(61 days)
No
The summary describes a standard electrosurgical instrument and does not mention any AI or ML capabilities.
No.
The device is used for surgical procedures (coagulation, dissection, grasping) and does not inherently treat diseases or conditions.
No
The device is an electrosurgical instrument for coagulation, dissection, and grasping tissue during surgical procedures. Its function is therapeutic and interventional, not diagnostic.
No
The device description explicitly states it is a sterile, single-use, invasive instrument used in laparoscopic surgery, and mentions performance studies related to biocompatibility, electrical safety, sterilization, and thermal effects on tissue, all of which are characteristic of hardware medical devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "electrosurgical coagulation, dissection, and grasping of tissue during the performance of laparoscopic and general surgical procedures." This describes a surgical tool used directly on the patient's body for treatment and manipulation of tissue.
- Device Description: The description confirms it's a "sterile, single-use, invasive instrument that used in laparoscopic surgery." This further reinforces its role as a surgical instrument.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze samples for diagnostic purposes. This device is used in vivo (inside the body) for surgical procedures.
N/A
Intended Use / Indications for Use
Indications for use include electrosurgical coagulation, dissection, and grasping of tissue during the performance of laparoscopic and general surgical procedures.
Product codes
GEI
Device Description
The ArtiSential Laparoscopic Instruments – Electrodes, Bipolar series(four versions, ABF01 series, ABD01 series, ABD02 series and ABD04 series) are sterile, single-use, invasive instruments that used in laparoscopic surgery. There are four versions, ABF01 series, ABD01 series, ABD02 series and ABD04 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
The device has been evaluated for its biological safety according to ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1 : Evaluation and Testing Within a Risk Management Process". Following endpoints have been assessed during the evaluation:
- Cytotoxicity -
- -Intracutaneous reactivity
- -Skin Sensitization
- Acute systemic toxicity -
- -Pyrogenicity
The ArtiSential Laparoscopic Instruments-Electrodes, Bipolar Series(four versions, ABF01 series, ABD01 series, ABD02 series and ABD04 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:
The device had passed all performed tests.
ArtiSential Laparoscopic Instruments-Electrodes, Bipolar Series(four versions, ABF01 series. ABD01 series, ABD02 series and ABD04 series) are provided sterile, intended to be single-use. This product is EO-Sterilization in accordance with ISO-11135.
The proposed expiration date is 3 years from the manufacturing date. The real-time testing will be performed to confirm the shelf-life for 3 years.
The device had passed all performed tests.
- Appearance: Implement the visual inspection for surface of the device
- Test requirement: There should be no defects in the appearance of the product and there should be no problem in use.
- Results-Remarks: No crack, stain or no substances on the surface of the product
- Dimension: Measure by ruler and vernier calipers
- Test requirement: It shall be within +/- 5% of the indicated value of the dimensional term.
- Results-Remarks: Pass. Refer to [Test result] on 9-50 page at attachment 12
- Operational test: Manipulating the grip and control ring, and measure the angle at bending and rotation by goniometer.
- Test requirement: The jaw must be smoothly opened and closed and free from jamming, the jaw and hub can be bent up, down, left, and right a range of above +/- 80° and are capable of 360° rotation.
- Results-Remarks: The jaw and hub are bent up, down, left and right within above 80° and can rotate 360°.
- Tensile strength: Hold the jaw and shaft connections respectively and apply a force of 20 N using Push pull gauge.
- Test requirement: The jaw and shaft connections shall not be damaged from pulling of 20 N.
- Results-Remarks: No damage to the connection when applying a force of 20N
- Feedthrough test: Electrical conduction between the electrode tip and the connector is tested using a DMM (digital multi meter).
- Test requirement: Electricity should be transmitted between the electrode tip and the connector.
- Results-Remarks: The resistance value between the electrode tip and the connector is less than 1Ω
Thermal effects on tissue were also tested. A histological analysis was performed on thermal effect to porcine tissues(liver, kidney and abdominal muscle) through an electrosurgical device.
