Electrosurgical accessory
Device Facts
| Record ID | K183126 |
|---|---|
| Device Name | Electrosurgical accessory |
| Applicant | New Deantronics Taiwan , Ltd. |
| Product Code | GEI · General, Plastic Surgery |
| Decision Date | May 8, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4400 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Flexible Argon Electrode is intended to be used in open or laparoscopic and thoracoscopic surgical procedures (general, neurosurgical, gynecologic) where argon-enhanced monopolar coagulation is desired. The Retractable Argon Electrode is intended to be used in laparoscopic and thoracoscopic surgical procedures (general, neurosurgical, gynecologic) where standard monopolar electrosurgery (cutting and coagulation) or argon-enhanced monopolar coagulation is desired. The New Deantronics Argon Electrodes have to be attached to the argon handset and are the electrosurgical electrodes applied in electrosurgical procedures.
Device Story
Argon electrodes connect to third-party argon handsets for use in open, laparoscopic, and thoracoscopic surgeries. Device conducts RF electrical energy and argon gas to target tissue. Upon activation, argon gas transforms into plasma state at electrode tip, facilitating coagulation or cutting. Operated by surgeons in clinical settings. Output is plasma thermal energy and RF current for tissue effect. Benefits include controlled coagulation and cutting during surgical procedures.
Clinical Evidence
Bench testing only. No clinical data provided. Testing included electrical safety (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-2-18) and performance testing to demonstrate equivalence to predicate.
Technological Characteristics
Materials: Tungsten or 304 stainless steel tips, aluminum/polymer shafts, polycarbonate collets, LDPE/PVC tip protectors. Energy: RF electrical current and plasma thermal energy. Dimensions: 5.0mm (flexible) or 4.7mm (retractable) shaft diameter. Connectivity: Attaches to third-party argon handsets. Sterilization: EtO. Standards: IEC 60601-1, 60601-1-2, 60601-2-2, 60601-2-18.
Indications for Use
Indicated for open, laparoscopic, and thoracoscopic surgical procedures (general, neurosurgical, gynecologic) requiring argon-enhanced monopolar coagulation or standard monopolar electrosurgical cutting and coagulation.
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
- Force Argon II Argon Enhanced Electrosurgical System (K964636)
Submission Summary (Full Text)
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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.
May 8, 2019
New Deantronics Taiwan Ltd % Mr. Craig Coombs Coombs Medical Device Consulting, Inc 1193 Sherman St Alameda, California 94501
Re: K183126
Trade/Device Name: Electrosurgical accessory Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: April 8, 2019 Received: April 9, 2019
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.
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
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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
Jennifer R. Stevenson Acting Division Director Division of General Surgery Devices Office of Surgical and Infection Control Devices Office of Product Evaluation & Quality Center for Devices and Radiological Devices
Enclosure
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# Indications for Use
510(k) Number (if known) K183126
Device Name Argon Electrodes
#### Indications for Use (Describe)
The Flexible Argon Electrode is intended to be used in open or laparoscopic surgical procedures (general, neurosurgical, gynecologic) where argon-enhanced monopolar coagulation is desired.
The Retractable Argon Electrode is intended to be used in lapacoscopic survical procedures (general, neurosurgical, gynecologic) where standard monopolar electrosurgery (cutting and coagulation) or argon-enhanced monopolar coagulation is desired.
The New Deantronics Argon Electrodes have to be attached to the argon handset and are the electrodes applied in electrosurgical procedures.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for "NEW DEANTRONICS". The word "NEW" is in blue, and the word "DEANTRONICS" is in blue as well. There is a blue circle with a red dot in the middle between the two words.
# Section 5: 510(k) Summary
#### A. 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 |
| Correspondent Contact<br>Information: | Craig Coombs<br>Coombs Medical Device Consulting<br>1193 Sherman Street<br>Alameda, CA 94501<br>Tel: 510-337-0140 |
| Device Common Name: | Electrosurgical accessory |
| Device Classification Number: | 21 CFR 878.4400 |
| Device Classification &<br>Product Code: | Class 2,<br>GEI |
| Device Proprietary Name: | New Deantronics Argon Electrodes |
### Predicate Device Information:
| Predicate Device: | Force Argon II Argon Enhanced<br>Electrosurgical System |
|----------------------------------------------------|------------------------------------------------------------------------------|
| Predicate Device Manufacturer: | Covidien |
| Predicate Device Common Name: | Electrosurgical, Cutting & Coagulation<br>& Accessories,<br>Argon Electrodes |
| Predicate Device Premarket Notification #: | K964636 |
| Predicate Device Classification: | 21 CFR 878.4400 |
| Predicate Device Classification &<br>Product Code: | Class 2,<br>GEI |
### B. Date Summary Prepared
6 May 2019
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Image /page/4/Picture/0 description: The image contains the logo for New Deantronics. The logo has the word "NEW" in a smaller font size on the left side of a blue circle with a red dot in the center. To the right of the circle is the word "DEANTRONICS" in a larger, bold, blue font. The logo is simple and professional, and it is likely used to represent the company on its website and marketing materials.
