Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories)

K192342 · Hangzhou AGS MedTech Co., Ltd. · KNS · May 21, 2020 · Gastroenterology, Urology

Device Facts

• Record ID: K192342
• Device Name: Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories)
• Applicant: Hangzhou AGS MedTech Co., Ltd.
• Product Code: KNS · Gastroenterology, Urology
• Decision Date: May 21, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Electrosurgical Generator is intended to deliver High Frequency (HF) electrical current for the cutting and/or coagulation of tissue. Bipolar Polypectomy Snare Combination has been designed to be used with endoscope and electrosurgical unit for the removal of sessile polyps, pedunculated polyps, tissue and foreign bodies from within the GI tract using high-frequency current. Single Use Electrosurgical Knife Combination has been designed to be used with endoscopes and electrosurgical units to cut tissue within the digestive tract using high-frequency current.

Device Story

Electrosurgical system comprises generator, bipolar polypectomy snare, and electrosurgical knife. Generator delivers bipolar high-frequency current for tissue cutting/coagulation; output controlled via two-pedal footswitch. System uses proprietary software for energy delivery. Accessories (snare/knife) include distal attachment providing return path for bipolar current, eliminating need for patient neutral electrode. Used in endoscopic procedures; operated by physicians. Distal attachment increases contact area to reduce current density, preventing tissue burns. Benefits include precise tissue removal/cutting in GI tract with reduced risk of stray current injury compared to monopolar systems.

Clinical Evidence

No clinical data. Evidence consists of bench testing, electrical safety/EMC (IEC 60601), biocompatibility (ISO 10993), sterility (ISO 11135), and ex-vivo/in-vivo thermal effect on tissue studies.

Technological Characteristics

Bipolar electrosurgical generator (460 kHz output). Accessories: PTFE sheath, SUS304/SUS303 stainless steel electrodes. Distal attachment: TPE cap, SUS304/SUS303 components. Energy: Bipolar high-frequency current. Connectivity: Wired footswitch/cables. Sterilization: EO for accessories. Software: Proprietary generator control.

Indications for Use

Indicated for cutting and/or coagulation of tissue in the GI tract, including removal of sessile/pedunculated polyps, tissue, and foreign bodies, using high-frequency current via endoscope.

Regulatory Classification

Identification

An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.

Predicate Devices

• ERBE ESU Model VIO 300D with Accessories (K083452)
• Polypectomy snare (K172729)
• Single use Electrosurgical Knife Series (K092309)
• Single use Electrosurgical knife (K171158)

Submission Summary (Full Text)

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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.

May 21, 2020

Hangzhou AGS MedTech Co., Ltd. Chunqi Han R&D Director Building 5, Building 6, No.597 Kangxin Road Yuhang District Hangzhou, Zhejiang, 311106 CHINA

Re: K192342

> Trade/Device Name: Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories) Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: KNS Dated: August 23, 2019 Received: August 28, 2019

Dear Chunqi Han:

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 medical devices and radiation-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

Shani P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology 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)

#### K192342

#### Device Name

Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories)

#### Indications for Use (Describe)

Electrosurgical Generator is intended to deliver High Frequency (HF) electrical current for the cutting and/or coagulation of tissue.

Bipolar Polypectomy Snare Combination has been designed to be used with endoscope and electrosurgical unit for the removal of sessile polyps, pedunculated polyps, tissue and foreign bodies from within the GI tract using high-frequency current.

Single Use Electrosurgical Knife Combination has been designed to be used with endoscopes and electrosurgical units to cut tissue within the digestive tract using high-frequency current.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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K192342 Page 1 of 10

Image /page/3/Picture/1 description: The image shows the logo for AGS Medtech. The logo consists of a circular design with three curved shapes in blue and green. To the right of the circular design, the text "AGS MEDTECH" is written in English, followed by the same text in Chinese characters. The logo appears to be for a medical technology company.

Section 5 510(k) Summary Electrosurgical System

# 510(k) Summary

We submit this 510(k) Summary as per 21 CFR 807.92, it meets the content and format regulatory requirements.

