU Argon Gas Delivery System | Same for K964636 | Identical | | Design - Handset Mechanism | | | | | Electrode Configuration | Blade | Blade | Identical | | Electrode Length | ~17.5mm | ~17.5mm | Identical | | Electrode Extension/Retraction | Slide Guide | Slide Guide | Identical | | Electrode Interchangeable | Yes | Yes | Identical | | Control Type | Hand Control | Hand Control | Identical | | Activation Mechanism | Rocker Switch | Rocker Switch | Identical | | Gas On/Off Control | Slide Switch | Slide Switch | Identical | | Cable Set Length | 10 ft | 10 ft | Identical | | Feature | Application Device: Argon Handset | Predicate Device: Force Argon II Argon Enhanced Electrosurgical System (K964636) | Pertinence of Feature to Consideration of Substantial Equivalence. | | Connection Interface | ESU: banana lead Argon Gas Delivery: gas filter Signal Control: 3-pin connector | Same for K964636 | Identical | | Argon Gas Flow Rate | up to 12LPM | up to 12LPM | Identical | | Handset Insulation | electrosurgical energy line: double layer of polymer handset body: polymer shell | electrosurgical energy line: double layer of polymer handset body: polymer shell | Identical | | Electrical Safety | Withstand 5.6kVp for High Frequency breakdown Withstand 5.6kVp AC at Main Frequency (60Hz) breakdown | (unknown, but electrical safety complies with consensus standard) | Identical | | Handset Electrode | Stainless Steel SUS 304 | Stainless Steel SUS 302/SUS 304 | Functionally Identical | | Handset Handle | Nozzle: Aluminum Ceramic | Nozzle: Aluminum Ceramic Electrode Extension Guide: HDPE | Identical | | | Electrode Extension Guide: HDPE Activation Switch: PC Gas Switch: PC Handset Body: HIPS | Activation Switch: PC Gas Switch: PC Handset Body: HIPS | | | Cable Set | Outer Jacket: PVC Argon Gas Tube: PVC Electrosurgical Energy Line: PE+EVA, Copper Signal Control Line: PVC, Copper | Outer Jacket: PVC Argon Gas Tube: PVC Electrosurgical Energy Line: PE+EVA, Copper Signal Control Line: PVC, Copper | Identical | | Connectors | ESU: Copper Argon Gas Delivery: Acrylic Signal Control: PVC mold, Copper | ESU: Copper Argon Gas Delivery: Acrylic Signal Control: PVC mold, Copper | Identical | | Single Use or Reusable | Single use | Single use | Identical | | Sterilization | Gamma | Gamma | Identical | | Performance/ Safety Testing in accordance with: | IEC 60601-1 IEC 60601-1-2 IEC 60601-2-2 | IEC 60601-1 IEC 60601-1-2 IEC 60601-2-2 | Nearly Identical, Application device in conformance with latest version of the listed Standards | ### Tabular Comparison of the Argon Handset to Predicate Device {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for New Deantronics. The word "NEW" is in blue, and to the right of it is a blue circle with a red dot in the center. To the right of the circle is the word "DEANTRONICS" in blue. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for New Deantronics. The word "NEW" is in blue, and there 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. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for New Deantronics. The logo features the word "NEW" in a smaller font size, followed by a stylized letter "D" with a red dot in the center. The word "DEANTRONICS" is written in a larger, bold font to the right of the "D" symbol. The logo is primarily in shades of blue. # F. Summary of Supporting Data. New Deantronics has conducted extensive testing to ensure that the subject device met design specifications, functions as intended and conforms to the internationally recognized standards. # Bench Testing All the test results demonstrate the performance of Argon Handset meets the requirements of its pre-defined acceptance criteria and intended uses. The results of the non-clinical testing demonstrate that the Argon Handset is as safe and effective as the predicate device and reference device. Performance bench testing was conducted in accordance with FDA's guidance Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery issued August 15, 2016. Besides the tests derived from FDA guidance, some internal requirements were conducted to verify the design specification (e.g. electrode slide, activation force, activation overtime, and continuity); and some testing was performed to confirm the integrity and safety of argon gas delivery as well (e.g. gas filter test, impact and back pressures, and HF breakdown with argon gas). Thermal Effects on Tissue testing were conducted to demonstrate adequate performance within a system. # Electrical Safety and Electromagnetic Compatibility Testing Electrical safety testing was conducted in accordance with: IEC 60601-1:2005+AM1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance 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. Electromagnetic Compatibility Testing (EMC) was conducted in accordance with 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. The Argon Handset passed all electrical safety and EMC testing. # Shelf-Life Testing Shelf-life testing was conducted in accordance with FDA's guidance document Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery issued August 15, 2016 and internal requirements. The Argon Handset was subjected to accelerated aging. The aging studies established that the device and packaging remain functional and maintain sterility for 2 years. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for "NEW DEANTRONICS". The word "NEW" is in blue, and to the right of 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. # Biocompatibility Testing Biocompatibility testing was conducted in accordance with ISO 10993-1:2009/AC:2010, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, and FDA's guidance documents, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" issued June 16, 2016 and Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery issued August 15, 2016. This testing demonstrates that the materials in the device will not cause a biocompatibility reaction when used as intended. ### Package Testing The argon handset package has been verified and vali…