(35 days)
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.
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.
The provided document is a 510(k) premarket notification for a medical device: the New Deantronics Trigger Switch and Cord. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the device meets novel acceptance criteria for an AI/ML powered device.
Therefore, many of the specific questions you've asked (e.g., sample size for test set, number of experts for ground truth, MRMC study, sample size for training set, how ground truth for training set was established, effect size of human readers improving with AI) are not applicable to this document. This document deals with electrosurgical accessories, which are hardware devices, not software or AI-driven systems.
However, I can extract information related to the acceptance criteria and study that does apply to this electrosurgical accessory, focusing on performance and safety testing against established standards and the predicate device.
Here's the information extracted from the document, tailored to the context of a hardware medical device and addressing the relevant parts of your request:
Acceptance Criteria and Device Performance for New Deantronics Trigger Switch and Cord
This document (K200455) is a 510(k) premarket notification for a traditional medical device (electrosurgical accessory), not an AI-powered one. Therefore, the "acceptance criteria" and "study" are focused on demonstrating the device's safety and effectiveness and its substantial equivalence to a predicate device through engineering and performance testing, rather than clinical efficacy studies with human readers or AI algorithm performance.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily defined by adherence to recognized international and domestic standards for electrosurgical devices, as well as meeting predefined performance thresholds in mechanical and electrical tests. Performance is reported as "Pass" or "Fail" for each test.
| Acceptance Criteria (Specification/Test Purpose) | Standard/Method of Verification | Reported Device Performance | Comments |
|---|---|---|---|
| Minimize risks associated with mechanical failure and short circuit (Electrosurgical instruments mechanical testing) | Connector pull force | Pass | Minimizes risks by mechanical testing before and after transit. |
| 0.26kg Dynamic Strain Relief | Pass | ||
| 10 Pound Static Strain Relief | Pass | ||
| Anchorage Test | Pass | ||
| Visual Inspection | (General Requirement) | PASS | |
| Continuity test | (General Requirement) | PASS | |
| Drop Test (preconditioning) | IEC 60601-1:2005+ AM1:2012 (Clause 15.3.4.1) | 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 | IEC 60601-2-2:2017 | PASS | |
| Fluid Ingress Test | IEC 60601-2-2:2017 (Clause 201.11.6.5) | PASS | |
| EMC Test | IEC 60601-2-2:2017 (Clause 201.17, 202) | PASS | |
| Package and product performance criteria after ship testing | ASTM D4169 (Transit test) | Met Acceptance Criteria | Results demonstrate that the device and sterile packaging are functional after shipping transportation. |
2. Sample Size Used for the Test Set and Data Provenance
This document does not specify exact sample sizes for each bench test conducted. The testing described is primarily bench testing (engineering and electrical safety tests), not human subject clinical trials. The data provenance is internal testing performed by New Deantronics Taiwan, Ltd. and its contractors. The studies are prospective in the sense that they were conducted for this premarket submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
Not applicable in the context of an AI/ML device. For this hardware device, "ground truth" is established by adherence to recognized engineering standards (e.g., IEC, ASTM) and predefined physical and electrical specifications. The expertise would lie in the engineers and technicians performing and verifying the tests in accordance with these standards.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like "2+1" or "3+1" are relevant for clinical endpoints adjudicated by multiple experts, typically in clinical trials. For bench testing, test results are typically objective measurements against a Pass/Fail criterion.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. MRMC studies are specific to evaluating diagnostic accuracy and reader performance, commonly used for imaging AI. This device is an electrosurgical accessory, not a diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a hardware accessory and does not contain an algorithm in the sense of an AI/ML model. Its performance is evaluated through physical and electrical tests.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is the engineering specifications and safety standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, ASTM D4169) to which the device must conform to be considered safe and effective. It's based on established physical and electrical properties, not clinical outcomes or expert consensus on a medical condition.
8. The Sample Size for the Training Set
Not applicable. This device is a hardware accessory, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. As the device is not an AI/ML model, there is no training set or ground truth associated with it in that context.