# 5.1 Submitter

| Submitted by/Owner: | Hangzhou AGS MedTech Co., Ltd.<br>Building 5, Building 6, NO.597 Kangxin Road Yuhang<br>District, Hangzhou, Zhejiang 311106 China |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Establishment<br>Registration Number: | 3010288205 |
| Registration Status: | Active |
| Contact Person: | Yanping Fu<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared: | July 18, 2019 |

#### 5.2 Proposed Device

| Trade Name: | Electrosurgical System (Electrosurgical Generator with<br>Bipolar polypectomy snare combination and Single use<br>electrosurgical knife combination accessories) |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Electrosurgical System (Electrosurgical Generator with<br>Bipolar polypectomy snare combination and Single use<br>electrosurgical knife combination accessories) |
| Common Name: | Electrosurgical System |
| Regulation class: | Class II |
| Regulation Number: | 876.4300 |
| Regulation Description: | Endoscopic electrosurgical unit and accessories |
| Review Panel: | Gastroenterology/Urology |
| Product Code: | KNS |
| Product Code Name: | Unit, Electrosurgical, Endoscopic (With Or Without<br>Accessories) |

# 5.3 Predicate Device

| Trade Name: | ERBE ESU Model VIO 300D with Accessories |
|-------------------------|-----------------------------------------------------------------|
| Device Name: | ERBE ESU Model VIO 300D with Accessories |
| Common Name: | Electrosurgical Unit (ESU/Generator) System |
| 510(k) Number: | K083452 |
| Regulation class: | Class II |
| Regulation Number: | 21 CFR 878.4400 |
| Regulation Description: | Electrosurgical cutting and coagulation device and accessories. |

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K192342 Page 2 of 10

Image /page/4/Picture/1 description: The image shows a logo for AGS Medtech. The logo consists of a circular design with three blue curved shapes forming a triangle, with a green triangle in the center. To the right of the circular design, the text "AGS MEDTECH" is written in English, followed by "安杰思医学" in Chinese.

Section 5 510(k) Summary Electrosurgical System

| Review Panel: | General & Plastic Surgery |
|--------------------|------------------------------------------------------|
| Product Code: | GEI |
| Product Code Name: | Electrosurgical, Cutting & Coagulation & Accessories |

| Trade Name: | Polypectomy snare |
|-------------------------|-------------------------------------------------|
| Device Name: | Polypectomy snare |
| Common Name: | Polypectomy snare |
| 510(k) Number: | K172729 |
| Regulation class: | Class II |
| Regulation Number: | 21 CFR 876.4300 |
| Regulation Description: | Endoscopic electrosurgical unit and accessories |
| Review Panel: | Gastroenterology/Urology |
| Product Code: | FDI |
| Product Code Name: | Snare, Flexible |

| Trade Name: | Single use Electrosurgical Knife Series |
|-------------------------|-----------------------------------------------------------------|
| Device Name: | Single use Electrosurgical Knife Series |
| Common Name: | Electrosurgical Knife |
| 510(k) Number: | K092309 |
| Regulation class: | Class II |
| Regulation Number: | 21 CFR 876.4300 |
| Regulation Description: | Endoscopic electrosurgical unit and accessories |
| Review Panel: | Gastroenterology/Urology |
| Product Code: | KNS |
| Product Code Name: | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) |

| Trade Name: | Single use Electrosurgical knife |
|-------------------------|-----------------------------------------------------------------|
| Device Name: | Single use Electrosurgical knife |
| Common Name: | Single use Electrosurgical knife |
| 510(k) Number: | K171158 |
| Regulation class: | Class II |
| Regulation Number: | 21 CFR 876.4300 |
| Regulation Description: | Endoscopic electrosurgical unit and accessories |
| Review Panel: | Gastroenterology/Urology |
| Product Code: | KNS |
| Product Code Name: | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) |

# 5.4 Device Description

The Electrosurgical System comprises:

- ◆ Electrosurgical Generator;
- ◆ Bipolar polypectomy snare combination;

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K192342 Page 3 of 10

Image /page/5/Picture/1 description: The image shows the logo for AGS Medtech. The logo consists of a blue and green circular design on the left, with the text "AGS MEDTECH" and "安杰思医学" on the right. The circular design appears to be a stylized representation of three interconnected shapes, with the green shape in the center.

