(35 days)
Not Found
No
The device description and performance studies focus on basic electrical and mechanical functionality, with no mention of AI or ML. The device is a simple electrical switch and cord.
No
The device is an accessory (switch and cord) for electrosurgical procedures, providing an electrical path from a generator to an electrode. While used in therapeutic procedures, the device itself is not performing a therapeutic function but rather facilitating the control of a therapeutic device (the electrosurgical generator and electrode).
No
The device is an accessory to an electrosurgical generator, providing an electrical path and allowing hand switching of current. It is used for therapeutic electrosurgical procedures, not for diagnosing conditions.
No
The device description clearly states it is an electrical connecting cord assembly with a physical trigger switch, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "monopolar laparoscopic and thoracoscopic electrosurgical procedures where handswitching of laparoscopic instruments is desired." This describes a surgical accessory used during a medical procedure on a patient.
- Device Description: The device is an "electrical connecting cord assembly" that provides an electrical path between an electrosurgery generator and a surgical electrode. It allows for hand switching of the electrical current. This is a tool used in surgery.
- Lack of IVD Characteristics: IVD devices are used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with patient specimens in this way. It is a surgical tool.
Therefore, the Trigger Switch and Cord is a surgical accessory, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Trigger Switch and Cord are accessories that are intended for use in monopolar laparoscopic and thoracoscopic electrosurgical procedures where handswitching of laparoscopic and thoracoscopic instruments is desired.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Trigger Switch and Cord are an electrical connecting cord assembly, intended to provide an electrical path between an RF electrosurgery generator and an RF surgical electrode. The insulated wire of the Cord is 10ft long. The Cord is intended to be plugged into an in-line Trigger Switch which is attached to the RF electrode handle with an adhesive backing. The Trigger Switch allows hand switching of the electrical current through the Cord during surgery. These devices can be used in hospitals and are used by trained professionals only.
The Trigger Switch and Cord are compatible with the monopolar instruments with a shrouded 4mm male electrical connector and with an electrosurgical generator.
Typically, these application devices are used in place of foot switches in the flow of electrosurgical current to the target site.
These devices are sold as sterile, single-use devices.
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
used by trained professionals only.
used in hospitals
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 New Deantronics Trigger Switch and Cord meet the requirements of its pre-defined acceptance criteria and intended uses. The results of the non-clinical testing demonstrate that the Trigger Switch and 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
Only Item B, Active Component/Accessory is applicable
Scope (major component or system): Active Component/Accessory
Specification Name or Description or Test Purpose: Perform mechanical testing of electrosurgical instruments to minimize the risks associated with mechanical failure and short circuit
Method of Verification: Standard (list), Testing Method or Audit: Connector pull force, 0.26kg Dynamic Strain Relief, 10 Pound Static Strain Relief, Anchorage Test
Pass / Fail?: Pass for all
Comments: This submission is an Active Accessory and has demonstrated the risks associated with mechanical failure and short circuit is minimized by mechanical testing before and after transit. The mechanical testing includes anchorage test and connector pull force. Also, this submission covers the devices intended to be single used rather than re-used.
The following table summarizes the tests performed and test results. Some listed here are repeated from the Guidelines table above. The results demonstrated that the Trigger Switch and Cord is safe for its intended use and supports a finding of substantial equivalence with the predicate device.
Standard Used for Testing Protocol: (General Requirement)
Specific Clause in Standard used for Testing Protocol: Not specified
Test Item: Visual Inspection, Continuity test
Results: PASS for both
Standard Used for Testing Protocol: IEC 60601-1:2005+ AM1:2012
Specific Clause in Standard used for Testing Protocol: 15.3.4.1, 8.10.2
Test Item: Drop Test (preconditioning), 0.26kg Dynamic Strain Relief, 10 Pound Static Strain Relief
Results: PASS for all
Standard Used for Testing Protocol: IEC 60601-2-2:2017
Specific Clause in Standard used for Testing Protocol: 201.8.10.4.2, 201.8.8.3.102, 201.8.8.3.103, 201.8.8.3.104, 201.11.6.5, 201.17, 202
Test Item: Anchorage Test, HF Leakage Current Test, High Frequency Dielectric Test, Hi-Pot Test, Mains Frequency Dielectric Strength Test, Fluid Ingress Test, EMC Test
Results: PASS for all
A transit test validated achievement of the package and product performance criteria after ship testing. The package system performance testing per ASTM D4169 met the acceptance criteria. The results demonstrate that the device and sterile packaging is functional 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.
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 contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the agency's name written out in a smaller font next to it.
