(176 days)
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.
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.
The provided text describes the New Deantronics Argon Electrodes, which are electrosurgical accessories, and asserts their substantial equivalence to a predicate device based on various comparisons and non-clinical testing. However, the document does not contain the detailed information required to answer all parts of your request, particularly regarding specific acceptance criteria metrics and a human-focused study design.
Here's a breakdown of what can be extracted and what is missing:
1. Table of acceptance criteria and the reported device performance
The document mentions "pre-defined acceptance criteria" but does not provide a specific table outlining those criteria or the reported performance against them for functionality, safety, or clinical effectiveness. The only specific performance data mentioned related to criteria is:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| High Frequency (HF) breakdown withstand voltage | 13.5kV peak to peak |
| Main Frequency (60Hz) breakdown withstand voltage | 5.2kV RMS AC |
Beyond these electrical safety parameters, the document states: "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." This is a general statement rather than specific data.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "electrical safety testing and bench testing" but does not specify the sample size for the test sets used in these non-clinical tests. It also does not mention the data provenance or whether the tests were retrospective or prospective. Given that it's bench testing, it's typically conducted in a controlled lab environment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as the document describes non-clinical "electrical safety testing and bench testing," not a study involving human interpretation or expert ground truth establishment for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the same reason as point 3.
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
The document describes development and testing of an "Electrosurgical accessory" (Argon Electrodes) and explicitly states it conducted "electrical safety testing and bench testing." It does not mention a MRMC comparative effectiveness study involving human readers or AI. Therefore, there is no effect size related to human readers improving with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document details "electrical safety testing and bench testing" of the device itself (Argon Electrodes), which can be considered a form of standalone performance evaluation for the device's physical and electrical characteristics. However, it's not an "algorithm only" standalone performance as the device itself is a physical medical instrument, not software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the electrical safety and functional bench testing, the "ground truth" would be established by engineering specifications, industry standards (e.g., IEC 60601 series), and controlled measurements using calibrated equipment, not expert consensus, pathology, or outcomes data which are typically associated with clinical or diagnostic studies.
8. The sample size for the training set
This information is not applicable. The device is an electrosurgical accessory, not an AI/ML algorithm that requires a "training set." The testing described is for physical product performance, not algorithm training.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
In summary:
This document focuses on regulatory clearance for an electrosurgical accessory based on its physical properties and electrical safety, largely through comparison to a predicate device and non-clinical bench testing. It does not involve AI, human reader studies, or complex clinical ground truth assessments as would be relevant for diagnostic imaging or similar AI-driven medical devices.
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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.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: | New Deantronics Argon Electrodes |
Predicate Device Information:
| Predicate Device: | Force Argon II Argon EnhancedElectrosurgical System |
|---|---|
| Predicate Device Manufacturer: | Covidien |
| Predicate Device Common Name: | Electrosurgical, Cutting & Coagulation& Accessories,Argon Electrodes |
| Predicate Device Premarket Notification #: | K964636 |
| Predicate Device Classification: | 21 CFR 878.4400 |
| Predicate Device Classification &Product Code: | Class 2,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:New Deantronics ArgonElectrode | Predicate Device:Force Argon II Argon EnhancedElectrosurgical System(K964636) | Pertinence ofFeature toConsideration ofSubstantialEquivalence. |
|---|---|---|---|
