ArtiSeal Vessel Sealing System-ArtiSeal Instruments are a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation (Cutting) of vessels and tissue bundles is desired. ArtiSeal Vessel Sealing System - ArtiSeal Instruments can be used on veins) up to and including 7 mm. It is indicated for use in general surgery.

The ArtiSeal Vessel Sealing System - ArtiSeal Generator is a high-frequency electrosurgical device used in conjunction with disposable hand-controlled electrosurgical instruments, known as ArtiSeal Instruments. It provides radiofrequency (RF) energy to ligate vessels and tissue bundles. This energy platform automatically detects the connected instrument and immediately performs safety and diagnostic functions for the instrument. It is indicated for use in general surgery.

Device Description

ArtiSeal Vessel Sealing System - ArtiSeal Instruments

The ArtiSeal Vessel Sealing System - ArtiSeal invasive invasive instruments which are used with electrosurgical generator), intended to be used during laparoscopic/minimally invasive or open surgical procedures where ligation and division of vessels and tissue bundles is desired.

When activating the sealing button of ArtiSeal Vessel Sealing System-ArtiSeal instruments, the ArtiSeal Generator applies a high frequency (RF) energy to the electrode portion of the jaw. Heat is generated from the electrode for ligation.

During a procedure with this product, the jaw opens, and jaw closes if the grip lever pulled. In addition, the jaw is also bent up, down, left, and right within a range of ±80° or more by moving the grip up, down, left, and tight, and the jaw can also turn 360° when rotating the grip.

ArtiSeal Vessel Sealing System - ArtiSeal Generator

The ArtiSeal Vessel Sealing System - ArtiSeal Generator supplies RF energy to the ArtiSeal Instruments. This energy supply device uses a touchscreen interface and features a unique instrument connecting the ArtiSeal Instrument. By connecting the connector on the ArtiSeal Instrument connection socket, the energy supply device can provide energy to the electrode.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the ArtiSeal Vessel Sealing System and outlines its indications for use and a summary of non-clinical/clinical tests. However, it does not contain detailed information regarding acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, or adjudication methods in the manner typically presented for AI/ML device studies. The text focuses on establishing substantial equivalence to predicate electrosurgical devices through performance in animal studies rather than rigorous statistical evaluation of an AI component.

Therefore, many of the requested details cannot be extracted from the given input.

Here's a breakdown of what can and cannot be answered:

What can be extracted/inferred:

Study Type: Non-clinical (animal) studies were conducted.
Purpose of Study: "To evaluate the vessel sealing performance and tissue effects of ArtiSeal Instruments and ArtiSeal Generator. The evaluations included the device's ability to seal vessels of various sizes and types, its effect on tissue damage, as well as the device's safety and efficacy."
Performance Metrics Mentioned (Qualitative): "complete vessel sealing was achieved without rebleeding as well as problematic macroscopic complications." "evaluation of sealing quality parameters such as tissue adhesion, transparency, desication, and damage to adjacent tissue."
Ground Truth Type: Inferred to be a combination of direct observation in animal models and evaluation of sealing quality parameters.
Data Provenance: Conducted in "pigs."

What cannot be extracted from the provided text:

Table of acceptance criteria and reported device performance: The document only provides qualitative statements about performance, not a table of specific numerical acceptance criteria or results.
Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): The document mentions "pigs" but no specific numbers for the sample size, nor details on the country of origin or whether it was retrospective/prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
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 an electrosurgical system, not an AI/ML-driven diagnostic or assistive tool for human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as there's no mention of a standalone algorithm component for diagnostic or interpretive purposes. The "automatic detection" and "safety and diagnostic functions" refer to hardware/firmware functions, not an AI algorithm generating standalone performance metrics.
The sample size for the training set: Not mentioned (and likely not applicable in the context of an electrosurgical device without a distinct AI training phase for data interpretation).
How the ground truth for the training set was established: Not mentioned.

Summary based on the provided text:

The provided document describes the clearance of an electrosurgical device, the ArtiSeal Vessel Sealing System. The "study" mentioned is a non-clinical (animal) evaluation to demonstrate the physical performance of the device in sealing and dividing vessels, and its safety. This is distinct from the type of performance study typically conducted for AI/ML-driven diagnostic devices, which would involve detailed metrics of sensitivity, specificity, AUC, and human reader performance with and without AI assistance.

