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 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.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device: "ArtiSential Laparoscopic Instruments-Electrodes." This document primarily focuses on establishing substantial equivalence to a predicate device, as required by the FDA. As such, it details physical and electrical performance characteristics of the device rather than the results of a clinical study involving human or AI interpretation of medical images.

Therefore, many of the requested points regarding acceptance criteria for AI/human reader performance in a clinical setting, sample sizes for test sets in a clinical study, expert adjudication, MRMC studies, standalone AI performance, and ground truth establishment for training sets in AI models are not applicable or find no direct mention in this document.

The document discusses engineering and safety tests for a physical instrument, not a diagnostic AI system or a comparative study of human readers.

However, I can extract and present the acceptance criteria and performance data that are relevant to the described device and its specified tests:

Acceptance Criteria and Reported Device Performance for ArtiSential Laparoscopic Instruments-Electrodes

The device under review is an electrosurgical instrument, not an AI or imaging device requiring human reader studies. Therefore, the "acceptance criteria" and "device performance" relate to physical, electrical, and mechanical integrity and function, rather than diagnostic accuracy or human interpretation.

1. Table of Acceptance Criteria and Reported Device Performance

Test Clause and Test Requirement	Test Specification	Acceptance Criteria	Reported Device Performance
AppearanceNo defects in the appearance; no problem in use.	Visual observation	No crack, stain, or substances on the surface of the product.	"No crack, stain or no substances on the surface of the product" (Passed)
DimensionWithin ± 5% of the indicated dimensional value.	Measure by Vernier calipers and dial gauge etc.	Within ± 5% of the indicated value.	"Pass" (Referenced Attachment #11 for detailed test result, but summary states pass).
Operational testEnd-tip and hub can bend up, down, left, right above ±80° and rotate 360°.	Adjusting the end-tip by manipulating the grip and control ring and measure the angle.	End-tip and hub bend up, down, left, right within above 80° and rotate 360°.	"The end-tip and hub are bent up, down, left and right within above 80° and can rotate 360°." (Passed)
Tensile strengthEnd-tip and shaft connections shall not be damaged from pulling of 20 N.	Hold the end-tip and shaft connections respectively and apply a force of 20 N.	No damage to the connection when applying a force of 20N.	"No damage to the connection when applying a force of 20N" (Passed)
Feedthrough testElectricity should be transmitted between the electrode tip and the connector.	Electrical conduction between the electrode tip and the connector is tested using a DMM.	Resistance value between the electrode tip and the connector is less than 1Ω.	"The resistance value between the electrode tip and the connector is less than 1Ω" (Passed)
Biocompatibility (General safety evaluation)	ISO 10993-1	Acceptable results for cytotoxicity, intracutaneous reactivity, skin sensitization, acute systemic toxicity, pyrogenicity.	"The device has been evaluated for its biological safety according to ISO 10993-1... Following endpoints have been assessed... (all listed above)" (Implied passed for substantial equivalence)
Electrical Safety	IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-18, IEC 60601-2-2	Compliance with all relevant clauses for active accessory insulation, hf leakage, hf dielectric strength, mains frequency dielectric strength, and feedthrough.	"The device had passed all performed tests."
Sterilization	ISO 11135	Device provided sterile; single-use, EO-sterilization in accordance with ISO 11135.	"This product is EO-Sterilization in accordance with ISO-11135." (Passed)
Shelf-life (Proposed)	Not specified (real-time testing to be performed)	3 years from manufacturing date.	"The proposed expiration date is 3 years from the manufacturing date. The real-time testing will be performed to confirm the shelf-life for 3 years." (Ongoing/Proposed)

2. Sample size used for the test set and the data provenance:
The document does not refer to a "test set" in the context of clinical images or data provenance (e.g., country of origin, retrospective/prospective) because this device is a physical surgical instrument being evaluated for its engineering and safety characteristics. The tests described are laboratory and bench studies (e.g., measuring dimensions, tensile strength, electrical resistance) on samples of the manufactured device. Specific sample sizes for each test are not explicitly stated in this summary, but implied to be sufficient for engineering validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth and expert review in the context of diagnostic performance are irrelevant for the evaluation of this physical electrosurgical instrument. The "ground truth" for these tests is based on established engineering standards and physical measurements.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as this refers to adjudication of discrepancies in expert medical interpretation, which is not part of this device's evaluation.

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:
Not applicable. This device is a surgical instrument, not an AI or diagnostic imaging tool. MRMC studies are used to assess the impact of AI on human diagnostic performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. There is no algorithm or AI component in this device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device's performance evaluation is based on engineering specifications, standardized test methods (e.g., ISO, IEC standards for biocompatibility and electrical safety), and objective physical measurements (e.g., dimensions, force, resistance, angles).

8. The sample size for the training set:
Not applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:
Not applicable. There is no "training set" or "ground truth" in the AI sense for this device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

June 5, 2023

LivsMed Inc. Dong Lee OMR (Ouality Management Representative) #304, D-dong, 700, Pangyo-ro, Bundang-gu Seongnam-si, Gyeonggi-do 13516 Korea. South

Re: K230498

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 24, 2023 Received: February 24, 2023

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.

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

{1}------------------------------------------------

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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mark
Digitally signed by
Mark Trumbore -S
Trumbore -S Date: 2023.06.05
11:54:14 -04'00'

Mark Trumbore, 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

{2}------------------------------------------------

Indications for use Statement

3. Indications for Use Statement

A FDA Form 3881 is provided on the following pages.

