Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the mechanical and optical components of a trocar and does not mention any AI or ML capabilities. The performance studies are bench and animal tests, not related to algorithmic performance.

Therapeutic

No
The device is a surgical instrument (trocar) used to establish a path of entry for other instruments; it does not directly treat or diagnose a disease or condition.

Diagnostic

No

The device description indicates it is used for providing a path of entry for endoscopic instruments and aids in the insertion of surgical instruments, which are functional aspects of surgery, not diagnostic. While an optical element provides "visibility of individual tissue layers during insertion", this is for guiding the trocar placement, not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a sterile, single-use instrument consisting of physical components like a main body, cannula, obturator, optical element, and funnel. This indicates it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, the ArtiSential Trocar is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the device is used in surgical procedures to establish a path of entry for endoscopic instruments. This is an in-vivo (within the body) application, not an in-vitro (outside the body) diagnostic test.
Device Description: The description details a surgical instrument used for accessing body cavities during minimally invasive procedures. It does not describe a device used to examine specimens like blood, urine, or tissue samples for diagnostic purposes.
Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples, detect markers, or provide diagnostic information based on laboratory testing.

Therefore, the ArtiSential Trocar is a surgical instrument, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

ArtiSential Trocar has an application in general, abdominal, thoracic, and gynecologic minimally invasive procedures to establish a path of entry for endoscopic instruments.

Product codes (comma separated list FDA assigned to the subject device)

GCJ

Device Description

ArtiSential Trocar is for use during endoscopic minimally invasive procedures or to gain access potential spaces for endoscopic instruments. This device is a sterile, single-use instruments consisting of a main body, cannula, obturator. An optical element, which when used with an endoscope, provides visibility of individual tissue layers during insertion. And a funnel serves as an instrument insertion guide and aids in the insertion of a passive multijoint surgical instrument into the cannula.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

general, abdominal, thoracic, and gynecologic

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 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
Pyrogenicity

Sterilization

ArtiSential Trocar is provided sterile, intended to be single-use. This product is EO-Sterilization in accordance with ISO-11135.

Shelf life

The proposed expiration date is 3 years from the manufacturing date. Following tests were conducted zero time point and 3 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/F88M-15)
- Dye penetration test (per ASTM F1929)
- Sterility test (per ISO 11737- 2)
Performance test 2)
- Appearance
- Dimension
- Leak test
- Tensile Strength

Performance test

Bench test

The testing was conducted side-by-side with the predicate device as following and had passed all performed tests.

Appearance
Dimension
Leak test
Tensile Strength
the ability to 1) maintain pneumoperitoneum (with and without instruments inserted) and 2) manipulate instruments for laparoscopic surgery.

Animal testing

The device was conducted side-by-side in vivo (micro pig, M-type) testing with the predicate device as following. The device had passed all performed tests.

Tissue insertion and retention forces
Intra-abdominal pressure
Obturator integrity after insertion

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 the same or similar 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.

K060096

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

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Summary

0

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December 3, 2021

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

Re: K212500

Trade/Device Name: ArtiSential Trocar Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: October 18, 2021 Received: October 19,2021

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/cdrh/cfdocs/cfpm/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 and Part 809); 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-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 (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

2

Indications for Use

510(k) Number (if known) K212500

Device Name ArtiSential Trocar

Indications for Use (Describe)

ArtiSential Trocar has an application in general, abdominal, thoracic, and gynecologic minimally invasive procedures to establish a path of entry for endoscopic instruments.

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

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:	11-19-2021

2. Device Name and Code

Device Trade Name	ArtiSential Trocar
Common Name	Sterile Trocars for Endoscopic surgery
Classification Name	Endoscope and accessories
Product Code	GCJ
Regulation Number	21 CFR 876.1500
Classification	Class II
Review Panel	General & Plastic Surgery

3. Predicate Devices

ArtiSential Trocar is the same or similar to the device in Table 3.1.