Section 5 510(k) Summary Electrosurgical System

Single use electrosurgical knife combination. �

The Electrosurgical Generator is designed to deliver bipolar high-frequency current for the purpose of cutting and coagulating tissue. It consists of High frequency generator, footswitch, bipolar connecting cable and power cord. The Electrosurgical Generator output is actuated via a two-pedal Footswitch. One pedal activated the bipolar high-frequency current output for cut; the other pedal activates the bipolar high-frequency current output for coagulation. The Electrosurgical Generator incorporates proprietary software developed by AGS for generating and controlling the two energies delivered. The Bipolar connecting cable connects electrosurgical instruments to the Electrosurgical Generator, it transfer electrical energy - without changing the energy - from devices to instruments. The Electrosurgical Generator, Footswitch, Bipolar connecting cable and Power cord are non-sterile and reusable.

Bipolar polypectomy snare combination is an accessory to Electrosurgical Generator. It is a sterile device consists of Polypectomy snare (Bipolar) and Distal attachment. It is for endoscopic use. It is used for removal of polyps within the digestive tract using high-frequency current. EO sterilization and use for single use only.

Single use electrosurgical knife combination is an accessory to Electrosurgical Generator. It is a sterile device consists of Single use electrosurgical knife and Distal attachment. It is for endoscopic use. It is used for cutting tissues within the digestive tract using high-frequency current. EO sterilization and use for single use only.

#### 5.5 Indication for use statement

Electrosurgical Generator is intended to deliver High Frequency (HF)

electrical current for the cutting and/or coagulation of tissue.

Bipolar Polypectomy Snare Combination has been designed to be used with endoscope and electrosurgical unit for the removal of sessile polyps, pedunculated polyps, tissue and foreign bodies from within the GI tract using high-frequency current.

Single Use Electrosurgical Knife Combination has been designed to be used with endoscopes and electrosurgical units to cut tissue within the digestive tract using high-frequency current.

#### 5.6 Comparison of Technology Characteristics

Our proposed device Electrosurgical System is substantially equivalent to the predicate devices. The differences between the Electrosurgical System and the predicate devices do not raise any questions regarding its safety and effectiveness. The differences are listed in the table below.

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Image /page/6/Figure/0 description: The image shows a logo for AGS Medtech. The logo consists of a blue circular design with a green triangle in the center. To the right of the logo, the text "AGS MEDTECH" is written in English, followed by the same name written in Chinese characters.

# 5.6.1 Electrosurgical Generator

| Difference | Proposed device | Predicate device<br>K083452 | Performance Testing |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Output parameters | CUT I:<br>Rated Output frequency: 460 kHz±10%;<br>Max. voltage output: 480Vp; | Bipolar CUT:<br>Rated Output frequency: 350kHz ±10%;<br>Max. voltage output: 740Vp; | Different rated output frequency, but in the range of<br>200k-500MHz;<br>Electrical safety reports.<br>Thermal Effect on Tissue study report;<br>The difference raises no new questions regarding<br>safety and efficacy. |
| | CUT II:<br>Working mode: Bipolar;<br>Rated Output frequency: 460 kHz±10%;<br>Rated Power: 120W±20%;<br>Max. voltage output: 650Vp;<br>Crest factor: 1.4~6.3 | ENDO CUT Q:<br>Working mode: Monopolar;<br>Rated Output frequency: 350kHz ±10%;<br>Rated Power: 400W+0%/-20%;<br>Max. voltage output: 770Vp;<br>Crest factor: 1.4 ( $RL=500Ω$ ) | Electrical safety reports.<br>Thermal Effect on Tissue study report;<br>Animal study report;<br>The difference raises no new questions regarding<br>safety and efficacy. |
| | CUT III:<br>Working mode:<br>Bipolar;<br>Rated Output frequency: 460kHz±10%;<br>Rated Power: 60W±20%;<br>Max. voltage output: 560Vp;<br>Crest factor: 1.9~7.6 | ENDO CUT I:<br>Working mode:<br>Monopolar;<br>Rated Output frequency: 350kHz ±10%;<br>Rated Power: 170W±20%;<br>Max. voltage output: 550Vp;<br>Crest factor: 1.4 ( $RL=500Ω$ ) | Electrical safety reports.<br>Thermal Effect on Tissue study report;<br>Animal study report;<br>The difference raises no new questions regarding<br>safety and efficacy. |
| | COAG I:<br>Rated Output frequency: 460 kHz±10%;<br>Rated load: 100Ω; | Bipolar Soft COAG:<br>Rated Output frequency: 350kHz ±10%;<br>Rated load: 75Ω; | Different rated output frequency, but in the range of<br>200k-500MHz;<br>Electrical safety reports.<br>Thermal Effect on Tissue study report; |
| Difference | Proposed device | Predicate device<br>K083452 | Performance Testing |
| | | | The difference raises no new questions regarding<br>safety and efficacy. |
| | COAG II:<br>Rated Output frequency: 460 kHz±10%; | Bipolar Forced COAG:<br>Rated Output frequency: 350kHz±10%; | Different rated output frequency, but in the range of<br>200k-500MHz;<br>Electrical safety reports.<br>Thermal Effect on Tissue study report;<br>The difference raises no new questions regarding<br>safety and efficacy. |

