(77 days)
Indications for use include electrosurgical coagulation, dissection, and grasping of tissue during the performance of laparoscopic and general surgical procedures.
The ArtiSential Laparoscopic Instruments - Electrodes, Bipolar series are sterile, single-use, invasive instruments that used in laparoscopic surgery. There are three versions, ABF01 series, and ABD02 series. Three versions are same except for jaw shape. 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.
The provided text describes a 510(k) premarket notification for a medical device, specifically the "ArtiSential Laparoscopic Instruments - Electrodes". This document asserts the substantial equivalence of the new device to a predicate device (K190909) and details various performance tests conducted.
However, it does not contain information related to acceptance criteria, reported device performance in those terms, sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for AI/ML device studies. The document describes a traditional medical device (surgical instruments) and its non-AI related testing for regulatory clearance.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study that proves an AI/ML device meets them based on the provided text. The document focuses on demonstrating substantial equivalence to a predicate device through manufacturing and basic performance testing, not on the validation of an AI/ML component.
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June 17, 2020
LivsMed Inc. Dong Wook Lee QMR (Quality Management Representative) #304, D-dong, 700, Pangyo-ro, Bundang-gu Seongnam-si, Gyeonggi-do 13516 Republic of Korea
Re: K200875
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: May 18, 2020 Received: May 21, 2020
Dear Dong Wook 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
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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 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 (QS) 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 medical devices and radiation-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,
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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K200875
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) N/A K200875
Device Name
ArtiSential Laparoscopic Instruments-Electrodes
Indications for Use (Describe)
Indications for use include electrosurgical coagulation, dissection, and grasping of tissue during the performance of laparoscopic and general surgical 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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (7/17)
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PSC Publishing Services (301) 443-6740 EF
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Special 510(k) Summary
Special 510(k) Summary
1. General Information
| Applicant/Submitter: LivsMed Inc. | |
|---|---|
| Address: | #304, D-dong, 700, Pangyo-ro, Bundang-gu, 13516Seongnam-si, Gyeonggi-do, Republic of KoreaTel) +82-70-4282-7652Fax) +82-31-706-3211 |
| Contact Person: | Dong Wook Lee / QMR(Quality Management Representative) |
| Address: | #304, D-dong, 700, Pangyo-ro, Bundang-gu, 13516Seongnam-si, Gyeonggi-do, Republic of KoreaTel) +82-70-7709-4993Fax) +82-31-706-3211Email) dongwook.livsmed@gmail.com |
| Preparation Date: | 05-15-2020 |
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, Bipolar Series are substantially equivalent to the following devices
Table 3.1 Predicate device
| Applicant | Device Name | 510(k) Number |
|---|---|---|
| Livsmed Inc. | ArtiSential Bipolar FenestratedForceps | K190909 |
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Special 510(k) Summary
4. Device Description
The ArtiSential Laparoscopic Instruments - Electrodes, Bipolar series are sterile, single-use, invasive instruments that used in laparoscopic surgery. There are three versions, ABF01 series, and ABD02 series. Three versions are same except for jaw shape. 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 / Intended Use
5.1 Intended Use
The ArtiSential Laparoscopic Instruments - Electrodes, Bipolar series are invasive instruments which is used with electrosurgical generator. They are intended to be used during laparoscopic surgical procedures for incision/coagulation (to electrocauterize, grasp and dissect tissue) during surgery.
5.2 Indications for use
Indications for use include electrosurgical coagulation, dissection, and grasping of tissue during the performance of laparoscopic and general surgical procedures.