| Indications forUse | The Flexible Argon Electrode isintended to be used in open orlaparoscopic andthoracoscopic surgicalprocedures (general,neurosurgical, gynecologic)where argon-enhancedmonopolar coagulation isdesired.The Retractable ArgonElectrode is intended to beused in laparoscopic andthoracoscopic surgicalprocedures (general,neurosurgical, gynecologic)where standard monopolarelectrosurgery (cutting andcoagulation) or argon-enhanced monopolarcoagulation is desired.The New Deantronics ArgonElectrodes have to be attachedto the argon handset and arethe electrosurgical electrodesapplied in electrosurgicalprocedures. | The Force Argon II EnhancedElectrosurgical System isintended for use in both open,laparoscopic and thoracoscopicsurgical procedures (general,neurosurgical, gynecologic)where monopolarelectrosurgery (cutting andcoagulation) is normally used.The Force Argon II ArgonEnhanced Electrosurgical Systemprovides a controlled flow ofargon to electrosurgical handsetduring cutting and coagulation.When the handset is activatedin the gas enhanced mode, anargon gas plasma is createdbetween the electrode and thetissue. | The Indications forUse of theapplication andpredicate devicesare nearly the same;both of thesedevices are for RFcutting orcoagulation inlaparoscopic andthoracoscopicsurgical procedures(general,neurosurgical,gynecologic).We have separatedout the indicationsfor Use for theseparate models ofdevices.We have alsoeliminated the lastsentence in thepredicate since it'snot needed in theIndications for Use. |
| Product Code | GEI | GEI | Identical |
| Feature | Application Device:New Deantronics ArgonElectrode | Predicate Device:Force Argon II Argon EnhancedElectrosurgical System(K964636) | Pertinence ofFeature toConsideration ofSubstantialEquivalence. |
| Technology | |||
| Mechanism ofStandardElectrosurgery | The retractable argonelectrode is designed to beattached with an argonhandset. When activated, theelectrosurgical energy will beconducted from argon handsetto the electrode tip, to cut orcoagulate in surgicalprocedures | Same RF cutting and coagulationcapability | Identical |
| Mechanism ofArgon-EnhancedOperation | The argon electrode isdesigned to be attached withan argon handset. The hollowelectrode shaft provides a gaschannel for argon gas flowingthrough. At the distal end ofelectrode, the argon gas willturn into plasma state andthen emit to target site. | Same as application device | Identical |
| Energy Used | Radiofrequency ElectricalCurrent & Plasma thermalenergy | Radiofrequency ElectricalCurrent & Plasma ThermalEnergy | Identical |
| OperationPrinciple | Monopolar Electrosurgery | Monopolar Electrosurgery | Identical |
| Operation Gas | Argon Gas | Argon Gas | Identical |
| HandpieceMated | Covidien E2520H/E3520H | Covidien E2520H | Identical |
| Design - Electrode Mechanism | |||
| ElectrodeLength | Flexible: 3 inch, 6 inch, 28cm | Flexible: 7.6cm, 15cm, 28cm | Identical |
| Retractable: 28cm | Retractable: 28cm | Identical | |
| ConnectionInterface | Collet overlapped on argonhandset nozzle | Collet overlapped on argonhandset nozzle | Identical |
| Feature | Application Device:New Deantronics ArgonElectrode | Predicate Device:Force Argon II Argon EnhancedElectrosurgical System(K964636) | Pertinence ofFeature toConsideration ofSubstantialEquivalence. |
| Electrode TipConfiguration | Flexible: needle | Flexible: needle | Nearly identical topredicate device, theretractableapplication devicelacks a sharp needleelectrode option |
| Retractable: blade, flat L, bluntneedle | Retractable: blade, flat L, bluntneedle, sharp needle, | ||
| ElectrodeShaft Diameter | Flexible: 5.0 mm | Flexible: 5.0 mm | Identical |
| Retractable: 4.7 mm | Retractable: 4.7 mm | ||
| Argon GasFlow Rate | Flexible: Maximum 13.8 LPMor 4 LPMRetractable: Maximum 4 LPM | Flexible: 12 LPM or 4LPMRetractable: 4 LPM | Identical |
| ElectricalSafety | Withstand 13.5kV peak to peakfor High Frequency breakdownWithstand 5.2kV RMS AC atMain Frequency (60Hz)breakdown | (unknown, but electrical safetycomplies with consensusstandard) | Identical, Highwithstand voltage iscomplied withconsensus standardas does thepredicate devices. |
| ElectrodeInsulation | Flexible: double layers ofpolymerRetractable: single layer ofpolymer | Flexible: double layers ofpolymerRetractable: single layer ofpolymer | Identical |
| Electrode Tip | Flexible: tungstenRetractable: tungsten or 304stainless steel | Flexible: tungstenRetractable: tungsten or 304stainless steel | Identical |
| ElectrodeSheath | Flexible: aluminum tubecovered by 2 layersof POF (polyolefin)Retractable: POLYGONPOLYMED® | Flexible: aluminum tube coveredby 2 layers of POF(polyolefin)Retractable: POLYGONPOLYMED® | Identical |
| Feature | Application Device:New Deantronics ArgonElectrode | Predicate Device:Force Argon II Argon EnhancedElectrosurgical System(K964636) | Pertinence ofFeature toConsideration ofSubstantialEquivalence. |
| ElectrodeCollet | Polycarbonate | Polycarbonate | Identical |
| Tip Protector | Distal: LDPEProximal: LDPE | Flexible: Distal: PVCProximal: LDPERetractable: Distal: LDPEProximal: LDPE | FunctionallyIdentical |
| Other Attributes | |||
| Single Use orReusable | Single use | Single use | Identical |
| Sterilization | EtO | EtO | Identical |
| Performance/SafetyTesting inaccordancewith: | IEC 60601-1IEC 60601-1-2IEC 60601-2-2IEC 60601-2-18 | IEC 60601-1IEC 60601-1-2IEC 60601-2-2 | Nearly Identical,Application device inconformance withlatest version of thelisted 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).
§ 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.