Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and performance studies do not mention any AI/ML capabilities.

Therapeutic

Yes
The device is described as an "invasive instrument that used in laparoscopic surgery" for "cutting and coagulation," indicating it performs a therapeutic function (i.e., treating or alleviating a disease or condition).

Diagnostic

No
The device is described as an instrument for cutting and coagulation in surgical procedures, which are therapeutic actions, not diagnostic ones.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "sterile, single-use, invasive instrument" and mentions physical components like "jaw" and "hook and spatula," indicating it is a hardware device used in surgery.

IVD (In Vitro Diagnostic)

No, 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 on the body during a procedure, not a device used to test samples from the body in a lab setting.
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 tool.
Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening

The information provided describes a surgical instrument used in electrosurgery, which falls under the category of medical devices used for treatment and intervention, not in vitro diagnostics.

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 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: Tested according to ISO 10993-1. Endpoints assessed: Cytotoxicity, Sensitization, Intracutaneous reactivity, 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. Test setup included Active accessory insulation, Active accessory hf leakage, Active accessory hf dielectric strength, Active accessory mains frequency dielectric strength, Feedthrough test. Passed all tests.
Sterilization: EO-Sterilization in accordance with ISO-11135.
Shelf life: Proposed expiration date is 2 years from manufacturing date. Real-time testing will be performed to confirm 3-year shelf-life.
Performance test: Passed all performed tests including Appearance, Dimension, Operational test, Tensile strength, Feedthrough test. Thermal effects were performed within 3 pigs on Liver, kidney and abdominal muscle tissues. Results demonstrated the subject device can perform the intended use safely and effectively.

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.

K091869

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.

K190909, K142868

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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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: 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 and the words "U.S. FOOD & DRUG ADMINISTRATION".

May 11, 2020

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

Re: K200501

Trade/Device Name: ArtiSential Laparoscopic Instrument-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 16, 2020 Received: March 17, 2020

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.

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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 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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200501

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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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:	02-18-2020

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, Monopolar Series are substantially equivalent to the following devices

Table 3.1 Predicate device

Applicant	Device Name	510(k) Number
Covidien LP	SILSTM L-Hook	K091869

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Table 3.2 Reference device

Applicant	Device Name	510(k) Number
Livsmed Inc.	ArtiSential Bipolar Fenestrated
Forceps	K190909
Purple Surgical
International Limited	Laparoscopic Electrodes &
Monopolar cables	K142868

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

	Proposed device	Predicate device	Equivalence
510(K) Number	In process	K091869	N/A
Manufacture	LivsMed, Inc.	Covidien LP	N/A
Device Name	ArtiSential Laparoscopic
Instruments-Electrodes	SILSTML-Hook	N/A
Clearance Date	N/A	09-01-2009	N/A
Classification /
Regulation	Class 2 / 878.4400	Class 2 / 876.1500	Equivalent
Product Code	GEI	GCJ	Equivalent
Intended for	Prescription Use	Prescription Use	Same
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.	The SILSTM L-Hook*
single use articulating
hook with monopolar
cautery has application in
endoscopic,
gynecological, and
general abdominal and
thoracic laparoscopic
procedures. When
connected by a standard
cable to an electrosurgical
power source, the device
may be utilized for
monopolar cautery.	Equivalent
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),
∅8 diameter shaft, grip
part, and electrosurgical
unit connection electrode
plug.
During a procedure with
this product, the end-tip is
bent up, down, left and
right within a range of
$\pm$ 80° or more by moving
the grip up, down, left
and right, and the end-tip
can also turn 360° when
rotating the grip.	SILS Hand instrument
contains a pistol grip, a
rigid shaft with an
articulating and rotating
end effector, and
opposing jaws or an
electrocautery hook at the
distal end.
The SILS Hook single use
articulating hook with
monopolar cautery has
application in endoscopic,
gynecological, and
general
abdominal and thoracic
laparoscopic
procedures. When
connected by a standard
cable to an electrosurgical
power source, the
device may be utilized for
monopolar cautery.
The hook administer
electrocautery. The end
effector of the instrument
articulates when the
handle is deflected
relative to the shaft and
rotates when a rotation
wheel is turned.	N/A
Energy Type	Radiofrequency	Radiofrequency	Same
Electrode type
(monopolar or
bipolar)	Monopolar	Monopolar	Same
End-tip type	Hook, Spatula	Hook	Same
Physical
dimensions and
design (size,
length)	- Shaft diameter: 8mm

