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 Dissector and Scissors. 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 document is a 510(k) summary for the ArtiSential Laparoscopic Instruments-Electrodes, Monopolar Series. It describes the device, its indications for use, and a comparison to predicate and reference devices. The document does not contain acceptance criteria in the traditional sense of specific performance metrics (e.g., sensitivity, specificity, accuracy) that are typically used to evaluate the performance of diagnostic or AI-driven medical devices.

Instead, this document focuses on demonstrating substantial equivalence to a legally marketed predicate device (K200501) and a reference device (K201063) by ensuring the new device meets established safety and performance standards for electrosurgical instruments. The "tests" here are primarily engineering and biocompatibility tests to prove the device is safe and performs its intended function reliably, not clinical performance metrics against a "ground truth" as would be seen for a diagnostic AI.

Therefore, many of the requested sections regarding acceptance criteria, sample sizes for test/training sets, ground truth establishment, expert adjudication, and MRMC studies are not applicable to the information provided in this document as it pertains to a physical surgical instrument, not an AI/diagnostic software.

Here's an attempt to extract relevant information given the limitations:

1. Table of Acceptance Criteria and Reported Device Performance:

Since specific numerical acceptance criteria (like accuracy percentages for AI models) are not provided for this type of device, the "acceptance criteria" are implied by the standards and categories of tests performed, aiming to show compliance and functionally equivalent performance to the predicate device.

Category of Test	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	Compliance with ISO 10993-1 (Biological Evaluation of Medical Devices) for various endpoints.	Evaluated for Cytotoxicity, Sensitization, Intracutaneous reactivity, and Acute systemic toxicity. (Passed all assessed endpoints)
Electrical Safety	Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-18, and IEC 60601-2-2.	Passed all performed electrical safety tests.
Sterilization	Provided sterile, single-use, EO-sterilization in accordance with ISO-11135.	Complies with ISO-11135.
Shelf Life	Maintenance of packaging integrity, sterility, and performance after storage (2 years accelerated aging).	Proposed expiration date is 2 years. Tests conducted at zero and 2-year accelerated aging points. Passed: Packaging integrity, Sealing strength (ASTM F 88), Dye penetration (ASTM F1929-15), Sterility (ISO 11737-2:2009), Appearance, Dimension, Operational test, Tensile Strength, Feedthrough test. (Passed all tests, demonstrating 2-year shelf life)
Performance Test	Satisfactory operational and physical characteristics.	Passed: Appearance, Dimension, Operational test, Tensile Strength, Feedthrough test. (Passed all performed tests)
Thermal Effect	Demonstrate intended cutting and coagulation effects at various power settings without adverse outcomes.	Thermal effects testing conducted on liver, kidney, abdominal muscle at three power settings (10W, 40W, 300W). Results demonstrate performance requirements were met and device performs as intended. The report concludes it has substantially equivalent performance characteristics to the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is typically not provided for engineering and biocompatibility testing of physical medical devices. The "test set" here refers to the actual device units subjected to the various physical, electrical, and thermal tests mentioned. The number of units tested for each specific test is not detailed in this summary. Data provenance (country of origin, retrospective/prospective) is also not applicable in the context of these device verification studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. "Ground truth" in the context of diagnostic AI refers to a definitive correct answer for a medical condition. For a physical electrosurgical instrument, the "ground truth" is its ability to meet engineering specifications and functional performance (e.g., cutting and coagulating as intended), which is assessed through standardized tests and not by expert consensus on clinical cases. The thermal effects study likely involved technicians or engineers performing the tests and evaluating the tissue response according to predefined criteria.

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

Not applicable. Adjudication methods are used in clinical studies, particularly for diagnostic imaging, to resolve discrepancies among expert interpretations. For engineering tests, results are typically objective measurements or observations against predefined pass/fail criteria.

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. MRMC studies are specific to diagnostic AI or imaging interpretation and are not relevant to the evaluation of a physical electrosurgical instrument.

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

Not applicable. This device is a physical surgical tool, not an algorithm, and its use inherently involves a human surgeon.

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

As explained above, traditional "ground truth" for diagnostic AI is not applicable. For this device, the "ground truth" is defined by adherence to established engineering standards (e.g., IEC 60601, ISO 10993, ISO 11135, ASTM F88, ASTM F1929) and successful demonstration of functional performance characteristics (cutting and coagulation on tissue samples).

8. The sample size for the training set

Not applicable. This device is not an AI model requiring a training set.

