The Electrosurgical Generator – Model FW-350A is a non-sterile, reusable multi-purpose electrosurgical generator that is designed to perform monopolar and bipolar functions in the surgical operation area.

Device Description

Electrosurgical Generator-Model FW-350A has Monopolar and Bipolar modes that can satisfy the general requirements of electrosurgical field. The CQMS function can monitor the area of patient body applied with ESU pad during the operation every 40ps. Once the pad loses or that area shrinks, the computer will cut off all outputs within 40us to prevent patient from getting burnt. The PPS system ensure the safety of a constant output that send out compulsory stimulation at the initial instant of every CUT or COAG to make the operation process go smoothly. Moreover, the memory function can decrease the medical staff workload and human errors. At last, the Power ON self diagnostics function can diagnosis whether all working modes and functions are working normally and feedback information by code displaying and alarm voice prompt that the operational safety is improved greatly.

AI/ML Overview

The provided text describes a 510(k) premarket notification for an Electrosurgical Generator, Model FW-350A. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive details on novel acceptance criteria and comprehensive study results as would be typical for a de novo submission or a new technology.

Therefore, the information available in the document primarily addresses the safety and performance of the device relative to existing standards and a predicate device. It does not contain an "acceptance criteria" table in the classical sense, nor detailed study results that prove the device meets these criteria in a standalone, statistically robust manner. Instead, the "acceptance criteria" are implied by compliance with recognized standards and a demonstration of comparable performance to the predicate device through bench testing.

Here's a breakdown of the information that can be extracted, interpreted based on the context of a 510(k) submission:

1. Table of Implied Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission, the "acceptance criteria" are primarily based on demonstrating equivalence to the predicate device and compliance with relevant safety standards. The reported device performance is presented in comparison to the predicate.

Implied Acceptance Criteria (Based on Compliance & Predicate Comparison)	Reported Device Performance (FW-350A)
Safety and EMC Compliance: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2	Complies with IEC 60601-1: 2012, IEC60601-1-2: 2014, and IEC60601-2-2: 2009.
System Performance and waveform outputs: Comparable to predicate	Monopolar CUT, COAG, and Bipolar modes described with specific power settings (e.g., Pure cut: 350Wmax), load (500Ω), and crest factors. Waveforms are primarily 431kHz sinusoids with varying duty cycles/burst patterns. Minor differences from predicate (e.g., max power, specific waveform parameters, output frequency, Vp-p) are deemed not to raise new safety/effectiveness concerns.
Thermal effects: Comparable thermal damage to predicate	Thermal effects testing conducted on ex vivo animal tissues (porcine muscle, liver, and kidney). Thermal damage (size: length, width, depth of thermal zone) was measured at minimum, default, and maximum power settings. Comparison indicated minor differences from predicate do not affect safety.
Software Validation: Developed according to FDA guidance	Software designed and developed according to a software development process and was verified and validated, in accordance with FDA guidance: "The content of premarket submissions for software contained in medical devices, on May 11, 2005."
Intended Use: Match predicate	"A non-sterile, reusable multi-purpose electrosurgical generator that is designed to perform monopolar and bipolar functions in the surgical operation area." – identical to predicate in essence, with minor phrasing differences.
Working Theories: Match predicate	Monopolar and Bipolar modes described, consistent with predicate's working principles.
CQMS (Contact Quality Monitoring System) Functionality: Comparable	FW-350A (CQMS): Alarm range: > 113ohms (split ESU pad). Predicate (REM): Alarm range < 5ohms or ≥ 135ohms. Deemed not to influence safety/effectiveness due to explicit instruction for split ESU pad use.
PPS/Instant Response Technology: Similar functionality	Automatically senses resistance and adjusts output voltage to maintain consistent effect, similar to predicate.
Power ON self-diagnostics: Serves same safety purpose	Both devices perform self-diagnostics at power-on to ensure normal operation and display error codes if issues arise. Differences in test sequence and specific error codes do not impact the underlying safety purpose.