Shaft Length: 250mm,
380mm, 450mm | - Shaft diameter: 5mm
Shaft Length: 360mm,
460mm | Different
(Shaft diameter of the
proposed device is
the same as reference
predicated device
(K190909).
The risk analysis for
shaft diameter and
length has been
completed) |
| Rated voltage | 3,933Vp | Not found | N/A |
| Materials
(electrode) | Stainless steel | Not found | N/A |
| Materials
(insulation) | Polyetherimide / Zirconia | Not found | N/A |
| Materials (Shaft) | Glass fiber | Not found | N/A |
| Articulating
feature | Pitch: $\pm$ 80° or more,
Yaw: $\pm$ 80° or more and
Open-Close | Pitch: $\pm$ 80°
Yaw: $\pm$ 80 | Same |
| Sterilization | EO | EO | Same |

Table 6.1 Predicate Device

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6

Table 6.2 Reference Predicate Device

| | Proposed device | Reference
Predicate Device
1 | Reference
Predicate Device
2 | Equivalence |
|------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K)
Number | In process | K190909 | K142868 | N/A |
| Manufacture | LivsMed, Inc. | LivsMed, Inc. | Purple Surgical
International
Limited | N/A |
| Device Name | ArtiSential
Laparoscopic
Instruments-
Electrodes | ArtiSential
Bipolar
Fenestrated
Forceps | Laparoscopic
Electrodes &
Monopolar cables | N/A |
| Clearance
Date | N/A | 02-13-2020 | 11-21-2014 | N/A |
| Classification
/ Regulation | Class 2 / 878.4400 | Class 2 / 878.4400 | Class 2 / 878.4400 | Equivalent |
| Product Code | GEI | GEI | GEI | Equivalent |
| Intended for | Prescription Use | Prescription Use | Prescription Use | Same |
| 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. | Electrosurgical
coagulation,
dissection, and
grasping of tissue
during the
performance of
laparoscopic and
general surgical
procedures. | use in general
laparoscopic
surgery requiring
the use of
monopolar
electrosurgical
cutting and/or
coagulation | Equivalent |
| 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 | 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 electrode
to the human body
to generate heat by | Not found | N/A |
| Energy Type
Electrode type
(monopolar or
bipolar) | | | | |
| | tissues and cause
coagulation.
It is composed of a
end-tip (hook or
spatula type), Φ8
diameter shaft,
grip part, and | bioimpedance
when radio
frequency (RF)
energy from the
electrosurgical
unit applies an
electric current to | | |
| | electrosurgical
unit connection
electrode plug.
During a
procedure with
this product, the
end-tip is bent up,
down, left and | the electrode part,
and using the
generated heat to
incise cellular
tissues and cause
coagulation.
It is composed of a
jaw, Φ8 diameter | | |
| | 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 | shaft, grip
(including a
control ring), and
electrosurgical
unit connection
electrode
connector.
During a
procedure with | | |
| | grip. | 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. | | |
| Radiofrequency
Monopolar | Radiofrequency
Bipolar | Radiofrequency
Monopolar | Same
N/A | |
| Physical
dimensions
and design
(size, length) | - Shaft diameter:
8mm

Shaft Length:
250mm, 380mm,
450mm | - Shaft diameter:
8mm
Shaft Length:
380mm | - Shaft diameter:
5mm
Shaft Length:
330mm | Different
(Shaft diameter of
the proposed
device is the same
as reference
predicated device
(K190909).
The risk analysis
for shaft diameter
and length has
been completed) |
| Rated voltage | 3,933Vp | 200Vp | Not found | N/A |
| Materials (electrode) | Stainless steel | Stainless steel | Not found | Equivalent |
| Materials (insulation) | Polyetherimide /
Zirconia | Polyetherimide | Not found | Equivalent |
| Materials (Shaft) | Glass fiber | Glass fiber | Not found | Equivalent |
| Articulating feature | Pitch:±80° or
more,
Yaw:±80° or more
and Open-Close | Pitch:±80° or
more,
Yaw:±80° or more
and
Open-Close | N/A | Equivalent |
| Tip rotation | 360° | 360° | Not found | Equivalent |
| Sterilization | EO | EO | Radiation | Equivalent |

7

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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 -
-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 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.

9

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. 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 (Appearance, Dimension, Operational test, Tensile strength, Feedthrough test). Thermal effects were also performed, as recommended by the FDA guidance, Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery, within 3 pigs on Liver, kidney and abdominal muscle tissues. Results demonstrated the subject device can perform the intended use safely and effectively.

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 similar to the predicate device (K091869). 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 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.