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Image /page/7/Figure/0 description: The image shows the logo for AGS Medtech. The logo consists of a circular design with three blue curved shapes and a green shape in the center. To the right of the logo is the text "AGS MEDTECH" in English, followed by the same name in Chinese characters. The text is in a simple, sans-serif font.

5.6.2 For Bipolar polypectomy snare combination

| Difference | Proposed device | Predicate device<br>K172729 | Performance Testing |
|------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Principles of<br>operation | Bipolar Polypectomy Snare Combination is an applied<br>part of electrosurgical generator, using bipolar<br>high-frequency current delivered by the<br>electrosurgical generator to cut and coagulate tissue<br>with the electrode.<br>We designed a diffusion electrode attached to the tip<br>of its sheath and an active electrode attached to the<br>electrode on the end of the sheath, and designed the<br>Distal Attachment to connect with the diffusion<br>electrode to provide a larger contact area. The<br>high-frequency electricity flows from the electrode to<br>the Distal Attachment. Distal Attachment provides a<br>return path for high-frequency current with a low | Monopolar Polypectomy Snare manufactured<br>is an applied part of electrosurgical generator,<br>using monopolar high-frequency current<br>delivered by the electrosurgical generator to<br>cut and coagulate tissue with the electrode.<br>The high-frequency electricity flows from the<br>active electrode to the neutral electrode placed<br>on patient skin. | Electrical safety reports.<br>Thermal effect on tissue study report.<br>The difference raises no new<br>questions regarding safety and<br>efficacy. |
| Difference | Proposed device | Predicate device<br>K172729 | Performance Testing |
| | current density and closer to the other electrode, to<br>reduce the area of human tissue where<br>high-frequency currents circulate and prevent the<br>occurrence of anticipated burns in human tissue. No<br>neutral electrode is needed. | | |
| Energy Use | Biopolar High-Frequency Current | Monopolar Radio Frequency Current | Electrical safety reports.<br>Thermal effect on tissue study report.<br>The difference raises no new<br>questions regarding safety and<br>efficacy. |
| Structure | Bipolar Polypectomy snare combination consists of<br>Polypectomy snare (Bipolar) and Distal Attachment.<br>Polypectomy snare (Bipolar) consists of Electrode,<br>External tube, Sheath tube, Base, Connector, Handle<br>and Conductor.<br>Distal Attachment consists of Plastic cap, Connect<br>piece, Metal tube and Connect tube. | Polypectomy snare consists of Electrode,<br>Sheath, Fixed/Rotary part, Sliding handle,<br>Connector plug and handle. | Bench testing report.<br>Thermal effect on tissue study report.<br>The difference raises no new<br>questions regarding safety and<br>efficacy. |
| Materials or<br>substances in<br>contact with the<br>same human tissue<br>or body fluids | 1. Polypectomy Snare (Bipolar):<br>Sheath: PTFE;<br>External tube:SUS304;<br>Electrode:SUS304;<br>2.Distal Attachment:<br>Plastic Cap: TPE;<br>Connect piece: SUS304; | Sheath: PTFE;<br>Electrode: SUS304; | Biocompatibility tests reports.<br>The difference raises no new<br>questions regarding safety and<br>efficacy. |
| Difference | Proposed device | Predicate device | Performance Testing |
| | | K172729 | |
| | Metal tube: SUS303; | | |
| | Connect tube:SUS304; | | |
| | 5.6.3 For Single use electrosurgical knife combination | | |
| Difference | Proposed device | Predicate device | Performance Testing |
