Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard laparoscopic instrument and does not mention any AI or ML capabilities.

Therapeutic

Yes.
The device is used for cutting and coagulation in surgical procedures, which are therapeutic interventions.

Diagnostic

No

The device is indicated for cutting and coagulation in surgical procedures, not for diagnosis. It is a tool for intervention, not for identifying a condition or disease.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "sterile, single-use, invasive instrument" and a "specific component" used in laparoscopic surgery, indicating it is a physical hardware device, not software.

IVD (In Vitro Diagnostic)

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's a "sterile, single-use, invasive instrument that used in laparoscopic surgery." This reinforces its use as a surgical tool.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.

IVD devices are specifically designed to perform tests on samples taken from the human body to aid in diagnosis, monitoring, or screening. This device's function is to perform a surgical action directly on tissue within the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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 (comma separated list FDA assigned to the subject device)

GEI

Device Description

This product is sterile, single-use, invasive instrument that used in laparoscopic surgery. There are two Version, one for Dissector and Scissors. 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, thoracic (for general laparoscopic procedures), endoscopic, gynecological

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Prescription Use

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 was evaluated for:

Biocompatibility: According to ISO 10993-1. Endpoints assessed included Cytotoxicity, Sensitization, Intracutaneous reactivity, and Acute systemic toxicity.
Electrical Safety: Tested according to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-18 and IEC 60601-2-2. The device passed all performed tests.
Sterilization: Provided sterile, single-use, EO-Sterilization in accordance with ISO-11135.
Shelf life: Proposed expiration date is 2 years from manufacturing date. Tests conducted at zero time point and 2 years accelerated aging point.
- Packaging and sterility test: Packaging integrity test, Sealing strength test of packaging (per ASTM F 88), Dye penetration test (per ASTM F1929-15), Sterility test (per ISO 11737- 2:2009).
- Performance test: Appearance, Dimension, Operational test, Tensile Strength, Feedthrough test.
Performance test: Appearance, Dimension, Operational test, Tensile Strength, Feedthrough test.
Thermal effect: Testing conducted on liver, kidney, abdominal muscle at three different power settings (10, 40, and 300W).

Key Results: "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 device."

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.

K200501

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.

K201063

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

Regulation Number and Section

§ 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.

Summary

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April 30, 2021

LivsMed Inc. Dong Wook Lee QMR (Quality Management Representative) #304, D-dong, 700, Pangyo-ro, Bundang-gu 13516 Seongnam-si, Gyeonggi-do Republic of Korea

Re: K203580

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: March 5, 2021 Received: March 8, 2021

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/cdth/cfdocs/cfpmn/pmn.cfm identifies cocombination 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.

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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 (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-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). you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-DICE website the assistance/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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Indications for Use

510(k) Number (if known) K203580

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)

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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:	01-27-2021

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 Device and Reference Device

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
Instruments-Electrodes	K200501

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Table 3.2 Reference Device

Applicant	Device Name	510(k) Number
DANNIK	DANNIK Disposable
Monopolar Laparoscopic
Instruments	K201063

4. Device Description

This product is sterile, single-use, invasive instrument that used in laparoscopic surgery. There are two Version, one for Dissector and Scissors. 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

5.1 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 Device and Reference Device

Table 6.1 Substantial Equivalence Assessment of Proposed device and predicate device and reference device

| | Proposed
device | Predicate
Device | Reference
device | Substantial
Equivalence |
|--------------------------------|-----------------------------------------------------------|-----------------------------------------------------------|------------------------------------------------------------------|----------------------------|
| 510(K) Number | K203580 | K200501 | K201063 | N/A |
| Manufacture | LivsMed Inc. | LivsMed Inc. | DANNIK | N/A |
| Device Name | ArtiSential
Laparoscopic
Instruments-
Electrodes | ArtiSential
Laparoscopic
Instruments-
Electrodes | DANNIK
Disposable
Monopolar
Laparoscopic
Instruments | N/A |
| Clearance Date | N/A | 05-11-2020 | 06-09-2020 | N/A |
| Classification /
Regulation | Class 2 /
878.4400 | Class 2 /
878.4400 | Class 2 /
878.4400 | N/A |
| Product Code | GEI | GEI | GEI | Same |
| Intended for | Prescription
Use | Prescription
Use | Prescription
Use | Same |

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| Indications for Use | ArtiSential
Laparoscopic
Instruments-
Electrodes,
Monopolar
Series have
application in
endoscopic,
gynecological,
and general
abdominal and
thoracic and
general
laparoscopic
procedures.
When
connected by a
standard cable
to an
electrosurgical
power source,
the device may
be utilized for
monopolar
cautery. | ArtiSential
Laparoscopic
Instruments-
Electrodes,
Monopolar
Series have
application in
endoscopic,
gynecological,
and general
abdominal and
thoracic and
general
laparoscopic
procedures.
When
connected by a
standard cable
to an
electrosurgical
power source,
the device may
be utilized for
monopolar
cautery. | The DANNIK
Disposable
Monopolar
Laparoscopic
Instrument
have
application in a
variety of
minimally
invasive
procedures to
facilitate
grasping,
mobilization,
dissection and
transection of
tissue. | Same |
|--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Energy Type | Radiofrequency | Radiofrequency | Radiofrequency | Same |
| Electrode type
(monopolar or
bipolar) | Monopolar | Monopolar | Monopolar | Same |
| Jaw type | Dissector,
Scissors | Hook, Spatula | Dissector,
Scissors | Same |
| Physical
dimensions and
design (size,
length) | - Shaft
diameter: 8mm

Shaft Length:
250mm,
380mm,
450mm | - Shaft
diameter: 8mm
Shaft Length:
250mm,
380mm,
450mm | - Shaft
diameter: 3mm,
5mm
Shaft Length:
330mm | Same |
| Sterilization | EO | EO | EO | Same |

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 =
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Image /page/6/Picture/1 description: The image shows the logo for LIV'SMED. The logo is in a dark blue color. The apostrophe in the logo is a lighter blue color.

Sensitization =
் Intracutaneous reactivity
Acute systemic toxicity -

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 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 2 years from the manufacturing date. Following tests were conducted both zero time point and 2 years accelerated aging point and the device had passed all tests as below.

1. Packaging and sterility test
. Packaging integrity test
. Sealing strength test of packaging (per ASTM F 88)
. Dye penetration test (per ASTM F1929-15)
. Sterility test (per ISO 11737- 2:2009)
1. Performance test
. Appearance
Dimension .
. Operational test
. Tensile Strength
. Feedthrough test

7.5 Performance test

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The device had passed all performed tests as below.

. Appearance
. Dimension
Operational test .
Tensile Strength .
Feedthrough test .

7.6 Thermal effect

Thermal effects testing was conducted on liver, kidney, abdominal muscle at three different power settings (10, 40, and 300W).

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 device.

8. Substantial Equivalence

Indication for use, principles of operation, energy type, electrode type, jaw type, physical dimension, rated voltage, materials (electrode, shaft), articulating feature, tip rotation, sterilization method of the proposed ArtiSential Laparoscopic Instruments-Electrodes, Monopolar Series are as same as the predicate device. Although there is a minor difference of raw material (insulation) between the ArtiSential Monopolar Series and the predicate device, the difference does 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 as same as 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 device has demonstrated substantial equivalence of the subject device to the predicate in terms of safety and effectiveness for requested intended use.