### C. Description of Device
The New Deantronics Argon Electrode is designed to connect to a third-party argon handset. The electrosurgical energy is conducted from the argon handset, through the electrode to the electrosurgical target site, as is the argon gas flow. When the device is activated, the argon gas will be transformed into a plasma state flowing out of the electrode. By directly or indirectly contacting the energized electrode with the target tissue, the New Deantronics Argon Electrode can facilitate argon-enhanced coagulation, as well as standard electrosurgical cut and coagulation, as indicated .
#### D. Indications for Use
The Flexible Argon Electrode is intended to be used in open or laparoscopic and thoracoscopic surgical procedures (general, neurosurgical, gynecologic) where argon-enhanced monopolar coagulation is desired.
The Retractable Argon Electrode is intended to be used in laparoscopic and thoracoscopic surgical procedures (general, neurosurgical, gynecologic) where standard monopolar electrosurgery (cutting and coagulation) or argon-enhanced monopolar coagulation is desired.
The New Deantronics Argon Electrodes have to be attached to the argon handset and are the electrosurgical electrodes applied in electrosurgical procedures.
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Image /page/5/Picture/0 description: The image shows the logo for New Deantronics. The logo features the word "NEW" in blue, followed by a stylized letter "D" with a red dot in the center. The word "DEANTRONICS" is written in blue to the right of the "D".
#### E. Comparison to Predicate Device
As described below, the application New Deantronics Argon Electrodes are substantially equivalent in intended use, technology, design and physician use to the predicate Force Argon II Argon Enhanced Electrosurgical System (K964636).
| Feature | Application Device:<br>New Deantronics Argon<br>Electrode | Predicate Device:<br>Force Argon II Argon Enhanced<br>Electrosurgical System<br>(K964636) | Pertinence of<br>Feature to<br>Consideration of<br>Substantial<br>Equivalence. |
|-------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | The Flexible Argon Electrode is<br>intended to be used in open or<br>laparoscopic and<br>thoracoscopic surgical<br>procedures (general,<br>neurosurgical, gynecologic)<br>where argon-enhanced<br>monopolar coagulation is<br>desired.<br>The Retractable Argon<br>Electrode is intended to be<br>used in laparoscopic and<br>thoracoscopic surgical<br>procedures (general,<br>neurosurgical, gynecologic)<br>where standard monopolar<br>electrosurgery (cutting and<br>coagulation) or argon-<br>enhanced monopolar<br>coagulation is desired.<br>The New Deantronics Argon<br>Electrodes have to be attached<br>to the argon handset and are<br>the electrosurgical electrodes<br>applied in electrosurgical<br>procedures. | The Force Argon II Enhanced<br>Electrosurgical System is<br>intended for use in both open,<br>laparoscopic and thoracoscopic<br>surgical procedures (general,<br>neurosurgical, gynecologic)<br>where monopolar<br>electrosurgery (cutting and<br>coagulation) is normally used.<br>The Force Argon II Argon<br>Enhanced Electrosurgical System<br>provides a controlled flow of<br>argon to electrosurgical handset<br>during cutting and coagulation.<br>When the handset is activated<br>in the gas enhanced mode, an<br>argon gas plasma is created<br>between the electrode and the<br>tissue. | The Indications for<br>Use of the<br>application and<br>predicate devices<br>are nearly the same;<br>both of these<br>devices are for RF<br>cutting or<br>coagulation in<br>laparoscopic and<br>thoracoscopic<br>surgical procedures<br>(general,<br>neurosurgical,<br>gynecologic).<br>We have separated<br>out the indications<br>for Use for the<br>separate models of<br>devices.<br>We have also<br>eliminated the last<br>sentence in the<br>predicate since it's<br>not needed in the<br>Indications for Use. |
| Product Code | GEI | GEI | Identical |
| Feature | Application Device:<br>New Deantronics Argon<br>Electrode | Predicate Device:<br>Force Argon II Argon Enhanced<br>Electrosurgical System<br>(K964636) | Pertinence of<br>Feature to<br>Consideration of<br>Substantial<br>Equivalence. |
| Technology | | | |
| Mechanism of<br>Standard<br>Electrosurgery | The retractable argon<br>electrode is designed to be<br>attached with an argon<br>handset. When activated, the<br>electrosurgical energy will be<br>conducted from argon handset<br>to the electrode tip, to cut or<br>coagulate in surgical<br>procedures | Same RF cutting and coagulation<br>capability | Identical |
| Mechanism of<br>Argon-<br>Enhanced<br>Operation | The argon electrode is<br>designed to be attached with<br>an argon handset. The hollow<br>electrode shaft provides a gas<br>channel for argon gas flowing<br>through. At the distal end of<br>electrode, the argon gas will<br>turn into plasma state and<br>then emit to target site. | Same as application device | Identical |
| Energy Used | Radiofrequency Electrical<br>Current & Plasma thermal<br>energy | Radiofrequency Electrical<br>Current & Plasma Thermal<br>Energy | Identical |
