(52 days)
A Monopolar Cord is intended to be used with a compatible electrosurgical generator and an RF electrode to cut tissue and control bleeding by use of high-frequency electrical current.
The Monopolar Cord, sold as sterile packaged, and ready for use devices, is intended to be used with compatible accessories to cut tissue and control bleeding by use of high-frequency electrical current. The Monopolar Cord is compatible with the monopolar instruments with shrouded 2.5 mm female electrical connections, electrosurgical generator, and patient return electrode. During the operation, the sterile cord should connect to the sterile accessory, and then generator connector end is inserted into the adapter and generator which it receives the high frequency current and delivers the current onto a target tissue for cutting and coagulation in a procedure. These devices can be used in hospitals and are used by trained professionally only.
This is a medical device for electrosurgical cutting and coagulation, not an AI/ML device. Therefore, the questions related to AI/ML specific criteria (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth type for test set, training set size, and training set ground truth) are not applicable.
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Visual Inspection (General Mfr Requirement) | PASS |
| Continuity test (General Mfr Requirement) | PASS |
| Drop Test (preconditioning) (IEC 60601-1:2005+ AM1:2012, Clause 15.3.4.1) | PASS |
| Cable pull force from Terminal Pin (IEC 60601-1:2005+ AM1:2012, Clause 8.10.2) | PASS |
| 0.26kg Dynamic Strain Relief | PASS |
| 10 Pound Static Strain Relief | PASS |
| Anchorage Test (IEC 60601-2-2:2017, Clause 201.8.10.4.2) | PASS |
| HF Leakage Current Test (IEC 60601-2-2:2017, Clause 201.8.8.3.102) | PASS |
| High Frequency Dielectric Test (IEC 60601-2-2:2017, Clause 201.8.8.3.103) | PASS |
| Hi-Pot Test (IEC 60601-2-2:2017, Clause 201.8.8.3.104) | PASS |
| Mains Frequency Dielectric Strength Test | PASS |
| Connector pull force (IEC 60601-2-2:2017, Clause 201.15.4.1) | PASS |
| EMC Test (IEC 60601-2-2:2017, Clause 201.17, 202) | PASS |
| Package system performance testing per ASTM D4169 | Met acceptance criteria (functional and remains in sterile barrier after shipping) |
2. Sample size used for the test set and the data provenance: Not applicable. This device is subjected to bench and electrical safety testing, not a clinical test set with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a device like this is established through engineering and regulatory standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth is based on established engineering and safety standards (e.g., IEC 60601 series, ASTM D4169) and the functional requirements for an electrosurgical accessory.
8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set. The device development process involves design, prototyping, and testing against pre-defined specifications.
9. How the ground truth for the training set was established: Not applicable.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 19, 2019
New Deantronics Taiwan Ltd % Mr. Craig J. Coombs President Coombs Medical Device Consulting, Inc 1100 Pacific Marina, Suite 806 Alameda. California 94501
Re: K193004
Trade/Device Name: Monopolar Cord Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: October 24, 2019 Received: October 28, 2019
Dear Mr. 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.
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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 801 and Part 809): medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or post marketing 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,
for
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) K193004
Device Name Monopolar Cord
Indications for Use (Describe)
A Monopolar Cord is intended to be used with a compatible electrosurgical generator and an RF electrode to cut tissue and control bleeding by use of high-frequency electrical current.
