(101 days)
No
The document describes a standard laparoscopic instrument with electrodes for cutting and coagulation. There is no mention of AI, ML, image processing, or any data-driven decision-making capabilities. The performance studies focus on physical and thermal properties, not algorithmic performance.
No
This device is an instrument used to perform cutting and coagulation during surgery, which is a surgical tool, not a therapeutic device.
No
This device is described as an invasive instrument used for cutting and coagulation in surgical procedures, indicating a therapeutic function rather than a diagnostic one.
No
The device description explicitly states it is a "sterile, single-use, invasive instrument" and mentions physical performance tests like "Tensile strength" and "Feedthrough test," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "cutting and coagulation in endoscopic, gynecological, and general abdominal and thoracic and general laparoscopic procedures." This describes a surgical instrument used in vivo (within the body) during a medical procedure.
- Device Description: The description further clarifies it is a "sterile, single-use, invasive instrument that used in laparoscopic surgery." This reinforces its use as a surgical tool.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided description does not mention any testing of samples or analysis of biological materials.
Therefore, the ArtiSential Laparoscopic Instruments-Electrodes, Monopolar Series are surgical instruments, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
ArtiSential Laparoscopic Instruments-Electrodes, Monopolar Series are indicated for cutting and coagulation in endoscopic, gynecological, and general abdominal and thoracic and general laparoscopic procedures.
Product codes
GEI
Device Description
This product is sterile, single-use, invasive instrument that used in laparoscopic surgery. There are two Version, one for Hook and Spatula. The two models are same except for jaw. 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
abdominal and thoracic
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)
Biocompatibility: The device was evaluated for biological safety according to ISO 10993-1. Assessed endpoints included Cytotoxicity, Intracutaneous reactivity, Skin Sensitization, Acute systemic toxicity, and Pyrogenicity.
Electrical Safety: The device was tested according to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-18 and IEC 60601-2-2. Tests included Active accessory insulation, Active accessory hf leakage, Active accessory hf dielectric strength, Active accessory mains frequency dielectric strength, and Feedthrough test. All performed tests were passed.
Sterilization: The device is provided sterile, intended for single-use, and is EO-Sterilized in accordance with ISO-11135.
Shelf life: The proposed expiration date is 3 years from the manufacturing date. Real-time testing will be performed to confirm the 3-year shelf-life.
Performance test:
- Appearance: Visual observation; Result: No crack, stain or no substances on the surface of the product.
- Dimension: Measured by Vernier calipers and dial gauge; Result: Passed, within ± 5% of the indicated value.
- Operational test: Adjusted end-tip by manipulating grip and control ring, measured angle at bending and turning; Result: End-tip and hub bent up, down, left and right within above 80° and rotated 360°.
- Tensile strength: Held end-tip and shaft connections, applied 20 N force using Push pull gauge; Result: No damage to the connection when applying a force of 20N.
- Feedthrough test: Electrical conduction between electrode tip and connector tested using a DMM; Result: Resistance value between the electrode tip and the connector is less than 1Ω.
The device passed all performed tests. Thermal effects on tissue were also tested.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
June 5, 2023
LivsMed Inc. Dong Lee OMR (Ouality Management Representative) #304, D-dong, 700, Pangyo-ro, Bundang-gu Seongnam-si, Gyeonggi-do 13516 Korea. South
Re: K230498
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 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.
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
1
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 (OS) 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
Digitally signed by
Mark Trumbore -S
Trumbore -S Date: 2023.06.05
11:54:14 -04'00'
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
2
Indications for use Statement
3. Indications for Use Statement
A FDA Form 3881 is provided on the following pages.
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K230498
Device Name
ArtiSential Laparoscopic Instruments-Electrodes
Indications for Use (Describe)
ArtiSential Laparoscopic Instruments-Electrodes, Monopolar Series 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 ) | X Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
4
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 |
|---|---|
| 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, Monopolar Series are substantially equivalent to the following devices
Table 3.1 Predicate device
| Applicant | Device Name | 510(k) Number |
|---|---|---|
| LivsMed Inc. | ArtiSential Laparoscopic | |
| Instrument-Electrodes | K200501 |
5
4. Device Description
This product is sterile, single-use, invasive instrument that used in laparoscopic surgery. There are two Version, one for Hook and Spatula. The two models are same except for jaw. 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
ArtiSential Laparoscopic Instruments-Electrodes, Monopolar Series are indicated for cutting and coagulation in endoscopic, gynecological, and general abdominal and thoracic and general laparoscopic procedures.