{3}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K230498

Device Name

ArtiSential Laparoscopic Instruments-Electrodes

Indications for Use (Describe)

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)
----------------------------------------------------------	--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

{4}------------------------------------------------

4. 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:	02-24-2023

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
LivsMed Inc.	ArtiSential LaparoscopicInstrument-Electrodes	K200501

{5}------------------------------------------------

4. Device Description

5. Indications for Use

6. Technical Characteristics in Comparison to Predicate Devices

Table 6.1 Predicate Device

	Proposeddevice	Predicatedevice
510(K) Number	K230498	K200501
Manufacture	LivsMed, Inc.	LivsMed, Inc.
Device Name	ArtiSential LaparoscopicInstruments-Electrodes	ArtiSential LaparoscopicInstruments-Electrodes
Clearance Date	N/A	11-05-2020
Classification /Regulation	Class 2 / 878.4400	Class 2 / 878.4400
Product Code	GEI	GEI
Intended forUse	Prescription Use	Prescription Use
Indications forUse	ArtiSential LaparoscopicInstruments-Electrodes,Monopolar Series are indicatedfor cutting and coagulation inendoscopic, gynecological, andgeneral abdominal and thoracicand general laparoscopicprocedures.	ArtiSential LaparoscopicInstruments-Electrodes,Monopolar Series are indicatedfor cutting and coagulation inendoscopic, gynecological, andgeneral abdominal and thoracicand general laparoscopicprocedures.
Principles ofoperation	It uses the principle of applyinghigh-frequency currents from theelectrode to the human body togenerate heat by bioimpedancewhen radio frequency (RF)energy from the electrosurgicalunit applies an electric current tothe electrode part, and using thegenerated heat to incise cellulartissues and cause coagulation.It is composed of a end-tip (hookor spatula type), Ф8 diametershaft, grip part, andelectrosurgical unit connectionelectrode plug.	It uses the principle of applyinghigh-frequency currents from theelectrode to the human body togenerate heat by bioimpedancewhen radio frequency (RF)energy from the electrosurgicalunit applies an electric current tothe electrode part, and using thegenerated heat to incise cellulartissues and cause coagulation.It is composed of a end-tip (hookor spatula type), Ф8 diametershaft, grip part, andelectrosurgical unit connectionelectrode plug.

{6}------------------------------------------------

	During a procedure with thisproduct, the end-tip is bent up,down, left and right within arange of ±80° or more bymoving the grip up, down, leftand right, and the end-tip can	During a procedure with thisproduct, the end-tip is bent up,down, left and right within arange of ±80° or more bymoving the grip up, down, leftand right, and the end-tip can
	also turn 360° when rotating thegrip.	also turn 360° when rotating thegrip.
Energy Type	Radiofrequency	Radiofrequency
Electrode type(monopolar orbipolar)	Monopolar	Monopolar
End-tip type	Hook, Spatula	Hook, Spatula
Physicaldimensions anddesign (size,length)	- Shaft diameter: 8mm- Shaft Length: 250mm, 380mm,450mm	- Shaft diameter: 8mm- Shaft Length: 250mm, 380mm,450mm
Rated voltage	3,933Vp	3,933Vp
Materials(electrode)	Stainless steel	Stainless steel
Materials(insulation)	Zirconia / Teflon	Polyetherimide / Zirconia
Materials (Shaft)	Glass fiber	Glass fiber
Articulatingfeature	Pitch:±80° or more,Yaw:±80° or more and Open-Close	Pitch:±80° or more,Yaw:±80° or more and Open-Close
Sterilization	EO	EO

{7}------------------------------------------------

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 -
-Intracutaneous reactivity
-Skin Sensitization
-Acute systemic toxicity
Pyrogenicity -

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.

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 3 years from the manufacturing date. The real-time testing will be performed to confirm the shelf-life for 3 years

{8}------------------------------------------------

7.5 Performance test

Test clause and Test requirement	Test specification	Results- Remarks
1. AppearanceThere should be no defects in theappearance of the product andthere should be no problem in use.	Visual observation	No crack, stain or nosubstances on the surfaceof the product
2. DimensionIt shall be within ± 5% of theindicated value of the dimensionalterm.	Measure by Verniercalipers and dial gaugeetc.	PassRefer to [Test result] on8-37 page at attachment#11
3. Operational testThe end-tip and hub can be bentup, down, left, and right a range ofabove ±80° and are capable of360° rotation.	Adjusting the end-tip bymanipulating the gripand control ring andmeasure the angle atbending and turning.	The end-tip and hub arebent up, down, left andright within above 80°and can rotate 360°.
4. Tensile strengthThe end-tip and shaft connectionsshall not be damaged from pullingof 20 N.	Hold the end-tip andshaft connectionsrespectively and apply aforce of 20 N using Pushpull gauge.	No damage to theconnection when applyinga force of 20N
5. Feedthrough testElectricity should be transmittedbetween the electrode tip and theconnector.	Electrical conductionbetween the electrodetip and the connector istested using a DMM(digital multi meter).	The resistance valuebetween the electrode tipand the connector is lessthan 1Ω

The device had passed all performed tests.

Thermal effects on tissue were also tested. Please refer to attachment 16. 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 same to the predicate device (K200501). 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

{9}------------------------------------------------

well as performance characteristics. The testing was conducted to evaluate the performance of subject device in comparison to the predicate and reference devices. 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.