(145 days)
The Electrosurgical Generator is an electrosurgical generator containing monopolar and bipolar technology. It is intended for use with accessories during surgical procedures where the surgeon requires electrosurgical cutting and coagulating.
The application device, the Electrosurgical Generator, is a solid state generator designed to supply radiofrequency electrical energy for general electrosurgical purposes, with physical dimensions around 37cm (L) x 29cm (W) x 17cm (H) and 5kg unit weight. The Electrosurgical Generator supplies high frequency electrosurgical power from low power (<30W), medium power (Cut: 30100W, Coag: 3070W), to high power (Cut >100W, Coag>70W). The Electrosurgical Generator outputs high frequency energy in the following modes: 1. Monopolar CUT: Pure Blend 1 Blend 2 2. Monopolar COAG: Pin Point Spray 3. Bipolar: Standard The Electrosurgical Generator can be activated via a hand switch or a foot switch. The Electrosurgical Generator has a Return Electrode Contact Quality Monitor to alert the user when inadequate contact is being made with the Return (aka Neutral) Electrode. The Electrosurgical Generator is mains powered.
This document is a 510(k) premarket notification for an Electrosurgical Generator (Model: ES300) and describes its substantial equivalence to a predicate device, the Covidien Force FX™ Electrosurgical Generator (K143161). The focus of the provided text is on demonstrating the device's adherence to relevant standards and its similarity in function and design to the predicate, rather than providing details of a study with specific acceptance criteria and performance metrics in the format requested.
Therefore, the requested information (acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and MRMC study details) is not explicitly available in the provided text in the detailed format you requested for an AI/device performance study. The document primarily focuses on regulatory compliance through comparison to a predicate device and adherence to established electrical safety and performance standards.
Here's an attempt to extract and infer information based on the provided text, while also noting what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present acceptance criteria and reported device performance in a numerical table for clinical or diagnostic accuracy as would be found in a study for an AI-powered diagnostic device. Instead, "acceptance criteria" are implied by adherence to and compliance with recognized standards and guidelines. "Device performance" is largely described qualitatively and by comparison to the predicate device's established performance.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Indications for Use equivalence | The indications for use are "identical, except specific examples of clinical techniques were dropped as unnecessary." The device is intended for use with accessories during surgical procedures where the surgeon requires electrosurgical cutting and coagulating. |
| Operating Principle equivalence | "Identical" - both devices are radio-frequency (RF) electrosurgical generators delivering energy to compatible surgical instruments to produce heat for cutting and coagulation. |
| Output Configuration equivalence | "Identical" - Isolated. |
| Type (electrical protection) equivalence | "Identical" - CF. |
| Working Theories Monopolar/Bipolar equivalence | "Identical" - monopolar involves a cyclic circuit with an electrosurgical electrode and a neutral pad; bipolar involves a cyclic circuit between two tips of bipolar forceps. |
| Performance Specification (Output Mode, Waveforms) equivalence | Nonclinical differences exist but "have no influence on safety and performance." Both have monopolar CUT, monopolar COAG, and BIPOLAR modes with similar output power and crest factors. Waveforms have "similar shapes" and frequencies above 200 kHz, with "slight differences" due to component parameters, which "have no influence in the actual application process." |
| Safety and Essential Performance (IEC 60601-1) | "Tested and found to be in compliance" with IEC 60601-1: 2005+A1:2012. |
| Electromagnetic Compatibility (IEC 60601-1-2) | "Tested and found to be in compliance" with IEC 60601-1-2: 2014. |
| Particular Requirements for HF Surgical Equipment (IEC 60601-2-2) | "Tested and found to be in compliance" with IEC 60601-2-2: 2017. |
| Medical Device Software Life Cycle Processes (IEC 62304) | "Tested and found to be in compliance" with IEC 62304: 2006+AMD 1:2015. |
| Shipping/Transit Testing (ISTA 3A) | "Tested and found to be in compliance" with ISTA 3A: 2008. |
| Compliance with FDA Guidance | "Fully tested and in compliance with the FDA guideline Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery: Guidance for Industry and Food and Drug Administration Staff (9 March 2020)." |
| Similar Safety Features (Pad Control System, Activation Tones, Alarm Tone) | Pad Control System (CQM) is "identical" to predicate's REM. Activation Tones and Alarm Tone frequencies/number of tones are different but "do not affect device safety and performance." |
2. Sample Size Used for the Test Set and the Data Provenance
This information is not provided in the document. The testing described is primarily related to compliance with electrical, safety, and performance standards for the device itself, rather than a clinical study with a test set of patient data. The provenance of data from such compliance testing would typically be from laboratory settings or engineering evaluations, not patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided. The document describes regulatory compliance and engineering testing, not a study involving expert-established ground truth for a test set of cases.
