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K Number
K240657
Device Name
ArtiSential Laparoscopic Instruments-Electrodes (AMHD01-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01S-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01L-LH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHD01-LH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHD01S-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01-FH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01S-FH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01L-
Manufacturer
LivsMed Inc.
Date Cleared
2024-06-06

(90 days)

Product Code
GEI
Regulation Number
878.4400
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ArtiSential Laparoscopic Instruments-Electrodes, Monopolar Series (Hand-controlled) are indicated for cutting and coagulation in endoscopic, gynecological, and general abdominal and thoracic and general laparoscopic procedures.
Device Description
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, Φ5, Φ8 diameter shaft, grip part, and electrosurgical unit connection electrode plug.
More Information

K230498

Not Found

No
The description focuses on the electrosurgical principle and components, with no mention of AI or ML.

No.
The device is described as an electrosurgical instrument for cutting and coagulation of tissues, which is a surgical tool rather than a therapeutic device designed for treatment or rehabilitation.

No

The device description clearly states its purpose is for "cutting and coagulation" and to "incise cellular tissues and cause coagulation" using high-frequency currents to generate heat. This describes a therapeutic, not a diagnostic, function.

No

The device description explicitly lists physical components such as an end-tip, shaft, grip part, and electrosurgical unit connection electrode plug, indicating it is a hardware device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that the device is used for "cutting and coagulation in endoscopic, gynecological, and general abdominal and thoracic and general laparoscopic procedures." This describes a surgical instrument used directly on the patient's body.
  • Device Description: The description explains how the device works by applying high-frequency currents to the human body to generate heat for tissue incision and coagulation. This is a direct interaction with living tissue.
  • Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information about a person's health. The provided information does not mention any analysis of specimens or diagnostic purposes.

Therefore, the ArtiSential Laparoscopic Instruments-Electrodes, Monopolar Series (Hand-controlled) is a surgical device, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

ArtiSential Laparoscopic Instruments-Electrodes, Monopolar Series (Hand-controlled) are indicated for cutting and coagulation in endoscopic, gynecological, and general abdominal and thoracic and general laparoscopic procedures.

Product codes

GEI

Device Description

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, Φ5, Φ8 diameter shaft, grip part, and electrosurgical unit connection electrode plug.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

abdominal and thoracic

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Thermal spread testing was performed in accordance with the FDA guidance. Trocar Compatibility Testingwas performedin accordance with FDA Usability guidance.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K230498

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

June 6, 2024

LivsMed Inc. Hyeonbin Chung Assistant Manager 304, D-dong, 700, Pangyo-ro, Bundang-gu Seongnam-si, Gyeonggi-do 13516 Korea, South

Re: K240657

Trade/Device Name: ArtiSential Laparoscopic Instruments-Electrodes (AMHD01-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01S-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01L-LH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHD01-LH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHD01S-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01-FH): ArtiSential Laparoscopic Instruments-Electrodes (AMHD01S-FH): ArtiSential Laparoscopic Instruments-Electrodes (AMHD01L-FH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHD01-FH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHD01S-FH); ArtiSential Laparoscopic Instruments-Electrodes (AMHU01-LH): ArtiSential Laparoscopic Instruments-Electrodes (AMHU01S-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHU01L-LH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHU01-LH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHU01S-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHU01-FH); ArtiSenti

Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: March 8, 2024 Received: March 8, 2024

Dear Hyeonbin Chung:

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 (the 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

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available at https://www.accessdata.fda.gov/scripts/cdrb/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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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

2

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 H. Chen -S-s
Digitally signed by Long H. Chen
Date: 2024.06.06 07:44:33 -04'00'

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

Submission Number (if known)

