ArtiSential Laparoscopic Instruments-Electrodes

K220384 · Livsmed, Inc. · GEI · Feb 24, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K220384
• Device Name: ArtiSential Laparoscopic Instruments-Electrodes
• Applicant: Livsmed, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Feb 24, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ArtiSential Laparoscopic Instruments – Electrodes, Bipolar series are invasive instruments which is used with electrosurgical generator. They are intended to be used during laparoscopic surgical procedures for incision/coagulation (to electrocauterize, grasp and dissect tissue) during surgery.

Device Story

Sterile, single-use, invasive laparoscopic instruments; used with electrosurgical generator. Input: RF energy from electrosurgical unit. Operation: High-frequency current applied to electrode; bioimpedance generates heat for tissue incision and coagulation. Features: 8mm diameter shaft; articulating jaw (pitch/yaw ±80°); 360° rotation; controlled via grip/control ring. Used in laparoscopic/general surgery by surgeons. Output: Mechanical grasping/dissection and thermal coagulation. Benefits: Enables precise tissue manipulation and hemostasis in minimally invasive procedures.

Clinical Evidence

Bench testing only. No clinical data provided. Performance verified via appearance, dimension, operational, tensile strength, feedthrough, grasping force, and jaw failure testing. Electrical safety verified per IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-18, and IEC 60601-2-2.

Technological Characteristics

Bipolar electrosurgical instrument. Materials: Stainless steel (electrode), Polyetherimide (insulation), Glass fiber (shaft). Dimensions: 8mm shaft diameter; 250mm/380mm/450mm lengths. Energy: RF (200Vp). Articulation: ±80° pitch/yaw; 360° rotation. Sterilization: Ethylene Oxide (EO).

Indications for Use

Indicated for electrosurgical coagulation, dissection, and grasping of tissue during the performance of laparoscopic and general surgical 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

• ArtiSential Laparoscopic Instruments - Electrodes (K200875)

Submission Summary (Full Text)

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February 24, 2022

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

Re: K220384

Trade/Device Name: ArtiSential Laparoscopic Instruments-Electrodes Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: February 8, 2022 Received: February 10, 2022

Dear Dong Wook 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.

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

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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 (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-devices/medical-device-safety/medical-device-reporting-mdr-howreport-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) 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-devices/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 Quality Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K220384

Device Name

ArtiSential Laparoscopic Instruments-Electrodes

Indications for Use (Describe)

Indications for use include electrosurgical coagulation, dissection, and grasping of tissue during the performance of laparoscopic and general surgical 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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# Special 510(k) Summary

## 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: | 08-02-2022 |

## 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, Bipolar Series are substantially equivalent to the following devices

Table 3.1 Predicate device

| Applicant | Device Name | 510(k) Number |
|--------------|------------------------------------------------------|---------------|
| LivsMed Inc. | ArtiSential Laparoscopic Instruments -<br>Electrodes | K200875 |

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## 4. Device Description

The ArtiSential Laparoscopic Instruments - Electrodes, Bipolar series are sterile, single-use, invasive instruments that used in laparoscopic surgery. There are three versions, ABF01 series and ABD02 series. Three versions are same except for jaw shape. 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 / Intended Use

#### 5.1 Intended Use

The ArtiSential Laparoscopic Instruments – Electrodes, Bipolar series are invasive instruments which is used with electrosurgical generator. They are intended to be used during laparoscopic surgical procedures for incision/coagulation (to electrocauterize, grasp and dissect tissue) during surgery.

- 5.2 Indications for use
Indications for use include electrosurgical coagulation, dissection, and grasping of tissue during the performance of laparoscopic and general surgical procedures.

## 6. Technical Characteristics in Comparison to Predicate Devices

Table 6.1 Predicate Device

| | Proposed device | Predicate Device | Equivalence |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| 510(K)<br>Number | K220384 | K200875 | N/A |
| Manufacture | LivsMed, Inc. | LivsMed, Inc. | Same |
| Device Name | ArtiSential Laparoscopic<br>Instruments-Electrodes | ArtiSential Laparoscopic<br>Instruments-Electrodes | Same |
| Clearance<br>Date | N/A | 06-17-2020 | N/A |
| Classification<br>/ Regulation | Class 2 / 878.4400 | Class 2 / 878.4400 | Same |
| Product Code | GEI | GEI | Same |
| Intended for | Prescription Use | Prescription Use | Same |
| Indications<br>for Use | Electrosurgical<br>coagulation, dissection, and<br>grasping of tissue during<br>the performance of<br>laparoscopic and general<br>surgical procedures. | Electrosurgical<br>coagulation, dissection,<br>and grasping of tissue<br>during the performance of<br>laparoscopic and general<br>surgical procedures. | Same |
| Principles of<br>operation | This product is a single-use<br>instrument used in<br>electrosurgical units to hold<br>soft tissues or coagulate<br>and make an incision<br>(tissue dissection) during<br>general laparoscopic<br>surgery, which uses the<br>principle of applying high-<br>frequency currents from the | This product is a single-<br>use instrument used in<br>electrosurgical units to<br>hold soft tissues or<br>coagulate and make an<br>incision (tissue dissection)<br>during general<br>laparoscopic surgery,<br>which uses the principle of<br>applying high-frequency | Same |

