ArtiSential Laparoscopic Instrument-Electrodes

K200501 · Livsmed, Inc. · GEI · May 11, 2020 · General, Plastic Surgery

Device Facts

• Record ID: K200501
• Device Name: ArtiSential Laparoscopic Instrument-Electrodes
• Applicant: Livsmed, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: May 11, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ArtiSential Laparoscopic Instruments-Electrodes, Monopolar Series are indicated for cutting and coagulation in endoscopic, gynecological, and general abdominal and thoracic and general laparoscopic procedures.

Device Story

Sterile, single-use laparoscopic instrument; used in endoscopic, gynecological, abdominal, and thoracic surgeries. Device consists of end-tip (hook or spatula), 8mm diameter shaft, grip, and electrosurgical unit connection plug. Operates by applying high-frequency RF current from electrosurgical unit to electrode, generating heat via bioimpedance to incise and coagulate tissue. Surgeon manipulates grip to articulate end-tip (pitch/yaw ±80°) and rotate 360°. Device connects to standard electrosurgical power source via cable. Provides surgeon with precise tissue dissection and coagulation capabilities during minimally invasive procedures, potentially reducing trauma and improving surgical outcomes.

Clinical Evidence

Bench testing only. Included biocompatibility (ISO 10993-1), electrical safety (IEC 60601 series), and performance testing (appearance, dimension, operational, tensile strength, feedthrough). Thermal effects evaluated in a porcine model (liver, kidney, abdominal muscle) to confirm safe and effective tissue interaction.

Technological Characteristics

Monopolar electrosurgical instrument; 8mm shaft diameter; lengths 250mm, 380mm, 450mm. Materials: stainless steel (electrode), polyetherimide/zirconia (insulation), glass fiber (shaft). Articulation: pitch/yaw ±80°, 360° rotation. Energy: RF. Sterilization: EO (ISO 11135).

Indications for Use

Indicated for cutting and coagulation in endoscopic, gynecological, and general abdominal and thoracic and general laparoscopic procedures.

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

• SILSTM L-Hook (K091869)

Reference Devices

• ArtiSential Bipolar Fenestrated Forceps (K190909)
• Laparoscopic Electrodes & Monopolar cables (K142868)

Submission Summary (Full Text)

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May 11, 2020

LivsMed Inc. Dong Wook Lee Ouality Management Representative #304, D-dong, 700, Pangyo-ro, Bundang-gu Seongnam-si. Gyeonggi-do. Republic of Korea 13516

Re: K200501

Trade/Device Name: ArtiSential Laparoscopic Instrument-Electrodes Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: March 16, 2020 Received: March 17, 2020

Dear Dong Lee:

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.

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K200501

Device Name

ArtiSential Laparoscopic Instruments-Electrodes

Indications for Use (Describe)

ArtiSential Laparoscopic Instruments-Electrodes, Monopolar Series are indicated for cutting and coagulation in endoscopic, gynecological, and general abdominal and thoracic and general laparoscopic procedures.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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# 1. General Information

| Applicant/Submitter: | LivsMed Inc. |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | #304, D-dong, 700, Pangyo-ro, Bundang-gu, 13516<br>Seongnam-si, Gyeonggi-do, Republic of Korea<br>Tel) [phone]<br>Fax) [phone] |
| Contact Person: | Dong Wook Lee / QMR<br>(Quality Management Representative) |
| Address: | #304, D-dong, 700, Pangyo-ro, Bundang-gu, 13516<br>Seongnam-si, Gyeonggi-do, Republic of Korea<br>Tel) [phone]<br>Fax) [phone]<br>Email) [e-mail] |
| Preparation Date: | 02-18-2020 |

# 2. Device Name and Code

| Device Trade Name | ArtiSential Laparoscopic Instruments-Electrodes |
|---------------------|------------------------------------------------------|
| Common Name | Electrosurgical Instruments |
| Classification Name | Electrosurgical, cutting & coagulation & accessories |
| Product Code | GEI |
| Regulation Number | 21 CFR 878.4400 |
| Classification | Class II |
| Review Panel | General & Plastic Surgery |

# 3. Predicate Devices

ArtiSential Laparoscopic Instruments-Electrodes, Monopolar Series are substantially equivalent to the following devices

