Electrosurgical Generator

K183564 · Fulwell, LLC · GEI · Jun 13, 2019 · General, Plastic Surgery

Device Facts

• Record ID: K183564
• Device Name: Electrosurgical Generator
• Applicant: Fulwell, LLC
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jun 13, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Electrosurgical generator (Model FW-350A) performs monopolar and bipolar electrosurgical cutting and coagulation. Monopolar mode uses ESU pencil and return electrode pad; bipolar mode uses forceps for localized hemostasis. Device features Contact Quality Monitoring System (CQMS) to monitor pad-to-patient resistance and cut output if pad contact is lost; Power Performance System (PPS) for consistent output at start of activation; and Power ON self-diagnostics. Operated by surgical staff in OR; provides high-frequency electrical energy to tissue. Output settings and error codes displayed on high-definition screen. Benefits include reduced tissue damage in bipolar mode and improved safety via automated monitoring and self-testing. Device is reusable and non-sterile.

Clinical Evidence

No clinical data. Bench testing only. Performance validated via system performance/waveform output tests and thermal effect testing (histology) on ex vivo porcine muscle, liver, and kidney tissues to assess thermal damage zones. Safety and EMC compliance verified against IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2.

Technological Characteristics

High-frequency electrosurgical generator; 350W max power; 330-460 kHz working frequency. Class I, Type CF defibrillator-proof equipment. Features microprocessor-based control, CQMS, and PPS. Connectivity: standalone. Sterilization: N/A (non-sterile). Software version 350AV1.1.

Indications for Use

Indicated for use in surgical operations requiring monopolar and bipolar electrosurgical cutting and coagulation. Suitable for general surgical procedures, including brain surgery, microsurgery, ophthalmology, otorhinolaryngology, and gynecological surgery (specifically ligation of small vessels <4mm).

Regulatory Classification

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.

Predicate Devices

• Valleylab Force Fx (K944602)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

| | X Prescription Use (Part 21 CFR 801 Subpart D)<br>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: [phone] Post code: 33142 Contact Person: Mrs Perla Melisa Mcliberty E-mail: [e-mail]

# 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: [phone] Email: [e-mail]

# 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

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.

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 the<br>operating temperature range, allow one hour for the<br>generator 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:

1) IEC 60601-1: 2012: Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance

2) IEC60601-1-2: 2014: Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance. Collateral Standard: Electromagnetic Compatibility

3) 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.

1) System Performance and waveform outputs test.

2) 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.

- 3) 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.