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

Test Set Sample Size: The document does not specify a numerical "sample size" for the performance tests in the typical sense (e.g., number of patients or cases). For the thermal effects testing, it states "ex vivo animal tissues (porcine muscle, liver, and kidney)," but does not quantify the number of tissue samples or repetitions.
Data Provenance: The thermal effects testing was performed on "ex vivo animal tissues" (porcine). These are non-clinical, bench tests. The document does not specify the country of origin for the tissue data, nor if it was retrospective or prospective, though "ex vivo" implies a laboratory setting. Clinical or animal studies were explicitly stated as "not necessary."

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

There is no mention of experts used to establish ground truth for a test set, expert qualifications, or adjudication methods in this document. This is typical for electrosurgical generators in a 510(k) submission, where performance is evaluated through physical and electrical bench testing against established standards and comparison to a predicate, rather than human expert assessment of outcomes.

4. Adjudication Method for the Test Set

Not applicable/Not mentioned. As performance evaluation relies on objective bench testing against standards and direct comparison of measurable parameters to a predicate device, human adjudication of "ground truth" for a test set is not part of this submission process.

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

Not applicable/Not mentioned. This document concerns an electrosurgical generator, which is not an AI-powered diagnostic or interpretive device that would involve human "readers" or an "AI assistance" component in the clinical workflow. Therefore, an MRMC comparative effectiveness study is not relevant to this device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable/Not mentioned. This is an electrosurgical generator, a hardware device, not a standalone algorithm. Its performance is evaluated for physical and electrical characteristics and tissue effects, not as an interpretive algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the performance testing, specifically thermal effects testing, the "ground truth" (or objective measure) was the directly measured "size (length, width and depth) of the thermal zone" on the ex vivo animal tissues. This is a direct physical measurement. For other aspects, compliance with international standards (IEC 60601 series) served as the "ground truth" for safety and basic performance parameters.

8. The Sample Size for the Training Set

Not applicable/Not mentioned. This document does not describe an AI/machine learning model that would require a "training set." The software validation refers to standard software development and verification/validation processes, not machine learning model training.

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

Not applicable/Not mentioned. As there is no described AI/machine learning model or training set, the establishment of ground truth for such a set is not discussed.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 13, 2019

FULWELL LLC % Jet Li Regulation Manager Guangzhou LETA Testing Tech Co., Ltd. 6F, No.1 TianTai road, Science City, LuoGang District GuangZhou, China 510060

Re: K183564

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: May 14, 2019 Received: May 16, 2019

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/cfpmp/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 and Part 809): medical device reporting (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

Jennifer R. Stevenson Acting Division 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) K183564

Device Name

Electrosurgical Generator, Model FW-350A

Indications for Use (Describe)

	X Prescription Use (Part 21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92. There is no prior submission for this device.

1 510 (k) submitter

Company Name: FULWELL LLC Address: 3411 NW 48 Street, Miami, FL 33142 USA Phone: +1-305-535-3568 Post code: 33142 Contact Person: Mrs Perla Melisa Mcliberty E-mail: register@fulwell.us.com

Application Correspondent:

Guangzhou LETA Testing Technology Co., Ltd. Address: 6F, No.1 TianTai road, Science City, LuoGang District, GuangZhouCity,China Contact Person: Mr. Jet Li Tile: Regulation Manager Tel: +86-18588874857 Email: med-jl@foxmail.com

2 Subject Device Information:

Type of 510(k) submission: Traditional Trade Name: Electrosurgical Generator - Model FW-350A Common Name: Electrosurqical cutting and coaqulation device and accessories. Classification Name: electrosurgical, cutting & coagulation & accessories Review Panel: General& Plastic Surgery Product Code: GEI Regulation Number: 21 CFR 878.4400 Regulation Class: II

3 Predicate Device Information:

Sponsor	Valleylab. Inc.
Device Name	Valleylab Force Fx
510(k) Number	K944602
Product Code	GEI
Regulation Number	878.4400

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Regulation Class	2
------------------	---	--

1. Device Description

The electrosurgical generator can be compatible with electrosurgical accessories based on their output rating with FDA clearance. For example:

FDA 510k cleared Electrosurgical pencil : 510(k) No.: K092634 or other FDA cleared pencil FDA 510k cleared Electrosurgical pad: 510(k) No.: K102372 or other FDA cleared pad

5. Intended Use / Indications for Use

The Electrosurgical Generator - Model FW-350A is a non-sterile, reusablemulti-purpose electrosurgical generator that is designed to perform monopolar and bipolar functions in the surgical operation area.