March 31, 2020
New Deantronics Taiwan, Ltd. % Mr. Craig Coombs President Coombs Medical Device Consulting, Inc 1100 Pacific Marina, Suite 806 Alameda, California 94501
Re: K200455
Trade/Device Name: Trigger Switch and Cord Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: February 21, 2020 Received: February 25, 2020
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.
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200455
Device Name Trigger Switch and Cord
Indications for Use (Describe)
The Trigger Switch and Cord are accessories that are intended for use in monopolar laparoscopic and thoracoscopic electrosurgical procedures where handswitching of laparoscopic instruments is desired.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for New Deantronics. The word "NEW" is in blue, and next to it is a blue circle with a red dot in the center. The word "DEANTRONICS" is in blue and is to the right of the circle.
Section 5: 510(k) Summary
A. Device Information:
| Category | Comments |
|---|---|
| Sponsor: | New Deantronics Taiwan Ltd. |
| 12F., No.51, Sec. 4, Zhongyang Rd., | |
| TuCheng District | |
| New Taipei City 236, 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 |
| Trigger Switch and Cord | |
| Device Classification Number: | 21 CFR 878.4400 |
| Device Classification & | |
| Product Code: | Class 2, |
| GEI | |
| Device Proprietary Name: | Trigger Switch and Cord |
Predicate Device Information:
| Predicate Device: | Trigger Switch and Cord |
|---|---|
| Predicate Device Manufacturer: | Valleylab, Inc. |
| Predicate Device Common Name: | Electrosurgical accessory |
| Predicate Device Premarket Notification # | K970140 |
| 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
20 March 2020
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Image /page/4/Picture/1 description: The image shows the logo for New Deantronics. The logo features the word "NEW" stacked on top of a stylized letter "O" with a red dot in the center. To the right of the "O" is the word "DEANTRONICS" in a bold, sans-serif font. The logo is primarily blue in color.
C. Description of Device
The Trigger Switch and Cord are an electrical connecting cord assembly, intended to provide an electrical path between an RF electrosurgery generator and an RF surgical electrode. The insulated wire of the Cord is 10ft long. The Cord is intended to be plugged into an in-line Trigger Switch which is attached to the RF electrode handle with an adhesive backing. The Trigger Switch allows hand switching of the electrical current through the Cord during surgery. These devices can be used in hospitals and are used by trained professionals only.
The Trigger Switch and Cord are compatible with the monopolar instruments with a shrouded 4mm male electrical connector and with an electrosurgical generator.
Typically, these application devices are used in place of foot switches in the flow of electrosurgical current to the target site.
These devices are sold as sterile, single-use devices.
D. Indications for Use
The Trigger Switch and Cord are accessories that are intended for use in monopolar laparoscopic and thoracoscopic electrosurgical procedures where handswitching of laparoscopic and thoracoscopic instruments is desired.
E. Comparison to Predicate Device
As described below, the application New Deantronics Trigger Switch and Cord is substantially equivalent in intended use, technology, design and physician use to the predicate Valleylab, Inc. Trigger Switch and Cord (K970140).
| Feature | Application Device:
New Deantronics Trigger Switch
and Cord (Catalog No. LC002) | Predicate Device:
Valleylab, Inc. Trigger Switch
and Cord (K970140) | Pertinence of Feature
to Consideration of
Substantial
Equivalence. |
|---------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The Trigger Switch and Cord are
accessories that are intended
for
in
monopolar
use
laparoscopic and thoracoscopic
electrosurgical
procedures
handswitching
of
where
laparoscopic and thoracoscopic
instruments is desired. | The Trigger Switch and Cord
accessories are intended for use
in monopolar laparoscopic and
thoracoscopic electrosurgical
procedures where
handswitching of laparoscopic
and thoracoscopic instruments,
such as scissors and graspers, is
desired. | Identical, except for
grammatical changes,
and specific examples
of instruments were
dropped as
unnecessary. |
| Product Code | GEI | GEI | Identical |
| Feature | Application Device:
New Deantronics Trigger Switch
and Cord (Catalog No. LC002) | Predicate Device:
Valleylab, Inc. Trigger Switch
and Cord (K970140) | Pertinence of Feature
to Consideration of
Substantial
Equivalence. |
| Technology | | | |
| Mechanism of
Standard
Electrosurgery | The Trigger Switch and Cord is
designed to connect an
electrosurgical generator with a
monopolar instrument. When
electrosurgery is activated by
Trigger Switch, the
electrosurgical energy will be
delivery from electrosurgical
generator through the Cord and
to the electrode, to coagulate in
surgical procedures. | The Trigger Switch and Cord is
