(51 days)
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 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.
This document is a 510(k) Premarket Notification for the Argon Handset device, a type of electrosurgical accessory. It seeks to demonstrate substantial equivalence to a predicate device, the Valleylab Force Argon II Argon Enhanced Electrosurgical System (K964636).
The document does not describe a study that proves the device meets acceptance criteria related to AI/ML algorithm performance, nor does it pertain to a diagnostic or assistive AI medical device that would involve human readers, ground truth establishment by experts, or MRMC studies.
Instead, this 510(k) submission focuses on the safety and performance of a physical medical device (an electrosurgical accessory) through bench testing, electrical safety, EMC testing, shelf-life testing, biocompatibility testing, and package testing.
Therefore, most of the requested information (sample size for test/training sets, data provenance, number/qualification of experts, adjudication methods, MRMC studies, standalone algorithm performance, ground truth types for AI) is not applicable to this type of device and submission.
However, I can extract the acceptance criteria and the methods used to prove the device meets these criteria for this physical medical device.
Acceptance Criteria and Study for the Argon Handset (Electrosurgical Accessory)
The document primarily demonstrates substantial equivalence through technical and performance characteristics compared to a predicate device, supported by extensive non-clinical testing rather than clinical or AI performance studies.
1. Table of Acceptance Criteria and Reported Device Performance
The submission states that "All the test results demonstrate the performance of Argon Handset meets the requirements of its pre-defined acceptance criteria and intended uses." Specific quantitative acceptance criteria are not explicitly tabulated in this document; rather, it details the types of tests conducted and concludes that the device passed them, implying the predefined criteria were met. The performance is reported as meeting "requirements" or "passing" standards.
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Bench Testing | All test results met the requirements of pre-defined acceptance criteria and intended uses. Device performs as safely and effectively as the predicate. Specific tests included: - Electrode slide - Activation force - Activation overtime - Continuity - Gas filter test - Impact and back pressures - HF breakdown with argon gas - Thermal Effects on Tissue (within a system) |
| Electrical Safety | The Argon Handset passed all electrical safety tests. Tested in accordance with: - IEC 60601-1:2005+AM1:2012 (General requirements for basic safety and essential performance) - IEC 60601-2-2:2017 (Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories). |
| Electromagnetic Compatibility (EMC) | The Argon Handset passed all EMC tests. Tested in accordance with: - IEC 60601-1-2:2014 (Electromagnetic disturbances - Requirements and tests). |
| Shelf-Life | Established that the device and packaging remain functional and maintain sterility for 2 years through accelerated aging studies. Tested in accordance with FDA guidance and internal requirements. |
| Biocompatibility | Demonstrates that the materials in the device will not cause a biocompatibility reaction when used as intended. Tested in accordance with: - ISO 10993-1:2009/AC:2010 (Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process) - FDA guidance documents. |
| Package Integrity | The sterile package integrity remains uncompromised and the sterile barrier is not adversely affected after testing. Verified and validated in accordance with associated ASTM package standards. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a number of devices. Testing typically involves a representative sample of devices, but the exact quantity is not detailed in this summary.
- Data Provenance: The testing was conducted by New Deantronics Taiwan Ltd. ("New Deantronics") and its "extended team," implying internal testing conducted by the manufacturer. The document doesn't specify data origin by country other than the manufacturer's location (Taiwan). It's not relevant whether it's retrospective or prospective, as this applies to clinical data, not bench/lab testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This device is a physical electrosurgical accessory. The "ground truth" (i.e., whether the device performs as intended and is safe) is established through engineering and laboratory testing against defined standards and specifications, not through expert human interpretation of data like in an AI medical device.
4. Adjudication method for the test set:
- N/A. Adjudication methods like 2+1 or 3+1 are used for human review of medical images or data in studies involving expert consensus on ground truth. This is not applicable to an electrosurgical accessory undergoing physical and electrical bench testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. An MRMC study is not relevant to this device. This is a physical electrosurgical tool, not an AI or imaging-based diagnostic/assistive device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an algorithm. Therefore, "standalone performance" in the context of an algorithm is not applicable.
7. The type of ground truth used:
- For this device, the "ground truth" is defined by international consensus standards (e.g., IEC, ISO, ASTM) and the predetermined design specifications and acceptance criteria of the manufacturer, all validated through bench, electrical, and materials testing. It is not expert consensus, pathology, or outcomes data in the sense used for diagnostic/AI devices.
8. The sample size for the training set:
- N/A. There is no "training set" for this type of device, as it does not involve machine learning or AI.
9. How the ground truth for the training set was established:
- N/A. As there is no training set, this question is not applicable.