Table 3.1 Predicate device

| Applicant | Device Name | 510(k) Number |
|-------------|---------------|---------------|
| Covidien LP | SILSTM L-Hook | K091869 |

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Table 3.2 Reference device

| Applicant | Device Name | 510(k) Number |
|------------------------------------------|-----------------------------------------------|---------------|
| Livsmed Inc. | ArtiSential Bipolar Fenestrated<br>Forceps | K190909 |
| Purple Surgical<br>International Limited | Laparoscopic Electrodes &<br>Monopolar cables | K142868 |

# 4. Device Description

This product is sterile, single-use, invasive instrument that used in laparoscopic surgery. There are two Version, one for Hook and Spatula. The two models are same except for jaw. This product is a specific component, but not the entire electrosurgical device. The device is not intended to be marketed with multiple components, accessories, and as part of a system.

## 5. Indications for Use

ArtiSential Laparoscopic Instruments-Electrodes, Monopolar Series are indicated for cutting and coagulation in endoscopic, gynecological, and general abdominal and thoracic and general laparoscopic procedures.

## 6. Technical Characteristics in Comparison to Predicate Devices

| | Proposed device | Predicate device | Equivalence |
|--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) Number | In process | K091869 | N/A |
| Manufacture | LivsMed, Inc. | Covidien LP | N/A |
| Device Name | ArtiSential Laparoscopic<br>Instruments-Electrodes | SILSTML-Hook | N/A |
| Clearance Date | N/A | 09-01-2009 | N/A |
| Classification /<br>Regulation | Class 2 / 878.4400 | Class 2 / 876.1500 | Equivalent |
| Product Code | GEI | GCJ | Equivalent |
| Intended for | Prescription Use | Prescription Use | Same |
| Indications for<br>Use | ArtiSential Laparoscopic<br>Instruments-Electrodes,<br>Monopolar Series are<br>indicated for cutting and<br>coagulation in<br>endoscopic,<br>gynecological, and<br>general abdominal and<br>thoracic and general<br>laparoscopic procedures. | The SILSTM L-Hook*<br>single use articulating<br>hook with monopolar<br>cautery has application in<br>endoscopic,<br>gynecological, and<br>general abdominal and<br>thoracic laparoscopic<br>procedures. When<br>connected by a standard<br>cable to an electrosurgical<br>power source, the device<br>may be utilized for<br>monopolar cautery. | Equivalent |
| Principles of<br>operation | It uses the principle of<br>applying high-frequency<br>currents from the<br>electrode to the human<br>body to generate heat by<br>bioimpedance when radio<br>frequency (RF) energy<br>from the electrosurgical<br>unit applies an electric<br>current to the electrode<br>part, and using the<br>generated heat to incise<br>cellular tissues and cause<br>coagulation.<br>It is composed of a end-<br>tip (hook or spatula type),<br>∅8 diameter shaft, grip<br>part, and electrosurgical<br>unit connection electrode<br>plug.<br>During a procedure with<br>this product, the end-tip is<br>bent up, down, left and<br>right within a range of<br>$\pm$ 80° or more by moving<br>the grip up, down, left<br>and right, and the end-tip<br>can also turn 360° when<br>rotating the grip. | SILS Hand instrument<br>contains a pistol grip, a<br>rigid shaft with an<br>articulating and rotating<br>end effector, and<br>opposing jaws or an<br>electrocautery hook at the<br>distal end.<br>The SILS Hook single use<br>articulating hook with<br>monopolar cautery has<br>application in endoscopic,<br>gynecological, and<br>general<br>abdominal and thoracic<br>laparoscopic<br>procedures. When<br>connected by a standard<br>cable to an electrosurgical<br>power source, the<br>device may be utilized for<br>monopolar cautery.<br>The hook administer<br>electrocautery. The end<br>effector of the instrument<br>articulates when the<br>handle is deflected<br>relative to the shaft and<br>rotates when a rotation<br>wheel is turned. | N/A |
| Energy Type | Radiofrequency | Radiofrequency | Same |
| Electrode type<br>(monopolar or<br>bipolar) | Monopolar | Monopolar | Same |
| End-tip type | Hook, Spatula | Hook | Same |
| Physical<br>dimensions and<br>design (size,<br>length) | - Shaft diameter: 8mm<br>- Shaft Length: 250mm,<br>380mm, 450mm | - Shaft diameter: 5mm<br>- Shaft Length: 360mm,<br>460mm | Different<br>(Shaft diameter of the<br>proposed device is<br>the same as reference<br>predicated device<br>(K190909).<br>The risk analysis for<br>shaft diameter and<br>length has been<br>completed) |
| Rated voltage | 3,933Vp | Not found | N/A |
| Materials<br>(electrode) | Stainless steel | Not found | N/A |
| Materials<br>(insulation) | Polyetherimide / Zirconia | Not found | N/A |
| Materials (Shaft) | Glass fiber | Not found | N/A |
| Articulating<br>feature | Pitch: $\pm$ 80° or more,<br>Yaw: $\pm$ 80° or more and<br>Open-Close | Pitch: $\pm$ 80°<br>Yaw: $\pm$ 80 | Same |
| Sterilization | EO | EO | Same |