designed to connect an
electrosurgical generator with a
monopolar instrument. When
electrosurgery is activated by
Trigger Switch, the
electrosurgical energy will be
delivery from electrosurgical
generator through the Cord and
to the electrode, to coagulate in
surgical procedures. | Identical |
| 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 |
| Design -Mechanism | | | |
| Control Type | Hand Control | Hand Control | Identical |
| Cord Set
Length | Trigger Cord: 10 ft
Trigger Switch: 0.5 ft. | Trigger Cord: 10 ft
Trigger Switch: 0.5 ft. | Identical |
| Design- Material | | | |
| Cable | Insulation: PVC | Insulation: PVC | Identical |
| | Wire: Copper (24 AWG) | Wire: Copper (24 AWG) | |
| Generator
connector | Brass, nickel-plated female
contact terminal with PVC
overmold. | Identical | Identical |
| Monopolar
instrument
connector | Brass, nickel-plated female
contact terminal with PVC
overmold. 4mm female
connector | Identical | Identical |
| Other Attributes | | | |
| Single Use or
Reusable | Single use | Single use | Identical |
| Sterilized | Yes | Yes | Identical |
| Performance/
Safety Testing
in accordance
with | IEC 60601-1:2005+A1:2012
IEC 60601-1-2:2014
IEC 60601-2-2:2017
Premarket Notification (510(k))
Submissions for Electrosurgical
Devices for General Surgery:
Guidance for Industry and Food
and Drug Administration Staff | IEC 601-1:1988
IEC 601-2-2:1991
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 logo has the word "NEW" in a smaller font on the left side of a blue circle with a red dot in the center. The word "DEANTRONICS" is in a larger blue font on the right side 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 black font and is located to the left of a blue circle with a red dot in the center. The word "DEANTRONICS" is in blue font and is located to the right of the circle. The logo is simple and professional.
F. Summary of Supporting Data
Electrical safety testing and bench testing has demonstrated that the performance of New Deantronics Trigger Switch and Cord meet the requirements of its pre-defined acceptance criteria and intended uses. The results of the non-clinical testing demonstrate that the Trigger Switch and 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
Only Item B, Active Component/Accessory is applicable
| ltem | Scope (major
component or
system) | Specification Name
or Description or
Test Purpose | Method of
Verification: Standard
(list), Testing Method
or Audit | Pass /
Fail? | Comments |
|------|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| B | Active
Component/
Accessory | Perform mechanical
testing of
electrosurgical
instruments to
minimize the risks
associated with
mechanical failure
and short circuit | Connector pull force | Pass | This submission is an Active
Accessory and has demonstrated
the risks associated with
mechanical failure and short
circuit is minimized by
mechanical testing before and
after transit. The mechanical
testing includes anchorage test
and connector pull force. Also,
this submission covers the
devices intended to be single
used rather than re-used. |
| | | | 0.26kg Dynamic
Strain Relief | Pass | |
| | | | 10 Pound Static
Strain Relief | Pass | |
| | | | Anchorage Test | Pass | |
The following table summarizes the tests performed and test results. Some listed here are repeated from the Guidelines table above. The results demonstrated that the Trigger Switch and 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 Item | Results |
|---------------------------------------|-------------------------------------------------------------|------------------------------------------|---------|
| (General Requirement) | | Visual Inspection | PASS |
| | | Continuity test | PASS |
| IEC 60601-1:2005+ AM1:2012 | 15.3.4.1 | Drop Test (preconditioning) | PASS |
| | 8.10.2 | 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 |
| | 201.8.8.3.102 | HF Leakage Current Test | PASS |
| | 201.8.8.3.103 | High Frequency Dielectric Test | PASS |
| | 201.8.8.3.104 | Hi-Pot Test | PASS |
| | | Mains Frequency Dielectric Strength Test | PASS |
| | 201.11.6.5 | Fluid Ingress Test | PASS |
| | 201.17
202 | EMC Test | PASS |
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Image /page/7/Picture/0 description: The image shows the logo for New Deantronics. The word "NEW" is in blue, and 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 easy to read.
A transit test validated achievement of the package and product performance criteria after ship testing. The package system performance testing per ASTM D4169 met the acceptance criteria. The results demonstrate that the device and sterile packaging is functional after shipping transportation.
G. Conclusion
After comparing the Indications for Use, technology and design of the Trigger Switch and 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 FDA-recognized consensus standards for electrical safety, New Deantronics concludes that the Trigger Switch and Cord are substantially equivalent to the predicate Valleylab, Inc. Trigger Switch and Cord (K970140).