Hypothetical Table (Illustrative, as data is not available in the text):

If this were an AI device, the table would look something like this, but the data below is purely illustrative of what would be present if the document contained AI study details and is NOT from the provided text:

Acceptance Criteria (Example for AI Device)	Reported Device Performance (Example for AI Device)
Sensitivity for detecting finding X > 90%	92.5%
Specificity for detecting finding X > 85%	88.0%
AUC > 0.95	0.965
No clinically significant false positives	Observed 0.1% unacceptable false positives
No clinically significant false negatives	Observed 0.05% unacceptable false negatives
Average reading time reduction with AI	15% reduction

In conclusion, based solely on the provided text, it is not possible to describe the acceptance criteria and study proving the device meets them in the context of an AI/ML device per your detailed request. The device in question is a traditional electrosurgical system, and the provided documentation focuses on its physical performance and safety in animal studies, not statistical validation of an AI algorithm against a specific set of rigorous metrics.

Summary

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November 15, 2024

LivsMed Inc. % Dave Yungvirt Official Contact Person Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059

Re: K241138

Trade/Device Name: ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing System-ArtiSeal Generator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: November 13, 2024 Received: November 15, 2024

Dear Dave Yungvirt:

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 available 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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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 (QS) 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 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).

Sincerelv.

Long H. Chen -S Digitally signed by Long H. Chen -S
Date: 2024.11.15 14:31:04 -05'00'

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices

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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) K241138

Device Name

ArtiSeal Vessel Sealing System - ArtiSeal Instruments ArtiSeal Vessel Sealing System - ArtiSeal Generator

Indications for Use (Describe)

ArtiSeal Vessel Sealing System-ArtiSeal Instruments

ArtiSeal Vessel Sealing System - ArtiSeal Instruments are a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation (Cutting) of vessels and tissue bundles is desired. ArtiSeal Vessel Sealing System - ArtiSeal Instruments can be used on veins) up to and including 7 mm. It is indicated for use in general surgery.

ArtiSeal Vessel Sealing System-ArtiSeal Generator

	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)

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510(k) Summary - K241138

Contact Details

Applicant Name : LivsMed Inc. Applicant Address : 304, D-dong, 700, Pangyo-ro, Bundang-gu, Seongnam-si, Gyenggi-do, 13516, Republic of Korea Applicant Contact Telephone : +82 70 7708 1399 Applicant Contact : Hera Park Applicant Contact Email : hera@livsmed.com

Device Name

Device Trade Name: ArtiSeal Vessel Sealing System - ArtiSeal Instruments ArtiSeal Vessel Sealing System - ArtiSeal Generator 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

Predicate device : K162941/Ligasure Blunt Tip, Sealer/Divider, Nano-coated/GEI

Predicate device : K181389/Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform/GEI

Device Description Summary

ArtiSeal Vessel Sealing System - ArtiSeal Instruments

ArtiSeal Vessel Sealing System - ArtiSeal Generator

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K241138

Indications for Use

ArtiSeal Vessel Sealing System - ArtiSeal Instruments

ArtiSeal Vessel Sealing System - ArtiSeal Instruments are a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation (sealing) and division (Cutting) of vessels and tissue bundles is desired. Artiseal Vessel Sealing System - ArtiSeal Instruments can be used on veins) up to and including 7 mm. It is indicated for use in general surgery.

ArtiSeal Vessel Sealing System - ArtiSeal Generator

The ArtiSeal Vessel Sealing System - ArtiSeal Generator is a high-frequency electrosurgical device used in conjunction with disposable hand-controlled electrosureits, known as ArtiSeal Instruments. It provides radiofrequency (RF) energy to ligate vessels and tissue bundles. This energy platform automatically detects the connected instrument and immediately performs safety and diagnostic functions for the instrument. It is indicated for use in general surgery.

Non-Clinical and/or Clinical Tests Summary & Conclusions

Tested to verify equivalent performance with similar devices (Ligasure Blunt Tip, Sealer/Divider, Nano-coated), complete vessel sealing was achieved without rebleeding as well as problematic macroscopic complications. The purpose of this study was to evaluate the vessel sealing performance and tissue effects of ArtiSeal Instruments and ArtiSeal Generator. The evaluations included the device's ability to seal vessels of various sizes and types, its effect on tissue damage, as well as the device's safety and efficacy. The study involved sealing(ligation) and cutting(dividing) of some blood vessels and tissue bundles in pigs, along with the evaluation of sealing quality parameters such as tissue adhesion, transparency, desication, and damage to adjacent tissue.

As a result of clinical observation, no dead animals were observed during the entire experiment period, and no abnormal symptoms related to the application of the test device were observed.

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.