3.1 Subject Device Description
ArtiSential Trocar is for use during endoscopic minimally invasive procedures or to gain access potential spaces for endoscopic instruments. This device is a sterile, single-use instruments consisting of a main body, cannula, obturator. An optical element, which when used with an endoscope, provides visibility of individual tissue layers during insertion. And a funnel serves as an instrument insertion guide and aids in the insertion of a passive multijoint surgical instrument into the cannula.

4

The device falls within Section 876.1500 Endoscope and accessories and is a prescription use only.

Table 3.1 Predicate device

Applicant	Device Name	510(k) Number
Applied Medical Resources
Corp.	Modular Trocar System	K060096

4. Indications for Use

4.1 Indications for use
ArtiSential Trocar has an application in general, abdominal, thoracic, and gynecologic minimally invasive procedures to establish a path of entry for endoscopic instruments.

5. Technical Characteristics in Comparison to Predicate Devices

Table 5.1 Comparison of Proposed device and predicate device

| device device Equivalence
Assessment |--------------------------------------------------------------------------| | 510(K) Number | Manufacture Resources Corp. | Device Name | Clearance Date | N/A | Classification /
Regulation | Class 2 / 876.1500 | Product Code | GCJ | Intended for | Indications for
Use | ArtiSential application in general,
abdominal, thoracic, and
gynecologic minimally
invasive procedures to
establish a path of entry for
endoscopic instruments. Modular Trocar System
is a sterile single use
device, or may be used
with a reusable stainless
steel or reusable
DuraGold® cannula and
is intended for use in
conjunction with
Applied's currently
marketed trocar
products to establish a
path of entry for
endoscopic instruments
for use during general,
abdominal, | | | | invasive procedures or
to gain access through
tissue planes and/or
potential spaces for
endoscopic instruments.
If utilizing the Applied
Medical Optical
Separator Obturator
with the Modular Trocar
System it may be used
with or without
visualization for primary
and secondary
insertions. | Description use during endoscopic
minimally invasive
procedures or to gain
access potential spaces for
endoscopic instruments.
This device is a sterile,
single-use instruments
consisting of a main body,
cannula, obturator. An
optical element, which
when used with an
endoscope, provides
visibility of individual
tissue layers during
insertion.
And a funnel serves as an
instrument insertion guide
and aids in the insertion of
a passive multi-joint
surgical instrument into the
cannula. | The Modular Trocar
System is a sterile single
use device, intended for
use in conjunction with
Applied's currently
marketed Trocar products.
A standard trocar assembly
consists of an obturator, a
seal and a cannula system.
The Modular Trocar
System will be available
in sizes of 5mm, 8mm,
11mm, 12mm and
15mm diameter in
lengths ranging from
55mm to 150mm. description of
the proposed
ArtiSential
Trocar is as
same as the
predicate
devices except
for the function
of the funnel
part, which is an
optional feature
that the user
selects. Also,
given the
technological
characteristics
of the proposed
ArtiSential
Trocar are
identical to the
predicate
products.
Design
verification and
validation
testing of the
proposed Trocar
have provided
reasonable
assurance that
the proposed
ArtiSential
Trocar are
appropriate for
the proposed
indications for
use and can be
as safely and
effectively used |
| | devices. | Principles of
operation | This product single-use product
which is composed of
main body, cannula,
obturator that is
generally used in
invasive surgery to
create passageways for
surgery in the abdomen,
gynecology, chest,
access through tissues,
or to make space for
endoscopic instruments.
The obturator has an
optical element applied
to visualize the tissue
layer during insertion
into the body, and a
funnel serves as an
instrument insertion
guide and aids in the
insertion of a passive
multi-joint surgical
instrument into the
cannula. | This product consists of
a sleeve and an
obturator that are
generally used in
minimally invasive
surgery to create a
passageway for surgery
in the abdomen,
gynecology, chest,
access through tissue, or
to make space for
endoscopic instruments.
It is a sterile disposable
product.
The optical type uses a
separate obturator with
optical elements applied to
visualize the tissue layer
during insertion, and the
shielded bladed type
includes a blade. | Similar: The
operation
principle of the
proposed
ArtiSential
Trocar is as
same as the
predicate
devices except
for the function
of the funnel
part, which is an
optional feature
that the user
selects. Also,
given the
technological
characteristics
of the proposed
ArtiSential
Trocar are
identical to the
predicate
products.
Design
verification and
validation
testing of the
proposed Trocar
have provided
reasonable
assurance that
the proposed
ArtiSential
Trocar are
appropriate for
the proposed
indications for
use and can be
as safely and
effectively used
as predicate
devices. |
| Physical
dimensions and
design
(diameter, length
of Cannula) | -Diameter: 8mm
-Length: 100mm -Length: 100mm | Raw Materials | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Sterilization | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Proposed
| Predicate
| Substantial
|
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K212500 | K060096 | N/A |
| LivsMed, Inc. | Applied Medical
| N/A |
| ArtiSential Trocar | Modular Trocar System | N/A |
| 01-24-2006 | N/A |
| Class 2 / 876.1500 | Same |
| GCJ | Same |
| Prescription Use | Prescription Use | Same |
Trocar has an
| The Applied Medical
| Same |
| | |
| thoracic minimally
| |
| ArtiSential Trocar is for
| Similar: The
| | as predicate
|
is a sterile,
| -Diameter: 8mm
| Same |
| | Similar |
| -Cannula: Polycarbonate (PC) | -Cannula: Copolyester | : Raw materials |
| -Obturator: Polycarbonate (PC) | -Obturator: Polycarbonate (PC) | of the proposed |
| | ArtiSential |
| | Trocar are same |
| | as the predicate |
| | device(K060096 |
| | ), except |
| | Copolyester of |
| | the predicate |
| | device's raw |
| | material. All |
| | patient |
| | contacting |
| | materials of |
| | proposed |
| | ArtiSential |
| | Trocar have |
| | been tested per |
| | the same |
| | standards of |
| | ISO 10993-1. |
| | Given the |
| | favorable |
| | biocompatibility |
| | test results, the |
| | difference |
| | between raw |
| | material of |
| | proposed device |
| | and predicate |
| | device does not |
| | raise different |
| | questions in |
| | safety and |
| | effectiveness |
| EO Sterilization | Radiation | Although it is |
| | different from |
| | the sterilization |
| | method of the |
| | predicate |
| | device, the |
| | effectiveness of |
| | our sterilization |
| | method was |
| | verified through |
| | the sterilization |
| | validation test |
| | and the |
| | accelerated |
| | aging test |