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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
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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
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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) 2-2268-1726Fax: (886) 2-2268-3800 |
| Correspondent ContactInformation: | Craig CoombsCoombs Medical Device Consulting1193 Sherman StreetAlameda, CA 94501Tel: 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 EnhancedElectrosurgical System |
|---|---|
| Predicate Device Manufacturer: | Valleylab, Inc. |
| Predicate Device Common Name: | Electrosurgical accessory |
| Predicate Device Premarket Notification # | K964636 |
| Predicate Device Classification: | 21 CFR 878.4400Electrosurgical, Cutting & CoagulationDevice 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 ArgonEnhanced ElectrosurgicalSystem (K964636) | Pertinence ofFeature toConsideration ofSubstantialEquivalence. |
|---|---|---|---|
| Indications for Use | The Argon Handset is anelectrosurgical accessoryintended to be used in open orlaparoscopic and thoracoscopicsurgical procedures (general,neurosurgical, gynecologic)where monopolar standard orargon enhanced electrosurgeryis desired. The electrosurgicalenergy is controlled by theelectrosurgical generator duringcutting and coagulation and theargon gas flow is controlled bythe argon gas delivery system,via the Argon Handset, duringargon-shrouded cutting andargon-enhanced coagulation.When the Argon Handset isactivated in the argon-enhancedmode, argon gas plasma iscreated between the electrodeand target tissue. | The Force Argon IIEnhanced ElectrosurgicalSystem is intended for usein both open, laparoscopicand thoracoscopic surgicalprocedures (general,neurosurgical, gynecologic)where monopolarelectrosurgery (cutting andcoagulation) is normallyused. The Force Argon IIArgon EnhancedElectrosurgical Systemprovides a controlled flowof argon to electrosurgicalhandset during cutting andcoagulation. When thehandset is activated in thegas enhanced mode, anargon gas plasma is createdbetween the electrode andthe tissue. | The Indications forUse of the applicationand predicate devicesare the same, bothdevices are forstandard cutting orcoagulation; argonenhancedelectrosurgery is alsoavailable when thehandset is activatedin the gas enhancedmode.The Argon shroudedmode was included inthe devicedescription of thepredicate. It allowsthe use of argon gasto blow smoke out ofthe surgical fieldduring RF cutting. |
| Product Code | GEI | GEI | Identical |
| Technology | |||
| Mechanism of StandardElectrosurgery | The Argon Handset is designedto connect with electrosurgicalgenerator and argon gas deliverysystem. When standardelectrosurgery is activated, theelectrosurgical energy will bedelivery from electrosurgicalgenerator to the handsetelectrode, to cut or coagulate insurgical procedures | Same for K964636 | Identical |
| Feature | Application Device:Argon Handset | Predicate Device:Force Argon II ArgonEnhanced ElectrosurgicalSystem (K964636) | Pertinence ofFeature toConsideration ofSubstantialEquivalence. |
| Mechanism of Argon-Enhanced or ShroudedOperation | The Argon Handset is designedto connect with electrosurgicalgenerator and argon gas deliverysystem. The argon gas tubeserves a gas path for argon gasto flow through to the surgicalfield.At the distal end of electrode,the argon gas will turn intoplasma state and then emit tothe target site when the ArgonGas Delivery System is in the"enhanced" mode or the gas willblow out smoke formed duringRF cutting when in "shrouded"mode. | Same for K964636 | Identical |
| Energy Used | Radiofrequency ElectricalCurrent | Radiofrequency ElectricalCurrent | Identical |
| Operation Principle | Monopolar Electrosurgery | Monopolar Electrosurgery | Identical |
| Operation Gas | Argon Gas | Argon Gas | Identical |
| Equipment Mated | Electrosurgical Generator:Covidien Force EZTM or ForceFXTM seriesArgon Gas Delivery System:Covidien Argon Gas Delivery UnitII or ForceTM GSU Argon GasDelivery System | Same for K964636 | Identical |
| Design - Handset Mechanism | |||
| Electrode Configuration | Blade | Blade | Identical |
| Electrode Length | ~17.5mm | ~17.5mm | Identical |
| ElectrodeExtension/Retraction | Slide Guide | Slide Guide | Identical |
| ElectrodeInterchangeable | 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 ArgonEnhanced ElectrosurgicalSystem (K964636) | Pertinence ofFeature toConsideration ofSubstantialEquivalence. |
| Connection Interface | ESU: banana leadArgon Gas Delivery: gas filterSignal 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 polymerhandset body: polymer shell | electrosurgical energy line:double layer of polymerhandset body: polymer shell | Identical |
| Electrical Safety | Withstand 5.6kVp for HighFrequency breakdownWithstand 5.6kVp AC at MainFrequency (60Hz) breakdown | (unknown, but electricalsafety complies withconsensus standard) | Identical |
| Handset Electrode | Stainless Steel SUS 304 | Stainless Steel SUS 302/SUS304 | Functionally Identical |
| Handset Handle | Nozzle: Aluminum Ceramic | Nozzle: Aluminum CeramicElectrode Extension Guide:HDPE | Identical |
| Electrode Extension Guide: HDPEActivation Switch: PCGas Switch: PCHandset Body: HIPS | Activation Switch: PCGas Switch: PCHandset Body: HIPS | ||
| Cable Set | Outer Jacket: PVCArgon Gas Tube: PVCElectrosurgical Energy Line:PE+EVA, CopperSignal Control Line: PVC, Copper | Outer Jacket: PVCArgon Gas Tube: PVCElectrosurgical Energy Line:PE+EVA, CopperSignal Control Line: PVC,Copper | Identical |
| Connectors | ESU: CopperArgon Gas Delivery: AcrylicSignal Control: PVC mold,Copper | ESU: CopperArgon Gas Delivery: AcrylicSignal Control: PVC mold,Copper | Identical |
| Single Use or Reusable | Single use | Single use | Identical |
| Sterilization | Gamma | Gamma | Identical |
| Performance/ SafetyTesting in accordancewith: | IEC 60601-1IEC 60601-1-2IEC 60601-2-2 | IEC 60601-1IEC 60601-1-2IEC 60601-2-2 | Nearly Identical,Application device inconformance withlatest version of thelisted 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.
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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).
§ 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.