Key Metrics
Not Found
Predicate Device(s)
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 26, 2023
LivsMed Inc. Dong Wook Lee QMR (Quality Management Representative) #304, D-dong, 700, Pangyo-ro, Bundang-gu Seongnam-si. Gyeonggi-do 13516 Korea, South
Re: K230499
Trade/Device Name: ArtiSential Laparoscopic Instruments-Electrodes, Bipolar series (four versions, ABF01series, ABD01 series, ABD02 series and ABD04 series)
Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: February 24, 2023 Received: February 24, 2023
Dear Dong 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.
1
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 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 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).
Sincerely.
Mark Trumbore, 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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Image /page/2/Picture/0 description: The image shows the logo for LIV'SMED. The logo is in a dark blue color, with the apostrophe in LIV'SMED being a lighter blue color. The font is sans-serif and the letters are all capitalized.
3. Indications for Use Statement
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K230499
Device Name
ArtiSential Laparoscopic Instruments-Electrodes, Bipolar series (four versions, ABF01 series, ABD02 series and ABD04 series)
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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4
510(k) Summary
1. General Information
| Applicant/Submitter: LivsMed Inc. | |
|---|---|
| Address: | #304, D-dong, 700, Pangyo-ro, Bundang-gu, 13516 |
| Seongnam-si, Gyeonggi-do, Republic of Korea | |
| Tel) +82-70-4282-7652 | |
| Fax) +82-31-706-3211 | |
| Contact Person: | Dong Wook Lee / QMR |
| (Quality Management Representative) | |
| Address: | #304, D-dong, 700, Pangyo-ro, Bundang-gu, 13516 |
| Seongnam-si, Gyeonggi-do, Republic of Korea | |
| Tel) +82-70-7709-4993 | |
| Fax) +82-31-706-3211 | |
| Email) dongwook.livsmed@gmail.com | |
| Preparation Date: | 02-24-2023 |
2. Device Name and Code
| Device Trade Name | ArtiSential Laparoscopic Instruments-Electrodes,
Bipolar Series (four versions, ABF01 series, ABD01
series, ABD02 series and ABD04 series) |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| 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(four versions, ABF01 series, ABD01 series, ABD02 series and ABD04 series) are substantially equivalent to the following devices
5
Table 3.1 Predicate device 1
| Applicant | Device Name | 510(k) Number |
|---|---|---|
| LivsMed Inc. | ArtiSential Bipolar | |
| Fenestrated Forceps | K200875 |
Table 3.2 Predicate device 2
| Applicant | Device Name | 510(k) Number |
|---|---|---|
| LivsMed Inc. | ArtiSential Bipolar | |
| Fenestrated Forceps | K220384 |
4. Device Description
The ArtiSential Laparoscopic Instruments – Electrodes, Bipolar series(four versions, ABF01 series, ABD01 series, ABD02 series and ABD04 series) are sterile, single-use, invasive instruments that used in laparoscopic surgery. There are four versions, ABF01 series, ABD01 series, ABD02 series and ABD04 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 for use
- 5.1 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
| Proposed device | Predicate Device 1 | Predicate Device 2 | |
|---|---|---|---|
| 510(K) | |||
| Number | In process | K200875 | K220384 |
| Manufacture | LivsMed, Inc. | LivsMed, Inc. | LivsMed, Inc. |
| Device Name | ArtiSential Laparoscopic | ||
| Instruments-Electrodes | ArtiSential Laparoscopic | ||
| Instruments-Electrodes | ArtiSential Laparoscopic | ||
| Instruments-Electrodes | |||
| Clearance Date | N/A | 05-21-2020 | 02-24-2022 |
| Classification / | |||
| Regulation | Class 2 / 878.4400 | Class 2 / 878.4400 | Class 2 / 878.4400 |
| Product Code | GEI | GEI | GEI |
| Intended for | Prescription Use | Prescription Use | Prescription Use |
| Indications for | |||
| Use | Electrosurgical | ||
| coagulation, dissection, | |||
| and grasping of tissue | |||
| during the performance | |||
| of laparoscopic and | |||
| general surgical | |||
| procedures. | Electrosurgical | ||
| coagulation, dissection, | |||
| and grasping of tissue | |||
| during the performance | |||
| of laparoscopic and | |||
| general surgical | |||
| procedures. | Electrosurgical | ||
| coagulation, dissection, | |||
| and grasping of tissue | |||
| during the performance | |||
| of laparoscopic and | |||
| general surgical | |||
| procedures. | |||
| Principles of | This product is a single- | This product is a single- | This product is a single- |
| operation | use instrument used in | use instrument used in | use instrument used in |
