RF Surgical Generator by Fulwell LLC

RF Surgical Generator FW-120A 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.

Device Description

RF Surgical Generator FW-120A, is a compact source of high power RF energy, enhanced capability of radiosurgery generator, which can be employed for a variety of radiosurgery procedures, such as cut and coagulate living human tissue.

The device which is consisted of a generator, an IEC Neutral Plate, and a Two Pedal Footswitch, provides 5 modes and corresponding output power ranges that is user/operator selectable based on the surgical procedure undertaken. The action is achieved by front panel selection of waveforms and power level. All selection is affected through push buttons and indicators which give the operator feedback of status. Power level for each mode is indicated by front panel digital displays

The device is provided with safety features of automatically system initialize self-check after power on and continuously monitored during the device running. The device will provide error information and/ or alerts when detect following faults, such as a) Accessary fail connection, b) Overheating of Main Unit, c) Neutral plates Contact resistance exceed the limit, d) System initialize error. The error monitoring is interlocked with the controls to prevent operation when fault condition happened in the unit.

The generator is configured for Monopolar and Biopolar output and the final output power could be controlled by pedal foot switch and/or hand switches. Recommended Monopolar Handpieces 510(k) No.: K092634. Recommended IEC Neutral Plate 510(k) No.: K102372.

AI/ML Overview

This document is a 510(k) premarket notification for an RF Surgical Generator (Model: FW-120A) and focuses on demonstrating substantial equivalence to a predicate device, rather than providing details on a study to meet specific acceptance criteria for a new device.

Therefore, many of the requested categories about acceptance criteria, detailed study design, ground truth, and expert involvement are not applicable or not provided in this type of submission. This document primarily reports on verification testing against established standards and a comparison to a predicate device.

Here's a breakdown based on the information available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not outline specific numerical "acceptance criteria" in the way one might see for a diagnostic device (e.g., sensitivity/specificity targets). Instead, it relies on demonstrating compliance with recognized safety and performance standards and showing equivalence to a predicate device.

Category	Acceptance Criteria (Implied)	Reported Device Performance
Electrical Safety	Compliance with ANSI AAMI ES60601-1	Device evaluated and found in compliance with ANSI AAMI ES60601-1:2005/(R)2012 and associated amendments.
EMC Performance	Compliance with IEC 60601-1-2	Device evaluated and found in compliance with IEC 60601-1-2 (2014).
HF Surgical Equipment Specific Safety	Compliance with IEC 60601-2-2	Device evaluated and found in compliance with IEC 60601-2-2 (Edition 6.0 2017-03).
Thermal Effects	Performance comparable to predicate device for cutting/coagulating tissue with acceptable thermal damage.	Thermal damage (length, width, depth of thermal zone) measured in porcine muscle, liver, and kidney in all applicable modes. Performance supports substantial equivalence.
System Performance/Waveform Output	Performance comparable to predicate device.	System performance and waveform outputs tested. Results support substantial equivalence.
Software Verification	Compliance with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" for moderate concern level.	Software verifications performed to ensure appropriate operation as a moderated concern level software.
Monopolar Neutral Electrode Monitor Resistance	MAX 1000Ω	MAX 1000Ω
Rated Duty Cycle	10s on, 30s off	10s on, 30s off
Output Power	Comparable to predicate device (specific values provided in table)	Cutting: 120W@500Ω; Blend cutting and coagulation: 80W@500Ω; Hemostasis: 60W@500Ω; Fulguration: 40W@500Ω; Bipolar: 120W@200Ω

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified in terms of number of human subjects or distinct test cases. The testing involved "lab bench testing" and "porcine muscle, liver, and kidney" tissue. The number of samples/tests for each tissue type is not detailed.
Data Provenance: The testing was "lab bench testing" using "porcine" tissue. The country of origin for the data is not explicitly stated beyond the applicant being based in China. The data is from prospective testing conducted specifically for this submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not Applicable / Not Provided: This type of submission (510(k)) for an electrosurgical generator typically relies on objective physical measurements and engineering evaluations against standards, rather than expert-established ground truth like in diagnostic imaging. There is no mention of experts establishing a ground truth for a test set in this context.

