(14 days)
Not Found
No
The summary describes a standard electrosurgical instrument and does not mention any AI or ML capabilities, image processing, or data-driven performance metrics.
No.
The device is described as surgical instrumentation for electrosurgical cutting and coagulation, which are procedures, not therapeutic effects in themselves. Its function is to facilitate surgery, not directly treat a disease or condition.
No
The device description and indications for use clearly state its function is for electrosurgical coagulation, dissection, and grasping of tissue during surgical procedures, not for identifying the presence, nature, or absence of a disease or condition.
No
The device description explicitly states it is a sterile, single-use, invasive instrument used in laparoscopic surgery, describing physical components like jaw shape and undergoing physical performance tests (tensile strength, grasping force, etc.). This indicates a hardware device, not software only.
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 tissue, not a device used to examine samples (like blood, urine, or tissue) outside the body to diagnose a condition.
- Device Description: The description clearly states it's a "sterile, single-use, invasive instrument that used in laparoscopic surgery." This further reinforces its role as a surgical instrument used within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information based on in vitro analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely surgical manipulation of tissue.
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 (comma separated list FDA assigned to the subject device)
GEI
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.
February 24, 2022
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: K220384
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: February 8, 2022 Received: February 10, 2022
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 statutes and
1
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 (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-devices/medical-device-safety/medical-device-reporting-mdr-howreport-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) 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-devices/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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K220384
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)
X Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Special 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: | 08-02-2022 |
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 Laparoscopic Instruments - | |
| Electrodes | K200875 |
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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 | Equivalence | |
|---|---|---|---|
| 510(K) | |||
| Number | K220384 | K200875 | N/A |
| Manufacture | LivsMed, Inc. | LivsMed, Inc. | Same |
| Device Name | ArtiSential Laparoscopic | ||
| Instruments-Electrodes | ArtiSential Laparoscopic | ||
| Instruments-Electrodes | Same | ||
| Clearance | |||
| Date | N/A | 06-17-2020 | N/A |
| Classification | |||
| / Regulation | Class 2 / 878.4400 | Class 2 / 878.4400 | Same |
| Product Code | GEI | GEI | Same |
| Intended for | Prescription Use | Prescription Use | Same |
| 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. | Same | ||
| Principles of | |||
| operation | This product is a single-use | ||
| instrument used in | |||
| electrosurgical units to hold | |||
| soft tissues or coagulate | |||
| and make an incision | |||
| (tissue dissection) during | |||
| general laparoscopic | |||
| surgery, which uses the | |||
| principle of applying high- | |||
| frequency currents from the | This product is a single- | ||
| use instrument used in | |||
| electrosurgical units to | |||
| hold soft tissues or | |||
| coagulate and make an | |||
| incision (tissue dissection) | |||
| during general | |||
| laparoscopic surgery, | |||
| which uses the principle of | |||
| applying high-frequency | Same |
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| Energy Type | 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 jaw, Φ8
diameter shaft, grip
(including a control ring),
and electrosurgical unit
connection electrode
connector.
During a procedure with
this product, the jaw opens
if the control ring opens,
and jaw closes if the
control ring closes. 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 right,
and the jaw can also turn
360° when rotating the
grip. | 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 jaw, Φ8 diameter shaft, grip
(including a control ring),
and electrosurgical unit
connection electrode
connector.
During a procedure with
this product, the jaw opens
if the control ring opens,
and jaw closes if the
control ring closes. 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
right, and the jaw can also
turn 360° when rotating
the grip. | | | | | |
|--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|--|-----------------------------------------------------------|------|--|
| Electrode
type
(monopolar
or bipolar) | Radiofrequency
Bipolar | Radiofrequency
Bipolar | Same | | | | |
| Control ring
type | Standard, Adjustable (Type
A, B) | Standard, Adjustable
(Type A) | Equivalent | | | | |
| Physical
dimensions
and design
(size, length) | - Shaft diameter: 8mm
-
Shaft Length: 250mm,
380mm, 450mm | - Shaft diameter: 8mm -
Shaft Length: 250mm,
380mm, 450mm | Same | | | | |
| Rated
voltage | 200Vp | 200Vp | Same | | | | |
| Materials
(electrode) | Stainless steel | Stainless steel | Same | | | | |
| Materials
(insulation) | Polyetherimide | Polyetherimide | Same | | | | |
| Materials
(Shaft) | Glass fiber | Glass fiber | Same | | | | |
| Articulating
feature | | Pitch:±80° or more,
Yaw:±80° or more and
Open Close | Open-Close | | Pitch:±80° or more,
Yaw:±80° or more and
Open Close | Same | |
| Tip rotation | 360° | 360° | Same | | | | |
| Sterilization | EO | EO | Same | | | | |
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The difference between the Predicate device and the Proposed device is the type of control ring. The difference between adjustable control ring type A and B is the position of the control ring. The raw materials of the control ring type A and B are the same and are biologically equivalent because they are non-contact part of the human body. In addition, comparative performance tests between A type and B type models were conducted, and there are no new technology and no difference that would raise new or different questions of safety or efficacy.
7. Performance Data
- 7.1 Biocompatibility
The characteristics associated with biocompatibility are the same as in the predicate device K200875.
7.2 Electrical Safety
The ArtiSential Laparoscopic Instruments-Electrodes, Bipolar Series(Predicate device; K200875) have been tested according to IEC 60601-1-2, 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 -
- -Feedthrough test
The characteristics associated with electrical safety are the same as in the predicate device K200875.
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 K200875.
- 7.4 Shelf life
The proposed expiration date is 2 years from the manufacturing date. These characteristics are same with the predicate device K200875.
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
7
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 (K200875). 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.