6. Design

Operating principles:

There're two working modes of electrosurgical generator: monopolar and bipolar

A. monopolar mode:

With this mode, cutting and coaqulation of the tissues are accomplished by an integral circuit that consists of electrosurgical generator and its applicable accessories (ESU pencil, split ESU pad, which are not included in this submission, as long as the Up≥4500V of these accessories that will be

compatible, details refer to user manual). In most applications the current goes through the patient body by electrosurgical pencils and then returns to the generator by the circuit made of electrosurgical pad.

B. Bipolar forceps mode:

Bipolar forceps provide high frequency electric power to human body by the two points of the forceps that coagulate the blood to make hemostatic effect through dehydratingthe vessels between the bipolar forceps. However, this function is limited within the area between the two forceps points and its damage on the tissue and influence area is far less than the electrosurgical pencils does, therefore, it is suitable to the ligation of small vessels (diameter <4mm) and salpinx and more widely used in the operations requiring high precision such as brain surgery, microsurgery, Ophthalmology and Otorhinolaryngology and gynecological surgery. The safety advantage of bipolar forceps is gaining more and more recognitions and its applications are being enriched.

Please refer to "VOL_006_Attachment 4. Proposed Labeling" to get detailed information

7. Physical characteristics

Please refer to "VOL_007_Attachment 5. Performance Test Report" to get more information.

Basic Unit Characteristics

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Model	FW-350A
Category of the Device:	Class I Equipment (IEC 60601-1)
Type:	[Heart Icon] Type CF Equipment Defibrillator Proof
Duty Cycle:	Intermittent loading continuous operation(10s/30s)
Max. power:	350W
Working frequency:	(330~460) kHz
Software version of the equipment:	Version: 350AV1.1
Input power:
Input Voltage:	120/230V~VAC
Mains line frequency:	60Hz/50Hz
Power consumption:	880VA
Fuse(two):	F6AΦ5X20
Dimensions and Weight:
Width:	380mm
Depth:	430mm
Height:	165mm
Weight:	7kg
Operating Parameters:
Ambient temperature range:	5~40 C°
Relative humidity:	≤80%
Atmospheric pressure:	86.0~106.0 kPa
Warm-up time:	If transported or stored at temperatures outside theoperating temperature range, allow one hour for thegenerator to reach room temperature before use.
Transport and Storage:
Ambient temperature range:	-40C° to +55C°
Relative humidity:	RH≤80 %
Atmospheric pressure:	50kPa to 106kPa

8. Test Summary

Electrosurgical Generator – Model FW-350A had been evaluated the safety and performance by lab bench testing as following:

8.1 Safety and EMC Compliance with following standard:

IEC 60601-1: 2012: Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance
IEC60601-1-2: 2014: Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance. Collateral Standard: Electromagnetic Compatibility
IEC60601-2-2: 2009: Medical Electrical Equipment - Part 2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

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8.2 Performance testing

To demonstrate that the Electrosurgical Generator meets all design specifications and performance requirements, nonclinical bench testing has been performed in accordance with the internal R&D process in compliance with the proposals and recommendations of FDA quidance: "Premarket Notification [510(k)] Submissions for Electrosurgical Devices for General Surgery" - Guidance for Industry and Food and Drug Administration Staff, August 15, 2016.

In particular, tests have been carried out with respect to the following subject areas.

System Performance and waveform outputs test.
Thermal effects testing: the thermal damage of 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.

1. Preclinical Test/Histology study
  Thermal Zone Damage on tissue. Side by side testing was performed on ex vivo animal tissues (liver, kidney, and muscle) and thermal damage was assessed by measuring the depth/length/width of damage at minimum, default, and maximum power settings using histology.