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| Energy Type | 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 jaw, Φ8<br>diameter shaft, grip<br>(including a control ring),<br>and electrosurgical unit<br>connection electrode<br>connector.<br>During a procedure with<br>this product, the jaw opens<br>if the control ring opens,<br>and jaw closes if the<br>control ring closes. In<br>addition, the jaw is also<br>bent up, down, left and<br>right within a range of ±80°<br>or more by moving the grip<br>up, down, left and right,<br>and the jaw can also turn<br>360° when rotating the<br>grip. | currents from the electrode<br>to the human body to<br>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 jaw, Φ8 diameter shaft, grip<br>(including a control ring),<br>and electrosurgical unit<br>connection electrode<br>connector.<br>During a procedure with<br>this product, the jaw opens<br>if the control ring opens,<br>and jaw closes if the<br>control ring closes. In<br>addition, the jaw is also<br>bent up, down, left and<br>right within a range of<br>±80° or more by moving<br>the grip up, down, left and<br>right, and the jaw can also<br>turn 360° when rotating<br>the grip. | | | | | |
|--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|--|-----------------------------------------------------------|------|--|
| Electrode<br>type<br>(monopolar<br>or bipolar) | Radiofrequency<br>Bipolar | Radiofrequency<br>Bipolar | Same | | | | |
| Control ring<br>type | Standard, Adjustable (Type<br>A, B) | Standard, Adjustable<br>(Type A) | Equivalent | | | | |
| Physical<br>dimensions<br>and design<br>(size, length) | - Shaft diameter: 8mm<br><br>- Shaft Length: 250mm,<br>380mm, 450mm | - Shaft diameter: 8mm<br><br>- Shaft Length: 250mm,<br>380mm, 450mm | Same | | | | |
| Rated<br>voltage | 200Vp | 200Vp | Same | | | | |
| Materials<br>(electrode) | Stainless steel | Stainless steel | Same | | | | |
| Materials<br>(insulation) | Polyetherimide | Polyetherimide | Same | | | | |
| Materials<br>(Shaft) | Glass fiber | Glass fiber | Same | | | | |
| Articulating<br>feature | | Pitch:±80° or more,<br>Yaw:±80° or more and<br>Open Close | Open-Close | | Pitch:±80° or more,<br>Yaw:±80° or more and<br>Open Close | Same | |
| Tip rotation | 360° | 360° | Same | | | | |
| Sterilization | EO | EO | Same | | | | |

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The difference between the Predicate device and the Proposed device is the type of control ring. The difference between adjustable control ring type A and B is the position of the control ring. The raw materials of the control ring type A and B are the same and are biologically equivalent because they are non-contact part of the human body. In addition, comparative performance tests between A type and B type models were conducted, and there are no new technology and no difference that would raise new or different questions of safety or efficacy.

## 7. Performance Data

- 7.1 Biocompatibility
The characteristics associated with biocompatibility are the same as in the predicate device K200875.

### 7.2 Electrical Safety

The ArtiSential Laparoscopic Instruments-Electrodes, Bipolar Series(Predicate device; K200875) have been tested according to IEC 60601-1-2, 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 characteristics associated with electrical safety are the same as in the predicate device K200875.

#### 7.3 Sterilization

ArtiSential Laparoscopic Instruments-Electrodes, Bipolar Series are provided sterile, intended to be single-use. This part is same with the predicate device K200875.

- 7.4 Shelf life
The proposed expiration date is 2 years from the manufacturing date. These characteristics are same with the predicate device K200875.

#### 7.5 Performance test

The device had passed all performed tests.

- Appearance -
- Dimension -
- Operational test -
- Tensile strength -
- -Feedthrough test
- Grasping Force -
- Force to jaw failure -

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

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substantially equivalent performance characteristics to the predicate devices.

## 8. Substantial Equivalence

ArtiSential Laparoscopic Instruments-Electrodes, Bipolar Series indication for use is same to the predicate device (K200875). The energy type, electrode type, sterilization as well as physical characteristics are the same. Although there are some minor differences with each product, these differences between the ArtiSential Bipolar 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, Bipolar Series are same to the predicate device in principles of operation, technological characteristics, as well as performance characteristics. The testing was conducted to evaluate the performance of subject device in comparison to the predicate device. Results of validation and verification activities in design control that include testing/certification to designated standards and performance testing of the devices has demonstrated substantial equivalence of the subject device to the predicate in terms of safety and effectiveness for requested intended use.