| electrosurgical units to | electrosurgical units to | electrosurgical units to | |
| hold soft tissues or | hold soft tissues or | hold soft tissues or | |
| coagulate and make an | coagulate and make an | coagulate and make an | |
| incision (tissue | incision (tissue | incision (tissue | |
| dissection) during | dissection) during | dissection) during | |
| general laparoscopic | general laparoscopic | general laparoscopic | |
| surgery, which uses the | surgery, which uses the | surgery, which uses the | |
| principle of applying | principle of applying | principle of applying | |
| high-frequency currents | high-frequency currents | high-frequency currents | |
| from the electrode to the | from the electrode to the | from the electrode to the | |
| human body to generate | human body to generate | human body to generate | |
| heat by bioimpedance | heat by bioimpedance | heat by bioimpedance | |
| when radio frequency | when radio frequency | when radio frequency | |
| (RF) energy from the | (RF) energy from the | (RF) energy from the | |
| electrosurgical unit | electrosurgical unit | electrosurgical unit | |
| applies an electric | applies an electric | applies an electric | |
| current to the electrode | current to the electrode | current to the electrode | |
| part, and using the | part, and using the | part, and using the | |
| generated heat to incise | generated heat to incise | generated heat to incise | |
| cellular tissues and cause | cellular tissues and cause | cellular tissues and cause | |
| coagulation. | coagulation. | coagulation. | |
| It is composed of a jaw, | It is composed of a jaw, | It is composed of a jaw, | |
| Φ8 diameter shaft, grip | Φ8 diameter shaft, grip | Φ8 diameter shaft, grip | |
| (including a control | (including a control | (including a control | |
| ring), and electrosurgical | ring), and electrosurgical | ring), and electrosurgical | |
| unit connection | unit connection | unit connection | |
| electrode connector. | electrode connector. | electrode connector. | |
| During a procedure with | During a procedure with | During a procedure with | |
| this product, the jaw | this product, the jaw | this product, the jaw | |
| opens if the control ring | opens if the control ring | opens if the control ring | |
| opens, and jaw closes if | opens, and jaw closes if | opens, and jaw closes if | |
| the control ring closes. | the control ring closes. | the control ring closes. | |
| In addition, the jaw is | In addition, the jaw is | In addition, the jaw is | |
| also bent up, down, left | also bent up, down, left | also bent up, down, left | |
| and right within a range | and right within a range | and right within a range | |
| of ±80° or more by | of ±80° or more by | of ±80° or more by | |
| moving the grip up, | moving the grip up, | moving the grip up, | |
| down, left and right, and | |||
| the jaw can also turn | down, left and right, and | ||
| the jaw can also turn | down, left and right, and | ||
| the jaw can also turn | |||
| 360° when rotating the | 360° when rotating the | 360° when rotating the | |
| grip. | grip. | grip. | |
| Energy Type | Radiofrequency | Radiofrequency | Radiofrequency |
| Electrode type | Bipolar | Bipolar | Bipolar |
| (monopolar or | |||
| bipolar) | |||
| Physical | - Shaft diameter: 8mm | - Shaft diameter: 8mm | - Shaft diameter: 8mm |
| dimensions | - Shaft Length: 250mm, | - Shaft Length: 250mm, | - Shaft Length: 250mm, |
| and design | 380mm, 450mm | 380mm, 450mm | 380mm, 450mm |
| (size, length) | |||
| Rated voltage | 200Vp | 200Vp | 200Vp |
| Materials | Stainless steel | Stainless steel | Stainless steel |
| (electrode) | |||
| Materials | |||
| (insulation) | Polyetherimide | Polyetherimide | Polyetherimide |
| Materials | |||
| (Shaft) | Glass fiber | Glass fiber | Glass fiber |
| Articulating | |||
| feature | Pitch:±80° or more, | ||
| Yaw:±80° or more and | |||
| Open-Close | 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° | 360° |
| Sterilization | EO | EO | EO |
Table 6.1 Predicate Device
6
7
7. Performance Data
7.1 Biocompatibility
The device has been evaluated for its biological safety according to ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1 : Evaluation and Testing Within a Risk Management Process". Following endpoints have been assessed during the evaluation:
- Cytotoxicity -
- -Intracutaneous reactivity
- -Skin Sensitization
- Acute systemic toxicity -
- -Pyrogenicity
7.2 Electrical Safety
The ArtiSential Laparoscopic Instruments-Electrodes, Bipolar Series(four versions, ABF01 series, ABD01 series, ABD02 series and ABD04 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:
The device had passed all performed tests.