8.3 Software validation

The software was designed and developed according to a software development process and was verified and validated. The software information is provided in accordance with FDA guidance: The content of premarket submissions for software contained in medical devices, on May 11, 2005.

8.4 Clinical testing

Clinical and animal studies were not necessary.

9. Comparison to predicate device and conclusion

The technological characteristics, features, specifications, materials, and intended use of Electrosurgical Generator - Model FW-350A is substantially equivalent to the predicate devices quoted above.

The differences between the subject device and predicate devices is below listed items, but they do not raise new issues of safety or effectiveness:

· Minor difference on Maximum power, and some output waveform parameters
Out shape and dimension

Substantial equivalence is demonstrated by acknowledged verification/validation methodologies.

ElementofComparison	Subject Device	Predicate Device	SEComparison
Manufacturer	FULWELL LLC	Valleylab. Inc.	N/A
Model name	FW-350A	Valleylab Force Fx	N/A
510(k) number	pending	K944602	N/A
Type	CF(with protection for discharge effect of defibrillator)	CF	Same
Elementof		Subject Device	Predicate Device	SEComparison
Comparison
Indication for use		The ESU generator FW-350A is a non-sterile, reusable multi-purpose ESU generator that is designed to perform monopolar and bipolar functions in the surgical operation area.	The Valleylab Force Fx is an isolated, microprocessor based ESU generator intended for use in the operating room for general procedures where ESU cutting and coagulation is required. The generator is equipped with monopolar and bipolar outputs.	Same
Working theories	Monopolar	ESU generator connects its accessories of a ESU pencil and a split ESU pad (adhered to patient skin) to form a cyclic circuit, the HF current generated from the generator and through the ESU pencil to achieve CUT or COAG, then return to generator by the ESU pad.	ESU generator connects its accessories of a ESU pencil and a split ESU pad (adhered to patient skin) to form a cyclic circuit, the HF current generated from the generator and through the ESU pencil to achieve CUT or COAG, then return to generator by the ESU pad.	Same
	Bipolar	HF current generated from the generator and the cyclic circuit formed between the two tips of the bipolar forceps, the HF power through the two tips to work on patient obtaining COAG, no need extra ESU pad.	HF current generated from the generator and the cyclic circuit formed between the two tips of the bipolar forceps, the HF power through the two tips to work on patient obtaining COAG, no need extra ESU pad.
Labeling		See Chapter 13	See Chapter 13	SE
PhysicalSpecification	Appearance	Image: ESU generator FW-350A	Image: Valleylab Force Fx	N/A
Element ofComparison		Subject Device	Predicate Device	SEComparison
	Essentialcomponents	Chassis and Cover, Frontpanel controls, Power supplyboard,Microprocessorboard,Footswitch board,Interface circuits, Front panelreceptacles.	Chassis and Cover, Front panelcontrols, Power supply board,Microprocessorboard,Footswitch board,Interfacecircuits, Frontpanelreceptacles.	Same