4. Adjudication Method for the Test Set
This information is not provided. As there's no mention of a clinical test set with ground truth, an adjudication method is not applicable in this context.
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
This information is not provided. The device is an electrosurgical generator, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device and was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. The device is a physical electrosurgical generator, not an algorithm. Performance tests mentioned are for the physical device's electrical outputs and safety features, not standalone algorithmic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the type of device described (an electrosurgical generator), "ground truth" would typically refer to objective measurements and adherence to specified performance parameters defined by engineering standards (e.g., output power within tolerance, impedance monitoring accuracy, alarm functionality). The document indicates that the device was "tested and found to be in compliance" with various IEC standards and FDA guidance, which serve as the "ground truth" or benchmarks for electrical safety and performance.
8. The sample size for the training set
This information is not applicable/not provided. As this is not an AI/machine learning device, there is no "training set" in the computational sense.
9. How the ground truth for the training set was established
This information is not applicable/not provided. There is no training set for this type of device.
In summary: The provided FDA 510(k) summary document focuses on demonstrating substantial equivalence of an electrosurgical generator to a predicate device through adherence to recognized technical standards and comparison of features. It does not contain information about a clinical or diagnostic study with acceptance criteria, sample sizes, expert ground truth, or AI-related performance metrics as requested for an AI/CAD-type device.
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September 28, 2020
New Deantronics Taiwan Ltd. % Craig Coombs President Coombs Medical Device Consulting, Inc. 1100 Pacific Marina, Suite 806 Alameda. California 94501
Re: K201221
Trade/Device Name: Electrosurgical Generator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: September 8, 2020 Received: September 9, 2020
Dear 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); 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201221
Device Name Electrosurgical Generator
Indications for Use (Describe)
The Electrosurgical Generator is an electrosurgical generator containing monopolar and bipolar technology. It is intended for use with accessories during surgical procedures where the surgeon requires electrosurgical cutting and coagulating.
| 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 there 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.
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. | |
| Tel: (886) 2-2268-1726 | |
| Fax: (886) 2-2268-3800 | |
| Sponsor Contact: Ms. Jane Liu, President | |
| Email: jane@newdean.com.tw | |
| Correspondent ContactInformation: | 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 Generator |
| Device Classification Number: | 21 CFR 878.4400 |
| Device Classification &Product Code: | Class II,GEI |
| Device Proprietary Name: | Electrosurgical Generator |
Predicate Device Information:
| Predicate Device: | Force FX™ electrosurgical generators |
|---|---|
| Predicate Device Manufacturer: | Covidien (formerly Valleylab, Inc.) |
| Predicate Device Common Name: | Electrosurgical Generator |
| Predicate Device Premarket Notification #: | K143161 |
| Predicate Device Classification: | 21 CFR 878.4400Electrosurgical, Cutting & CoagulationDevice and Accessories |
| Predicate Device Classification &Product Code: | Class 2,GEI |
B. Date Summary Prepared
4 May 2020
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C. Description of Device
The application device, the Electrosurgical Generator, is a solid state generator designed to supply radiofrequency electrical energy for general electrosurgical purposes, with physical dimensions around 37cm (L) x 29cm (W) x 17cm (H) and 5kg unit weight.
The Electrosurgical Generator supplies high frequency electrosurgical power from low power (<30W), medium power (Cut: 30100W, Coag: 3070W), to high power (Cut >100W, Coag>70W).
The Electrosurgical Generator outputs high frequency energy in the following modes:
-
- Monopolar CUT: Pure Blend 1 Blend 2
-
- Monopolar COAG: Pin Point Spray
-
- Bipolar: Standard
The Electrosurgical Generator can be activated via a hand switch or a foot switch.
The Electrosurgical Generator has a Return Electrode Contact Quality Monitor to alert the user when inadequate contact is being made with the Return (aka Neutral) Electrode.
The Electrosurgical Generator is mains powered.
D. Indications for Use
The Electrosurgical Generator is an electrosurgical generator containing monopolar and bipolar technology. It is intended for use with accessories during surgical procedures where the surgeon requires electrosurgical cutting and coagulating.