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/1 description: The image shows the logo for New Deantronics. The word "NEW" is in blue, and the word "DEANTRONICS" is in a larger, bolded blue font. 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) 2-2268-3800Sponsor Contact: Ms. Jane Liu, PresidentEmail: jane@newdean.com.tw |
| Correspondent ContactInformation: | Mr. Craig CoombsPresidentCoombs Medical Device Consulting1100 Pacific Marina, Suite 806Alameda, CA 94501Tel: 510-995-8499Email: CraigJCoombs@gmail.com |
| Device Common Name: | Electrosurgical accessoryMonopolar Cord |
| Device Classification Number: | 21 CFR 878.4400 |
| Device Classification &Product Code: | Class 2,GEI |
| Device Proprietary Name: | Monopolar Cord |
Predicate Device Information:
| Predicate Device: | New Deantronics Foot Control Pencil |
|---|---|
| Predicate Device Manufacturer: | New Deantronics Taiwan Ltd. |
| Predicate Device Common Name: | Electrosurgical accessory |
| Predicate Device Premarket Notification # | K982749 |
| Predicate Device Classification: | 21 CFR 878.4400Electrosurgical, Cutting & CoagulationDevice and Accessories |
| Predicate Device Classification &Product Code: | Class 2,GEI |
B. Date Summary Prepared
13 December 2019
C. Description of Device
The Monopolar Cord, sold as sterile packaged, and ready for use devices, is intended to be used with compatible accessories to cut tissue and control bleeding by use of high-frequency electrical current.
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Image /page/4/Picture/1 description: The image shows the logo for New Deantronics. The word "NEW" is in blue, and the word "DEANTRONICS" is in a darker blue. There is a blue circle with a red dot in the middle between the two words. The logo is simple and modern.
The Monopolar Cord is compatible with the monopolar instruments with shrouded 2.5 mm female electrical connections, electrosurgical generator, and patient return electrode.
During the operation, the sterile cord should connect to the sterile accessory, and then generator connector end is inserted into the adapter and generator which it receives the high frequency current and delivers the current onto a target tissue for cutting and coagulation in a procedure. These devices can be used in hospitals and are used by trained professionally only.
D. Indications for Use
A Monopolar Cord is intended to be used with a compatible electrosurgical generator and an RF electrode to cut tissue and control bleeding by use of high-frequency electrical current.
E. Comparison to Predicate Device
As described below, the application Monopolar Cord is substantially equivalent in intended use, technology, design and physician use to the predicate New Deantronics Foot Control Pencil (K982749).
| Feature | Application Device:Monopolar Cord(K193004) | Predicate Device:New Deantronics Foot ControlPencil (K982749) | Pertinence of Featureto Consideration ofSubstantialEquivalence. |
|---|---|---|---|
| Indications forUse | A Monopolar Cord is intendedto be used with a compatibleelectrosurgical generator and anRF electrode to cut tissue andcontrol bleeding by use of high-frequency electrical current. | Electrosurgical accessory. Afoot activated electrosurgicalpencil is intended to removetissue and control bleeding byuse of high-frequency electricalcurrent. | The Indications for Useof the application andpredicate devices arethe same; both devicesare for use in standardcutting or coagulation.The application devicedoes not include anattached electrode, sothe specific action ofthe electrode isomitted. |
| Product Code | GEI | GEI | Identical |
| Technology | |||
| Mechanism ofStandardElectrosurgery | The Monopolar Cord isdesigned to connect aelectrosurgical generator withan RF electrode. Whenelectrosurgery is activated byfoot pedal, the electrosurgicalenergy will be delivery fromelectrosurgical generatorthrough the Cord and to theelectrode, to cut or coagulate insurgical procedures | The Foot Control Pencil isdesigned to connect withelectrosurgical generator. Whenelectrosurgery is activated byfoot pedal, the electrosurgicalenergy will be delivery fromelectrosurgical generatorthrough the cord and to theelectrode, to cut or coagulate insurgical procedures | Identical as far as theconnecting cordportion is concerned |
| Energy Used | Radiofrequency ElectricalCurrent | Radiofrequency ElectricalCurrent | Identical |
| OperationPrinciple | Monopolar Electrosurgery | Monopolar Electrosurgery | Identical |