	Energy	HF energy	HF energy	Same
	Dimensionsand weight	43cm(L)×38cm(W)×16.5(H),Weight:7kg	35.6cm(L)×43.9cm(W)×11.1(H),Weight<10.9kg	NA
	Workingcondition	Circumstance Temperature :5~~40 C°Relative Humidity : ≤80%AtmosphericPressure:86.0~~106.0 Кра.	Circumstance Temperature :10~~40 C°Relative Humidity : 30 ≤RH≤95%AtmosphericPressure:70.0~~106.0 kPa.	1.MinorDifferent
	Transport andStorage	Ambient temperature :-40C° to +55C°RH≤80 %Atmosphericpressure:50kPa to 106kPa	Ambient temperature :-40C° to +70C°RH:10% to 100%,noncondensingAtmospheric pressure:50kPa to 106kPa	2. MinorDifferent
	Fuses	Two, 6A	Two, 8A	3.MinorDifferent
	Safetyperformance	Conforming withES60601-1 ;IEC 60601-2-2 ;	Conforming withIEC 60601-1 ;IEC 60601-2-2 ;	Same
	EMCperformance	IEC60601-1-2	IEC60601-1-2	Same
	Sterility	Not applicable	Not applicable	Same
	Display	Huge High-definition digitaldisplay	Power and Err display with hugehigh-definition digital on thedisplay screen	Same
	Input power	120V/230V, 60Hz/50Hz	100-120V/220-240V,60Hz/50Hz	4.MinorDifferent
	Output mode	CUT:Pure cut:350Wmax,Load:500Ω,Crestfactor:1.6Blend 1(macro):250Wmax, Load:500Ω,Crestfactor:1.8	CUT:Low cut: 300Wmax, Load:300Ω,Crest factor:1.5Pure cut: 300Wmax, Load:300Ω,Crest factor:1.5Blend:200Wmax,Load:300Ω,	5. MinorDifferent
ElementofComparison	Subject Device	Predicate Device	SEComparison
	Blend 2(micro):150Wmax, Load:500Ω, Crestfactor:2.4COAG:COAG1(Spray):120Wmax, Load:500Ω, Crestfactor:7.2COAG2(Forced):100Wmax, Load:500Ω, Crestfactor:6.7COAG3(Soft):50Wmax, Load:500Ω, Crestfactor:4.7BIPOLAR:Bipolar1(macro):100Wmax, Load:100Ω, Crestfactor:1.6Bipolar2(micro):100Wmax, Load:100Ω, Crestfactor:1.6	Crest factor:2.5COAG:Low (Desiccate):120Wmax, Load:500Ω,Crest factor:5.0Med (Fulgurate):120Wmax, Load:500Ω,Crest factor:7.0High (Spray):120Wmax, Load:500Ω,Crest factor:8.0BIPOLAR:Low (Precise):70Wmax, Load:100Ω, Crestfactor:1.5Med (Standard):70Wmax, Load:100Ω, Crestfactor:1.5Macro:70Wmax, Load:100Ω, Crestfactor:1.5
CUT	Pure cut:431kHz sinusoid, 100%dutycycle;Blend1:431kHz sinusoid at50% duty cycle with a 32kHzrepetition rate;Blend2:431kHz sinusoid at70% duty cycle with a 32kHzrepetition rate.	Low: 390kHz sinusoid, 100%dutycycle, similar to Pure cut modeexcept the maximum voltage islimited to a low er value;Pure: 390kHz sinusoid with effectmode, 100%duty cycle;Blend: 390kHz bursts of sinusoidrecurring at 27kHzintervals.50%duty cycle.
Waveforms	COAGCOAG1(Spray):431kHz sinusoidal bursts with arepetition frequency of 32kHz;COAG2(Forced):431kHz sinusoidal bursts with arepetition frequency of 32kHz;COAG3(Soft):431kHz sinusoidal bursts with arepetition frequency of 32kHz;	Low (Desiccate):240kHz sinusoid repeated at39kHz, 8% duty cycle;Med (Fulgurate):470kHz damped sinusoid burstswith a repetition frequency of 30kHzinto 500ohms;High (Spray):470kHz damped sinusoidal burstswith a randomized repetitioncentered at 28kHz, frequenciesinclude 21kHz < f < 35kHz. Output isfurther modulated by a random250Hz envelop with a variable dutycycle.	6. MinorDifferent