6. Technical Characteristics in Comparison to Predicate Devices
Table 6.1 Predicate Device
| | Proposed
device | Predicate
device |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) Number | K230498 | K200501 |
| Manufacture | LivsMed, Inc. | LivsMed, Inc. |
| Device Name | ArtiSential Laparoscopic
Instruments-Electrodes | ArtiSential Laparoscopic
Instruments-Electrodes |
| Clearance Date | N/A | 11-05-2020 |
| Classification /
Regulation | Class 2 / 878.4400 | Class 2 / 878.4400 |
| Product Code | GEI | GEI |
| Intended for
Use | Prescription Use | Prescription Use |
| Indications for
Use | ArtiSential Laparoscopic
Instruments-Electrodes,
Monopolar Series are indicated
for cutting and coagulation in
endoscopic, gynecological, and
general abdominal and thoracic
and general laparoscopic
procedures. | ArtiSential Laparoscopic
Instruments-Electrodes,
Monopolar Series are indicated
for cutting and coagulation in
endoscopic, gynecological, and
general abdominal and thoracic
and general laparoscopic
procedures. |
| 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 (hook
or spatula type), Ф8 diameter
shaft, grip part, and
electrosurgical unit connection
electrode plug. | 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 (hook
or spatula type), Ф8 diameter
shaft, grip part, and
electrosurgical unit connection
electrode plug. |
6
| | During a procedure with this
product, the end-tip is bent up,
down, left and right within a
range of ±80° or more by
moving the grip up, down, left
and right, and the end-tip can | During a procedure with this
product, the end-tip is bent up,
down, left and right within a
range of ±80° or more by
moving the grip up, down, left
and right, and the end-tip can |
|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | also turn 360° when rotating the
grip. | also turn 360° when rotating the
grip. |
| Energy Type | Radiofrequency | Radiofrequency |
| Electrode type
(monopolar or
bipolar) | Monopolar | Monopolar |
| End-tip type | Hook, Spatula | Hook, Spatula |
| Physical
dimensions and
design (size,
length) | - Shaft diameter: 8mm
-
Shaft Length: 250mm, 380mm,
450mm | - Shaft diameter: 8mm -
Shaft Length: 250mm, 380mm,
450mm |
| Rated voltage | 3,933Vp | 3,933Vp |
| Materials
(electrode) | Stainless steel | Stainless steel |
| Materials
(insulation) | Zirconia / Teflon | Polyetherimide / Zirconia |
| Materials (Shaft) | 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 |
| Sterilization | EO | EO |
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, Monopolar 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 -
- Feedthrough test -
The device had passed all performed tests.
7.3 Sterilization
ArtiSential Laparoscopic Instruments-Electrodes, Monopolar 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
8
7.5 Performance test
| Test clause and Test requirement | Test specification | Results- Remarks |
|---|---|---|
| 1. Appearance | ||
| There should be no defects in the | ||
| appearance of the product and | ||
| there should be no problem in use. | Visual observation | No crack, stain or no |
| substances on the surface | ||
| of the product | ||
| 2. Dimension | ||
| It shall be within ± 5% of the | ||
| indicated value of the dimensional | ||
| term. | Measure by Vernier | |
| calipers and dial gauge | ||
| etc. | Pass | |
| Refer to [Test result] on | ||
| 8-37 page at attachment | ||
| #11 | ||
| 3. Operational test | ||
| The end-tip and hub can be bent | ||
| up, down, left, and right a range of | ||
| above ±80° and are capable of | ||
| 360° rotation. | Adjusting the end-tip by | |
| manipulating the grip | ||
| and control ring and | ||
| measure the angle at | ||
| bending and turning. | The end-tip and hub are | |
| bent up, down, left and | ||
| right within above 80° | ||
| and can rotate 360°. | ||
| 4. Tensile strength | ||
| The end-tip and shaft connections | ||
| shall not be damaged from pulling | ||
| of 20 N. | Hold the end-tip and | |
| shaft connections | ||
| respectively and apply a | ||
| force of 20 N using Push | ||
| pull gauge. | No damage to the | |
| connection when applying | ||
| a force of 20N | ||
| 5. Feedthrough test | ||
| Electricity should be transmitted | ||
| between the electrode tip and the | ||
| connector. | Electrical conduction | |
| between the electrode | ||
| tip and the connector is | ||
| tested using a DMM | ||
| (digital multi meter). | The resistance value | |
| between the electrode tip | ||
| and the connector is less | ||
| than 1Ω |
The device had passed all performed tests.
Thermal effects on tissue were also tested. Please refer to attachment 16. 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, Monopolar Series indication for use is same to the predicate device (K200501). The energy type, electrode type, sterilization as well as similar physical characteristics are the same. Although there are some minor differences with each product, these differences between the ArtiSential Monopolar 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, Monopolar Series are considerably similar to the predicate and reference devices in principles of operation, technological characteristics, as
9
well as performance characteristics. The testing was conducted to evaluate the performance of subject device in comparison to the predicate and reference devices. 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.