| | | K171158; | |
| | | K092309; | |
| Principles of | AGS's Bipolar Electrosurgical Knife Combination is | Monopolar Single Use Electrosurgical Knife | Electrical safety reports. |
| operation | an applied part of electrosurgical generator, using | is an applied part of electrosurgical generator, | Thermal effect on tissue study report. |
| | bipolar high-frequency current delivered by the | using monopolar high-frequency current | difference raises no<br>The<br>new |
| | electrosurgical generator to cut and cauterize tissue | delivered by the | questions<br>regarding safety<br>and |
| | with the electrode. | electrosurgical generator to cut and cauterize | efficacy. |
| | The Bipolar Electrosurgical Knife Combination has | tissue with the electrode. The high-frequency | |
| | a diffusion electrode (named 'External tube') | electricity flows from the active electrode to | |
| | attached to the tip of its sheath and an active | the neutral electrode placed on patient skin. | |
| | electrode attached to the knife on the end of the | | |
| | sheath. The active electrode is used to perform cut | | |
| | and cauterize while the external tube provides a | | |
| | return path for bipolar high-frequency current. | | |
| | However, the contact area of External tube is so | | |
| | small, we design the Distal Attachment to provide a | | |
| | larger contact area. Distal Attachment is installed at | | |
| | the distal end of the endoscope, Bipolar Single Use | | |
| | Electrosurgical Knife pass through the channel of | | |
| | endoscope, connect tube of the Distal Attachment | | |
| Difference | Proposed device | Predicate device<br>K171158;<br>K092309; | Performance Testing |
| | connect with the External tube of the Bipolar Single<br>Use Electrosurgical Knife. The high-frequency<br>electricity flows from the knife to the Distal<br>Attachment. Distal Attachment provides a return<br>path for high-frequency current with a low current<br>density and closer to the other electrode, to reduce<br>the area of human tissue where high-frequency<br> | | |
| Energy Use | Biopolar High-Frequency Current | Monopolar Radio Frequency Current | Electric safety reports.<br>Thermal effect on tissue study report.<br>The difference raises no new<br>questions regarding safety and<br>efficacy. |
| Structure | Single use electrosurgical knife combination consists<br>of single use electrosurgical knife and distal<br>attachment. Single use electrosurgical knife consists<br>of electrode part, sheath part and handle part.<br>Distal Attachment consists of Plastic cap, Connect<br>piece, Metal tube and Connect tube. | Single use electrosurgical knife consists of<br>electrode part, sheath part and handle part. | Bench test report.<br>Thermal effect on tissue study report.<br>The difference raises no new<br>questions regarding safety and<br>efficacy. |
| Maximum insertion<br>portion diameter | $\Phi$ 2.4mm | KD-655 L: $\Phi$ 2.7mm;<br>KD-620LR: $\Phi$ 2.6mm; | Bench test report.<br>The difference raises no new<br>questions regarding safety and<br>efficacy. |
| Difference | Proposed device | Predicate device | Performance Testing |
| (mm) | | K171158;<br>K092309; | |
| Working Length | 5521: 1650mm,1950mm, 2300mm;<br>5522: 1650mm,1950mm;<br>5524: 1650mm,1950mm, 2300mm; | KD-612L: Φ2.6mm.<br>KD-655L: 1650mm;<br>KD-620LR: 1650mm;<br>KD-611IL: 1650mm; | questions regarding safety and efficacy. |
| Cutting knife length | 5521: 1.4mm, 2.1mm<br>5522: 4.0mm<br>5524: 3.0mm, 3.5mm | KD-655 L: 2.0mm;<br>KD-620LR: 4.5mm;<br>KD-611L: 4mm; | |
| Tip diameter | 5524: Ф1.2mm, Ф1.7mm…