6. Technical Characteristics in Comparison to Predicate Devices
Table 6.1 Predicate Device
| Proposed device | Predicate Device | |
|---|---|---|
| 510(K) Number | In process | K190909 |
| Manufacture | LivsMed, Inc. | LivsMed, Inc. |
| Device Name | ArtiSential Laparoscopic Instruments-Electrodes | ArtiSential Bipolar Fenestrated Forceps |
| Clearance Date | N/A | 02-13-2020 |
| Classification /Regulation | Class 2 / 878.4400 | Class 2 / 878.4400 |
| Product Code | GEI | GEI |
| Intended for | Prescription Use | Prescription Use |
| Indications forUse | Electrosurgical coagulation, dissection,and grasping of tissue during theperformance of laparoscopic andgeneral surgical procedures. | Electrosurgical coagulation, dissection,and grasping of tissue during theperformance of laparoscopic andgeneral surgical procedures. |
| Principles ofoperation | This product is a single-use instrumentused in electrosurgical units to hold softtissues or coagulate and make anincision (tissue dissection) duringgeneral laparoscopic surgery, whichuses the principle of applying high-frequency currents from the electrodeto the human body to generate heat bybioimpedance when radio frequency(RF) energy from the electrosurgicalunit applies an electric current to theelectrode part, and using the generated | This product is a single-use instrumentused in electrosurgical units to hold softtissues or coagulate and make anincision (tissue dissection) duringgeneral laparoscopic surgery, whichuses the principle of applying high-frequency currents from the electrodeto the human body to generate heat bybioimpedance when radio frequency(RF) energy from the electrosurgicalunit applies an electric current to theelectrode part, and using the generated |
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Image /page/5/Picture/1 description: The image shows the word "LIVSMED" in a sans-serif font. The letters are dark blue, except for the apostrophe in "LIV'SMED", which is a lighter blue. The letters are evenly spaced and the word is centered.
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| heat to incise cellular tissues and causecoagulation.It is composed of a jaw, Φ8 diametershaft, grip (including a control ring),and electrosurgical unit connectionelectrode connector.During a procedure with this product,the jaw opens if the control ring opens,and jaw closes if the control ringcloses. In addition, the jaw is also bentup, down, left and right within a rangeof ±80° or more by moving the grip up,down, left and right, and the jaw canalso turn 360° when rotating the grip. | heat to incise cellular tissues and causecoagulation.It is composed of a jaw, Φ8 diametershaft, grip (including a control ring),and electrosurgical unit connectionelectrode connector.During a procedure with this product,the jaw opens if the control ring opens,and jaw closes if the control ringcloses. In addition, the jaw is also bentup, down, left and right within a rangeof ±80° or more by moving the grip up,down, left and right, and the jaw canalso turn 360° when rotating the grip. | |
|---|---|---|
| Energy Type | Radiofrequency | Radiofrequency |
| Electrode type(monopolar orbipolar) | Bipolar | Bipolar |
| Physicaldimensionsand design(size, length) | - Shaft diameter: 8mm- Shaft Length: 250mm, 380mm,450mm | - Shaft diameter: 8mm- Shaft Length: 380mm |
| Rated voltage | 200Vp | 200Vp |
| Materials(electrode) | Stainless steel | Stainless steel |
| Materials(insulation) | Polyetherimide | Polyetherimide |
| Materials(Shaft) | Glass fiber | Glass fiber |
| Articulatingfeature | Pitch:±80° or more,Yaw:±80° or more and Open-Close | Pitch:±80° or more,Yaw:±80° or more and Open-Close |
| Tip rotation | 360° | 360° |
| Sterilization | EO | EO |
Special 510(k) Summary
7. Performance Data
7.1 Biocompatibility
The characteristics associated with biocompatibility are the same as in the predicate device K190909.
7.2 Electrical Safety
The ArtiSential Laparoscopic Instruments-Electrodes, Bipolar 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
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Page 4 of 4
Special 510(k) Summary
-
-Feedthrough test
The device had passed all performed tests. -
7.3 Sterilization
ArtiSential Laparoscopic Instruments-Electrodes, Bipolar Series are provided sterile, intended to be single-use. This part is same with the predicate device K190909.
7.4 Shelf life
The proposed expiration date is 2 years from the manufacturing date. These characteristics are same with the predicate device K190909.
7.5 Performance test
The device had passed all performed tests.
- -Appearance
- -Dimension
- Operational test -
- -Tensile strength
- -Feedthrough test
- -Grasping Force
- Force to jaw failure -
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, Bipolar Series indication for use is same to the predicate device (K190909). The energy type, electrode type, sterilization as well as physical characteristics are the same. Although there are some minor differences with each product, these differences between the ArtiSential Bipolar 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, Bipolar Series are same to the predicate device in principles of operation, technological characteristics, as well as performance characteristics. The testing was conducted to evaluate the performance of subject device in comparison to the predicate device. 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.
§ 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.