7.3 Sterilization
ArtiSential Laparoscopic Instruments-Electrodes, Bipolar Series(four versions, ABF01 series. ABD01 series, ABD02 series and ABD04 series) are provided sterile, intended to be single-use. This product is EO-Sterilization in accordance with ISO-11135.
- 7.4 Shelf life
The proposed expiration date is 3 years from the manufacturing date. The real-time testing will be performed to confirm the shelf-life for 3 years
7.5 Performance test
The device had passed all performed tests.
8
| Test clause and specification | Test requirement | Results- Remarks |
|---|---|---|
| 1. Appearance | ||
| : Implement the visual | ||
| inspection for surface of the | ||
| device | There should be no defects in | |
| the appearance of the product | ||
| and there should be no | ||
| problem in use. | No crack, stain or no | |
| substances on the surface | ||
| of the product | ||
| 2. Dimension | ||
| : Measure by ruler and vernier | ||
| calipers | It shall be within $\pm$ 5% of the | |
| indicated value of the | ||
| dimensional term. | Pass | |
| Refer to [Test result] on | ||
| 9-50 page at attachment | ||
| 12 | ||
| 3. Operational test | ||
| : Manipulating the grip and | ||
| control ring, and measure the | ||
| angle at bending and rotation | ||
| by goniometer. | The jaw must be smoothly | |
| opened and closed and free | ||
| from jamming, the jaw and | ||
| hub can be bent up, down, | ||
| left, and right a range of | ||
| above $\pm$ 80° and are capable | ||
| of 360° rotation. | The jaw and hub are bent | |
| up, down, left and right | ||
| within above 80° and can | ||
| rotate 360°. | ||
| 4. Tensile strength | ||
| : Hold the jaw and shaft | ||
| connections respectively and | ||
| apply a force of 20 N using | ||
| Push pull gauge. | The jaw and shaft | |
| connections shall not be | ||
| damaged from pulling of 20 | ||
| N. | No damage to the | |
| connection when applying | ||
| a force of 20N | ||
| 5. Feedthrough test | ||
| : Electrical conduction | ||
| between the electrode tip and | ||
| the connector is tested using a | ||
| DMM (digital multi meter). | Electricity should be | |
| transmitted between the | ||
| electrode tip and the | ||
| connector. | The resistance value | |
| between the electrode tip | ||
| and the connector is less | ||
| than 1Ω |
7.6 Thermal effect
Thermal effects on tissue were also tested. A histological analysis was performed on thermal effect to porcine tissues(liver, kidney and abdominal muscle) through an electrosurgical device.
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(four versions, ABF01 series, ABD01 series, ABD02 series and ABD04 series) indication for use is same to the predicate device 1 (K200875) and predicate device 2 (K220384). 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
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(four versions, ABF01 series, ABD01 series, ABD02 series and ABD04 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.