(176 days)
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No
The document describes a standard electrosurgical electrode and its function, with no mention of AI or ML capabilities.
No.
The device is used for electrosurgical cutting and coagulation, which involves modifying tissue rather than restoring health or curing disease.
No
The device is described as an electrosurgical electrode used for cutting and coagulation of tissue during surgical procedures, not for diagnosing medical conditions.
No
The device description clearly indicates a physical electrode designed to connect to a third-party argon handset and deliver electrosurgical energy and argon gas. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring or compatibility purposes.
- Device Function: The description clearly states that this device is an electrosurgical electrode used in surgical procedures (open, laparoscopic, thoracoscopic) to apply energy and argon gas directly or indirectly to tissue for cutting and coagulation.
- Intended Use: The intended use is for surgical procedures where argon-enhanced monopolar coagulation or standard electrosurgical cutting and coagulation is desired. This is a therapeutic/surgical function, not a diagnostic one performed on a specimen outside the body.
The device interacts directly with the patient's tissue during surgery, which is the opposite of how an IVD functions.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
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 .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
open or laparoscopic surgical procedures (general, neurosurgical, gynecologic)
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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
1
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
2
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) 2-2268-1726 | |
| 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: | New Deantronics Argon Electrodes |
Predicate Device Information:
| Predicate Device: | Force Argon II Argon Enhanced
Electrosurgical 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 Argon
Electrode | Predicate Device:
Force Argon II Argon Enhanced
Electrosurgical System
(K964636) | Pertinence of
Feature to
Consideration of
Substantial
Equivalence. |
|-------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | 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 nearly the same;
both of these
devices are for RF
cutting or
coagulation in
laparoscopic and
thoracoscopic
surgical procedures
(general,
neurosurgical,
gynecologic).
We have separated
out the indications
for Use for the
separate models of
devices.
We have also
eliminated the last
sentence in the
predicate since it's
not needed in the
Indications for Use. |
| Product Code | GEI | GEI | Identical |
| Feature | Application Device:
New Deantronics Argon
Electrode | Predicate Device:
Force Argon II Argon Enhanced
Electrosurgical System
(K964636) | Pertinence of
Feature to
Consideration of
Substantial
Equivalence. |
| Technology | | | |
| Mechanism of
Standard
Electrosurgery | The retractable argon
electrode is designed to be
attached with an argon
handset. When activated, the
electrosurgical energy will be
conducted from argon handset
to the electrode tip, to cut or
coagulate in surgical
procedures | Same RF cutting and coagulation
capability | Identical |
| Mechanism of
Argon-
Enhanced
Operation | The argon electrode is
designed to be attached with
an argon handset. The hollow
electrode shaft provides a gas
channel for argon gas flowing
through. At the distal end of
electrode, the argon gas will
turn into plasma state and
then emit to target site. | Same as application device | Identical |
| Energy Used | Radiofrequency Electrical
Current & Plasma thermal
energy | Radiofrequency Electrical
Current & Plasma Thermal
Energy | Identical |
| Operation
Principle | Monopolar Electrosurgery | Monopolar Electrosurgery | Identical |
| Operation Gas | Argon Gas | Argon Gas | Identical |
| Handpiece
Mated | Covidien E2520H/E3520H | Covidien E2520H | Identical |
| Design - Electrode Mechanism | | | |
| Electrode
Length | Flexible: 3 inch, 6 inch, 28cm | Flexible: 7.6cm, 15cm, 28cm | Identical |
| | Retractable: 28cm | Retractable: 28cm | Identical |
| Connection
Interface | Collet overlapped on argon
handset nozzle | Collet overlapped on argon
handset nozzle | Identical |
| Feature | Application Device:
New Deantronics Argon
Electrode | Predicate Device:
Force Argon II Argon Enhanced
Electrosurgical System
(K964636) | Pertinence of
Feature to
Consideration of
Substantial
Equivalence. |
| Electrode Tip
Configuration | Flexible: needle | Flexible: needle | Nearly identical to
predicate device, the
retractable
application device
lacks a sharp needle
electrode option |
| | Retractable: blade, flat L, blunt
needle | Retractable: blade, flat L, blunt
needle, sharp needle, | |
| Electrode
Shaft Diameter | Flexible: 5.0 mm | Flexible: 5.0 mm | Identical |
| | Retractable: 4.7 mm | Retractable: 4.7 mm | |
| Argon Gas
Flow Rate | Flexible: Maximum 13.8 LPM
or 4 LPM
Retractable: Maximum 4 LPM | Flexible: 12 LPM or 4LPM
Retractable: 4 LPM | Identical |
| Electrical
Safety | Withstand 13.5kV peak to peak
for High Frequency breakdown
Withstand 5.2kV RMS AC at
Main Frequency (60Hz)
breakdown | (unknown, but electrical safety
complies with consensus
standard) | Identical, High
withstand voltage is
complied with
consensus standard
as does the
predicate devices. |
| Electrode
Insulation | Flexible: double layers of
polymer
Retractable: single layer of
polymer | Flexible: double layers of
polymer
Retractable: single layer of
polymer | Identical |
| Electrode Tip | Flexible: tungsten
Retractable: tungsten or 304
stainless steel | Flexible: tungsten
Retractable: tungsten or 304
stainless steel | Identical |
| Electrode
Sheath | Flexible: aluminum tube
covered by 2 layers
of POF (polyolefin)
Retractable: POLYGON
POLYMED® | Flexible: aluminum tube covered
by 2 layers of POF
(polyolefin)
Retractable: POLYGON
POLYMED® | Identical |
| Feature | Application Device:
New Deantronics Argon
Electrode | Predicate Device:
Force Argon II Argon Enhanced
Electrosurgical System
(K964636) | Pertinence of
Feature to
Consideration of
Substantial
Equivalence. |
| Electrode
Collet | Polycarbonate | Polycarbonate | Identical |
| Tip Protector | Distal: LDPE
Proximal: LDPE | Flexible: Distal: PVC
Proximal: LDPE
Retractable: Distal: LDPE
Proximal: LDPE | Functionally
Identical |
| Other Attributes | | | |
| Single Use or
Reusable | Single use | Single use | Identical |
| Sterilization | EtO | EtO | Identical |
| Performance/
Safety
Testing in
accordance
with: | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-2
IEC 60601-2-18 | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-2 | Nearly Identical,
Application device in
conformance with
latest version of the
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).