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 Instrument-Electrodes). It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than describing a clinical study with acceptance criteria and performance results in the context of an AI/ML medical device.

Therefore, the document does not contain the information requested regarding acceptance criteria related to a specific study proving the device meets those criteria, especially in the context of an AI/ML device that would involve a test set, expert ground truth, MRMC studies, or standalone algorithm performance.

The "Performance Data" section details engineering and biological safety tests typical for a medical instrument:

Biocompatibility: Evaluated according to ISO 10993-1 for cytotoxicity, sensitization, intracutaneous reactivity, and acute systemic toxicity.
Electrical Safety: Tested according to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-18, and IEC 60601-2-2 (various tests like insulation, leakage, dielectric strength).
Sterilization: EO-Sterilization in accordance with ISO-11135.
Shelf life: Proposed expiration of 2 years, with real-time testing for 3 years.
Performance test: Passed appearance, dimension, operational, tensile strength, and feedthrough tests. Thermal effects were demonstrated in 3 pigs on liver, kidney, and abdominal muscle tissues.

In summary, none of the requested categories related to acceptance criteria, test set characteristics (sample size, provenance), expert involvement (number of experts, qualifications, adjudication), MRMC studies, standalone performance, or ground truth for AI/ML validation are present in this document. The document states that "Results demonstrated the subject device can perform the intended use safely and effectively" and "the performance requirements were met," but it does not define these "performance requirements" as specific, quantifiable acceptance criteria in a table or describe a formal clinical study with ground truth establishment in humans.

Summary

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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 (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 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)

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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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:	02-18-2020

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 FenestratedForceps	K190909
Purple SurgicalInternational Limited	Laparoscopic Electrodes &Monopolar cables	K142868