5

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6

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8

6. Performance Data

6.1 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 -
Pyrogenicity -

6.2 Sterilization

ArtiSential Trocar is provided sterile, intended to be single-use. This product is EO-Sterilization in accordance with ISO-11135.

6.3 Shelf life

The proposed expiration date is 3 years from the manufacturing date. Following tests were conducted zero time point and 3 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/F88M-15)
Dye penetration test (per ASTM F1929)
. Sterility test (per ISO 11737- 2)
Performance test 2)
Appearance
. Dimension
Leak test .
Tensile Strength

6.4 Performance test

6.4.1 Bench test

9

The testing was conducted side-by-side with the predicate device as following and had passed all performed tests.

Appearance
. Dimension
Leak test .
. Tensile Strength
. the ability to 1) maintain pneumoperitoneum (with and without instruments inserted) and 2) manipulate instruments for laparoscopic surgery.

6.4.2 Animal testing

The device was conducted side-by-side in vivo (micro pig, M-type) testing with the predicate device as following. The device had passed all performed tests.

. Tissue insertion and retention forces
. Intra-abdominal pressure
. Obturator integrity after insertion

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 the same or similar performance characteristics to the predicate device.

7. Conclusions

Overall, the comparison carried out covers physical dimension, design, performance and the entire indication for use of the device under evaluation. The subject device which is the ArtiSential Trocar is 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 devices has demonstrated that the subject device is as safe, as effective, and performs as well as the legally marketed predicate device for the requested intended use.

In conclusion, no different questions in safety and effectiveness assessment are being raised compared to the predicate device.