	BIPOLAR	Bipolar1(macro):431kHz sinusoid, 100% dutycycle;Bipolar2(micro):431kHz sinusoid, 100% dutycycle;	Low (precise):470kHz sinusoid, 100%duty cycle;Med(standard):470kHz sinusoid, 100%duty cycle;Macro:470kHz sinusoid, 100%duty cycle
	Power	880VA	850VA	7. Minor
ElementofComparison	Subject Device	Predicate Device	SEComparison
	Outputfrequency	330~460KHz Sinusoid	390~470KHz Sinusoid	Different
	Current(120V)	Idle: 0.1AmaxCut: 5.0A maxCoag:2.5AmaxBipolar: 2.0A max	Idle:0.4A maxCut: 7.0A maxCoag: 4.0A maxBipolar: 2.0A max	9. MinorDifferent
	Compatibility	Vpeak=4500V	Vpeak=9000V	10. MinorDifferent
	Open circuitVp-p(max)	Monopolar CUTPure: 2120VBlend1: 2720VBlend2: 2200VMonopolar COAGCOAG1(Spray):4500VCOAG2(Forced): 4150VCOAG3(soft): 2500VBipolar:Bipolar1(macro): 500VBipolar2(micro):350V	Monopolar CUTLow: 1350VPure: 2300VBlend: 3300VMonopolar COAGDesiccate:3500VFulgurate: 8500VSpray: 9000VBipolar:Precise: 450VStandard: 320VMacro: 750V	11. MinorDifferent
	Operationmode	Under maximum power settingsand rated load conditions (purecut350W, 500ohm load) thegenerator is suitable foractivation times of 10secondson, 30seconds off for 1 hour.	Under maximum pow er settings andrated load conditions (purecut300W, 300ohm load) thegenerator is suitable for activationtimes of 10seconds on, 30secondsoff for 1 hour.	Same
	CQMS	The ESU pad contact qualitymonitor system (CQMS) willmeasure the resistancebetween the ESU pad andpatient, if the resistance wasbeyond the defined upper limit,the alarm system will beactivated.	Force FX (REM): The ReturnElectrode Contact Quality Monitorwill measure the resistance, if theresistance w as beyond the range ofdefined by an upper and low er limit,the alarm system will be activated.	12. MinorDifferent
Special Functions	PPS/Instantresponsetechnology	Automatically senses resistanceand adjusts the output voltage tomaintain a consistent effectacross different tissue density(bipolar or cut modes only)	Automatically senses resistanceand adjusts the output voltage tomaintain a consistent effect acrossdifferent tissue density (bipolar orcut modes only)	13. Similar
	Memory	10 memory settings, theprevious power setting digitspresented when restart	Recall the last activatedprevious setting when Power Onnext time by pressing RECALL	14. MinorDifferent
	Power ON selfdiagnostics	In the self diagnosis processafter Power ON, all workingmodes and functions operatingare simulated and monitored bysoftware control to determinewhether they are performednormally, follow ed bytransmitting of corresponding	Force Fx: When the generatorsenses a system alarmconditions, an alarm sounds andan alarm number is displayed onthe front panel. A system alam	15. MinorDifferent
Element	of	Subject Device	Predicate Device	SE
Comparison				Comparison
		test data to the display modulethrough the control module. Iffailure occurs, the respectivecode will be displayedaccordingly as prompt andalarm voice deliveredsimultaneously, which disablesall subsequent operationsautomatically.	condition deactivates thegenerator.
Operating		Only one output device to beactivated at any given time	Only one output device to beactivated at any given time	Same