Table 6.1 Predicate Device

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# Table 6.2 Reference Predicate Device

| | Proposed device | Reference<br>Predicate Device<br>1 | Reference<br>Predicate Device<br>2 | Equivalence |
|------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K)<br>Number | In process | K190909 | K142868 | N/A |
| Manufacture | LivsMed, Inc. | LivsMed, Inc. | Purple Surgical<br>International<br>Limited | N/A |
| Device Name | ArtiSential<br>Laparoscopic<br>Instruments-<br>Electrodes | ArtiSential<br>Bipolar<br>Fenestrated<br>Forceps | Laparoscopic<br>Electrodes &<br>Monopolar cables | N/A |
| Clearance<br>Date | N/A | 02-13-2020 | 11-21-2014 | N/A |
| Classification<br>/ Regulation | Class 2 / 878.4400 | Class 2 / 878.4400 | Class 2 / 878.4400 | Equivalent |
| Product Code | GEI | GEI | GEI | Equivalent |
| Intended for | Prescription Use | Prescription Use | Prescription Use | Same |
| Indications<br>for Use | ArtiSential<br>Laparoscopic<br>Instruments-<br>Electrodes,<br>Monopolar Series<br>are indicated for<br>cutting and<br>coagulation in<br>endoscopic,<br>gynecological, and<br>general abdominal<br>and thoracic and<br>general<br>laparoscopic<br>procedures. | Electrosurgical<br>coagulation,<br>dissection, and<br>grasping of tissue<br>during the<br>performance of<br>laparoscopic and<br>general surgical<br>procedures. | use in general<br>laparoscopic<br>surgery requiring<br>the use of<br>monopolar<br>electrosurgical<br>cutting and/or<br>coagulation | Equivalent |
| Principles of<br>operation | It uses the<br>principle of<br>applying high-<br>frequency currents<br>from the electrode<br>to the human body<br>to generate heat by<br>bioimpedance<br>when radio<br>frequency (RF)<br>energy from the<br>electrosurgical<br>unit applies an<br>electric current to<br>the electrode part,<br>and using the<br>generated heat to<br>incise cellular | This product is a<br>single-use<br>instrument used in<br>electrosurgical<br>units to hold soft<br>tissues or<br>coagulate and<br>make an incision<br>(tissue dissection)<br>during general<br>laparoscopic<br>surgery, which<br>uses the principle<br>of applying high-<br>frequency currents<br>from the electrode<br>to the human body<br>to generate heat by | Not found | N/A |
| Energy Type<br>Electrode type<br>(monopolar or<br>bipolar) | | | | |
| | tissues and cause<br>coagulation.<br>It is composed of a<br>end-tip (hook or<br>spatula type), Φ8<br>diameter shaft,<br>grip part, and | bioimpedance<br>when radio<br>frequency (RF)<br>energy from the<br>electrosurgical<br>unit applies an<br>electric current to | | |
| | electrosurgical<br>unit connection<br>electrode plug.<br>During a<br>procedure with<br>this product, the<br>end-tip is bent up,<br>down, left and | the electrode part,<br>and using the<br>generated heat to<br>incise cellular<br>tissues and cause<br>coagulation.<br>It is composed of a<br>jaw, Φ8 diameter | | |
| | right within a<br>range of ±80° or<br>more by moving<br>the grip up, down,<br>left and right, and<br>the end-tip can<br>also turn 360°<br>when rotating the | shaft, grip<br>(including a<br>control ring), and<br>electrosurgical<br>unit connection<br>electrode<br>connector.<br>During a<br>procedure with | | |
| | grip. | this product, the<br>jaw opens if the<br>control ring opens,<br>and jaw closes if<br>the control ring<br>closes. In addition,<br>the jaw is also | | |
| | | bent up, down, left<br>and right within a<br>range of ±80° or<br>more by moving<br>the grip up, down,<br>left and right, and<br>the jaw can also<br>turn 360° when | | |
| | | rotating the grip. | | |
| Radiofrequency<br>Monopolar | Radiofrequency<br>Bipolar | Radiofrequency<br>Monopolar | Same<br>N/A | |
| Physical<br>dimensions<br>and design<br>(size, length) | - Shaft diameter:<br>8mm<br>- Shaft Length:<br>250mm, 380mm,<br>450mm | - Shaft diameter:<br>8mm<br>- Shaft Length:<br>380mm | - Shaft diameter:<br>5mm<br>- Shaft Length:<br>330mm | Different<br>(Shaft diameter of<br>the proposed<br>device is the same<br>as reference<br>predicated device<br>(K190909).<br>The risk analysis<br>for shaft diameter<br>and length has<br>been completed) |
| Rated voltage | 3,933Vp | 200Vp | Not found | N/A |
| Materials (electrode) | Stainless steel | Stainless steel | Not found | Equivalent |
| Materials (insulation) | Polyetherimide /<br>Zirconia | Polyetherimide | Not found | Equivalent |
| Materials (Shaft) | Glass fiber | Glass fiber | Not found | Equivalent |
| Articulating feature | Pitch:±80° or<br>more,<br>Yaw:±80° or more<br>and Open-Close | Pitch:±80° or<br>more,<br>Yaw:±80° or more<br>and<br>Open-Close | N/A | Equivalent |
| Tip rotation | 360° | 360° | Not found | Equivalent |
| Sterilization | EO | EO | Radiation | Equivalent |