| Operation<br>Principle | Monopolar Electrosurgery | Monopolar Electrosurgery | Identical |
| Operation Gas | Argon Gas | Argon Gas | Identical |
| Handpiece<br>Mated | Covidien E2520H/E3520H | Covidien E2520H | Identical |
| Design - Electrode Mechanism | | | |
| Electrode<br>Length | Flexible: 3 inch, 6 inch, 28cm | Flexible: 7.6cm, 15cm, 28cm | Identical |
| | Retractable: 28cm | Retractable: 28cm | Identical |
| Connection<br>Interface | Collet overlapped on argon<br>handset nozzle | Collet overlapped on argon<br>handset nozzle | Identical |
| Feature | Application Device:<br>New Deantronics Argon<br>Electrode | Predicate Device:<br>Force Argon II Argon Enhanced<br>Electrosurgical System<br>(K964636) | Pertinence of<br>Feature to<br>Consideration of<br>Substantial<br>Equivalence. |
| Electrode Tip<br>Configuration | Flexible: needle | Flexible: needle | Nearly identical to<br>predicate device, the<br>retractable<br>application device<br>lacks a sharp needle<br>electrode option |
| | Retractable: blade, flat L, blunt<br>needle | Retractable: blade, flat L, blunt<br>needle, sharp needle, | |
| Electrode<br>Shaft Diameter | Flexible: 5.0 mm | Flexible: 5.0 mm | Identical |
| | Retractable: 4.7 mm | Retractable: 4.7 mm | |
| Argon Gas<br>Flow Rate | Flexible: Maximum 13.8 LPM<br>or 4 LPM<br>Retractable: Maximum 4 LPM | Flexible: 12 LPM or 4LPM<br>Retractable: 4 LPM | Identical |
| Electrical<br>Safety | Withstand 13.5kV peak to peak<br>for <b>High Frequency</b> breakdown<br>Withstand 5.2kV RMS AC at<br><b>Main Frequency (60Hz)</b><br>breakdown | (unknown, but electrical safety<br>complies with consensus<br>standard) | Identical, High<br>withstand voltage is<br>complied with<br>consensus standard<br>as does the<br>predicate devices. |
| Electrode<br>Insulation | Flexible: double layers of<br>polymer<br>Retractable: single layer of<br>polymer | Flexible: double layers of<br>polymer<br>Retractable: single layer of<br>polymer | Identical |
| Electrode Tip | Flexible: tungsten<br>Retractable: tungsten or 304<br>stainless steel | Flexible: tungsten<br>Retractable: tungsten or 304<br>stainless steel | Identical |
| Electrode<br>Sheath | Flexible: aluminum tube<br>covered by 2 layers<br>of POF (polyolefin)<br>Retractable: POLYGON<br>POLYMED® | Flexible: aluminum tube covered<br>by 2 layers of POF<br>(polyolefin)<br>Retractable: POLYGON<br>POLYMED® | Identical |
| Feature | Application Device:<br>New Deantronics Argon<br>Electrode | Predicate Device:<br>Force Argon II Argon Enhanced<br>Electrosurgical System<br>(K964636) | Pertinence of<br>Feature to<br>Consideration of<br>Substantial<br>Equivalence. |
| Electrode<br>Collet | Polycarbonate | Polycarbonate | Identical |
| Tip Protector | Distal: LDPE<br>Proximal: LDPE | Flexible: Distal: PVC<br>Proximal: LDPE<br>Retractable: Distal: LDPE<br>Proximal: LDPE | Functionally<br>Identical |
| Other Attributes | | | |
| Single Use or<br>Reusable | Single use | Single use | Identical |
| Sterilization | EtO | EtO | Identical |
| Performance/<br>Safety<br>Testing in<br>accordance<br>with: | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-2<br>IEC 60601-2-18 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-2 | Nearly Identical,<br>Application device in<br>conformance with<br>latest version of the<br>listed standards |
## Revised Tabular Comparison of the New Deantronics Argon Electrodes to the Predicate Device
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Image /page/6/Picture/0 description: The image shows the logo for New Deantronics. The logo has the word "NEW" in a smaller font size on the left side of a blue circle with a red dot in the center. The word "DEANTRONICS" is on the right side of the circle in a larger font size.
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Image /page/7/Picture/0 description: The image shows the logo for New Deantronics. The logo has the word "NEW" in a smaller font size on the left side of a blue circle with a red dot in the center. The word "DEANTRONICS" is on the right side of the circle in a larger font size.
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Image /page/8/Picture/0 description: The image shows the logo for New Deantronics. The word "NEW" is in blue, and it is stacked on top of the word "DEANTRONICS", which is also in blue. There is a blue circle with a red dot in the middle that is between the two words.
New Deantronics concludes that the devices are substantially equivalent.
## F. Summary of Supporting Data
Electrical safety testing and bench testing has demonstrated that the performance of New Deantronics Argon Electrodes meet the requirements of its pre-defined acceptance criteria and intended uses. The results of the non-clinical testing demonstrate that the New Deantronics Argon Electrodes are as safe and effective as the predicate devices.
#### G. Conclusion
New Deantronics concludes that the application New Deantronics Argon Electrodes are substantially equivalent in intended use, technology, design and physician use to the predicate Force Argon II Argon Enhanced Electrosurgical System (K964636).