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Difference further discussion

Items	Further discussion
Working, storageand transportationparameters(1,2 different)	These data is to specify the conditions of working, transportation and storage, fordifferent device, the internal circuit design and components choosing are different, sothey also have similar difference on working or storage conditions. But thetemperature, RH and atmospheric pressure are approximate and complied with thenormal conditions, so it can be deemed as the substantially equivalence.
Fuses(3. different)	The model selection of fuse is according to the maximum current that maybe present,and the function is to protect the unit. The different device has the different maximuminput current, accordingly with the different fuse parameter, but these factors do notaffect the actual application.
Input power(4. different)	The design of input voltage is according to the supply voltage of the local country orstate. Our parameter 120/230V, 60Hz/50Hz is applied to America and Europe, andmoreover, there is a permission of ±10% fluctuation, thus the subject device is actuallythe same as predicated ones.
Output mode(5. different)	Both the subject device and predicated ones have monopolar CUT, monopolar COAGand BIPOLAR. Both of them are sinusoid as well as a similar output power under thesame output mode, accordingly with the similar crest factor;For maximum power difference, Thermal effect testing was evaluated between subjectdevice and predicate device with comparable power and model setting, thecomparison shown that such minor difference will not affect the safety.So the delicate differences have no influence on safety and performance.
Waveforms(6. different)	The frequency is above 200 kHz, belong to High frequency range based on IEC60601-2-2 Requirement; The related waveform of FW-350A and Force Fx are mainly with thesame shape, the slight differences are because of respective design parameter, whichhave no influence in the actual application process. And through the thermal damagezone testing, Thermal effect was evaluated and compared between predicate deviceand subject device.
Items	Further discussion
	So such minor difference on waveform would not affect the safety and effectiveness
Power consumption(7. different)	It means the power absorbed by the unit itself, for different unit has differentconsumption. The lower consumption, the more power saving, however, more or lessof this parameter, doesn't impact the output effect on patients.
Output frequency(8. different)	The output frequency of subject device and predicated devices are more than 200kHz,so both of them are met the requirements of high frequency electrosurgical equipment.
Current(9. different)	The results were obtained from actual testing, and are very similar with the predicatedevice, furthermore, these data has no influence on application.
Compatibility(10. different)	It specifies the choosing of applied accessories, which as a safety information suppliedto inform user that the rated voltage of accessories must greater than unit Vpeak.Therefore, this data has no influence on normal output. (Please refer to IEC60601-1and IEC60601-2-2 test reports).
Open circuit Vp-p(max)(11. different)	The effect of each operational modes is determined by their frequency, waveforms,output power and Vp-p, even there is difference for Vp-p of the subject and predicatedevice, but it can still obtain the same effect by adjusting other parameters. CUT andBIPOLAR modes are small difference on Vp-p of the subject and predicate device, sowe can adjust the output power to obtain the same effect. However, the COAG modesVp-p of predicate device is much more than subject device, especially for the spraymode is very high of the Vp-p, it really can obtain a rapidly hemostasis for a large areableeding by its powerful spark, but a patient burnt is often caused by this fierce sparkdue to user mistakes or inexpert operation, considering this factor, we improved onFW-350A to reduce the Vp-p under the condition of ensuring the same effect so as toincrease the application safety.
CQMS(12. different)	FW-350A (CQMS): Alarm range: > 113ohms (a split ESU pad used);Force Fx (REM): Alarm range < 5ohms or ≥ 135ohms (a split ESU pad used);CQMS can monitor the contact quality of ESU pad to patient;REM can not only monitor the contact quality but also detect whether a solid ESU padwas being used.We have already informed there is a split ESU pad recommended to be used, thatmarked clearly in the Instruction for use. So this difference cannot influence the safetyand effectiveness of our FW-350A.
PPS/IRT(13. similar)	The PPS and IRT were proved as the similar functions.
Memory(14. different)	They are Substantially equivalence.
Power ON selfdiagnostics(15. different)	Force Fx: power On self diagnostics activated to perform a self test by turn of Bipolarmode, CUT mode, COAG mode, if there was any trouble, the related Error code wouldbe displayed;FW-350A: power On self diagnostics activated to perform a selfish test by turn of CUTmode, COAG mode, Bipolar mode, if there was any trouble, the related Error codewould be displayed;So, the difference is test sequence and Error code, both the subject device andpredicate device have the same purpose to ensure the unit is came into a normal idle
Items	Further discussion
	mode. Therefore, they are Substantially equivalent

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Substantially equivalence Conclusion:

Electrosurgical Generator- Model FW-350A has been carefully compared to legally marketed devices with respect to intended use, essential components, dimension and weight, safety and EMC performance, special functions and performance specifications. They are same in intended use, essential components, function and working theories, and they are identical in physical specification and special functions as well as performance specifications. The safety and performance tests have been done to validate the safety and performance of the device.

Although the FW-350A is slightly differ from the predicate devices as above described, after further discussing we can conclude that it won't affect the effectiveness and safety of the proposed device. Accordingly, we can come to conclusion that the proposed device and predicate devices are substantial equivalence

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.