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E. Comparison to Predicate Device
| Feature | Application Device:Electrosurgical Generator(Model: ES300, K201221) | Predicate:Covidien Force FXTMElectrosurgical Generator(K143161) | Pertinence of Feature toConsideration ofSubstantial Equivalence |
|---|---|---|---|
| Indications forUse | The ElectrosurgicalGenerator is anelectrosurgical generatorcontaining monopolar andbipolar technology. It isintended for use withaccessories during surgicalprocedures where thesurgeon requireselectrosurgical cutting andcoagulating. | The Force FX™ ElectrosurgicalGenerator is anelectrosurgical generatorcontaining monopolar andbipolar technology. It isintended for use withaccessories during surgicalprocedures where the surgeonrequires electrosurgical cutting(resecting, dividing, orseparating) and coagulating(hemostasis). | Identical, except specificexamples of clinicaltechniques were droppedas unnecessary. |
| FDA ProductCode | GEI | GEI | Identical |
| OperatingPrinciple | The ElectrosurgicalGenerator is a radio-frequency (RF)electrosurgical generatorthat delivers energy tocompatible surgicalinstruments. Theconcentration of energy atthe tip of the instrument inconjunction with tissuecharacteristics producesheat. The heating of tissueprovides the desired surgicaleffect (cutting, coagulation).Variations in the waveformresult in the differentsurgical effects achieved bydifferent modes. | The Force FXTM is a radio-frequency (RF) electrosurgicalgenerator that delivers energyto compatible surgicalinstruments. The concentrationof energy at the tip of theinstrument in conjunction withtissue characteristics producesheat. The heating of tissueprovides the desired surgicaleffect (cutting, coagulation).Variations in the waveformresult in the different surgicaleffects achieved by differentmodes. | Identical |
| Input Power | 100 - 240 V | 100 - 240 V | Identical |
| Outputconfiguration | Isolated | Isolated | Identical |
| Type | CF | CF | Identical |
| Working theories | |||
| Monopolar | ESU generator connects itselectrosurgical electrodeaccessories and a neutralpad to form a cyclic circuit,the HF current generatedfrom the generator andthrough the accessory toachieve CUT or COAG, andthen return to generator bythe neutral pad. | ESU generator connects itselectrosurgical accessories anda neutral ESU pad to form acyclic circuit, the HF currentgenerated from the generatorand through the accessory toachieve CUT or COAG, and thenreturn to generator by theneutral pad. | Identical |
| Monopolar | ESU generator connects itselectrosurgical electrodeaccessories and a neutralpad to form a cyclic circuit,the HF current generatedfrom the generator andthrough the accessory toachieve CUT or COAG, andthen return to generator bythe neutral pad. | ESU generator connects itselectrosurgical accessories anda neutral ESU pad to form acyclic circuit, the HF currentgenerated from the generatorand through the accessory toachieve CUT or COAG, and thenreturn to generator by theneutral pad. | Identical |
| Feature | Application Device:Electrosurgical Generator(Model: ES300,K201221) | Predicate:Covidien Force FX™Electrosurgical Generator(K143161) | Pertinence of Feature toConsideration ofSubstantial Equivalence |
| Bipolar | HF current generated fromthe generator and the cycliccircuit formed between thetwo tips of the bipolarforceps, the HF powerthrough the two tips towork on patient obtainingCOAG, no need extra ESUpad. | HF current generated from thegenerator and the cyclic circuitformed between the two tips ofthe bipolar forceps, the HFpower through the two tips towork on patient obtainingCOAG, no need extra ESU pad. | Identical |
| Physical Specification | |||
| Appearance | Image: Electrosurgical Generator (Model: ES300,K201221) | Image: Covidien Force FX Electrosurgical Generator (K143161) | Different, but they do notraise new issues of safetyor effectiveness. |
| Dimensions | 29.5 cm x 37.6 cm x 17.8 cm | 35.6 cm x 35.6 cm x 11.1 cm | |
| and weight | Weight: < 11.68 lb (< 5.3 kg) | Weight: < 18 lb (< 8.2 kg) | |
| Display | One 7.0" high digital display | Eight digital seven-segmentdisplays: 0.75″ high each | |
| Energy | HF energy | HF energy | Identical |
| Performance Specification | |||
| Monopolar CUT:PureBlend 1Blend 2 | Monopolar CUT:Low cutPure cutBlend | ||
| Output mode | Monopolar COAG:Pin pointSpray | Monopolar COAG:Low (Desiccate)Med (Fulgurate)High (Spray) | Nonclinical differences.Both the applicationdevice and predicatedones have monopolarCUT, monopolar COAGand BIPOLAR.Both of them are sinusoid |
| BIPOLAR:Standard | BIPOLAR:Low (Precise)Med (Standard)Macro | as well as a similar outputpower under the sameoutput mode, accordinglywith the similar crestfactor.The small differenceshave no influence onsafety and performance. | |