K240657 N/A

Device Name

ArtiSential Laparoscopic Instruments-Electrodes (AMHD01-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01S-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01L-LH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHD01-LH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHD01S-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01-FH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01S-FH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01L-FH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHD01-FH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHD01S-FH); ArtiSential Laparoscopic Instruments-Electrodes (AMHU01-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHU01S-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHU01L-LH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHU01-LH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHU01S-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHU01-FH); ArtiSential Laparoscopic Instruments-Electrodes (AMHU01S-FH); ArtiSential Laparoscopic Instruments-Electrodes (AMHU01L-FH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHU01-FH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHU01S-FH); ArtiSential Laparoscopic Instruments-Electrodes (AMHL01-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHL01S-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHL01L-LH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHL01-LH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHL01S-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHL01-FH); ArtiSential Laparoscopic Instruments-Electrodes (AMHL01S-FH); ArtiSential Laparoscopic Instruments-Electrodes (AMHL01L-FH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHL01-FH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHL01S-FH); ArtiSential Laparoscopic Instruments-Electrodes (AMHR01-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHR01S-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHR01L-LH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHR01-LH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHR01-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHR01-FH); ArtiSential Laparoscopic Instruments-Electrodes (AMHR01S-FH); ArtiSential Laparoscopic Instruments-Electrodes (AMHR01L-FH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHR01-FH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHR01S-FH); ArtiSential Laparoscopic Instruments-Electrodes (AMT01-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMT01S-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMT01L-LH); ArtiSential Laparoscopic Instruments-Electrodes (5AMT01-LH);

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

4

ArtiSential Laparoscopic Instruments-Electrodes (5AMT01S-LH);
ArtiSential Laparoscopic Instruments-Electrodes (AMT01-FH);
ArtiSential Laparoscopic Instruments-Electrodes (AMT01S-FH);
ArtiSential Laparoscopic Instruments-Electrodes (AMT01L-FH);
ArtiSential Laparoscopic Instruments-Electrodes (5AMT01-FH);
ArtiSential Laparoscopic Instruments-Electrodes (5AMT01S-FH)
Indications for Use (Describe)#### Indications for Use (Describe)

ArtiSential Laparoscopic Instruments-Electrodes, Monopolar Series (Hand-controlled) 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)

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:

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"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."

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510(k) SummaryPrepared on: 2024-03-08
Contact Details21 CFR 807.92(a)(1)
Applicant NameLivsMed Inc.
Applicant Address304, D-dong, 700, Pangyo-ro, Bundang-gu Seongnam-si Gyeonggi-do
13516 Korea, South
Applicant Contact Telephone82 10-2381-8195
Applicant ContactMs. HYEONBIN CHUNG
Applicant Contact Emailhyeonb@livsmed.com
Device NameArtiSential Laparoscopic Instruments-Electrodes (AMHD01-LH);
ArtiSential Laparoscopic Instruments-Electrodes (AMHD01S-LH);
ArtiSential Laparoscopic Instruments-Electrodes (AMHD01L-LH);
ArtiSential Laparoscopic Instruments-Electrodes (5AMHD01-LH);
ArtiSential Laparoscopic Instruments-Electrodes (5AMHD01S-LH);
ArtiSential Laparoscopic Instruments-Electrodes (AMHD01-FH);
ArtiSential Laparoscopic Instruments-Electrodes (AMHD01S-FH);
ArtiSential Laparoscopic Instruments-Electrodes (AMHD01L-FH);
ArtiSential Laparoscopic Instruments-Electrodes (5AMHD01-FH);
ArtiSential Laparoscopic Instruments-Electrodes (5AMHD01S-FH);
ArtiSential Laparoscopic Instruments-Electrodes (AMHU01-LH);
ArtiSential Laparoscopic Instruments-Electrodes (AMHU01S-LH);
ArtiSential Laparoscopic Instruments-Electrodes (AMHU01L-LH);
ArtiSential Laparoscopic Instruments-Electrodes (5AMHU01-LH);
ArtiSential Laparoscopic Instruments-Electrodes (5AMHU01S-LH);
ArtiSential Laparoscopic Instruments-Electrodes (AMHU01-FH);
ArtiSential Laparoscopic Instruments-Electrodes (AMHU01S-FH);
ArtiSential Laparoscopic Instruments-Electrodes (AMHU01L-FH);
ArtiSential Laparoscopic Instruments-Electrodes (5AMHU01-FH);
ArtiSential Laparoscopic Instruments-Electrodes (5AMHU01S-FH);
ArtiSential Laparoscopic Instruments-Electrodes (AMHL01-LH);
ArtiSential Laparoscopic Instruments-Electrodes (AMHL01S-LH);
ArtiSential Laparoscopic Instruments-Electrodes (AMHL01L-LH);
ArtiSential Laparoscopic Instruments-Electrodes (5AMHL01-LH);
ArtiSential Laparoscopic Instruments-Electrodes (5AMHL01S-LH);
ArtiSential Laparoscopic Instruments-Electrodes (AMHL01-FH);
ArtiSential Laparoscopic Instruments-Electrodes (AMHL01S-FH);
ArtiSential Laparoscopic Instruments-Electrodes (AMHL01L-FH);
ArtiSential Laparoscopic Instruments-Electrodes (5AMHL01-FH);
ArtiSential Laparoscopic Instruments-Electrodes (5AMHL01S-FH);
ArtiSential Laparoscopic Instruments-Electrodes (AMHR01-LH);
ArtiSential Laparoscopic Instruments-Electrodes (AMHR01S-LH);
ArtiSential Laparoscopic Instruments-Electrodes (AMHR01L-LH);
ArtiSential Laparoscopic Instruments-Electrodes (5AMHR01-LH);
ArtiSential Laparoscopic Instruments-Electrodes (5AMHR01L-LH);
Device Trade Name21 CFR 807.92(a)(2)

