Who is the manufacturer of ArtiSential Laparoscopic Instruments-Electrodes?

Livsmed, Inc. filed the 510(k) submission for ArtiSential Laparoscopic Instruments-Electrodes (K230498).

What is the FDA product code for ArtiSential Laparoscopic Instruments-Electrodes?

GEI. It is classified under 21 CFR 878.4400 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for ArtiSential Laparoscopic Instruments-Electrodes?

510(k) clearance (submission type: Traditional).

What are the predicate devices for ArtiSential Laparoscopic Instruments-Electrodes?

ArtiSential Laparoscopic Instrument-Electrodes (K200501).

Who can help prepare an FDA 510(k) submission like ArtiSential Laparoscopic Instruments-Electrodes?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ArtiSential Laparoscopic Instruments-Electrodes

K230498 · Livsmed, Inc. · GEI · Jun 5, 2023 · General, Plastic Surgery

Device Facts

Record ID	K230498
Device Name	ArtiSential Laparoscopic Instruments-Electrodes
Applicant	Livsmed, Inc.
Product Code	GEI · General, Plastic Surgery
Decision Date	Jun 5, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Device Story

The ArtiSential Laparoscopic Instruments-Electrodes are sterile, single-use, invasive electrosurgical instruments used in laparoscopic surgery. The device consists of an end-tip (hook or spatula), an 8mm diameter shaft, a grip, and an electrosurgical unit connection plug. It operates by applying high-frequency currents from an external electrosurgical unit to the electrode tip, generating heat via bioimpedance to incise and coagulate tissue. The device is operated by a surgeon during laparoscopic procedures. The grip allows the surgeon to articulate the end-tip up, down, left, and right (±80°) and rotate it 360°. The device is intended to be used as a component of an electrosurgical system. By providing precise articulation and electrosurgical cutting/coagulation capabilities, the device facilitates minimally invasive surgical interventions, potentially reducing trauma and improving surgical access compared to rigid instruments.

Clinical Evidence

No clinical data. The device underwent bench testing only, including biocompatibility (ISO 10993-1), electrical safety (IEC 60601-1, 60601-1-2, 60601-1-6, 60601-2-18, 60601-2-2), and mechanical performance testing (tensile strength, operational articulation, and electrical feedthrough).

Technological Characteristics

Materials: Stainless steel (electrode), Zirconia/Teflon (insulation), Glass fiber (shaft). Energy: Radiofrequency. Dimensions: 8mm shaft diameter; 250mm, 380mm, 450mm lengths. Articulation: Pitch/Yaw ±80°, 360° rotation. Sterilization: EO (ISO 11135). Connectivity: Wired connection to electrosurgical unit. Rated voltage: 3,933Vp.

Indications for Use

Indicated for cutting and coagulation in endoscopic, gynecological, general abdominal, thoracic, and general laparoscopic 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 Instrument-Electrodes (K200501)

Related Devices

K200501 — ArtiSential Laparoscopic Instrument-Electrodes · Livsmed, Inc. · May 11, 2020
K220384 — ArtiSential Laparoscopic Instruments-Electrodes · Livsmed, Inc. · Feb 24, 2022
K200875 — ArtiSential Laparoscopic Instruments - Electrodes · Livsmed, Inc. · Jun 17, 2020
K230499 — ArtiSential Laparoscopic Instruments-Electrodes · Livsmed, Inc. · Apr 26, 2023
K142868 — 5mm Laparoscopic Electrode with J Hook, 5mm Laparoscopic Electrode with L Hook, 5mm Laparoscopic Electrode with Spatula, Monopolar cable with 4mm pin, Monopolar cable with 8mm pin · Purple Surgical International Limited · Nov 21, 2014

Submission Summary (Full Text)