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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.
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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); 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
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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 DistrictNew Taipei City 236, 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 accessoryTrigger 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 Switchand Cord (Catalog No. LC002) | Predicate Device:Valleylab, Inc. Trigger Switchand Cord (K970140) | Pertinence of Featureto Consideration ofSubstantialEquivalence. |
|---|---|---|---|
| Indications forUse | The Trigger Switch and Cord areaccessories that are intendedforinmonopolaruselaparoscopic and thoracoscopicelectrosurgicalprocedureshandswitchingofwherelaparoscopic and thoracoscopicinstruments is desired. | The Trigger Switch and Cordaccessories are intended for usein monopolar laparoscopic andthoracoscopic electrosurgicalprocedures wherehandswitching of laparoscopicand thoracoscopic instruments,such as scissors and graspers, isdesired. | Identical, except forgrammatical changes,and specific examplesof instruments weredropped asunnecessary. |
| Product Code | GEI | GEI | Identical |
| Feature | Application Device:New Deantronics Trigger Switchand Cord (Catalog No. LC002) | Predicate Device:Valleylab, Inc. Trigger Switchand Cord (K970140) | Pertinence of Featureto Consideration ofSubstantialEquivalence. |
| Technology | |||
| Mechanism ofStandardElectrosurgery | The Trigger Switch and Cord isdesigned to connect anelectrosurgical generator with amonopolar instrument. Whenelectrosurgery is activated byTrigger Switch, theelectrosurgical energy will bedelivery from electrosurgicalgenerator through the Cord andto the electrode, to coagulate insurgical procedures. | The Trigger Switch and Cord isdesigned to connect anelectrosurgical generator with amonopolar instrument. Whenelectrosurgery is activated byTrigger Switch, theelectrosurgical energy will bedelivery from electrosurgicalgenerator through the Cord andto the electrode, to coagulate insurgical procedures. | Identical |
| 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 |
| Design -Mechanism | |||
| Control Type | Hand Control | Hand Control | Identical |
| Cord SetLength | Trigger Cord: 10 ftTrigger Switch: 0.5 ft. | Trigger Cord: 10 ftTrigger Switch: 0.5 ft. | Identical |
| Design- Material | |||
| Cable | Insulation: PVC | Insulation: PVC | Identical |
| Wire: Copper (24 AWG) | Wire: Copper (24 AWG) | ||
| Generatorconnector | Brass, nickel-plated femalecontact terminal with PVCovermold. | Identical | Identical |
| Monopolarinstrumentconnector | Brass, nickel-plated femalecontact terminal with PVCovermold. 4mm femaleconnector | Identical | Identical |
| Other Attributes | |||
| Single Use orReusable | Single use | Single use | Identical |
| Sterilized | Yes | Yes | Identical |
| Performance/Safety Testingin accordancewith | IEC 60601-1:2005+A1:2012IEC 60601-1-2:2014IEC 60601-2-2:2017Premarket Notification (510(k))Submissions for ElectrosurgicalDevices for General Surgery:Guidance for Industry and Foodand Drug Administration Staff | IEC 601-1:1988IEC 601-2-2:1991AAMI 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 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 (majorcomponent orsystem) | Specification Nameor Description orTest Purpose | Method ofVerification: Standard(list), Testing Methodor Audit | Pass /Fail? | Comments |
|---|---|---|---|---|---|
| B | ActiveComponent/Accessory | Perform mechanicaltesting ofelectrosurgicalinstruments tominimize the risksassociated withmechanical failureand short circuit | Connector pull force | Pass | This submission is an ActiveAccessory and has demonstratedthe risks associated withmechanical failure and shortcircuit is minimized bymechanical testing before andafter transit. The mechanicaltesting includes anchorage testand connector pull force. Also,this submission covers thedevices intended to be singleused rather than re-used. |
| 0.26kg DynamicStrain Relief | Pass | ||||
| 10 Pound StaticStrain 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 TestingProtocol | Specific Clause inStandard used forTesting 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 | |
| 201.17202 | 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).
§ 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.