4. Adjudication Method for the Test Set

Not Applicable / Not Provided: As there's no mention of expert ground truth establishment, there is no adjudication method described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No: An MRMC comparative effectiveness study is not mentioned as this device is an electrosurgical generator, not an interpretative diagnostic imaging device that involves human readers.

6. Standalone (Algorithm Only) Performance

Yes, implicitly: The "performance data" section (Section 6) describes "System Performance and waveform outputs test," "Thermal effects testing," and "software verifications" which represent the standalone performance of the device itself and its integrated software. These tests involve direct measurement of the device's output and effects, independently of human interpretation of a diagnostic output.

7. Type of Ground Truth Used

Objective Measurements and Physical Science Principles: The "ground truth" for this device's performance is established through objective measurements of electrical output parameters (waveform, power), physical effects on tissue (thermal damage size), and compliance with internationally recognized safety and performance standards (e.g., IEC 60601 series). For software, it's verification against design specifications and guidance documents.

8. Sample Size for the Training Set

Not Applicable / Not Provided: This device, an RF Surgical Generator, does not utilize machine learning or AI models that require a "training set" in the conventional sense. Its functionality is based on established engineering principles and not on learning from a large dataset.

9. How the Ground Truth for the Training Set Was Established

Not Applicable / Not Provided: As there is no training set for a machine learning model, this question is not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA" being larger and bolder than the rest of the text.

November 24, 2020

Fulwell LLC % Jet Li Regulation Manager Guangzhou KEDA Biological Tech Co., Ltd. 6F, No.1 TianTai road, Science City, LuoGang District Guangzhou, Guangdong China

Re: K200931

Trade/Device Name: RF Surgical 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 23, 2020 Received: September 28, 2020

Dear Jet Li:

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.

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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200931

Device Name RF Surgical Generator, Model: FW-120A

Indications for Use (Describe)

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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510(k) Summary (K200931)

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 878.4400, and there were no prior submissions for the subject device.

1 Submitter Information

Sponsor: Fulwell LLC Address: 3411 NW 48 Street, Miami, FL 33142 USA Contact Person: Mrs. Perla Melisa Mcliberty Title: Deputy General Manager Phone: +1-305-535-3568 E-mail: register@fulwell.us.com

Application Correspondent: Jet Li Company: Guangzhou KEDA Biological Technology Co., Ltd E-mail: med-jl@foxmail.com Phone: 86-18588874857 Address: 6F, No.1 TianTai road, Science City, LuoGang District, GuangZhou City, China

Subject Device Information 2

Type of 510(k) submission: Traditional Trade/Device Name: RF Surgical Generator Model: FW-120A Classification Name: Electrosurgical, Cutting & Coagulation & Accessories Review Panel: General & Plastic Surgery Product Code: GEI Regulation Number: 21 CFR 878.4400 Regulation Class: 2

3 Predicate Device Information

Sponsor: ELLMAN INTL., INC. Trade/Device Name: Surgitron 120 IEC 510K number: K013255 Classification Name: Electrosurgical, Cutting & Coagulation & Accessories Review Panel: General & Plastic Surgery Product Code: GEI Regulation Number: 21 CFR 878.4400 Requlation Class: 2

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Device Description 4

5 Intended Use/Indication for use

6 Performance data

Verification testing, including electrical safety/electromagnetic compatibility, software verification/validation were performed for RF Surgical Generator.

RF Surgical Generator has been evaluated the safety and performance by lab bench testing a) according to the following standards:
- ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009(R)2012 and A A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
- △ IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests, 2014
- IEC 60601-2-2, Medical Electrical Equipment - Part 2-2: Particular Requirements for The Basic Safety And Essential Performance Of High Frequency Surgical Equipment And

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High Frequency Surgical Accessories, Edition 6.0 2017-03

b) RF Surgical Generator has been evaluated the basic mechanical and functional capabilities to determine substantial equivalence to the predicate device. According to the guidance document Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery, the device has been tested for applicable items such as thermal damage, CQM and so on.
In particular, tests have been carried out with respect to the following subject areas.
1. System Performance and waveform outputs test.