{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) ArtiSential Laparoscopic Instruments-Electrodes, Monopolar Series are indicated for cutting and coagulation in endoscopic, gynecological, and general abdominal and thoracic and general laparoscopic 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) | |----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| 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](mailto: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, 13516 Seongnam-si, Gyeonggi-do, Republic of Korea Tel) +82-70-4282-7652 Fax) +82-31-706-3211 | | Contact Person: | Dong Wook Lee / QMR (Quality Management Representative) | | Address: | #304, D-dong, 700, Pangyo-ro, Bundang-gu, 13516 Seongnam-si, Gyeonggi-do, Republic of Korea Tel) +82-70-7709-4993 Fax) +82-31-706-3211 Email) 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 Laparoscopic Instrument-Electrodes | K200501 | {5}------------------------------------------------ ## 4. 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. ## 5. 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 Devices Table 6.1 Predicate Device | | Proposed device | Predicate device | |--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(K) Number | K230498 | K200501 | | Manufacture | LivsMed, Inc. | LivsMed, Inc. | | Device Name | ArtiSential Laparoscopic Instruments-Electrodes | ArtiSential Laparoscopic Instruments-Electrodes | | Clearance Date | N/A | 11-05-2020 | | Classification / Regulation | Class 2 / 878.4400 | Class 2 / 878.4400 | | Product Code | GEI | GEI | | Intended for Use | Prescription Use | Prescription Use | | 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. | ArtiSential Laparoscopic Instruments-Electrodes, Monopolar Series are indicated for cutting and coagulation in endoscopic, gynecological, and general abdominal and thoracic and general laparoscopic procedures. | | Principles of operation | It uses the principle of applying high-frequency currents from the electrode to the human body to generate heat by bioimpedance when radio frequency (RF) energy from the electrosurgical unit applies an electric current to the electrode part, and using the generated heat to incise cellular tissues and cause coagulation. It is composed of a end-tip (hook or spatula type), Ф8 diameter shaft, grip part, and electrosurgical unit connection electrode plug. | It uses the principle of applying high-frequency currents from the electrode to the human body to generate heat by bioimpedance when radio frequency (RF) energy from the electrosurgical unit applies an electric current to the electrode part, and using the generated heat to incise cellular tissues and cause coagulation. It is composed of a end-tip (hook or spatula type), Ф8 diameter shaft, grip part, and electrosurgical unit connection electrode plug. | {6}------------------------------------------------ | | During a procedure with this product, the end-tip is bent up, down, left and right within a range of ±80° or more by moving the grip up, down, left and right, and the end-tip can | During a procedure with this product, the end-tip is bent up, down, left and right within a range of ±80° or more by moving the grip up, down, left and right, and the end-tip can | |--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | also turn 360° when rotating the grip. | also turn 360° when rotating the grip. | | Energy Type | Radiofrequency | Radiofrequency | | Electrode type (monopolar or bipolar) | Monopolar | Monopolar | | End-tip type | Hook, Spatula | Hook, Spatula | | Physical dimensions and design (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 | | Articulating feature | 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. Appearance There should be no defects in the appearance of the product and there should be no problem in use. | Visual observation | No crack, stain or no substances on the surface of the product | | 2. Dimension It shall be within ± 5% of the indicated value of the dimensional term. | Measure by Vernier calipers and dial gauge etc. | Pass Refer to [Test result] on 8-37 page at attachment #11 | | 3. Operational test The end-tip and hub can be bent up, down, left, and right a range of above ±80° and are capable of 360° rotation. | Adjusting the end-tip by manipulating the grip and control ring and measure the angle at bending and turning. | The end-tip and hub are bent up, down, left and right within above 80° and can rotate 360°. | | 4. Tensile strength The end-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 using Push pull gauge. | No damage to the connection when applying a force of 20N | | 5. Feedthrough test Electricity should be transmitted between the electrode tip and the connector. | Electrical conduction between the electrode tip and the connector is tested using a DMM (digital multi meter). | The resistance value between the electrode tip and the connector is less than 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.