| Element<br>of<br>Comparison | Subject Device | Predicate Device | SE<br>Comparison | |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| 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 | |
| Element<br>of | | Subject Device | Predicate Device | SE<br>Comparison |
| 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 |
| Physical<br>Specification | Appearance | Image: ESU generator FW-350A | Image: Valleylab Force Fx | N/A |
| Element of<br>Comparison | | Subject Device | Predicate Device | SE<br>Comparison |
| | Essential<br>components | Chassis and Cover, Front<br>panel controls, Power supply<br>board,<br>Microprocessor<br>board,<br>Footswitch board,<br>Interface circuits, Front panel<br>receptacles. | Chassis and Cover, Front panel<br>controls, Power supply board,<br>Microprocessor<br>board,<br>Footswitch board,<br>Interface<br>circuits, Front<br>panel<br>receptacles. | Same |
| | Energy | HF energy | HF energy | Same |
| | Dimensions<br>and weight | 43cm(L)×38cm(W)×16.5(H),<br>Weight:7kg | 35.6cm(L)×43.9cm(W)×11.1(H),<br>Weight<10.9kg | NA |
| | Working<br>condition | Circumstance Temperature :<br>5~40 C°<br>Relative Humidity : ≤80%<br>Atmospheric<br>Pressure:<br>86.0~106.0 Кра. | Circumstance Temperature :<br>10~40 C°<br>Relative Humidity : 30 ≤RH≤<br>95%<br>Atmospheric<br>Pressure:<br>70.0~106.0 kPa. | 1.Minor<br>Different |
| | Transport and<br>Storage | Ambient temperature :<br>-40C° to +55C°<br>RH≤80 %<br>Atmospheric<br>pressure:<br>50kPa to 106kPa | Ambient temperature :<br>-40C° to +70C°<br>RH:10% to 100%,<br>non<br>condensing<br>Atmospheric pressure:<br>50kPa to 106kPa | 2. Minor<br>Different |
| | Fuses | Two, 6A | Two, 8A | 3.Minor<br>Different |
| | Safety<br>performance | Conforming with<br>ES60601-1 ;IEC 60601-2-2 ; | Conforming with<br>IEC 60601-1 ;IEC 60601-2-2 ; | Same |
| | EMC<br>performance | IEC60601-1-2 | IEC60601-1-2 | Same |
| | Sterility | Not applicable | Not applicable | Same |
| | Display | Huge High-definition digital<br>display | Power and Err display with huge<br>high-definition digital on the<br>display screen | Same |
| | Input power | 120V/230V, 60Hz/50Hz | 100-120V/220-240V,<br>60Hz/50Hz | 4.Minor<br>Different |
| | Output mode | CUT:<br>Pure cut:<br>350Wmax,<br>Load:500Ω,<br>Crest<br>factor:1.6<br>Blend 1(macro):<br>250Wmax, Load:500Ω,<br>Crest<br>factor:1.8 | CUT:<br>Low cut: 300Wmax, Load:300Ω,<br>Crest factor:1.5<br>Pure cut: 300Wmax, Load:300Ω,<br>Crest factor:1.5<br>Blend:<br>200Wmax,<br>Load:300Ω, | 5. Minor<br>Different |
| Element<br>of<br>Comparison | Subject Device | Predicate Device | SE<br>Comparison | |
| | Blend 2(micro):<br>150Wmax, Load:500Ω, Crest<br>factor:2.4<br><br>COAG:<br>COAG1(Spray):<br>120Wmax, Load:500Ω, Crest<br>factor:7.2<br>COAG2(Forced):<br>100Wmax, Load:500Ω, Crest<br>factor:6.7<br>COAG3(Soft):<br>50Wmax, Load:500Ω, Crest<br>factor:4.7<br><br>BIPOLAR:<br>Bipolar1(macro):<br>100Wmax, Load:100Ω, Crest<br>factor:1.6<br>Bipolar2(micro):<br>100Wmax, Load:100Ω, Crest<br>factor:1.6 | Crest factor:2.5<br><br>COAG:<br>Low (Desiccate):<br>120Wmax, Load:500Ω,<br>Crest factor:5.0<br>Med (Fulgurate):<br>120Wmax, Load:500Ω,<br>Crest factor:7.0<br>High (Spray):<br>120Wmax, Load:500Ω,<br>Crest factor:8.0<br><br>BIPOLAR:<br>Low (Precise):<br>70Wmax, Load:100Ω, Crest<br>factor:1.5<br>Med (Standard):<br>70Wmax, Load:100Ω, Crest<br>factor:1.5<br>Macro:<br>70Wmax, Load:100Ω, Crest<br>factor:1.5 | | |
| CUT | Pure cut:<br>431kHz sinusoid, 100%duty<br>cycle;<br>Blend1:431kHz sinusoid at<br>50% duty cycle with a 32kHz<br>repetition rate;<br>Blend2:431kHz sinusoid at<br>70% duty cycle with a 32kHz<br>repetition rate. | Low: 390kHz sinusoid, 100%duty<br>cycle, similar to Pure cut mode<br>except the maximum voltage is<br>limited to a low er value;<br>Pure: 390kHz sinusoid with effect<br>mode, 100%duty cycle;<br>Blend: 390kHz bursts of sinusoid<br>recurring at 27kHz<br>intervals.50%duty cycle. | | |
| Waveforms | COAG<br>COAG1(Spray):<br>431kHz sinusoidal bursts with a<br>repetition frequency of 32kHz;<br>COAG2(Forced):<br>431kHz sinusoidal bursts with a<br>repetition frequency of 32kHz;<br>COAG3(Soft):<br>431kHz sinusoidal bursts with a<br>repetition frequency of 32kHz; | Low (Desiccate):<br>240kHz sinusoid repeated at<br>39kHz, 8% duty cycle;<br>Med (Fulgurate):<br>470kHz damped sinusoid bursts<br>with a repetition frequency of 30kHz<br>into 500ohms;<br>High (Spray):<br>470kHz damped sinusoidal bursts<br>with a randomized repetition<br>centered at 28kHz, frequencies<br>include 21kHz < f < 35kHz. Output is<br>further modulated by a random<br>250Hz envelop with a variable duty<br>cycle. | 6. Minor<br>Different | |