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## 7. Performance Data

- 7.1 Biocompatibility
The device has been evaluated for its biological safety according to ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process". Following endpoints have been assessed during the evaluation:

- Cytotoxicity -
- -Sensitization
- -Intracutaneous reactivity
- Acute systemic toxicity -

### 7.2 Electrical Safety

The ArtiSential Laparoscopic Instruments-Electrodes, Monopolar Series have been tested according to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-18 and IEC 60601-2-2. The test setup included:

- -Active accessory insulation
- Active accessory hf leakage -
- -Active accessory hf dielectric strength
- Active accessory mains frequency dielectric strength -
- -Feedthrough test

The device had passed all performed tests.

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- 7.3 Sterilization
ArtiSential Laparoscopic Instruments-Electrodes, Monopolar Series are provided sterile, intended to be single-use. This product is EO-Sterilization in accordance with ISO-11135.

- 7.4 Shelf life
The proposed expiration date is 2 years from the manufacturing date. The real-time testing will be performed to confirm the shelf-life for 3 years

- 7.5 Performance test
The device had passed all performed tests (Appearance, Dimension, Operational test, Tensile strength, Feedthrough test). Thermal effects were also performed, as recommended by the FDA guidance, Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery, within 3 pigs on Liver, kidney and abdominal muscle tissues. Results demonstrated the subject device can perform the intended use safely and effectively.

Based on these performance characteristics, the results demonstrate that the performance requirements were met, the device performs as intended and that the subject device has substantially equivalent performance characteristics to the predicate devices.

## 8. Substantial Equivalence

ArtiSential Laparoscopic Instruments-Electrodes. Monopolar Series indication for use is similar to the predicate device (K091869). The energy type, electrode type, sterilization as well as similar physical characteristics are the same. Although there are some minor differences with each product, these differences between the ArtiSential Monopolar Series and the predicate device do not raise new or different questions of safety and efficacy. There is no new technology and no difference that would raise new or different questions of safety or efficacy.

## 9. Conclusions

In conclusion, the comparison carried out covers all products, models, sizes, and the entire intended purpose of the device under evaluation. The subject device which is the ArtiSential Laparoscopic Instruments-Electrodes, Monopolar Series are considerably similar to the predicate and reference devices in principles of operation, technological characteristics, as well as performance characteristics. The testing was conducted to evaluate the performance of subject device in comparison…