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

Not applicable. This device is not an AI model requiring a training set with established ground truth.

Summary

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April 30, 2021

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

Re: K203580

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: March 5, 2021 Received: March 8, 2021

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/cdth/cfdocs/cfpmn/pmn.cfm identifies cocombination 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 (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-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). you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-DICE website the assistance/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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Indications for Use

510(k) Number (if known) K203580

Device Name

ArtiSential Laparoscopic Instruments-Electrodes

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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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:	01-27-2021

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 Device and Reference Device

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 LaparoscopicInstruments-Electrodes	K200501

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Table 3.2 Reference Device

Applicant	Device Name	510(k) Number
DANNIK	DANNIK DisposableMonopolar LaparoscopicInstruments	K201063

4. Device Description

5. Indications for Use

5.1 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 Device and Reference Device

Table 6.1 Substantial Equivalence Assessment of Proposed device and predicate device and reference device

	Proposeddevice	PredicateDevice	Referencedevice	SubstantialEquivalence
510(K) Number	K203580	K200501	K201063	N/A
Manufacture	LivsMed Inc.	LivsMed Inc.	DANNIK	N/A
Device Name	ArtiSentialLaparoscopicInstruments-Electrodes	ArtiSentialLaparoscopicInstruments-Electrodes	DANNIKDisposableMonopolarLaparoscopicInstruments	N/A
Clearance Date	N/A	05-11-2020	06-09-2020	N/A
Classification /Regulation	Class 2 /878.4400	Class 2 /878.4400	Class 2 /878.4400	N/A
Product Code	GEI	GEI	GEI	Same
Intended for	PrescriptionUse	PrescriptionUse	PrescriptionUse	Same

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Indications for Use	ArtiSentialLaparoscopicInstruments-Electrodes,MonopolarSeries haveapplication inendoscopic,gynecological,and generalabdominal andthoracic andgenerallaparoscopicprocedures.Whenconnected by astandard cableto anelectrosurgicalpower source,the device maybe utilized formonopolarcautery.	ArtiSentialLaparoscopicInstruments-Electrodes,MonopolarSeries haveapplication inendoscopic,gynecological,and generalabdominal andthoracic andgenerallaparoscopicprocedures.Whenconnected by astandard cableto anelectrosurgicalpower source,the device maybe utilized formonopolarcautery.	The DANNIKDisposableMonopolarLaparoscopicInstrumenthaveapplication in avariety ofminimallyinvasiveprocedures tofacilitategrasping,mobilization,dissection andtransection oftissue.	Same
Energy Type	Radiofrequency	Radiofrequency	Radiofrequency	Same
Electrode type(monopolar orbipolar)	Monopolar	Monopolar	Monopolar	Same
Jaw type	Dissector,Scissors	Hook, Spatula	Dissector,Scissors	Same
Physicaldimensions anddesign (size,length)	- Shaftdiameter: 8mm- Shaft Length:250mm,380mm,450mm	- Shaftdiameter: 8mm- Shaft Length:250mm,380mm,450mm	- Shaftdiameter: 3mm,5mm- Shaft Length:330mm	Same
Sterilization	EO	EO	EO	Same

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 =
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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 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 2 years from the manufacturing date. Following tests were conducted both zero time point and 2 years accelerated aging point and the device had passed all tests as below.

1. Packaging and sterility test
. Packaging integrity test
. Sealing strength test of packaging (per ASTM F 88)
. Dye penetration test (per ASTM F1929-15)
. Sterility test (per ISO 11737- 2:2009)
1. Performance test
. Appearance
Dimension .
. Operational test
. Tensile Strength
. Feedthrough test

7.5 Performance test

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The device had passed all performed tests as below.

. Appearance
. Dimension
Operational test .
Tensile Strength .
Feedthrough test .

7.6 Thermal effect

Thermal effects testing was conducted on liver, kidney, abdominal muscle at three different power settings (10, 40, and 300W).

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 device.

8. Substantial Equivalence

Indication for use, principles of operation, energy type, electrode type, jaw type, physical dimension, rated voltage, materials (electrode, shaft), articulating feature, tip rotation, sterilization method of the proposed ArtiSential Laparoscopic Instruments-Electrodes, Monopolar Series are as same as the predicate device. Although there is a minor difference of raw material (insulation) between the ArtiSential Monopolar Series and the predicate device, the difference does 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 as same as 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 device 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.