| | BIPOL<br>AR | Bipolar1(macro):<br>431kHz sinusoid, 100% duty<br>cycle;<br>Bipolar2(micro):<br>431kHz sinusoid, 100% duty<br>cycle; | Low (precise):<br>470kHz sinusoid, 100%duty cycle;<br>Med(standard):<br>470kHz sinusoid, 100%duty cycle;<br>Macro:<br>470kHz sinusoid, 100%duty cycle | |
| | Power | 880VA | 850VA | 7. Minor |
| Element<br>of<br>Comparison | Subject Device | Predicate Device | SE<br>Comparison | |
| | Output<br>frequency | 330~460KHz Sinusoid | 390~470KHz Sinusoid | Different |
| | Current<br>(120V) | Idle: 0.1Amax<br>Cut: 5.0A max<br>Coag:2.5Amax<br>Bipolar: 2.0A max | Idle:0.4A max<br>Cut: 7.0A max<br>Coag: 4.0A max<br>Bipolar: 2.0A max | 9. Minor<br>Different |
| | Compatibility | Vpeak=4500V | Vpeak=9000V | 10. Minor<br>Different |
| | Open circuit<br>Vp-p(max) | Monopolar CUT<br>Pure: 2120V<br>Blend1: 2720V<br>Blend2: 2200V<br>Monopolar COAG<br>COAG1(Spray):4500V<br>COAG2(Forced): 4150V<br>COAG3(soft): 2500V<br><br>Bipolar:<br>Bipolar1(macro): 500V<br>Bipolar2(micro):350V | Monopolar CUT<br>Low: 1350V<br>Pure: 2300V<br>Blend: 3300V<br>Monopolar COAG<br>Desiccate:3500V<br>Fulgurate: 8500V<br>Spray: 9000V<br><br>Bipolar:<br>Precise: 450V<br>Standard: 320V<br>Macro: 750V | 11. Minor<br>Different |
| | Operation<br>mode | Under maximum power settings<br>and rated load conditions (pure<br>cut350W, 500ohm load) the<br>generator is suitable for<br>activation times of 10seconds<br>on, 30seconds off for 1 hour. | Under maximum pow er settings and<br>rated load conditions (pure<br>cut300W, 300ohm load) the<br>generator is suitable for activation<br>times of 10seconds on, 30seconds<br>off for 1 hour. | Same |
| | CQMS | The ESU pad contact quality<br>monitor system (CQMS) will<br>measure the resistance<br>between the ESU pad and<br>patient, if the resistance was<br>beyond the defined upper limit,<br>the alarm system will be<br>activated. | Force FX (REM): The Return<br>Electrode Contact Quality Monitor<br>will measure the resistance, if the<br>resistance w as beyond the range of<br>defined by an upper and low er limit,<br>the alarm system will be activated. | 12. Minor<br>Different |
| Special Functions | PPS/Instant<br>response<br>technology | Automatically senses resistance<br>and adjusts the output voltage to<br>maintain a consistent effect<br>across different tissue density<br>(bipolar or cut modes only) | Automatically senses resistance<br>and adjusts the output voltage to<br>maintain a consistent effect across<br>different tissue density (bipolar or<br>cut modes only) | 13. Similar |
| | Memory | 10 memory settings, the<br>previous power setting digits<br>presented when restart | Recall the last activated<br>previous setting when Power On<br>next time by pressing RECALL | 14. Minor<br>Different |
| | Power ON self<br>diagnostics | In the self diagnosis process<br>after Power ON, all working<br>modes and functions operating<br>are simulated and monitored by<br>software control to determine<br>whether they are performed<br>normally, follow ed by<br>transmitting of corresponding | Force Fx: When the generator<br>senses a system alarm<br>conditions, an alarm sounds and<br>an alarm number is displayed on<br>the front panel. A system alam | 15. Minor<br>Different |
| Element | of | Subject Device | Predicate Device | SE |
| Comparison | | | | Comparison |
| | | test data to the display module<br>through the control module. If<br>failure occurs, the respective<br>code will be displayed<br>accordingly as prompt and<br>alarm voice delivered<br>simultaneously, which disables<br>all subsequent operations<br>automatically. | condition deactivates the<br>generator. | |
| Operating | | Only one output device to be<br>activated at any given time | Only one output device to be<br>activated at any given time | Same |

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# Difference further discussion

| Items | Further discussion |
|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Working, storage<br>and transportation<br>parameters<br>(1,2 different) | These data is to specify the conditions of working, transportation and storage, for<br>different device, the internal circuit design and components choosing are different, so<br>they also have similar difference on working or storage conditions. But the<br>temperature, RH and atmospheric pressure are approximate and complied with the<br>normal conditions, so it can be deemed as the substantially equivalence. |
| Fuses<br>(3. different) | The model selection of fuse is according to the maximum current that maybe present,<br>and the function is to protect the unit. The different device has the different maximum<br>input current, accordingly with the different fuse parameter, but these factors do not<br>affect the actual application.…