Thermal effects testing: the thermal damage of the tissue due to the HF current was measured in terms of size (length, width and depth) of the thermal zone in all applicable modes: porcine muscle, liver, and kidney.

c) RF Surgical Generator has performed software verifications to ensure the device worked appropriately as a moderated concern level software according to the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. .

7 Comparison to Predicate Device

Compare with predicate device, the subject device is very similar in design principle, intended use, indications for use, functions, material and the applicable standards. The differences between subject device and predicate device do not raise any new questions of safety or effectiveness.

Elements ofcomparison	Subject Device	Predicate Device	Verdict
Manufacturer	Fulwell LLC	ELLMAN INTL., INC.	--
510K number	K200931	K013255	--
Product Name	RF Surgical GeneratorFW-120A	Surgitron 120 IECAlso known as Surgitron 4.0 Dual RF	--
ClassificationName	Electrosurgical, Cutting & Coagulation& Accessories	Electrosurgical, Cutting & Coagulation& Accessories	SE
RegulationClass	2	2	SE
RegulationNumber	21 CFR 878.4400	21 CFR 878.4400	SE
OTC & Rx	Rx	Rx	SE
Indications for Use
Indications forUse	RF Surgical Generator FW-120A is an electrosurgicalgenerator containingmonopolar and bipolartechnology. It is intended foruse with accessories duringsurgical procedures where thesurgeon requireselectrosurgical cutting andcoagulating.	Cutting: snoring, submucosal palatalshrinkage, traditional uvulopalatoplasty(RAUP), myringotomy with effectivehemorrhage control, epistaxistreatment, turbinate shrinkage, skinincisions, biopsy, cysts, abscesses,tumors, cosmetic repairs, developmentof skin flaps, skin tags andblepharoplasty.Blend cutting and coagulation: snoring,submucosal palatal shrinkage	SE,MinorDifference.We removethe specifiedindicationfor use forsubjectdevice; it donot raisesafety and

		traditional uvulopalatoplasty (RAUP),myringotomy with effective hemorrhagecontrol, epistaxis treatment, turbinateshrinkage, skin tags, papilloma keloids,keratosis, verrucae, basal cellcarcinoma, nevi, fistulas, epithelioma,cosmetic repairs, cysts, abscesses,development of skin flaps.Hemostasis: control of bleeding,epilation, telangiectasia.Fulguration: basal cell carcinoma,papilloma, cyst destruction, tumors,verrucae, hemostasis.Bipolar: pinpoint precise coagulation,pinpoint hemostasis in any field (wet ordry), snoring, submucosal palatalshrinkage, traditional uvulopalatoplasty(RAUP), myringotomy with effectivehemorrhage control, epistaxis treatmentand turbinate shrinkage.	effectiveness issue.
	Device Design
WorkingTheory	■ Monopolar: RF generator connectsits accessories of a handpiece and anIEC Neutral Plate (adhered to patientskin) to form a cyclic circuit, the RFcurrent generated from the generatorand through the Monopolar handpieceto achieve CUT or COAG, then returnto generator by the IEC Neutral Plate.■ Bipolar: RF current generated fromthe generator and the cyclic circuitformed between the two tips of thebipolar forceps, the RF power throughthe two tips to work on patient obtainingCOAG.	■ Monopolar: RF generator connectsits accessories of a handpiece and anIEC Neutral Plate (adhered to patientskin) to form a cyclic circuit, the RFcurrent generated from the generatorand through the Monopolar handpieceto achieve CUT or COAG, then returnto generator by the IEC Neutral Plate.■ Bipolar: RF current generated fromthe generator and the cyclic circuitformed between the two tips of thebipolar forceps, the RF power throughthe two tips to work on patient obtainingCOAG.	SE
Appearance	Image: FW-120A	Image: Ellman Surgitron Dual 11	SENote 1
InterfaceAccessories	Two Pedal Footswitch, Handpieces, IECNeutral Plate, Power Cord	Triple Footswith, Handpieces, NeutralPad, Power Cord	SENote 1
OperationMode	Cutting, Blend cutting and coagulation,Hemostasis, Fulguration, Bipolar	Cutting, Blend cutting and coagulation,Hemostasis, Fulguration, Bipolar	SE
Waveforms	Cutting:4.0MHz SinusoidBlend cutting and coagulation: 4.0MHzwith fully rectified envelopeHemostasis: 4.0MHz with partiallyrectified envelopeFulguration: 4.0MHz with modulatedBipolar: 1.7MHz	Cutting:4.0MHz CW Sin-WaveBlend cutting and coagulation: 4.0MHzwith rectified full-wave envelopeHemostasis: 4.0MHz with square waverectified envelopeFulguration: 4.0MHz Sin-WaveModulatedBipolar: 1.7MHz for Fulgurating Spark-Gap	SENote 2
Activation	Cutting: via footswitch or finger switchBlend cutting and coagulation: viafootswitch or finger switchHemostasis: via footswitch or fingerswitchFulguration: via footswitch or fingerswitch	Cutting: via footswitch or finger switchBlend cutting and coagulation: viafootswitch or finger switchHemostasis: via footswitch or fingerswitchFulguration: via footswitch or fingerswitch	SE

