(90 days)
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.
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.
The provided text is a 510(k) summary for the ArtiSential Laparoscopic Instruments-Electrodes. This document describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria and study results for device performance related to a diagnostic or AI-powered medical device.
The document primarily focuses on the physical and functional aspects of the laparoscopic instruments. Specifically, it mentions:
- Principles of operation: How the device uses high-frequency currents for cutting and coagulation.
- Components: End-tip, shaft, grip part, electrosurgical unit connection electrode plug.
- Minor differences from predicate: COAG/CUT button, cable, and connector.
- Non-Clinical and/or Clinical Tests: Thermal spread testing (in accordance with FDA guidance) and Trocar Compatibility Testing (in accordance with FDA Usability guidance).
Because the device is an electrosurgical instrument and not an AI-powered diagnostic tool, the typical "acceptance criteria" and "study proving the device meets the acceptance criteria" as described in your prompt (e.g., related to sensitivity, specificity, human reader improvement with AI assistance, ground truth establishment) are not applicable to this type of medical device submission.
Therefore, I cannot extract the information requested in your prompt based on the provided text. The document confirms the device's classification as Class II, product code GEI (Electrosurgical Cutting And Coagulation Device And Accessories), and its substantial equivalence to a predicate device (K230498). The studies performed (thermal spread and trocar compatibility) are standard for this type of device to demonstrate safety and effectiveness for surgical use.
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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
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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.
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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)
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| 510(k) Summary | Prepared on: 2024-03-08 | |
|---|---|---|
| Contact Details | 21 CFR 807.92(a)(1) | |
| Applicant Name | LivsMed Inc. | |
| Applicant Address | 304, D-dong, 700, Pangyo-ro, Bundang-gu Seongnam-si Gyeonggi-do13516 Korea, South | |
| Applicant Contact Telephone | 82 10-2381-8195 | |
| Applicant Contact | Ms. HYEONBIN CHUNG | |
| Applicant Contact Email | hyeonb@livsmed.com | |
| 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 (5AMHR01L-LH); | |
| Device Trade Name | 21 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.
§ 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.