| EquipmentMated | Electrosurgical Generator:Force FX or Force Triad | Electrosurgical Generator:Force FX or Force Triad | Identical |
| Feature | Application Device:Monopolar Cord(K193004) | Predicate Device:New Deantronics Foot ControlPencil (K982749) | Pertinence of Featureto Consideration ofSubstantialEquivalence. |
| RequiredAdapter | New Deantronics AG001adapter or Covidien E0502Series or E0017 adapter. | New Deantronics AG001adapter or Covidien E0502Series or E0017 adapter. | Identical |
| Design -Mechanism | |||
| Control Type | Foot Control | Foot Control | Identical |
| ActivationMechanism | Foot Switch | Foot Switch | Identical |
| Cable Set Length | 10 ft | 10 ft | Identical |
| ESU: banana lead with adapter | ESU: banana lead with adapter | Identical | |
| ConnectionInterface | Active Electrode: None.Designed to connect withmonopolar instruments withshrouded 2.5 mm femaleelectrical connections. | Active Electrode: StandardBlade | The application deviceis a subset of thepredicate device. |
| Design- Electrical Feature | |||
| Electrical Safety | Withstand 3.3kVp for HighFrequency breakdownWithstand 3.3kVp AC at MainFrequency (60Hz) breakdown | Withstand 3.3kVp for HighFrequency breakdownWithstand 3.3kVp AC at MainFrequency (60Hz) breakdown | Identical |
| Design- Material | |||
| Handle | N/A | ABS | Different |
| Insulation: PE | Insulation: PE | ||
| Cable | Colorant: Blue, PMS300 | Colorant: Blue, PMS300 | Identical |
| Wire: Copper | Wire: Copper | ||
| GeneratorConnector (pintip) | ESU: Brass | ESU: Brass | Identical |
| Active ElectrodeConnector | LDPE / Nickel plated brass | N/A | Different |
| Other Attributes | |||
| Single Use orReusable | Single use | Single use | Identical |
| Sterilization | Gamma (VDmax25) | Gamma (VDmax25) | Identical |
| Performance/Electrical SafetyTesting in | IEC 60601-1: 2005 +AM1:2012IEC 60601-1-2: 2014 | AAMI HF-18:1993 | Application device inconformance withlatest version of thelisted Standards |
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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 middle. The word "DEANTRONICS" is in blue and is to the right of the circle.
New Deantronics concludes that the devices are substantially equivalent.
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Image /page/6/Picture/0 description: The image shows the logo for New Deantronics. The word "NEW" is in a blue outlined font. To the right of the word "NEW" is a blue circle with a red dot in the center. To the right of the circle is the word "DEANTRONICS" in a bold blue font.
F. Summary of Supporting Data
A summary of the bench testing and electrical safety testing is presented on the next page.
Electrical safety testing and bench testing has demonstrated that the performance of the Monopolar Cord meets the requirements of its pre-defined acceptance criteria and intended uses. The results of the non-clinical testing demonstrate that the Monopolar Cord is as safe and effective as the predicate device.
Summary Tables of Supporting Data
Performance Data for FDA Guidance for Reviewer of Electrosurgical Device for General Surgery, issued on August 15, 2016 Method of Scope (major Verification: Specification Name or Pass / Item component or Standard (list), Comments Description or Test Purpose Fail? system) Testing Method or Audit Provide graphical display of the This submission is not A ESU --output waveform an ESU. This submission is an Active Accessory and Connector pull Pass has demonstrated the force risks associated with mechanical failure and short circuit is 0.26kg Dynamic Pass Perform mechanical testing of minimized by Strain Relief electrosurgical instruments to mechanical testing Active Component / B minimize the risks associated before and after transit. Accessorv with mechanical failure and The mechanical testing 10 Pound Static short circuit includes anchorage test Pass Strain Relief and connector pull force. Also, this submission covers the devices intended to be Anchorage Test Pass single used rather than re-used. This submission does C Neutral Electrodes Perform the following testing not include a Neutral ---Electrode The Monopolar Cord is Miscellaneous an Active Component Meet the design and D Components / ーー instead of performance specifications Accessories Miscellaneous Component
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Image /page/7/Picture/0 description: The image shows the logo for New Deantronics. The word "NEW" is in blue, followed by a blue circle with a red dot in the center. The word "DEANTRONICS" is in blue and to the right of the circle. The logo is simple and professional.
