(52 days)
Not Found
No
The device description and performance studies focus on electrical safety and bench testing of a simple electrical cord, with no mention of AI/ML capabilities or data processing.
Yes.
The device is used to cut tissue and control bleeding using high-frequency electrical current, which are therapeutic actions.
No
Explanation: The device description clearly states its purpose is to "cut tissue and control bleeding by use of high-frequency electrical current." This is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is a "Monopolar Cord, sold as sterile packaged, and ready for use devices" and describes its physical connection and function in delivering electrical current, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Monopolar Cord is used during a surgical procedure to deliver high-frequency electrical current directly to tissue within the body for cutting and coagulation. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for "cutting tissue and control bleeding by use of high-frequency electrical current," which is an in-vivo (within the body) procedure.
Therefore, the function and intended use of the Monopolar Cord align with a surgical accessory used in an in-vivo procedure, not an in-vitro diagnostic test.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
These devices can be used in hospitals and are used by trained professionally only.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
New Deantronics Foot Control Pencil (K982749)
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.
Not Found
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).
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image 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.
1
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
2
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) 2-2268-1726 | |
| Fax: (886) 2-2268-3800 | |
| Sponsor Contact: Ms. Jane Liu, President | |
| Email: jane@newdean.com.tw | |
| Correspondent Contact | |
| Information: | Mr. Craig Coombs |
| President | |
| Coombs Medical Device Consulting | |
| 1100 Pacific Marina, Suite 806 | |
| Alameda, CA 94501 | |
| Tel: 510-995-8499 | |
| Email: CraigJCoombs@gmail.com | |
| Device Common Name: | Electrosurgical accessory |
| Monopolar 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 878.4400 |
| Electrosurgical, Cutting & Coagulation | |
| Device 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 Control
Pencil (K982749) | Pertinence of Feature
to Consideration of
Substantial
Equivalence. |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | Electrosurgical accessory. A
foot activated electrosurgical
pencil is intended to remove
tissue and control bleeding by
use of high-frequency electrical
current. | The Indications for Use
of the application and
predicate devices are
the same; both devices
are for use in standard
cutting or coagulation.
The application device
does not include an
attached electrode, so
the specific action of
the electrode is
omitted. |
| Product Code | GEI | GEI | Identical |
| Technology | | | |
| Mechanism of
Standard
Electrosurgery | The Monopolar Cord is
designed to connect a
electrosurgical generator with
an RF electrode. When
electrosurgery is activated by
foot pedal, the electrosurgical
energy will be delivery from
electrosurgical generator
through the Cord and to the
electrode, to cut or coagulate in
surgical procedures | The Foot Control Pencil is
designed to connect with
electrosurgical generator. When
electrosurgery is activated by
foot pedal, the electrosurgical
energy will be delivery from
electrosurgical generator
through the cord and to the
electrode, to cut or coagulate in
surgical procedures | Identical as far as the
connecting cord
portion is concerned |
| Energy Used | Radiofrequency Electrical
Current | Radiofrequency Electrical
Current | Identical |
| Operation
Principle | Monopolar Electrosurgery | Monopolar Electrosurgery | Identical |
| Equipment
Mated | 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 Control
Pencil (K982749) | Pertinence of Feature
to Consideration of
Substantial
Equivalence. |
| Required
Adapter | New Deantronics AG001
adapter or Covidien E0502
Series or E0017 adapter. | New Deantronics AG001
adapter or Covidien E0502
Series or E0017 adapter. | Identical |
| Design -Mechanism | | | |
| Control Type | Foot Control | Foot Control | Identical |
| Activation
Mechanism | Foot Switch | Foot Switch | Identical |
| Cable Set Length | 10 ft | 10 ft | Identical |
| | ESU: banana lead with adapter | ESU: banana lead with adapter | Identical |
| Connection
Interface | Active Electrode: None.
Designed to connect with
monopolar instruments with
shrouded 2.5 mm female
electrical connections. | Active Electrode: Standard
Blade | The application device
is a subset of the
predicate device. |
| Design- Electrical Feature | | | |
| Electrical Safety | Withstand 3.3kVp for High
Frequency breakdown
Withstand 3.3kVp AC at Main
Frequency (60Hz) breakdown | Withstand 3.3kVp for High
Frequency breakdown
Withstand 3.3kVp AC at Main
Frequency (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 | |
| Generator
Connector (pin
tip) | ESU: Brass | ESU: Brass | Identical |
| Active Electrode
Connector | LDPE / Nickel plated brass | N/A | Different |
| Other Attributes | | | |
| Single Use or
Reusable | Single use | Single use | Identical |
| Sterilization | Gamma (VDmax25) | Gamma (VDmax25) | Identical |
| Performance/
Electrical Safety
Testing in | IEC 60601-1: 2005 +
AM1:2012
IEC 60601-1-2: 2014 | AAMI HF-18:1993 | Application device in
conformance with
latest version of the
listed 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 (major
component or
system) | Specification Name or
Description or Test Purpose | Method of
Verification:
Standard (list),
Testing Method
or Audit | Pass /
Fail? | Comments |
|------|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|-----------------|--------------------------------------------------------------------------------------------------------------------------------------|
| E | | | | | |
| E.1 | Thermal Effects on
Tissue | Active component or electrode
should demonstrate the
measurement of the size of the
thermal damage zone | -- | - | This submission does not
include an Active
Electrode. This accessory
is not intended to create
thermal damage by itself. |
| E.2 | Temperature
Monitoring | The temperature sensing under
simulated conditions meets
design specification and
performance requirements | -- | - | This submission does not
intend to include any
temperature sensing
capability. |
| E.3 | CQM and/or
Continuity
Monitoring | Test to demonstrate the CQM
and/or continuity monitoring
features work as intended. | -- | - | This is the requirement for
ESU and Neutral
Electrodes. This submission
does not include both of
these components. |
| E.4 | Capacitive Coupling | For minimally invasive surgery
application, test for active
coupling resistance between the
subject device and a conductive
cannula/trocar device under
simulated normal use condition. | -- | - | This device is not for
minimally invasive surgery
application. |
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 for
Testing Protocol | Specific Clause in
Standard used for
Testing 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 Dielectric
Strength Test | PASS |
| IEC 60601-2-2:2017 | 201.15.4.1 | Connector pull force | PASS |
| IEC 60601-2-2:2017 | 201.17
202 | 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).