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K200931
---------	--

Rated DutyCycle	10s on, 30s off	10s on, 30s off	SE
Energy type	RF	RF	SE
Feedbacksystem	Indicators, audio alarm, Error codes	Indicators, audio alarm, Error codes	SE
NeutralElectrodemonitorresistance	MAX 1000Ω	MAX 1000Ω	SE
Input Pow er	Nominal line voltage and frequency:120Vac~ ±10%, 60 Hz./230Vac~ ±10%, 50 Hz.Input current at max output pow er:3.3/1.5A.	Voltage: 240/220/120/100V, ±10%240/230/120/100V, ±10%Frequency: 50HzCurrent: For 240~~220V: 3.3A,For 120~~100V: 1.5A	SENote 1
Output Pow er	Cutting: 120W@500ΩBlend cutting and coagulation:80W@500ΩHemostasis: 60W@500ΩFulguration: 40W@500ΩBipolar: 120W@200Ω	Cutting: 120W@500ΩBlend cutting and coagulation:80W@500ΩHemostasis: 40W@500ΩFulguration: 40W@500ΩBipolar: 120W@200Ω	SENote 2
Fuses	T 2.0A, 250V, Tw o pieces for 230VacT 4.0A, 250V, Two pieces for 120Va	2* T 2.0AL, for 250V2* T 4.0AL, for 110V	SENote 1
Electric shockprotection	Class I	Class Ilb	SENote 1
Defibrillationprotection	Type BF	Type BF	SE
Dimensions	235mm120mm340mm(WHD)	9"5"13" (WHD)≈228mm127mm330mm	SENote 1
Weight	11Kg	18lbs, ≈8.16kg	SENote 1
Workingcondition	-10°C- +40°C30% - 75%	-10°C- +40°C30% - 75%	SE
Transport andStorage	-10°C- +50°C, 10% - 95%500hPa-1060hPA	-10°C- +50°C, 10% - 95%500hPa-1060hPA	SE
Sterility	Non-sterile	Non-sterile	SE
FDA-Recognized Standards
SafetyPerformance	ANSI AAMI ES60601-1IEC 60601-2-2	UL2601, IEC 601-1, IEC 601-2-2BS15724:2.2	SENote 2
EMCPerformance	IEC 60601-1-2	/	SENote 3

Note 1

Although the subject device design and specification parameters, such as appearance / dimensions / weight / power supply / electric shock protection, have a little difference to the predicate device, these minor differences do not affect the device' mainly function, which are has been testing the electrical safety via the IEC 60601 standards tests, and these differences will not create any new safety risks to the performance and safety.

Note 2

Although the waveform and output power of subject device has a little different to predicate device, the performance test has proved that the performance of subject device is substantial equivalence

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to the predicate device. So the differences do not affect the safety and effectiveness.

Note 3

Although the complied standards of electrical safety and EMC performance are different to the predicate device, it's only because the version of predicate device's complied standards are invalidated and been updated. The subject device has complied to the necessary standards as existing similar products, so the differences do not affect the safety and effectiveness.

9 Conclusion

The subject device RF Surgical Generator has all features of the predicate device for intended use. Thus, the subject device is substantially equivalent to the predicate device.

10 Summary Prepared Date

22 Nov. 2020

Regulation Number and Section

§ 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.