| Feature | Application Device:Electrosurgical Generator(Model: ES300, K201221) | Predicate:Covidien Force FX™Electrosurgical Generator(K143161) | Pertinence of Feature toConsideration ofSubstantial Equivalence |
| Waveforms -CutWaveforms -CoagWaveforms -Bipolar | Pure CutBlend 1Blend 2 | LowPureBlend | The frequencies areabove 200 kHz, belong toHigh frequency rangebased on IEC60601-2-2requirement; The relatedwaveforms of the ES300and Force FX have similarshapes, slight differencesexist because ofrespective componentparameters, which haveno influence in the actualapplication process. |
| Spray CoagulationPin point Coagulation | DesiccateFulgurateSpray | ||
| Bipolar Coagulation | Low(precise)Med(standard)Macro | ||
| Special Functions | |||
| Pad ControlSystem (PCS) | The Return ElectrodeContact Quality Monitor(CQM) will measure theresistance, if the resistancewas beyond the range ofdefined by an upper andlower limit, the alarmsystem will be activated. | The Return Electrode ContactQuality Monitor (REM) willmeasure the resistance, if theresistance was beyond therange of defined by an upperand lower limit, the alarmsystem will be activated. | Identical |
| Operating | Only one output device tobe activated at any giventime, except for monopolarcoagulation | Only one output device to beactivated at any given time,except for monopolarcoagulation | Identical |
| ActivationTones | Yes | Yes | The frequencies aredifferent, but it does notaffect device safety andperformance |
| Alarm Tone | Yes, Multiple | Yes, Single | The frequencies andnumber of tones aredifferent, but this doesnot affect device safetyand performance |
| Others | |||
| PrincipalOperator | Surgeon | Surgeon | Identical |
| Feature | Application Device:Electrosurgical Generator(Model: ES300, K201221) | Predicate:Covidien Force FX™Electrosurgical Generator(K143161) | Pertinence of Feature toConsideration ofSubstantial Equivalence |
| Performance/Safety Testingin accordancewith | IEC 60601-1: 2005+A1:2012IEC 60601-1-2:2014IEC 60601-2-2:2017Premarket Notification(510(k)) Submissions forElectrosurgical Devices forGeneral Surgery: Guidancefor Industry and Food andDrug Administration Staff (9March 2020) | IEC 60601-1:2005IEC 60601-1-2:2007IEC 60601-2-2:2009 | Both devices weredeveloped with the mostup-to-date IEC 60601standards at the time. |
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Image /page/6/Picture/0 description: The image shows the logo for New Deantronics. The word "NEW" is in blue, and there 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.
Electrosurgical Generator Traditional Premarket Notification
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Image /page/7/Picture/0 description: The image shows the logo for New Deantronics. The word "NEW" is in blue, with a blue circle and red dot next to it. The word "DEANTRONICS" is in blue and to the right of the circle.
Electrosurgical Generator Traditional Premarket Notification
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Image /page/8/Picture/0 description: The image shows the logo for New Deantronics. The word "NEW" is in blue, and the "N" is slightly larger than the other letters. To the right of "NEW" is a blue circle with a red dot in the center. To the right of the circle is the word "DEANTRONICS" in blue.
Electrosurgical Generator Traditional Premarket Notification
F. Summary of Supporting Data
The application Electrosurgical Generator was tested and found to be in compliance with the following standards:
| StandardsBody & # | Standard Name | StandardVersion |
|---|---|---|
| IEC 60601-1 | Medical electrical equipment - Part 1: General requirements for basicsafety and essential performance. | 2005 +AMD1:2012 |
| IEC 60601-1-2 | Medical electrical equipment – Part 1-2: General requirements forbasic safety and essential performance – Collateral Standard:Electromagnetic disturbances - Requirements and tests. | 2014 |
| IEC 60601-2-2 | Medical electrical equipment –Part 2-2: Particular requirements for thesafety of high frequency surgical equipment. | 2017 |
| IEC 62304 | Medical device software — Software life cycle processes | 2006+AMD 1:2015 |
| ISTA 3A | International Safe Transit Association Procedure 3A. | 2008 |
In addition, the Electrosurgical Generator was fully tested and in compliance with the FDA guideline Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery: Guidance for Industry and Food and Drug Administration Staff (9 March 2020).
G. Conclusion
After comparing the Indications for Use, technology and design of the Electrosurgical Generator, 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 Electrosurgical Generator is substantially equivalent to the predicate Covidien Force FX Electrosurgical Generator (K143161).
§ 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.