ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing System-ArtiSeal Generator
Device Facts
| Record ID | K241138 |
|---|---|
| Device Name | ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing System-ArtiSeal Generator |
| Applicant | Livsmed, Inc. |
| Product Code | GEI · General, Plastic Surgery |
| Decision Date | Nov 15, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4400 |
| Device Class | Class 2 |
| Attributes | Therapeutic, 3rd-Party Reviewed |
Intended 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 (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 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 Story
System comprises bipolar electrosurgical instruments and RF generator; used in minimally invasive or open general surgery. Instruments feature articulating jaws (±80° range) and 360° rotation; operated by surgeons. Generator supplies RF energy to instrument electrodes to ligate/seal vessels up to 7 mm and tissue bundles. Generator features touchscreen interface; automatically detects connected instruments; performs safety/diagnostic checks upon connection. Surgeon activates sealing via button on instrument handle. System provides thermal energy for vessel ligation; benefits include effective hemostasis and tissue division.
Clinical Evidence
Bench and animal testing only. Porcine study evaluated vessel sealing performance, tissue effects, and safety. Endpoints included sealing quality (adhesion, transparency, desiccation), damage to adjacent tissue, and absence of rebleeding. Results showed complete vessel sealing without rebleeding or macroscopic complications; no abnormal symptoms or mortality observed in animal subjects.
Technological Characteristics
Bipolar electrosurgical system. Components: disposable hand-controlled instruments and RF generator. Features: articulating jaws (±80°), 360° rotation, touchscreen generator interface. Energy: high-frequency RF. Connectivity: instrument-to-generator connection with automatic instrument detection/diagnostic capability. Sterilization: not specified.
Indications for Use
Indicated for use in general surgery for ligation and division of vessels up to 7 mm and tissue bundles in minimally invasive or open surgical 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
- Ligasure Blunt Tip, Sealer/Divider, Nano-coated (K162941)
- Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform (K181389)
Related Devices
- K981916 — LIGASURE VESSEL SEALING SYSTEM · Valleylab, Inc. · Aug 28, 1998
- K141288 — VOYANT ELECTROSURGICAL GENERATOR, VOYANT 5MM LAPAROSCOPIC SEALER-DIVIDER DEVICE · Applied Medical Resources · Aug 22, 2014
- K151858 — Caiman Seal and Cut Technology · Aesculap, Inc. · Jul 21, 2015
- K041587 — LIGASURE PRECISE MODEL #LS1200/LIGASURE 5MM LAPAROSCOPIC SEALER DIVIDER MODEL # LS1500 · Valleylab · Sep 28, 2004
- K130596 — CAIMAN SEAL AND CUT TECHNOLOGY · Aesculap, Inc. · Mar 22, 2013
Submission Summary (Full Text)
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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
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.
| | 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
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.
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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.