Monopolar Cord K193004: Traditional Premarket Notification
| Item | Scope (majorcomponent orsystem) | Specification Name orDescription or Test Purpose | Method ofVerification:Standard (list),Testing Methodor Audit | Pass /Fail? | Comments |
|---|---|---|---|---|---|
| E | |||||
| E.1 | Thermal Effects onTissue | Active component or electrodeshould demonstrate themeasurement of the size of thethermal damage zone | -- | - | This submission does notinclude an ActiveElectrode. This accessoryis not intended to createthermal damage by itself. |
| E.2 | TemperatureMonitoring | The temperature sensing undersimulated conditions meetsdesign specification andperformance requirements | -- | - | This submission does notintend to include anytemperature sensingcapability. |
| E.3 | CQM and/orContinuityMonitoring | Test to demonstrate the CQMand/or continuity monitoringfeatures work as intended. | -- | - | This is the requirement forESU and NeutralElectrodes. This submissiondoes not include both ofthese components. |
| E.4 | Capacitive Coupling | For minimally invasive surgeryapplication, test for activecoupling resistance between thesubject device and a conductivecannula/trocar device undersimulated normal use condition. | -- | - | This device is not forminimally invasive surgeryapplication. |
The following table summarizes the electrical safety tests performed and test results. Some listed here are repeated from the Guidelines table above. The results demonstrated that the Monopolar Cord is safe for its intended use and supports a finding of substantial equivalence with the predicate device.
| Standard Used forTesting Protocol | Specific Clause inStandard used forTesting Protocol | Test Description | Results |
|---|---|---|---|
| (General Mfr Requirement) | Visual Inspection | PASS | |
| (General Mfr Requirement) | Continuity test | PASS | |
| IEC 60601-1:2005+AM1:2012 | 15.3.4.1 | Drop Test (preconditioning) | PASS |
| IEC 60601-1:2005+AM1:2012 | 8.10.2 | Cable pull force from Terminal Pin | PASS |
| 0.26kg Dynamic Strain Relief | PASS | ||
| 10 Pound Static Strain Relief | PASS | ||
| IEC 60601-2-2:2017 | 201.8.10.4.2 | Anchorage Test | PASS |
| IEC 60601-2-2:2017 | 201.8.8.3.102 | HF Leakage Current Test | PASS |
| IEC 60601-2-2:2017 | 201.8.8.3.103 | High Frequency Dielectric Test | PASS |
| IEC 60601-2-2:2017 | 201.8.8.3.104 | Hi-Pot Test | PASS |
| Mains Frequency DielectricStrength Test | PASS | ||
| IEC 60601-2-2:2017 | 201.15.4.1 | Connector pull force | PASS |
| IEC 60601-2-2:2017 | 201.17202 | EMC Test | PASS |
Monopolar Cord Electrical Testing
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Image /page/8/Picture/0 description: The image shows the logo for New Deantronics. The word "NEW" is in blue outlined letters. To the right of the word "NEW" is a blue letter "D" with a red circle in the middle. The word "DEANTRONICS" is in blue and to the right of the letter "D".
The transit test was to define the product ship testing requirements and package and product performance after ship testing. The Package system performance testing per ASTM D4169 met the acceptance criteria. The results demonstrate that the Monopolar Cord is functional and remains in the sterile barrier after shipping transportation.
G. Conclusion
After comparing the Indications for Use, technology and design of the Monopolar Cord, along with all electrical safety (including IEC 60601-1: 2005 + AM1:2012; IEC 60601-1-2: 2014; IEC 60601-2-2: 2017) and performance testing, in accordance with the FDA's guidelines and FDArecognized consensus standards for electrical safety, New Deantronics concludes that the Monopolar Cord is substantially equivalent to the predicate New Deantronics Foot Control Pencil (K982749).
§ 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.