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| | ArtiSential Laparoscopic Instruments-Electrodes (AMHR01-FH);
ArtiSential Laparoscopic Instruments-Electrodes (AMHR01S-FH);
ArtiSential Laparoscopic Instruments-Electrodes (AMHR01L-FH);
ArtiSential Laparoscopic Instruments-Electrodes (5AMHR01-FH);
ArtiSential Laparoscopic Instruments-Electrodes (5AMHR01S-FH);
ArtiSential Laparoscopic Instruments-Electrodes (AMT01-LH);
ArtiSential Laparoscopic Instruments-Electrodes (AMT01S-LH);
ArtiSential Laparoscopic Instruments-Electrodes (AMT01L-LH);
ArtiSential Laparoscopic Instruments-Electrodes (5AMT01-LH);
ArtiSential Laparoscopic Instruments-Electrodes (5AMT01S-LH);
ArtiSential Laparoscopic Instruments-Electrodes (AMT01-FH);
ArtiSential Laparoscopic Instruments-Electrodes (AMT01S-FH);
ArtiSential Laparoscopic Instruments-Electrodes (AMT01L-FH);
ArtiSential Laparoscopic Instruments-Electrodes (5AMT01-FH);
ArtiSential Laparoscopic Instruments-Electrodes (5AMT01S-FH) | | |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|---------------------|
| Common Name | Electrosurgical cutting and coagulation device and accessories | | |
| Classification Name | Electrosurgical, Cutting & Coagulation & Accessories | | |
| Regulation Number | 878.4400 | | |
| Product Code | GEI | | |
| | Legally Marketed Predicate Devices | | 21 CFR 807.92(a)(3) |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | | Product Code |
| K230498 | ArtiSential Laparoscopic Instruments-Electrodes | | GEI |
| Device Description Summary | | | 21 CFR 807.92(a)(4) |
| 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, Φ5, Φ8 diameter shaft, grip part, and electrosurgical unit connection electrode plug. | | |
| Intended Use/Indications for Use | | | 21 CFR 807.92(a)(5) |
| | ArtiSential Laparoscopic Instruments-Electrodes, Monopolar Series (Hand-controlled) are indicated for cutting and coagulation in endoscopic, gynecological, and general abdominal and thoracic and general laparoscopic procedures. | | |
| Indications for Use Comparison | | | 21 CFR 807.92(a)(5) |
| | Indications for use is the same with Predicate device(K230498) | | |
| | ArtiSential Laparoscopic Instruments-Electrodes are indicated for cutting and coagulation in endoscopic, gynecological, and general abdominal and thoracic and general laparoscopic procedures. | | |
| Technological Comparison | | | 21 CFR 807.92(a)(6) |
| | ArtiSential Laparoscopic Instruments-Electrodes uses the principle of applying high-frequency currents from the electrode to the human body to generate heat by bio-impedance 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), Φ5, Φ8 diameter shaft, grip part, and COAG/CUT button, cable and connector. COAG/ | | |

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CUT button, cable and connector are different from predicate device(K230498).

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807 92(b)

Thermal spread testing was performed in accordance with the FDA guidance. Trocar Compatibility Testingwas performedin accordance with FDA Usability guidance.