(51 days)
Not Found
No
The 510(k) summary describes a standard electrosurgical accessory (handset) that works in conjunction with existing electrosurgical generators and argon gas delivery systems. There is no mention of AI, ML, image processing, or any data-driven decision-making within the device itself. The performance studies focus on standard electrical, mechanical, and biocompatibility testing, not on algorithmic performance.
Yes
The device is an electrosurgical accessory used in surgical procedures to deliver electrosurgical energy for cutting and coagulation, actions that directly treat or manage a patient's condition.
No
The Argon Handset is described as an electrosurgical accessory used for cutting and coagulation of tissue, not for identifying or assessing a medical condition.
No
The device description clearly states it is a physical "handset" with a "blade electrode" and "argon electrodes," requiring connection to an electrosurgical generator and argon gas delivery system. This indicates it is a hardware device, not software only.
Based on the provided information, the Argon Handset is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for use in surgical procedures (open, laparoscopic, thoracoscopic) to deliver electrosurgical energy and argon gas for cutting and coagulation of tissue. This is a therapeutic and surgical application, not a diagnostic one performed in vitro (outside the body).
- Device Description: The description reinforces its use in surgical procedures, acting as an electrosurgical pencil to deliver energy to target tissue.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide diagnostic information about a patient's condition.
- Bench Testing: The performance studies focus on the device's functionality in delivering electrosurgical energy and argon gas, electrical safety, shelf-life, biocompatibility, and package integrity – all related to its surgical application. There are no studies related to diagnostic accuracy or performance with biological samples.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Argon Handset's function is to directly interact with and modify tissue during surgery.
N/A
Intended Use / 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 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.
Product codes
GEI
Device Description
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained professionals / hospitals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
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 validated in accordance to the associated ASTM package standards. The test result demonstrates the sterile package of argon handset is adequate. After testing, the package integrity remains uncompromised and the sterile barrier is not adversely affected. No animal studies or clinical studies were performed.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
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.(b)
Classification. Class II.
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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.
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) |
|---|---|
| ------------------------------------------------------------------------------------ | ----------------------------------------------------------------------------------- |
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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
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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.
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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
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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.
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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.
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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 validated in accordance to the associated ASTM package standards. The test result demonstrates the sterile package of argon handset is adequate. After testing, the package integrity remains uncompromised and the sterile barrier is not adversely affected.
Animal Studies
No animal studies were performed as appropriate verification of the device was achieved from the results of the bench performance testing, biocompatibility evaluation, and electrical/safety testing.
Clinical Studies
No clinical studies were performed as appropriate verification of the device was achieved from the results of the bench performance testing, biocompatibility evaluation, and electrical/safety testing.
Conclusion
New Deantronics concludes that the validations demonstrate that the application Argon Handset is in conformance with the latest bench testing and biocompatibility standards and is substantially equivalent to the predicate Valleylab Force Argon II Argon Enhanced Electrosurgical System (K964636).