4. Device Description

5. Indications for Use

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 LaparoscopicInstruments-Electrodes	SILSTML-Hook	N/A
Clearance Date	N/A	09-01-2009	N/A
Classification /Regulation	Class 2 / 878.4400	Class 2 / 876.1500	Equivalent
Product Code	GEI	GCJ	Equivalent
Intended for	Prescription Use	Prescription Use	Same
Indications forUse	ArtiSential LaparoscopicInstruments-Electrodes,Monopolar Series areindicated for cutting andcoagulation inendoscopic,gynecological, andgeneral abdominal andthoracic and generallaparoscopic procedures.	The SILSTM L-Hook*single use articulatinghook with monopolarcautery has application inendoscopic,gynecological, andgeneral abdominal andthoracic laparoscopicprocedures. Whenconnected by a standardcable to an electrosurgicalpower source, the devicemay be utilized formonopolar cautery.	Equivalent
Principles ofoperation	It uses the principle ofapplying high-frequencycurrents from theelectrode 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 end-tip (hook or spatula type),∅8 diameter shaft, grippart, and electrosurgicalunit connection electrodeplug.During a procedure withthis product, the end-tip isbent up, down, left andright within a range of$\pm$ 80° or more by movingthe grip up, down, leftand right, and the end-tipcan also turn 360° whenrotating the grip.	SILS Hand instrumentcontains a pistol grip, arigid shaft with anarticulating and rotatingend effector, andopposing jaws or anelectrocautery hook at thedistal end.The SILS Hook single usearticulating hook withmonopolar cautery hasapplication in endoscopic,gynecological, andgeneralabdominal and thoraciclaparoscopicprocedures. Whenconnected by a standardcable to an electrosurgicalpower source, thedevice may be utilized formonopolar cautery.The hook administerelectrocautery. The endeffector of the instrumentarticulates when thehandle is deflectedrelative to the shaft androtates when a rotationwheel is turned.	N/A
Energy Type	Radiofrequency	Radiofrequency	Same
Electrode type(monopolar orbipolar)	Monopolar	Monopolar	Same
End-tip type	Hook, Spatula	Hook	Same
Physicaldimensions anddesign (size,length)	- Shaft diameter: 8mm- Shaft Length: 250mm,380mm, 450mm	- Shaft diameter: 5mm- Shaft Length: 360mm,460mm	Different(Shaft diameter of theproposed device isthe same as referencepredicated device(K190909).The risk analysis forshaft diameter andlength has beencompleted)
Rated voltage	3,933Vp	Not found	N/A
Materials(electrode)	Stainless steel	Not found	N/A
Materials(insulation)	Polyetherimide / Zirconia	Not found	N/A
Materials (Shaft)	Glass fiber	Not found	N/A
Articulatingfeature	Pitch: $\pm$ 80° or more,Yaw: $\pm$ 80° or more andOpen-Close	Pitch: $\pm$ 80°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	ReferencePredicate Device1	ReferencePredicate Device2	Equivalence
510(K)Number	In process	K190909	K142868	N/A
Manufacture	LivsMed, Inc.	LivsMed, Inc.	Purple SurgicalInternationalLimited	N/A
Device Name	ArtiSentialLaparoscopicInstruments-Electrodes	ArtiSentialBipolarFenestratedForceps	LaparoscopicElectrodes &Monopolar cables	N/A
ClearanceDate	N/A	02-13-2020	11-21-2014	N/A
Classification/ 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
Indicationsfor Use	ArtiSentialLaparoscopicInstruments-Electrodes,Monopolar Seriesare indicated forcutting andcoagulation inendoscopic,gynecological, andgeneral abdominaland thoracic andgenerallaparoscopicprocedures.	Electrosurgicalcoagulation,dissection, andgrasping of tissueduring theperformance oflaparoscopic andgeneral surgicalprocedures.	use in generallaparoscopicsurgery requiringthe use ofmonopolarelectrosurgicalcutting and/orcoagulation	Equivalent
Principles ofoperation	It uses theprinciple ofapplying high-frequency currentsfrom the electrodeto the human bodyto generate heat bybioimpedancewhen radiofrequency (RF)energy from theelectrosurgicalunit applies anelectric current tothe electrode part,and using thegenerated heat toincise cellular	This product is asingle-useinstrument used inelectrosurgicalunits to hold softtissues orcoagulate andmake an incision(tissue dissection)during generallaparoscopicsurgery, whichuses the principleof applying high-frequency currentsfrom the electrodeto the human bodyto generate heat by	Not found	N/A
Energy TypeElectrode type(monopolar orbipolar)
	tissues and causecoagulation.It is composed of aend-tip (hook orspatula type), Φ8diameter shaft,grip part, and	bioimpedancewhen radiofrequency (RF)energy from theelectrosurgicalunit applies anelectric current to
	electrosurgicalunit connectionelectrode plug.During aprocedure withthis product, theend-tip is bent up,down, left and	the electrode part,and using thegenerated heat toincise cellulartissues and causecoagulation.It is composed of ajaw, Φ8 diameter
	right within arange of ±80° ormore by movingthe grip up, down,left and right, andthe end-tip canalso turn 360°when rotating the	shaft, grip(including acontrol ring), andelectrosurgicalunit connectionelectrodeconnector.During aprocedure with
	grip.	this product, thejaw opens if thecontrol ring opens,and jaw closes ifthe control ringcloses. In addition,the jaw is also
		bent up, down, leftand right within arange of ±80° ormore by movingthe grip up, down,left and right, andthe jaw can alsoturn 360° when
		rotating the grip.
RadiofrequencyMonopolar	RadiofrequencyBipolar	RadiofrequencyMonopolar	SameN/A
Physicaldimensionsand design(size, length)	- Shaft diameter:8mm- Shaft Length:250mm, 380mm,450mm	- Shaft diameter:8mm- Shaft Length:380mm	- Shaft diameter:5mm- Shaft Length:330mm	Different(Shaft diameter ofthe proposeddevice is the sameas referencepredicated device(K190909).The risk analysisfor shaft diameterand length hasbeen completed)
Rated voltage	3,933Vp	200Vp	Not found	N/A
Materials (electrode)	Stainless steel	Stainless steel	Not found	Equivalent
Materials (insulation)	Polyetherimide /Zirconia	Polyetherimide	Not found	Equivalent
Materials (Shaft)	Glass fiber	Glass fiber	Not found	Equivalent
Articulating feature	Pitch:±80° ormore,Yaw:±80° or moreand Open-Close	Pitch:±80° ormore,Yaw:±80° or moreandOpen-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 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.