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

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.

AI/ML Overview

This document concerns the 510(k) premarket notification for the ArtiSential Laparoscopic Instruments-Electrodes. This is a medical device for electrosurgical cutting and coagulation and is a Class II device. The document is a Special 510(k) Summary, indicating that the device has minor modifications compared to a previously cleared predicate device (K200875).

Here's an analysis of the acceptance criteria and study information provided, focusing on what's available in the document:

1. A table of acceptance criteria and the reported device performance:

The document describes performance tests as having been conducted and met, but it does not provide specific quantitative acceptance criteria or detailed reported performance values in a table. Instead, it states that "The device had passed all performed tests" and "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."

The types of performance tests mentioned are:

Acceptance Test Category	Reported Device Performance
Appearance	Passed
Dimension	Passed
Operational test	Passed
Tensile strength	Passed
Feedthrough test	Passed
Grasping Force	Passed
Force to jaw failure	Passed

In addition, the following characteristics were declared the same as the predicate device (K200875):

Biocompatibility: Same as predicate.
Electrical Safety: Tested according to IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-18 and IEC 60601-2-2. Active accessory insulation, HF leakage, HF dielectric strength, and mains frequency dielectric strength, and feedthrough test were reportedly performed and are the same as the predicate.
Sterilization: EO (Ethylene Oxide) sterilization, same as predicate.
Shelf life: 2 years, same as predicate.

2. Sample size used for the test set and the data provenance:

The document does not specify the sample size used for the performance tests. There is no information regarding the provenance of the data (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable and not provided. The device is a surgical instrument, and its performance tests are primarily objective physical, electrical, and mechanical evaluations, not diagnostic assessments requiring expert ground truth for interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable and not provided as the tests are objective engineering evaluations, not subjective assessments requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable and not provided. This is a surgical instrument, not an AI-assisted diagnostic device, so MRMC studies or AI assistance effect sizes are not relevant.

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

This information is not applicable and not provided. This is a manually operated surgical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

This is not applicable in the sense of clinical ground truth for diagnostic accuracy since the device is a surgical instrument. The "ground truth" for the performance tests would be established by engineering specifications, regulatory standards (e.g., IEC standards for electrical safety), and industry best practices for mechanical and functional performance testing of such devices.

8. The sample size for the training set:

This information is not applicable and not provided as this is a physical medical device, not a machine learning algorithm requiring a training set.

9. How the ground truth for the training set was established:

This information is not applicable and not provided (see point 8).

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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, 13516Seongnam-si, Gyeonggi-do, Republic of KoreaTel) +82-70-4282-7652Fax) +82-31-706-3211
Contact Person:	Dong Wook Lee / QMR(Quality Management Representative)
Address:	#304, D-dong, 700, Pangyo-ro, Bundang-gu, 13516Seongnam-si, Gyeonggi-do, Republic of KoreaTel) +82-70-7709-4993Fax) +82-31-706-3211Email) dongwook.livsmed@gmail.com
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 -Electrodes	K200875

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4. Device Description

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)Number	K220384	K200875	N/A
Manufacture	LivsMed, Inc.	LivsMed, Inc.	Same
Device Name	ArtiSential LaparoscopicInstruments-Electrodes	ArtiSential LaparoscopicInstruments-Electrodes	Same
ClearanceDate	N/A	06-17-2020	N/A
Classification/ Regulation	Class 2 / 878.4400	Class 2 / 878.4400	Same
Product Code	GEI	GEI	Same
Intended for	Prescription Use	Prescription Use	Same
Indicationsfor Use	Electrosurgicalcoagulation, dissection, andgrasping of tissue duringthe performance oflaparoscopic and generalsurgical procedures.	Electrosurgicalcoagulation, dissection,and grasping of tissueduring the performance oflaparoscopic and generalsurgical procedures.	Same
Principles ofoperation	This product is a single-useinstrument used inelectrosurgical units to holdsoft tissues or coagulateand make an incision(tissue dissection) duringgeneral laparoscopicsurgery, which uses theprinciple of applying high-frequency currents from the	This product is a single-use instrument used inelectrosurgical units tohold soft tissues orcoagulate and make anincision (tissue dissection)during generallaparoscopic surgery,which uses the principle ofapplying high-frequency	Same

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Energy Type	electrode to the humanbody to generate heat bybioimpedance when radiofrequency (RF) energyfrom the electrosurgicalunit applies an electriccurrent to the electrodepart, and using thegenerated heat to incisecellular tissues and causecoagulation.It is composed of a jaw, Φ8diameter shaft, grip(including a control ring),and electrosurgical unitconnection electrodeconnector.During a procedure withthis product, the jaw opensif the control ring opens,and jaw closes if thecontrol ring closes. Inaddition, the jaw is alsobent up, down, left andright within a range of ±80°or more by moving the gripup, down, left and right,and the jaw can also turn360° when rotating thegrip.	currents from the electrodeto the human body togenerate heat bybioimpedance when radiofrequency (RF) energyfrom the electrosurgicalunit applies an electriccurrent to the electrodepart, and using thegenerated heat to incisecellular tissues and causecoagulation.It is composed of a jaw, Φ8 diameter shaft, grip(including a control ring),and electrosurgical unitconnection electrodeconnector.During a procedure withthis product, the jaw opensif the control ring opens,and jaw closes if thecontrol ring closes. Inaddition, the jaw is alsobent up, down, left andright within a range of±80° or more by movingthe grip up, down, left andright, and the jaw can alsoturn 360° when rotatingthe grip.
Electrodetype(monopolaror bipolar)	RadiofrequencyBipolar	RadiofrequencyBipolar	Same
Control ringtype	Standard, Adjustable (TypeA, B)	Standard, Adjustable(Type A)	Equivalent
Physicaldimensionsand design(size, length)	- Shaft diameter: 8mm- Shaft Length: 250mm,380mm, 450mm	- Shaft diameter: 8mm- Shaft Length: 250mm,380mm, 450mm	Same
Ratedvoltage	200Vp	200Vp	Same
Materials(electrode)	Stainless steel	Stainless steel	Same
Materials(insulation)	Polyetherimide	Polyetherimide	Same
Materials(Shaft)	Glass fiber	Glass fiber	Same
Articulatingfeature		Pitch:±80° or more,Yaw:±80° or more andOpen Close	Open-Close	Pitch:±80° or more,Yaw:±80° or more andOpen 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.

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.